Paxil CR is a selective serotonin reuptake inhibitor (SSRI) antidepressant.

Paxil CR is used to treat depression, including major depressive disorder.

Paxil CR is also used to treat panic disorder, obsessive-compulsive disorder (OCD), anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).

The Brisdelle brand of paroxetine is used to treat hot flashes related to menopause. Brisdelle is not for treating any other conditions.

Paxil CR may also be used for purposes not listed in this medication guide.

You should not use Paxil CR if you are also taking pimozide or thioridazine.

Do not use Paxil CR within 14 days before or 14 days after you have used an MAO inhibitor, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor

Seek medical attention right away if you have symptoms such as: agitation, hallucinations, muscle stiffness, twitching, loss of coordination, dizziness, warmth or tingly feeling, nausea, vomiting, diarrhea, fever, sweating, tremors, racing heartbeats, or a seizure (convulsions).

Do not stop using Paxil CR without first asking your doctor.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Swallow the extended-release tablet whole and do not crush, chew, or break it.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Tell your doctor if you have any changes in sexual function, such as loss of interest in sex, trouble having an orgasm, or (in men) problems with erections or ejaculation. Some sexual problems can be treated.

Do not stop using Paxil CR suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture, heat, and light.

You should not use Paxil CR if you are allergic to Paxil CR, or if you are also taking pimozide or thioridazine.

Do not use an MAO inhibitor within 14 days before or 14 days after you take Paxil CR. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. After you stop taking this medicine you must wait at least 14 days before you start taking an MAO inhibitor.

Tell your doctor if you have ever had:

• heart disease, high blood pressure, or a stroke;

• liver or kidney disease;

• a bleeding or blood clotting disorder;

• seizures or epilepsy;

• bipolar disorder (manic depression), drug addiction, or suicidal thoughts;

• sexual problems;

• narrow-angle glaucoma; or

• low levels of sodium in your blood.

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with Paxil CR and cause a serious condition called serotonin syndrome.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking an SSRI antidepressant during pregnancy may cause serious lung problems or other complications in the baby. However, you may have a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant. Do not start or stop taking this medicine without your doctor's advice.

Do not use Brisdelle if you are pregnant.

You should not breastfeed while using this medicine.

Paxil CR is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Paxil CR can be fatal.

Avoid driving or hazardous activity until you know how Paxil CR will affect you. Your reactions could be impaired.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with Paxil CR may cause you to bruise or bleed easily.

Drinking alcohol with this medicine can cause side effects.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Report any new or worsening symptoms to your doctor, 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.

Paxil CR may cause serious side effects. Call your doctor at once if you have:

• racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual;

• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;

• unusual bone pain or tenderness, swelling or bruising;

• changes in weight or appetite;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), coughing up blood;

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, fainting; or

• low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, loss of coordination, feeling unsteady.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects of Paxil CR may include:

• vision changes;

• weakness, drowsiness, dizziness, tiredness;

• sweating, anxiety, shaking;

• sleep problems (insomnia);

• loss of appetite, nausea, vomiting, diarrhea, constipation;

• dry mouth, yawning;

• infection;

• headache; or

• decreased sex drive, impotence, abnormal ejaculation, or difficulty having an orgasm.

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.

Using Paxil CR with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• cimetidine (Tagamet), digoxin, St. John's wort, tamoxifen, theophylline, tryptophan (sometimes called L-tryptophan), warfarin (Coumadin, Jantoven);

• a diuretic or "water pill";

• heart rhythm medicine;

• HIV or AIDS medications;

• certain medicines to treat narcolepsy or ADHD--amphetamine, atomoxetine, dextroamphetamine, Adderall, Dexedrine, Evekeo, Vyvanse, and others;

• narcotic pain medicine--fentanyl, tramadol;

• medicine to treat anxiety, mood disorders, thought disorders, or mental illness--such as buspirone, lithium, other antidepressants, or antipsychotics;

• migraine headache medicine--sumatriptan, rizatriptan, zolmitriptan, and others; or

• seizure medicine--phenobarbital, phenytoin.

This list is not complete. Other drugs may interact with paroxetine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.