Brand Names: Paxil, Paxil CR, Pexeva

Generic Name: paroxetine (Pronunciation: pa ROX a teen)

• What is paroxetine (Paxil)?
• What are the possible side effects of paroxetine (Paxil)?
• What is the most important information I should know about paroxetine (Paxil)?
• What should I discuss with my healthcare provider before taking paroxetine (Paxil)?
• How should I take paroxetine (Paxil)?
• What happens if I miss a dose (Paxil)?
• What happens if I overdose (Paxil)?
• What should I avoid while taking paroxetine (Paxil)?
• What other drugs will affect paroxetine (Paxil)?
• Where can I get more information?

What is paroxetine (Paxil)?

Paroxetine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Paroxetine affects chemicals in the brain that may become unbalanced.

Paroxetine is used to treat depression, obsessive-compulsive disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).

Paroxetine may also be used for other purposes not listed in this medication guide.

Paroxetine 10 mg-AND

round, white, imprinted with P1, G

Paroxetine 10 mg-APO

oblong, white, imprinted with APO, 097

Paroxetine 10 mg-PAR

oval, white, imprinted with par 876

Paroxetine 10 mg-TEV

round, yellow, imprinted with 7114, 9 3

Paroxetine 20 mg-AND

round, white, imprinted with P 2, G

Paroxetine 20 mg-APO

oblong, white, imprinted with APO, 083

Paroxetine 20 mg-PAR

oval, white, imprinted with par 877

Paroxetine 20 mg-TEV

round, pink, imprinted with 7115, 9 3

Paroxetine 30 mg-APO

oblong, white, imprinted with APO, 084

Paroxetine 30 mg-PAR

oval, white, imprinted with par 878

Paroxetine 30 mg-TEV

round, blue, imprinted with 7116, 93

Paroxetine 40 mg-APO

oval, white, imprinted with 101, APO

Paroxetine 40 mg-PAR

oval, white, imprinted with par 879

Paroxetine 40 mg-TEV

round, green, imprinted with 7121, 93

Paxil 10 mg

oblong, yellow, imprinted with PAXIL, 10

Paxil 20 mg

oblong, pink, imprinted with PAXIL, 2 0

Paxil 30 mg

oblong, blue, imprinted with PAXIL, 30

Paxil 40 mg

oblong, green, imprinted with PAXIL, 40

Paxil CR 12.5 mg

round, yellow, imprinted with PAXIL CR, 12.5

Paxil CR 25 mg

round, pink, imprinted with PAXIL CR, 25

Paxil CR 37.5 mg

round, blue, imprinted with PAXIL CR, 37.5

What are the possible side effects of paroxetine (Paxil)?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Contact your doctor promptly if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and/or physical hyperactivity), thoughts of suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• easy bruising or bleeding (such as a nosebleed);
• very stiff (rigid) muscles, high fever, sweating, fast or uneven heartbeats, tremors, overactive reflexes;
• nausea, vomiting, diarrhea, loss of appetite, feeling unsteady, loss of coordination; or
• headache, trouble concentrating, memory problems, weakness, confusion, hallucinations, fainting, seizure, shallow breathing or breathing that stops.

Less serious side effects may include:

• feeling nervous;
• drowsiness, dizziness;
• sleep problems (insomnia);
• mild nausea, constipation;
• weight changes;
• decreased sex drive, impotence, or difficulty having an orgasm; or
• dry mouth, yawning, or ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about paroxetine (Paxil)?

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Paroxetine may cause heart defects or serious, life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking paroxetine, do not stop taking the medication without first talking to your doctor.

Do not take paroxetine together with pimozide (Orap), thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).