Important Safety Information

IMPORTANT WARNING:

For people taking bupropion (Wellbutrin) for depression:

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as bupropion during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. This risk should be considered and compared with the potential benefit in the treatment of depression, in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take bupropion, but in some cases, a doctor may decide that bupropion is the best medication to treat a child's condition. No matter what your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal, especially at the beginning of your treatment or any time that your dose is increased or decreased. This risk is higher if you or anyone in your family has or has ever had bipolar disorder or mania or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

You should know that your mental health may change in unexpected ways when you take bupropion or other antidepressants even if you are an adult over age 24 or if you do not have a mental illness and you are taking bupropion to treat a different type of condition. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

For all patients taking bupropion:

Your health care provider will want to see you often while you are taking bupropion, especially at the beginning of your treatment. Be sure to keep all appointments or office visits with your doctor. Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with bupropion and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can visit the Food and Drug Administration (FDA) website: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm or the manufacturer's website to obtain the Medication Guide. Talk to your doctor about the risks and benefits of taking bupropion.

What special precautions should I follow?

Before taking bupropion, tell your doctor and pharmacist if you are allergic to bupropion, any other medications, or any of the ingredients in bupropion tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients. Tell your doctor if you are taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take bupropion. Do not take more than one product containing bupropion at a time. You could receive too much medication and experience severe side effects. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amantadine (Symmetrel); beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); cimetidine (Tagamet); clopidogrel (Plavix); cyclophosphamide (Cytoxan, Neosar); efavirenz (Sustiva, in Atripla); insulin or oral medications for diabetes; medications for irregular heartbeat such as flecainide (Tambocor) and propafenone (Rythmol); medications for mental illness such as haloperidol (Haldol), risperidone (Risperdal), and thioridazine (Mellaril); medications for seizures such as carbamazepine (Tegretol), phenobarbital (Luminal, Solfoton), and phenytoin (Dilantin); levodopa (Sinemet, Larodopa); lopinavir and ritonavir (Kaletra); nelfinavir (Viracept); nicotine patch; oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); orphenadrine (Norflex); other antidepressants such as citalopram (Celexa), desipramine (Norpramin), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), paroxetine (Paxil) and sertraline (Zoloft); ritonavir (Norvir); sedatives; sleeping pills; tamoxifen (Nolvadex, Soltamox); theophylline (Theobid, Theo-Dur, others); thiotepa; and ticlopidine (Ticlid). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Tell your doctor if you have or have ever had seizures, anorexia nervosa (an eating disorder) or bulimia (an eating disorder). Also tell your doctor if you drink large amounts of alcohol but expect to suddenly stop drinking or you take sedatives but expect to suddenly stop taking them. Your doctor will probably tell you not to take bupropion. Tell your doctor if you drink large amounts of alcohol, use street drugs, or overuse prescription medications and if you have ever had a heart attack; a head injury; a tumor in your brain or spine; high blood pressure; diabetes; or liver, kidney, or heart disease. Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking bupropion, call your doctor. You should know that bupropion may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you. Talk to your doctor about the safe use of alcoholic beverages while you are taking bupropion. Alcohol can make the side effects from bupropion worse. You should know that bupropion may cause an increase in your blood pressure. Your doctor may check your blood pressure before starting treatment and regularly while you are taking this medication, especially if you also are using nicotine replacement therapy. You should know that bupropion may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.

You should know that some people have reported symptoms such as changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts (thinking about harming or killing oneself or planning or trying to do so) while taking bupropion to stop smoking. The role of bupropion in causing these mood changes is unclear since people who quit smoking with or without medication may experience changes in their mental health due to nicotine withdrawal. However, some of these symptoms occurred in people who were taking bupropion and continued to smoke. Some people had these symptoms when they began taking bupropion, and others developed them after several weeks of treatment or after stopping bupropion. These symptoms have occurred in people without a history of mental illness and have worsened in people who already had a mental illness. Tell your doctor if you have or have ever had depression, bipolar disorder (mood that changes from depressed to abnormally excited), schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions), or other mental illnesses. If you experience any of the following symptoms, stop taking bupropion (Zyban) and call your doctor immediately: suicidal thoughts or actions; new or worsening depression, anxiety, or panic attacks; agitation; restlessness; angry or violent behavior; acting dangerously; mania (frenzied, abnormally excited or irritated mood); abnormal thoughts or sensations; hallucinations (seeing things or hearing voices that do not exist); feeling that people are against you; feeling confused; or any other sudden or unusual changes in behavior. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own. Your doctor will monitor you closely until your symptoms get better.

What side effects can this medication cause?

Bupropion may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
  
• anxiety
  
• excitement
  
• difficulty falling asleep or staying asleep
• dry mouth
• dizziness
• headache
• nausea
• vomiting
• stomach pain
• uncontrollable shaking of a part of the body
• loss of appetite
• weight loss
• constipation
• excessive sweating
• ringing in the ears
• changes in your sense of taste
• frequent urination
• sore throat
  

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

• seizures
  
• confusion
  
• hallucinating (seeing things or hearing voices that do not exist)
  
• irrational fears
• muscle or joint pain
• rapid, pounding, or irregular heartbeat
  

If you experience any of the following symptoms, stop taking bupropion and call your doctor immediately or get emergency medical treatment:

• fever
  
• rash or blisters
  
• itching
• hives
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing
• chest pain
  

Bupropion may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include seizure, hallucinating (seeing things or hearing voices that do not exist), loss of consciousness, or rapid or pounding heartbeat.

Reference: https://medlineplus.gov/druginfo/meds/a695033.html

Important Safety Information

IMPORTANT WARNING:

For people taking bupropion (Wellbutrin) for depression:

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as bupropion during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. This risk should be considered and compared with the potential benefit in the treatment of depression, in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take bupropion, but in some cases, a doctor may decide that bupropion is the best medication to treat a child's condition. No matter what your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal, especially at the beginning of your treatment or any time that your dose is increased or decreased. This risk is higher if you or anyone in your family has or has ever had bipolar disorder or mania or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

You should know that your mental health may change in unexpected ways when you take bupropion or other antidepressants even if you are an adult over age 24 or if you do not have a mental illness and you are taking bupropion to treat a different type of condition. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

For all patients taking bupropion:

Your health care provider will want to see you often while you are taking bupropion, especially at the beginning of your treatment. Be sure to keep all appointments or office visits with your doctor. Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with bupropion and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can visit the Food and Drug Administration (FDA) website: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm or the manufacturer's website to obtain the Medication Guide. Talk to your doctor about the risks and benefits of taking bupropion.

What special precautions should I follow?

Before taking bupropion, tell your doctor and pharmacist if you are allergic to bupropion, any other medications, or any of the ingredients in bupropion tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients. Tell your doctor if you are taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take bupropion. Do not take more than one product containing bupropion at a time. You could receive too much medication and experience severe side effects. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amantadine (Symmetrel); beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); cimetidine (Tagamet); clopidogrel (Plavix); cyclophosphamide (Cytoxan, Neosar); efavirenz (Sustiva, in Atripla); insulin or oral medications for diabetes; medications for irregular heartbeat such as flecainide (Tambocor) and propafenone (Rythmol); medications for mental illness such as haloperidol (Haldol), risperidone (Risperdal), and thioridazine (Mellaril); medications for seizures such as carbamazepine (Tegretol), phenobarbital (Luminal, Solfoton), and phenytoin (Dilantin); levodopa (Sinemet, Larodopa); lopinavir and ritonavir (Kaletra); nelfinavir (Viracept); nicotine patch; oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); orphenadrine (Norflex); other antidepressants such as citalopram (Celexa), desipramine (Norpramin), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), paroxetine (Paxil) and sertraline (Zoloft); ritonavir (Norvir); sedatives; sleeping pills; tamoxifen (Nolvadex, Soltamox); theophylline (Theobid, Theo-Dur, others); thiotepa; and ticlopidine (Ticlid). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Tell your doctor if you have or have ever had seizures, anorexia nervosa (an eating disorder) or bulimia (an eating disorder). Also tell your doctor if you drink large amounts of alcohol but expect to suddenly stop drinking or you take sedatives but expect to suddenly stop taking them. Your doctor will probably tell you not to take bupropion. Tell your doctor if you drink large amounts of alcohol, use street drugs, or overuse prescription medications and if you have ever had a heart attack; a head injury; a tumor in your brain or spine; high blood pressure; diabetes; or liver, kidney, or heart disease. Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking bupropion, call your doctor. You should know that bupropion may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you. Talk to your doctor about the safe use of alcoholic beverages while you are taking bupropion. Alcohol can make the side effects from bupropion worse. You should know that bupropion may cause an increase in your blood pressure. Your doctor may check your blood pressure before starting treatment and regularly while you are taking this medication, especially if you also are using nicotine replacement therapy. You should know that bupropion may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.

You should know that some people have reported symptoms such as changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts (thinking about harming or killing oneself or planning or trying to do so) while taking bupropion to stop smoking. The role of bupropion in causing these mood changes is unclear since people who quit smoking with or without medication may experience changes in their mental health due to nicotine withdrawal. However, some of these symptoms occurred in people who were taking bupropion and continued to smoke. Some people had these symptoms when they began taking bupropion, and others developed them after several weeks of treatment or after stopping bupropion. These symptoms have occurred in people without a history of mental illness and have worsened in people who already had a mental illness. Tell your doctor if you have or have ever had depression, bipolar disorder (mood that changes from depressed to abnormally excited), schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions), or other mental illnesses. If you experience any of the following symptoms, stop taking bupropion (Zyban) and call your doctor immediately: suicidal thoughts or actions; new or worsening depression, anxiety, or panic attacks; agitation; restlessness; angry or violent behavior; acting dangerously; mania (frenzied, abnormally excited or irritated mood); abnormal thoughts or sensations; hallucinations (seeing things or hearing voices that do not exist); feeling that people are against you; feeling confused; or any other sudden or unusual changes in behavior. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own. Your doctor will monitor you closely until your symptoms get better.

What side effects can this medication cause?

Bupropion may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
  
• anxiety
  
• excitement
  
• difficulty falling asleep or staying asleep
• dry mouth
• dizziness
• headache
• nausea
• vomiting
• stomach pain
• uncontrollable shaking of a part of the body
• loss of appetite
• weight loss
• constipation
• excessive sweating
• ringing in the ears
• changes in your sense of taste
• frequent urination
• sore throat
  

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

• seizures
  
• confusion
  
• hallucinating (seeing things or hearing voices that do not exist)
  
• irrational fears
• muscle or joint pain
• rapid, pounding, or irregular heartbeat
  

If you experience any of the following symptoms, stop taking bupropion and call your doctor immediately or get emergency medical treatment:

• fever
  
• rash or blisters
  
• itching
• hives
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing
• chest pain
  

Bupropion may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include seizure, hallucinating (seeing things or hearing voices that do not exist), loss of consciousness, or rapid or pounding heartbeat.

Reference: https://medlineplus.gov/druginfo/meds/a695033.html

Important Safety Information

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS

ZOLOFT and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Pay particular attention to such changes when ZOLOFT is started or when the dose is changed.

Call a doctor right away if you or a person you know who is taking ZOLOFT has any of the following symptoms, especially if they are new, worse, or worry you:

• Attempts to commit suicide
  
• Acting aggressive or violent
  
• New or worse depression
  
• Feeling agitated, restless, angry, or irritable
• An increase in activity or talking more than what is normal for you
• Acting on dangerous impulses
• Thoughts about suicide or dying
• New or worse anxiety or panic attacks
• Trouble sleeping
• Other unusual changes in behavior or mood
  

Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Tell your doctor immediately if you:

• Become severely ill and have some or all of these symptoms: agitation, hallucinations, coma, or other changes in mental status; coordination problems or muscle twitching (overactive reflexes); racing heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting, or diarrhea; muscle tightness, as these may be the symptoms of a life-threatening condition called Serotonin Syndrome
  
• Have a rash, hives, swelling, or trouble breathing as these may be the symptoms of an allergic reaction
  
• Have seizures or convulsions
• Have any increased or unusual bruising or bleeding, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAID), or aspirin
• Have a headache; weakness or feeling unsteady; confusion, problems concentrating, thinking, or remembering, as these may be the symptoms of low salt (sodium) levels in the blood (hyponatremia). Elderly people may be at greater risk for this
• Have sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including ZOLOFT, may cause sexual problems

The most common side effects in adults treated with ZOLOFT include:

• Nausea, loss of appetite, diarrhea, or indigestion
  
• Increased sweating
  
• Tremor or shaking
• Agitation
• Change in sleep habits including increased sleepiness or insomnia
• Sexual problems, including decreased libido and ejaculation failure
• Feeling tired or fatigued
• Anxiety

Before taking ZOLOFT, tell your doctor and pharmacist about all prescription and over-the-counter medications and supplements you take or plan to take, including those to treat migraines, psychiatric disorders (including other antidepressants or amphetamines) to avoid a potentially life-threatening condition called serotonin syndrome, and aspirin and other NSAID pain relievers or other blood thinners because they may increase the risk of bleeding.

Call your doctor if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include seizure, hallucinating (seeing things or hearing voices that do not exist), loss of consciousness, or rapid or pounding heartbeat.

Reference: https://www.zoloft.com/en/safety-info

Important Safety Information

IMPORTANT WARNING:

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as sertraline during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. You should know that your mental health may change in unexpected ways when you take sertraline or other antidepressants even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; new or worsening anxiety; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own. Your healthcare provider will want to see you often while you are taking sertraline, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with sertraline. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm. No matter what your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

What special precautions should I follow?

Before taking sertraline, tell your doctor and pharmacist if you are allergic to sertraline, any other medications, any of the ingredients in sertraline preparations, or latex (found in the dropper for the concentrate). Before taking sertraline liquid concentrate, tell your doctor if you are allergic to latex. Ask your pharmacist for a list of the ingredients. Tell your doctor if you are taking monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), and tranylcypromine (Parnate), or have stopped taking them within the past 2 weeks, or if you are taking pimozide (Orap). Your doctor will probably tell you not to take sertraline. If you stop taking sertraline, you should wait at least 2 weeks before you start to take an MAO inhibitor. Do not take disulfiram (Antabuse) while taking sertraline oral concentrate. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amiodarone (Nexterone, Pacerone); amphetamines; anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven) and heparin; aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); atomoxetine (Straterra); buspirone, chlorpromazine; clopidogrel (Plavix), dextromethorphan (found in many cough medications; in Nuedexta); fentanyl (Actiq, Fentora, Lazanda, others), droperidol (Inapsine); erythromycin (E.E.S, Eryc, Ery-tab, others); fosphenytoin (Cerebyx); iloperidone (Fanapt); lithium (Lithobid); medications for anxiety, mental illness, Parkinson's disease, and seizures; medications for irregular heartbeat such as flecainide and propafenone (Rythmol); metoprolol (Lopressor, Toprol XL); medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); mefloquine; methadone (Dolophine, Methadose); moxifloxacin (Avelox); nebivolol (Bystolic, in Byvalson); pentamidine (Nebupent, Pentam); perphenazine; phenytoin (Dilantin, Phenytek); procainamide; quinidine (in Nuedexta); sedatives; sleeping pills; other selective serotonin-reuptake inhibitors such as citalopram (Celexa), fluoxetine (Prozac), or fluvoxamine (Luvox); serotonin–norepinephrine reuptake inhibitors (SNRI) medications such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), levomilnacipran (Fetzima), and venlafaxine; sotalol (Betapace, Sotylize); tacrolimus (Astagraf, Envarsus XR, Prograf); thioridazine; tolterodine (Detrol); tramadol (Conzip, Qdolo, Ultram); tranquilizers; tricyclic antidepressants ('mood elevators') such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin, imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine; or ziprasidone (Geodon). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with sertraline, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

Tell your doctor what herbal products and nutritional supplements you are taking, especially St. John's wort and tryptophan. Tell your doctor if you have recently had a heart attack or stroke or if you have high blood pressure, bleeding problems, a low level of sodium in your blood and if you have or have ever had seizures or liver, kidney, or heart disease. Tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breastfeeding. If you become pregnant while taking sertraline, call your doctor. Sertraline may cause problems in newborns following delivery if it is taken during the last months of pregnancy. You should know that sertraline may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you. Ask your doctor about the safe use of alcoholic beverages while you are taking sertraline. You should know that sertraline may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.

What side effects can this medication cause?

Sertraline may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
  
• diarrhea
  
• constipation
• vomiting
• difficulty falling asleep or staying asleep
• dry mouth
• heartburn
• loss of appetite
• weight changes
• dizziness
• excessive tiredness
• headache
• nervousness
• uncontrollable shaking of a part of the body
• sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation
• sexual problems in females; decreased sex drive, or delayed orgasm or unable to have an orgasm
• excessive sweating
  

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS section, call your doctor immediately:

• seizures
  
• abnormal bleeding or bruising
  
• agitation, hallucinations, fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
  
• headache, weakness, unsteadiness, confusion, or memory problems
• rash
• hives
• swelling
• difficulty breathing
  

Sertraline may decrease appetite and cause weight loss in children. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor if you have concerns about your child's growth or weight while he or she is taking this medication. Talk to your child's doctor about the risks of giving sertraline to your child. Sertraline may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
 
Symptoms of overdose may include drowsiness, agitation, hallucinations, fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea, excessive tiredness, dizziness, agitation, mania, seizures, loss of consciousness, dizziness, rapid, irregular, or pounding heartbeat.

Reference: https://medlineplus.gov/druginfo/meds/a697048.html

Important Safety Information

IMPORTANT WARNING:

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as fluoxetine during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant.

You should know that your mental health may change in unexpected ways when you take fluoxetine or other antidepressants even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own. Your healthcare provider will want to see you often while you are taking fluoxetine, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with fluoxetine. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm. No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

What special precautions should I follow?

Before taking fluoxetine, tell your doctor and pharmacist if you are allergic to fluoxetine, any other medications, or any of the ingredients in fluoxetine capsules, tablets, or solution. Ask your pharmacist for a list of the ingredients. Tell your doctor if you are taking pimozide (Orap), thioridazine, or a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking a monoamine oxidase inhibitor within the past 2 weeks. Your doctor will probably tell you that you should not take fluoxetine. If you stop taking fluoxetine, you should wait at least 5 weeks before you begin to take thioridazine or a monoamine oxidase inhibitor. Tell your doctor and pharmacist what other prescription and nonprescription medications and vitamins you are taking or plan to take. Be sure to mention any of the following: alprazolam (Xanax); amiodarone (Pacerone, Nexterone); certain antibiotics such as erythromycin (E.E.S, Eryc, Ery-tab), gatifloxacin, moxifloxacin (Avelox), and sparfloxacin (no longer available in U.S., Zagam); amphetamines such as amphetamine (in Adderall), dextroamphetamine (Dexedrine, Dextrostat, in Adderall), and methamphetamine (Desoxyn); anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); antidepressants (mood elevators) such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin, imipramine (Tofranil), nortriptyline (Pamelor), protriptyline, and trimipramine; aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); buspirone; clopidogrel (Plavix); diazepam (Valium, Valtoco); digoxin (Lanoxin); diuretics ('water pills'); dolasetron (Anzemet); fentanyl (Fentora, Lazanda, Subsys, others); flecainide; insulin or oral medications for diabetes; lithium (Lithobid); medications for anxiety and Parkinson's disease; medications for mental illness such as chlorpromazine, clozapine (Clozaril, Versacloz), droperidol (Inapsine), haloperidol (Haldol), iloperidone (Fanapt), and ziprasidone (Geodon); methadone (Methadose); medications for migraine headaches such as almotriptan, eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); pentamidine (Pentam); quinidine (in Nuedexta); procainamide; medications for seizures such as carbamazepine (Epitol, Equetro, Tegretol, Teril) and phenytoin (Dilantin, Phenytek); sedatives; sleeping pills; other selective serotonin-reuptake inhibitors such as citalopram (Celexa), or fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft); serotonin–norepinephrine reuptake inhibitors (SNRI) medications desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), levomilnacipran (Fetzima), and venlafaxine; sotalol (Betapace, Sorine); tramadol (Conzip, Qdolo, Ultram, in Ultracet); tranquilizers; and vinblastine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Tell your doctor what nutritional supplements and herbal products you are taking, especially products that contain St. John's wort or tryptophan.
Tell your doctor if you or anyone in your family has or has ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death). Also tell your doctor if you have a low level of potassium, magnesium, or sodium in your blood or are being treated with electroshock therapy (procedure in which small electric shocks are administered to the brain to treat certain mental illnesses). Tell your doctor if you have recently had a heart attack and if you have or have ever had a slow or irregular heartbeat, heart failure, or any other heart problems; high blood pressure; bleeding problems; a stroke; diabetes; seizures; or liver or kidney disease.

Tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breastfeeding. If you become pregnant while taking fluoxetine, call your doctor. Fluoxetine may cause problems in newborns following delivery if it is taken during the last months of pregnancy. You should know that fluoxetine may make you drowsy and may affect your judgment, thinking, and movements. Do not drive a car or operate machinery until you know how this medication affects you.

Remember that alcohol can add to the drowsiness caused by this medication. You should know that fluoxetine may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.

What side effects can this medication cause?

Fluoxetine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nervousness
  
• anxiety
  
• difficulty falling asleep or staying asleep
  
• nausea
  
• diarrhea
  
• dry mouth
• heartburn
• yawning
• weakness
• uncontrollable shaking of a part of the body
• loss of appetite
• weight loss
• unusual dreams
• stuffy nose
• sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation
• sexual problems in females; decreased sex drive, or delayed orgasm or unable to have an orgasm
• excessive sweating
• headache, confusion, weakness, difficulty concentrating, or memory problems
  

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS section, call your doctor immediately:

• nervousness
  
• anxiety
  
• difficulty falling asleep or staying asleep
  
• nausea
• rash
• hives or blisters
• itching
• fever
• joint pain
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• difficulty breathing or swallowing
• agitation, fever, sweating, confusion, fast or irregular heartbeat, shivering, severe muscle stiffness or twitching, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
• fast, slow, or irregular heartbeat
• shortness of breath
• dizziness or fainting
• seizures
• abnormal bleeding or bruising
  

Fluoxetine may decrease appetite and cause weight loss in children. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor if you have concerns about your child's growth or weight while he or she is taking this medication. Talk to your child's doctor about the risks of giving fluoxetine to your child. Fluoxetine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of emergency/overdose

In case of overdose, call the poison control helpline at1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include unsteadiness, confusion, unresponsiveness, nervousness, uncontrollable shaking of a part of the body, dizziness, rapid, irregular, or pounding heartbeat, seeing things or hearing voices that do not exist (hallucinating), fever, fainting, seizures, coma (loss of consciousness for a period of time).

Reference: https://medlineplus.gov/druginfo/meds/a689006.html

Important Safety Information

IMPORTANT WARNING:

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as fluoxetine during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant.

You should know that your mental health may change in unexpected ways when you take fluoxetine or other antidepressants even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own. Your healthcare provider will want to see you often while you are taking fluoxetine, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with fluoxetine. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm. No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

What special precautions should I follow?

Before taking fluoxetine, tell your doctor and pharmacist if you are allergic to fluoxetine, any other medications, or any of the ingredients in fluoxetine capsules, tablets, or solution. Ask your pharmacist for a list of the ingredients. Tell your doctor if you are taking pimozide (Orap), thioridazine, or a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking a monoamine oxidase inhibitor within the past 2 weeks. Your doctor will probably tell you that you should not take fluoxetine. If you stop taking fluoxetine, you should wait at least 5 weeks before you begin to take thioridazine or a monoamine oxidase inhibitor. Tell your doctor and pharmacist what other prescription and nonprescription medications and vitamins you are taking or plan to take. Be sure to mention any of the following: alprazolam (Xanax); amiodarone (Pacerone, Nexterone); certain antibiotics such as erythromycin (E.E.S, Eryc, Ery-tab), gatifloxacin, moxifloxacin (Avelox), and sparfloxacin (no longer available in U.S., Zagam); amphetamines such as amphetamine (in Adderall), dextroamphetamine (Dexedrine, Dextrostat, in Adderall), and methamphetamine (Desoxyn); anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); antidepressants (mood elevators) such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin, imipramine (Tofranil), nortriptyline (Pamelor), protriptyline, and trimipramine; aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); buspirone; clopidogrel (Plavix); diazepam (Valium, Valtoco); digoxin (Lanoxin); diuretics ('water pills'); dolasetron (Anzemet); fentanyl (Fentora, Lazanda, Subsys, others); flecainide; insulin or oral medications for diabetes; lithium (Lithobid); medications for anxiety and Parkinson's disease; medications for mental illness such as chlorpromazine, clozapine (Clozaril, Versacloz), droperidol (Inapsine), haloperidol (Haldol), iloperidone (Fanapt), and ziprasidone (Geodon); methadone (Methadose); medications for migraine headaches such as almotriptan, eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); pentamidine (Pentam); quinidine (in Nuedexta); procainamide; medications for seizures such as carbamazepine (Epitol, Equetro, Tegretol, Teril) and phenytoin (Dilantin, Phenytek); sedatives; sleeping pills; other selective serotonin-reuptake inhibitors such as citalopram (Celexa), or fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft); serotonin–norepinephrine reuptake inhibitors (SNRI) medications desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), levomilnacipran (Fetzima), and venlafaxine; sotalol (Betapace, Sorine); tramadol (Conzip, Qdolo, Ultram, in Ultracet); tranquilizers; and vinblastine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Tell your doctor what nutritional supplements and herbal products you are taking, especially products that contain St. John's wort or tryptophan.
Tell your doctor if you or anyone in your family has or has ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death). Also tell your doctor if you have a low level of potassium, magnesium, or sodium in your blood or are being treated with electroshock therapy (procedure in which small electric shocks are administered to the brain to treat certain mental illnesses). Tell your doctor if you have recently had a heart attack and if you have or have ever had a slow or irregular heartbeat, heart failure, or any other heart problems; high blood pressure; bleeding problems; a stroke; diabetes; seizures; or liver or kidney disease.

Tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breastfeeding. If you become pregnant while taking fluoxetine, call your doctor. Fluoxetine may cause problems in newborns following delivery if it is taken during the last months of pregnancy. You should know that fluoxetine may make you drowsy and may affect your judgment, thinking, and movements. Do not drive a car or operate machinery until you know how this medication affects you.

Remember that alcohol can add to the drowsiness caused by this medication. You should know that fluoxetine may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.

What side effects can this medication cause?

Fluoxetine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nervousness
  
• anxiety
  
• difficulty falling asleep or staying asleep
  
• nausea
  
• diarrhea
  
• dry mouth
• heartburn
• yawning
• weakness
• uncontrollable shaking of a part of the body
• loss of appetite
• weight loss
• unusual dreams
• stuffy nose
• sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation
• sexual problems in females; decreased sex drive, or delayed orgasm or unable to have an orgasm
• excessive sweating
• headache, confusion, weakness, difficulty concentrating, or memory problems
  

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS section, call your doctor immediately:

• nervousness
  
• anxiety
  
• difficulty falling asleep or staying asleep
  
• nausea
• rash
• hives or blisters
• itching
• fever
• joint pain
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• difficulty breathing or swallowing
• agitation, fever, sweating, confusion, fast or irregular heartbeat, shivering, severe muscle stiffness or twitching, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
• fast, slow, or irregular heartbeat
• shortness of breath
• dizziness or fainting
• seizures
• abnormal bleeding or bruising
  

Fluoxetine may decrease appetite and cause weight loss in children. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor if you have concerns about your child's growth or weight while he or she is taking this medication. Talk to your child's doctor about the risks of giving fluoxetine to your child. Fluoxetine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of emergency/overdose

In case of overdose, call the poison control helpline at1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include unsteadiness, confusion, unresponsiveness, nervousness, uncontrollable shaking of a part of the body, dizziness, rapid, irregular, or pounding heartbeat, seeing things or hearing voices that do not exist (hallucinating), fever, fainting, seizures, coma (loss of consciousness for a period of time).

Reference: https://medlineplus.gov/druginfo/meds/a689006.html

Important Safety Information

IMPORTANT WARNING:

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as citalopram during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take citalopram, but in some cases, a doctor may decide that citalopram is the best medication to treat a child's condition.

You should know that your mental health may change in unexpected ways when you take citalopram or other antidepressants even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking citalopram, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood), or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

What special precautions should I follow?

Tell your doctor and pharmacist if you are allergic to citalopram, escitalopram (Lexapro), any other medications, or any of the ingredients in the citalopram product you are taking. Talk to your pharmacist or check the Medication Guide for a list of the ingredients.

Tell your doctor if you are taking pimozide (Orap) or a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), or tranylcypromine (Parnate), or if you have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take citalopram. If you stop taking citalopram, you should wait at least 14 days before you start to take an MAO inhibitor.

You should know that citalopram is very similar to another SSRI, escitalopram (Lexapro). You should not take these two medications together.

Tell your doctor and pharmacist what other prescription and nonprescription medications and vitamins you are taking or plan to take. Be sure to mention any of the following: amiodarone (Nexterone, Pacerone); amphetamines such as amphetamine (in Adderall, in Mydayis), dextroamphetamine (Dexedrine, in Adderall), and methamphetamine (Desoxyn); anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); carbamazepine (Carbatrol, Equetro, Tegretol, others); chlorpromazine; cimetidine (Tagamet); diuretics ('water pills); disopyramide (Norpace); dofetilide (Tikosyn); erythromycin (E.E.S. Ery-Tab, Erythrocin); fentanyl (Actiq, Duragesic, Fentora, Subsys); lithium (Lithobid); medications for anxiety, chronic pain, mental illness, and seizures; medications for migraine headaches such as almotriptan, eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, Tosymra, in Treximet), and zolmitriptan (Zomig); methadone (Methadose); metoprolol (Lopressor, Toprol XL); moxifloxacin; omeprazole (Prilosec, Zegerid); pentamidine (Nebupent, Pentam); other SSRIs such as fluoxetine (Prozac, in Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); serotonin–norepinephrine reuptake inhibitors (SNRIs) such as duloxetine (Cymbalta); procainamide; quinidine (in Nuedexta); sedatives; sleeping pills; sotalol (Betapace, Sorine, Sotylize); thioridazine (Mellaril); tramadol (Conzip, Qdolo, Ultram, in Ultracet); tranquilizers; and tricyclic antidepressants such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline, and trimipramine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with citalopram, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

Tell your doctor what nutritional supplements and herbal products you are taking, especially products that contain St. John's wort or tryptophan.

Tell your doctor if you drink or have ever drunk large amounts of alcohol or use or have ever used street drugs or have ever overused prescription medications. Also tell your doctor if you or anyone in your family has or has ever had long QT syndrome (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death),if you have recently had a heart attack, or if you have or have ever had a slow or irregular heartbeat, heart failure (condition in which the heart cannot pump enough blood to other parts of the body) or other heart conditions; high blood pressure; bleeding problems; stroke; low levels of magnesium, potassium, or sodium in your blood; seizures; or kidney or liver disease.

Tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking citalopram, call your doctor. Citalopram may cause problems in newborns following delivery if it is taken during the last months of pregnancy.

You should know that citalopram may make you drowsy and may affect your judgment, thinking, and movements. Do not drive a car or operate machinery until you know how this medication affects you.

Talk to your doctor about the safe use of alcoholic beverages during your treatment with citalopram. Alcohol can make the side effects of citalopram worse.

You should know that citalopram may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.

What side effects can this medication cause?

Citalopram may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
  
• diarrhea
  
• constipation
  
• vomiting
• stomach pain
• heartburn
• decreased appetite
• weight loss
• increased sweating
• increased thirst
• frequent urination
• difficulty falling asleep or staying asleep
• drowsiness
• excessive tiredness
• yawning
• weakness
• uncontrollable shaking of a part of the body
• muscle or joint pain
  
• dry mouth
  
• sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation
  
• sexual problems in females; decreased sex drive, or delayed orgasm or inability to have an orgasm
  
• heavy menstrual periods
  
• runny nose
  

Some side effects can be serious. If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

• chest pain
  
• shortness of breath
  
• dizziness
  
• fainting
• fever, sweating, confusion, fast or irregular heartbeat, severe muscle stiffness or twitching, agitation, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
• coma (loss of consciousness)
• hives or blisters
• rash
• itching
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• unusual bleeding or bruising
• nose bleeding
• headache
• unsteadiness
• problems with thinking, concentration, or memory
• seizures
  

Citalopram may decrease appetite and cause weight loss in children. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor if you have concerns about your child's growth or weight while he or she is taking this medication. Talk to your child's doctor about the risks of giving citalopram to your child.

Citalopram may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• dizziness
  
• sweating
  
• nausea
• vomiting
• uncontrollable shaking of a part of the body
• drowsiness
• fast, irregular, or pounding heartbeat
• memory loss
• confusion
• seizures
• coma (loss of consciousness)
• fast breathing
• bluish color around mouth, fingers, or fingernails
• muscle pain
• dark-colored urine
  

Important Safety Information

IMPORTANT WARNING:

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as citalopram during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take citalopram, but in some cases, a doctor may decide that citalopram is the best medication to treat a child's condition.

You should know that your mental health may change in unexpected ways when you take citalopram or other antidepressants even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking citalopram, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood), or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

What special precautions should I follow?

Tell your doctor and pharmacist if you are allergic to citalopram, escitalopram (Lexapro), any other medications, or any of the ingredients in the citalopram product you are taking. Talk to your pharmacist or check the Medication Guide for a list of the ingredients.

Tell your doctor if you are taking pimozide (Orap) or a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), or tranylcypromine (Parnate), or if you have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take citalopram. If you stop taking citalopram, you should wait at least 14 days before you start to take an MAO inhibitor.

You should know that citalopram is very similar to another SSRI, escitalopram (Lexapro). You should not take these two medications together.

Tell your doctor and pharmacist what other prescription and nonprescription medications and vitamins you are taking or plan to take. Be sure to mention any of the following: amiodarone (Nexterone, Pacerone); amphetamines such as amphetamine (in Adderall, in Mydayis), dextroamphetamine (Dexedrine, in Adderall), and methamphetamine (Desoxyn); anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); carbamazepine (Carbatrol, Equetro, Tegretol, others); chlorpromazine; cimetidine (Tagamet); diuretics ('water pills); disopyramide (Norpace); dofetilide (Tikosyn); erythromycin (E.E.S. Ery-Tab, Erythrocin); fentanyl (Actiq, Duragesic, Fentora, Subsys); lithium (Lithobid); medications for anxiety, chronic pain, mental illness, and seizures; medications for migraine headaches such as almotriptan, eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, Tosymra, in Treximet), and zolmitriptan (Zomig); methadone (Methadose); metoprolol (Lopressor, Toprol XL); moxifloxacin; omeprazole (Prilosec, Zegerid); pentamidine (Nebupent, Pentam); other SSRIs such as fluoxetine (Prozac, in Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); serotonin–norepinephrine reuptake inhibitors (SNRIs) such as duloxetine (Cymbalta); procainamide; quinidine (in Nuedexta); sedatives; sleeping pills; sotalol (Betapace, Sorine, Sotylize); thioridazine (Mellaril); tramadol (Conzip, Qdolo, Ultram, in Ultracet); tranquilizers; and tricyclic antidepressants such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline, and trimipramine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with citalopram, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

Tell your doctor what nutritional supplements and herbal products you are taking, especially products that contain St. John's wort or tryptophan.

Tell your doctor if you drink or have ever drunk large amounts of alcohol or use or have ever used street drugs or have ever overused prescription medications. Also tell your doctor if you or anyone in your family has or has ever had long QT syndrome (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death),if you have recently had a heart attack, or if you have or have ever had a slow or irregular heartbeat, heart failure (condition in which the heart cannot pump enough blood to other parts of the body) or other heart conditions; high blood pressure; bleeding problems; stroke; low levels of magnesium, potassium, or sodium in your blood; seizures; or kidney or liver disease.

Tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking citalopram, call your doctor. Citalopram may cause problems in newborns following delivery if it is taken during the last months of pregnancy.

You should know that citalopram may make you drowsy and may affect your judgment, thinking, and movements. Do not drive a car or operate machinery until you know how this medication affects you.

Talk to your doctor about the safe use of alcoholic beverages during your treatment with citalopram. Alcohol can make the side effects of citalopram worse.

You should know that citalopram may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.

What side effects can this medication cause?

Citalopram may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
  
• diarrhea
  
• constipation
  
• vomiting
• stomach pain
• heartburn
• decreased appetite
• weight loss
• increased sweating
• increased thirst
• frequent urination
• difficulty falling asleep or staying asleep
• drowsiness
• excessive tiredness
• yawning
• weakness
• uncontrollable shaking of a part of the body
• muscle or joint pain
  
• dry mouth
  
• sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation
  
• sexual problems in females; decreased sex drive, or delayed orgasm or inability to have an orgasm
  
• heavy menstrual periods
  
• runny nose
  

Some side effects can be serious. If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

• chest pain
  
• shortness of breath
  
• dizziness
  
• fainting
• fever, sweating, confusion, fast or irregular heartbeat, severe muscle stiffness or twitching, agitation, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
• coma (loss of consciousness)
• hives or blisters
• rash
• itching
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• unusual bleeding or bruising
• nose bleeding
• headache
• unsteadiness
• problems with thinking, concentration, or memory
• seizures
  

Citalopram may decrease appetite and cause weight loss in children. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor if you have concerns about your child's growth or weight while he or she is taking this medication. Talk to your child's doctor about the risks of giving citalopram to your child.

Citalopram may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• dizziness
  
• sweating
  
• nausea
• vomiting
• uncontrollable shaking of a part of the body
• drowsiness
• fast, irregular, or pounding heartbeat
• memory loss
• confusion
• seizures
• coma (loss of consciousness)
• fast breathing
• bluish color around mouth, fingers, or fingernails
• muscle pain
• dark-colored urine
  

Important Safety Information

Important Safety Information

What special precautions should I follow?

Before taking buspirone, tell your doctor and pharmacist if you are allergic to buspirone, any other medications, or any of the ingredients in buspirone tablets. Ask your pharmacist for a list of the ingredients. Tell your doctor if you are taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take buspirone. If you stop taking buspirone, you should wait at least 14 days before you start to take an MAO inhibitor. Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticonvulsants such as carbamazepine (Tegretol), phenobarbital, and phenytoin (Dilantin, Phenytek); dexamethasone; diazepam (Valium); diltiazem (Cardizem, Dilacor, Tiazac); erythromycin (E.E.S., E-Mycin, Erythrocin, others); haloperidol (Haldol); ketoconazole; itraconazole (Onmel, Sporanox); medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); muscle relaxants; nefazodone (Serzone); pain medications or narcotics; rifampin (Rifadin, Rimactane); ritonavir (Norvir); sedatives; selective serotonin-reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Selfemra), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); serotonin–norepinephrine reuptake inhibitors (SNRI) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), levomilnacipran (Fetzima), milnacipran (Savella), and venlafaxine (Effexor); sleeping pills; tranquilizers; trazodone (Desyrel); and verapamil (Calan, Covera, Verelan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with buspirone, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
Tell your doctor if you have or have ever had kidney or liver disease or a history of alcohol or drug abuse. Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking buspirone, call your doctor. If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking buspirone. You should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you. Remember that alcohol can add to the drowsiness caused by this drug. Do not drink alcohol while taking buspirone.

What side effects can this medication cause?

Buspirone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dizziness
  

• nausea
  

• diarrhea

• headache
  

• excitement
  

• confusion
  

• fatigue
  

• nervousness
  

• difficulty falling asleep or staying asleep
  

• feelings of anger or hostility

• lightheadedness
• headache
• weakness
• numbness
• increased sweating
  

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• rash
  
• hives
  
• itching
  
• swelling of the face, eyes, mouth, throat, tongue, or lips
  
• fast or irregular heartbeat
• blurred vision
• uncontrollable shaking of a part of the body
• agitation, fever, sweating, dizziness, flushing, confusion, fast or irregular heartbeat, shivering, severe muscle stiffness or twitching, seizures, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
  

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include nausea, vomiting, dizziness, drowsiness, blurred vision, or upset stomach.

Reference: https://medlineplus.gov/druginfo/meds/a688005.html

Important Safety Information

IMPORTANT WARNING:

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as escitalopram during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 12 years of age should not normally take escitalopram, but in some cases, a doctor may decide that escitalopram is the best medication to treat a child's condition.

You should know that your mental health may change in unexpected ways when you take escitalopram or other antidepressants even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own. Your healthcare provider will want to see you often while you are taking escitalopram, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.
The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with escitalopram. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. Tell your doctor if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

What special precautions should I follow?

Before taking escitalopram, tell your doctor or pharmacist if you are allergic to escitalopram, citalopram (Celexa), any other medications, or any of the ingredients in the tablets or solution. Ask your pharmacist or check the Medication Guide for a list of the ingredients. Tell your doctor if you are taking pimozide (Orap) or a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take escitalopram. If you stop taking escitalopram, you should wait at least 14 days before you start to take an MAO inhibitor. You should know that escitalopram is very similar to another SSRI, citalopram (Celexa). You should not take these two medications together. Tell your doctor or pharmacist what prescription and nonprescription medications and vitamins you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); amphetamines such as amphetamine (in Adderall, in Mydayis), dextroamphetamine (Dexedrine, in Adderall), and methamphetamine (Desoxyn); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); buspirone; carbamazepine (Carbatrol, Equetro, Tegretol, others); cimetidine (Tagamet); diuretics ('water pills'); fentanyl (Actiq, Duragesic, Fentora, Subsys); ketoconazole (Sporanox); lithium (Lithobid); medications for anxiety, mental illness, or seizures; medications for migraine headaches such as almotriptan, eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, Tosymra, in Treximet), and zolmitriptan (Zomig); metoprolol (Lopressor, Toprol XL); other SSRIs such as fluoxetine (Prozac, in Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); serotonin–norepinephrine reuptake inhibitors (SNRI) such as duloxetine (Cymbalta); sedatives; sleeping pills; tramadol (Conzip, Qdolo, Ultram, in Ultracet); tranquilizers; and tricyclic antidepressants such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline, and trimipramine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
Tell your doctor what nutritional supplements and herbal products you are taking, especially products containing St. John's wort or tryptophan. Tell your doctor if you have a low level of sodium in your blood, if you drink or have ever drunk large amounts of alcohol, or use or have ever used street drugs or have ever overused prescription medications. Also tell your doctor if you have recently had a heart attack and if you have or have ever had high blood pressure; a stroke; bleeding problems; seizures; or liver, kidney, or heart disease. Tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking escitalopram, call your doctor. Escitalopram may cause problems in newborns following delivery if it is taken during the last months of pregnancy. If You are having surgery, including dental surgery, tell the doctor or dentist that you are taking escitalopram. You should know that escitalopram may make you drowsy and may affect your judgment, thinking, and movements. Do not drive a car or operate machinery until you know how this medication affects you. Remember that alcohol can add to the drowsiness caused by this medication. You should know that escitalopram may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.

What side effects can this medication cause?

Escitalopram may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
  

• diarrhea
  

• constipation
  

• sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation
• sexual problems in females; decreased sex drive, or delayed orgasm or unable to have an orgasm
• drowsiness
• yawning
• shaking
• difficulty falling asleep or staying asleep
• increased sweating
• dizziness
• heartburn
• stomach pain
• excessive tiredness
• dry mouth
• decreased appetite
• weight loss
• flu-like symptoms
• runny nose
• sneezing
  

Some side effects can be serious. If you experience either of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately:

• unusual excitement
  
• seeing things or hearing voices that do not exist (hallucinating)
  
• rash
  
• hives or blisters
  
• itching
• fever
• joint pain
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, or eyes
• fever, sweating, confusion, fast or irregular heartbeat, severe muscle stiffness or twitching, agitation, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
• abnormal bleeding or bruising
• nose bleeding
• headache
• unsteadiness
• problems with thinking, concentration, or memory
• seizures
• difficult or painful urination
  

Escitalopram may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include dizziness, nausea, vomiting, drowsiness, fast or pounding heartbeat, seizures, or coma (loss of consciousness for a period of time).

Reference: https://medlineplus.gov/druginfo/meds/a603005.html