What Is Paroxetine?
Paroxetine is in a class of medicines called selective serotonin reuptake inhibitors (SSRIs). Paroxetine tablets and oral suspension are used to treat:
- Depression
- Panic disorder
- Social anxiety disorder (SAD)
- Obsessive-compulsive disorder (OCD)
- Posttraumatic stress disorder (PTSD)
- Generalized anxiety disorder (GAD)
Paroxetine CR is used to treat:
- Depression
- Panic disorder
- Social anxiety disorder (SAD)
- Premenstrual dysphoric disorder (PMDD)
Who Should Not Take Paroxetine?
Never take paroxetine if you are taking another drug used to treat depression, called a Monoamine Oxidase Inhibitor (MAOI), or if you have stopped taking an MAOI in the last 14 days. Taking paroxetine close in time to an MAOI can result in serious, sometimes fatal reactions including:
-High body temperature
-Coma
-Seizures (convulsions)
MAOI drugs include Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate), Marplan (isocarboxazid), and other brands.
Never take paroxetine if you are taking Mellaril (thioridazine), used to treat schizophrenia, because it can result in serious heart beat problems.
What Are The Risks?
- Suicidal thoughts or actions: See FDA Alert
http://www.paxilbirthdefect.com/alerts/fda_suicide0705.php
- Stopping paroxetine: Do not stop taking paroxetine suddenly because you could get side effects. Your healthcare professional will slowly decrease your dose.
- Bleeding problems: Paroxetine may cause bleeding problems, especially if taken with aspirin, NSAIDs (nonsteroidal anti-inflammatory drugs, such as ibuprofen or naproxen), or other drugs that affect bleeding.
- Mania: You may become hyperactive, excitable or elated.
- Seizures: You may experience a seizure (convulsion) even if you are not taking paroxetine close in time with a MAOI.
- Pregnancy: Tell your healthcare professional if you are or may be pregnant (see FDA Alert [12/2005] http://www.paxilbirthdefect.com/alerts/fda1205.php). In addition to the issues discussed in the alert, babies delivered to mothers taking paroxetine late in pregnancy have developed problems, such as difficulty breathing and feeding.
- Sexual problems: You may have problems with impotence (erectile dysfunction), abnormal ejaculation, difficulty reaching orgasm, or decreased libido (sexual desire).
- Other side effects include weakness, dry mouth, constipation, yawning, infection, diarrhea, sweating, dizziness, tremor, nervousness, nausea, difficulty sleeping, decreased appetite, and sleepiness.
- Tell your healthcare professional about all your medical conditions, especially if you have liver or kidney disease, or glaucoma. Tell your healthcare professional if you are breast-feeding or plan to breast-feed your baby.
Are There Any Interactions With Drugs or Foods?
- Paroxetine may interact with medicines other than the ones already mentioned in this information sheet. These interactions can cause serious side effects. Tell your healthcare professional about all medicines, vitamins, and herbal supplements you take.
- If you plan to drink alcohol, talk to your healthcare professional.
How Do I Take Paroxetine?
- Paroxetine is taken by mouth, with or without food, once a day.
- Swallow paroxetine tablets whole. Do not crush or chew them.
Is There Anything Else I Need to Know?
You can get more information about antidepressants at:
http://www.fda.gov/cder/drug/antidepressants/default.htm
Paxil FDA Approved 1992 Patient Information
Sheet Revised 07/2005 Patient Information Sheet Revised 12/2005 Questions? Call Drug Information,
1-888-INFO-FDA (automated) or 301-827-4570 Druginfo@cder.fda.gov