Facts About Paroxetine Hydrochloride (Paxil)

This is a summary of the most important information about paxil.For details, talk to your healthcare professional.

Paroxetine Hydrochloride (Paxil)-Usage

Paxil is in a class of medicines called selective serotonin reuptake inhibitors (SSRIs).

Paxil 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)

Paxil CR is used to treat:

• Depression

• Panic disorder

• Social anxiety disorder (SAD)

• Premenstrual dysphoric disorder (PMDD)

Paroxetine Hydrochloride (Paxil)-Precautions

• Never take paxil 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 paxil 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 paxil if you are taking Mellaril (thioridazine), used to treat schizophrenia, because it can result in serious heart beat problems.

Paroxetine Hydrochloride (Paxil)-Side Effects

• Suicidal thoughts or actions: See FDA Alert.

• Stopping paxil:Do not stop taking paxil suddenly because you could get side effects. Your healthcare professional will slowly decrease your dose.

• Bleeding problems:paxil 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 paxil close in time with a MAOI.

• Pregnancy: Tell your healthcare professional if you are or may be pregnant because babies delivered to mothers taking paxil 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.

Paroxetine Hydrochloride (Paxil)-Drug Interaction

• Paxil 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.

Paroxetine Hydrochloride (Paxil)-Directions

• Paxil is taken by mouth, with or without food, once a day.

• Swallow paxil tablets whole. Do not crush or chew them.

FDA ALERT [07/2005] – Suicidal Thoughts or Actions in Children and Adults Patients with depression or other mental illnesses often think about or attempt suicide.  Closely watch anyone taking antidepressants, especially early in treatment or when the dose is changed.  Patients who become irritable or anxious, or have new or increased thoughts of suicide or other changes in mood or behavior (or their care givers) should contact their healthcare professional right away. 

Paroxetine Hydrochloride (Paxil)-Children

Taking antidepressants may increase suicidal thoughts and actions in about 1 out of 50 people 18 years or younger.  Although paxil is prescribed for children, FDA has not approved paxil for use in children.

Paroxetine Hydrochloride (Paxil)-Adults

Several recent scientific publications report the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications.  Even before these reports became available, FDA began a complete review of all available data to determine whether there is an increased risk of suicidal thinking or behavior in adults being treated with antidepressant medications.  It is expected that this review will take a year or longer to complete.  In the meantime, FDA is highlighting that adults being treated with antidepressant medication, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior.

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information.

Reference for Paroxetine Hydrochloride (Paxil) Article

U.S. Food and Drug Administration

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