Paroxetine is an antidepressant that belongs to group of drugs called selective serotonin reuptake inhibitors (SSRIs). Paroxetine affects chemicals in the brain that may be unbalanced in people with depression, anxiety, or other disorders.

Paroxetine is used to treat depression, including major depressive disorder.

Paroxetine 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.

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

Do not use paroxetine 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 paroxetine without first asking your doctor.

Paroxetine comes as a tablet, a suspension (liquid), a controlled-release (long-acting) tablet, and a capsule to take by mouth. The tablets, suspension, and controlled-release tablets are usually taken once daily in the morning or evening, with or without food. The capsules are usually taken once a day at bedtime with or without food. You may want to take paroxetine with food to prevent stomach upset. Take paroxetine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take paroxetine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake the liquid well before each use to mix the medication evenly.

Swallow the extended-release and regular tablets whole; do not chew or crush them.

If you are taking paroxetine tablets, suspension, or controlled-release tablets, your doctor may start you on a low dose of paroxetine and gradually increase your dose, not more than once a week.

Paroxetine capsules contain a lower dose of paroxetine than is needed to treat depression and other forms of mental illness. Do not take paroxetine capsules to treat a mental illness. If you think you have depression or another mental illness, talk to your doctor about treatment.

Paroxetine may help control your symptoms but will not cure your condition. It may take several weeks or longer before you feel the full benefit of paroxetine. Continue to take paroxetine even if you feel well. Do not stop taking paroxetine without talking to your doctor. Your doctor may decrease your dose gradually. If you suddenly stop taking paroxetine tablets, suspension, or controlled-release tablets, you may experience withdrawal symptoms such as depression; mood changes; frenzied or abnormally excited mood; irritability; anxiety; confusion; dizziness; headache; tiredness; numbness or tingling in the arms, legs, hands, or feet; unusual dreams; difficulty falling asleep or staying asleep; nausea; or sweating. Tell your doctor if you experience any of these symptoms when your dose of paroxetine is decreased.

Take paroxetine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

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 paroxetine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using paroxetine. Follow your doctor's instructions about tapering your dose.

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

You should not use this medicine if you are allergic to paroxetine, 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 paroxetine. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. After you stop taking paroxetine you must wait at least 14 days before you start taking an MAO inhibitor.

To make sure paroxetine is safe for you, tell your doctor if you have:

• 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 paroxetine 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.

Paroxetine 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 paroxetine can be fatal.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid driving or hazardous activity until you know how paroxetine 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 paroxetine 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 to paroxetine (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.

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 paroxetine side effects 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 paroxetine 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.

Keep all appointments with your doctor.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are taking paroxetine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.