Important Safety Information

What special precautions should I follow?

Before taking paroxetine, tell your doctor and pharmacist if you are allergic to paroxetine, any other medications, or any of the ingredients in paroxetine tablets, controlled-release tablets, capsules, or suspension. Ask your pharmacist or check the Medication Guide 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); if you have stopped taking them within the past 2 weeks; or if you are taking thioridazine or pimozide (Orap). Your doctor will probably tell you not to take paroxetine. If you stop taking paroxetine, you should wait at least 2 weeks before you start to take an MAO 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: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven) and heparin; antidepressants ('mood elevators') such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin, imipramine (Tofranil), nortriptyline (Pamelor), protriptyline, and trimipramine; antihistamines; aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin), and naproxen (Aleve, Naprosyn); atomoxetine (Straterra); buspirone (Buspar); chlorpromazine (Thorazine); cimetidine (Tagamet); clopidogrel (Plavix); dextromethorphan (found in many cough medications; in Nuedexta); digoxin (Lanoxin); dipyridamole (Persantine); diuretics ('water pills'); fentanyl (Actiq, Fentora, Lazanda, others); fosamprenavir (Lexiva); haloperidol (Haldol); isoniazid (INH, Nydrazid); lithium (Lithobid); medications for irregular heartbeat such as flecainide or propafenone (Rythmol); medications for mental illness and nausea; medications for migraine headaches such as almotriptan, eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); medications for seizures such as phenobarbital and phenytoin (Dilantin);metoprolol (Lopressor, Toprol XL); other selective serotonin-reuptake inhibitors such as citalopram (Celexa), fluoxetine (Prozac), fluvoxamine (Luvox), and sertraline (Zoloft); propranolol (Inderal); risperidone (Risperdal); ritonavir (Norvir); serotonin–norepinephrine reuptake inhibitors (SNRI) medications such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), levomilnacipran (Fetzima), and venlafaxine; tamoxifen (Soltamox); theophylline (Theobid, Theo-Dur); tramadol (Conzip, Qdolo,Ultram, in Ultracet); and trazodone. 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 paroxetine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. 

You should know that paroxetine products that have different brand names are available and are used to treat different conditions. Do not take more than one product that contains paroxetine at a time. 

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

Tell your doctor if you use or have ever used street drugs or have overused prescription medications, if you have recently had a heart attack, and if you have a low level of sodium in your blood. Also tell your doctor if you have or have ever had seizures; glaucoma; bleeding problems; bone problems including osteoporosis (a condition in which the bones become thin and weak and break easily) or bone fractures; or liver, kidney, or heart disease. 

Tell your doctor if you are pregnant, if you plan to become pregnant, or if you are breastfeeding. If you become pregnant while taking paroxetine, call your doctor immediately. Paroxetine may cause heart defects in the fetus if it is taken during early pregnancy and problems in newborns following delivery if it is taken during the last months of pregnancy. 

Talk to your doctor about the risks and benefits of taking paroxetine if you are 65 years of age or older. Older adults should not usually take paroxetine because it is not as safe or effective as other medications that can be used to treat the same condition. 

If you are having surgery, including dental surgery tell the doctor or dentist that you are taking paroxetine. 

You should know that paroxetine may make you drowsy and affect your judgment and thinking. 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 paroxetine. 

You should know that paroxetine 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?

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

• headache

• dizziness

• weakness

• difficulty concentrating

• nervousness

• forgetfulness

• confusion

• sleepiness

• nausea

• vomiting

• diarrhea

• constipation

• gas

• stomach pain

• heartburn

• changes in ability to taste food

• decreased appetite

• weight loss or gain

• sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculatio

• sexual problems in females; decreased sex drive, or delayed orgasm or unable to have an orgasm

• dry mouth

• sweating

• yawning

• pain in the back, muscles, bones, or anywhere in the body

• tenderness or swelling of joints

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:

• seeing things or hearing voices that do not exist (hallucinating)

• fainting

• rapid, pounding, or irregular heartbeat

• chest pain

• difficulty breathing

• seizures

• agitation, fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness or twitching, hallucinations, loss of coordination, nausea, vomiting, or diarrhea

• abnormal bleeding or bruising

• tiny red spots directly under the skin

• peeling or blistering of skin

• sore throat, fever, chills, cough, and other signs of infection

• uncontrollable shaking of a part of the body

• unsteady walking that may cause falling

• numbness or tingling in your hands, feet, arms, or legs

• painful erection that lasts for hours

• sudden nausea, vomiting, weakness, cramping, bloating, swelling, tightness in hands and feet, dizziness, headache and/or confusion

• hives

• rash

• itching

• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs

• hoarseness

• black and tarry stools

• red blood in stools

• bloody vomit

• vomit that looks like coffee grounds

• bone pain or fracture

• tenderness, swelling, or bruising of one part of your body

Paroxetine 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.

Reference: https://medlineplus.gov/druginfo/meds/a698032.html