In the U.S.—

In Canada—

• Antianxiety agent
• antidepressant
• anti-obsessional agent
• antipanic agent
• posttraumatic stress disorder agent
• social anxiety disorder agent

Paroxetine (pa-ROX-uh-teen) is used to treat mental depression, obsessive-compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder (also known as social phobia), premenstrual dysphoric disorder (PMDD), and posttraumatic stress disorder (PTSD).

Paroxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of the chemical serotonin in the brain.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Oral
• Extended-release tablets (U.S.)
• Oral suspension (U.S.)
• Tablets (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For paroxetine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to paroxetine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Paroxetine has not been well studied in pregnant women. Paroxetine should only be used during pregnancy if the potential benefit outweighs the potential risk to the baby. Before taking this medicine, make sure your doctor knows if you are pregnant (especially if it is the third trimester) or if you may become pregnant.

Breast-feeding—Paroxetine passes into the breast milk. However, the effects of this medicine in nursing babies are not known. Caution should be used if you are breast-feeding.

Children—Paroxetine has not be shown to be safe and effective in children or adolescents, 18 years of age or younger. Children may be especially sensitive to the effects of paroxetine for the treatment of depression. This may increase the chance of a child planning to commit suicide or attempting to commit suicide. Talk to your doctor about the risks and benefits of taking this medication.

Older adults—In studies that have included elderly people, paroxetine did not cause different side effects or problems in older people than it did in younger adults. However, paroxetine may be removed from the body more slowly in elderly people. An older adult may need a lower dose than a younger adult.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking paroxetine, it is especially important that your health care professional know if you are taking any of the following:

• Aspirin or
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (celecoxib [e.g., Celebrex], diclofenac [e.g., Voltaren], diflunisal [e.g., Dolobid], etodolac [e.g., Lodine], fenoprofen [e.g., Nalfon], flurbiprofen [e.g., Ansaid], ibuprofen [e.g., Advil, Motrin, Nuprin], indomethacin [e.g., Indocin], ketoprofen [e.g., Orudis, Oruvail], ketorolac [e.g., Toradol], meclofenamate [e.g., Meclomen], mefenamic acid [e.g., Ponstel], meloxicam [e.g., Mobic], nabumatone [e.g., Relafen], naproxen [e.g., Aleve, Anaprox, Naprosyn], oxaprozin [e.g., Daypro], phenylbutazone, piroxicam [e.g., Feldene], rofecoxib [e.g., Vioxx], sulindac [e.g., Clinoril], tolmetin [e.g., Tolectin], valdecoxib [e.g., Bextra])—Taking any of these medicines with paroxetine may cause bleeding problems.

• Buspirone (e.g., BuSpar) or
• Bromocriptine (e.g., Parlodel) or
• Dextromethorphan (cough medicine) or
• Levodopa (e.g., Sinemet) or
• Lithium (e.g., Eskalith) or
• Meperidine (e.g., Demerol) or
• Nefazodone (e.g., Serzone) or
• Pentazocine (e.g., Talwin) or
• Selective serotonin reuptake inhibitors, other (citalopram [e.g., Celexa], fluoxetine [e.g., Prozac], fluvoxamine [e.g., Luvox], sertraline [Zoloft]) or
• Street drugs (LSD, MDMA [e.g., ecstasy], marijuana) or
• Sumatriptan (e.g., Imitrex) or
• Tramadol (e.g., Ultram) or
• Trazodone (e.g., Desyrel) or
• Tryptophan or
• Venlafaxine (e.g., Effexor)—Using these medicines with paroxetine may increase the chance of developing a rare, but very serious, unwanted effect known as the serotonin syndrome. This syndrome may cause confusion, diarrhea, fever, poor coordination, restlessness, shivering, sweating, talking or acting with excitement you cannot control, trembling or shaking, or twitching. If you develop these symptoms, contact your doctor as soon as possible.

• Moclobemide (e.g., Manerix)—The risk of developing serious unwanted effects, including the serotonin syndrome, is increased. Use of moclobemide with paroxetine is not recommended. Also, it is recommended that 3 to 7 days be allowed between stopping treatment with moclobemide and starting treatment with paroxetine, and that 2 weeks be allowed between stopping treatment with paroxetine and starting treatment with moclobemide

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])— Do not take paroxetine while you are taking or within 2 weeks of taking an MAO inhibitor, or you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, severe convulsions, or the serotonin syndrome. At least 14 days should be allowed between stopping treatment with one medicine (paroxetine or the MAO inhibitor) and starting treatment with the other

• St. John's Wort—Taking this medication with paroxetine may increase the chance of side effects.

• Thioridazine (e.g., Mellaril)—Taking thioridazine with paroxetine may cause serious heart problems.

• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Norpramin], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—Taking a tricyclic antidepressant together with paroxetine may increase the risk of side effects. Your doctor may need to adjust the dose of either medicine or check blood levels of the tricyclic antidepressant. Also, taking paroxetine with amitriptyline, clomipramine, or imipramine may increase the chance that the serotonin syndrome will develop

• Warfarin (e.g., Coumadin) or other medications that prevent the blood from clotting—Taking these medicines with paroxetine may cause bleeding problems.

• Bipolar disorder (mood disorder with alternating episodes of mania and depression) or risk of—May make condition worse. Your doctor will check you for this condition.

• Brain disease or damage or
• Mental retardation or
• Epilepsy or seizures (history of)—The risk of seizures may be increased.

• Glaucoma, narrow angle—Patients with this condition should use paroxetine with caution.

• Heart disease or
• Heart attack, recent—Use must be determined by your doctor.

• Kidney disease, severe, or
• Liver disease, severe—Higher blood levels of paroxetine may occur, increasing the chance of side effects

• Mania (history of)—The condition may be activated

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Paroxetine may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

You may have to take paroxetine for several weeks before you begin to feel better. Your doctor should check your progress at regular visits during this time. Also, if you are taking paroxetine for depression, you will probably need to continue taking it for at least 6 months to help prevent the depression from returning.

If you are taking the oral suspension form of paroxetine, shake the bottle well before measuring each dose. Use a small measuring cup or a measuring spoon to measure each dose. The teaspoons and tablespoons that are used for serving and eating food do not measure exact amounts.

If you are taking the extended-release tablet form of this medicine, swallow the tablet whole. Do not crush, break, or chew before swallowing.

Dosing—

The dose of paroxetine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of paroxetine. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral suspension dosage form:
  • For treatment of depression:
    • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg (25 mL) a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.
  • For treatment of generalized anxiety disorder:
    • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg (25 mL) a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.
  • For treatment of obsessive-compulsive disorder:
    • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg (30 mL) a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.
  • For treatment of panic disorder:
    • Adults—At first, 10 milligrams (mg) (5 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg (30 mL) a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.
  • For treatment of posttraumatic stress disorder:
    • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg (25 mL) a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.
  • For treatment of social anxiety disorder:
    • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg (30 mL) a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.

• For oral tablet dosage form:
  • For treatment of depression:
    • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
  • For treatment of generalized anxiety disorder:
    • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
  • For treatment of obsessive-compulsive disorder:
    • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
  • For treatment of panic disorder:
    • Adults—At first, 10 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
  • For treatment of posttraumatic stress disorder:
    • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
  • For treatment of social anxiety disorder:
    • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.

• For oral extended-release tablet dosage form:
  • For treatment of depression:
    • Adults—At first, 25 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 62.5 mg a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 12.5 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg a day.
  • For treatment of panic disorder:
    • Adults—At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 75 mg a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 12.5 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg a day.
  • For treatment of social anxiety disorder:
    • Adults—At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 37.5 mg a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 12.5 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 37.5 mg a day.
  • For treatment of premenstrual dysphoric disorder:
    • Adults—At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 25 mg a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the oral suspension form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is important that your doctor check your progress at regular visits, to allow for changes in your dose and to help reduce any side effects.

Tell your doctor right away if you develop any allergic reactions, such as skin rash or hives, while taking paroxetine.

Paroxetine may cause some people to be agitated, irritable or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away.

Do not suddenly stop taking your paroxetine. If you have been instructed to stop taking paroxetine, ask you healthcare professional how to slowly decrease the dose. This is to decrease the chance of having discontinuation symptoms such as agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or light-headedness, fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble in sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

Do not take paroxetine if you have taken a monoamine oxidase (MAO) inhibitor (furazolidone, phenelzine, procarbazine, selegiline, tranylcypromine) in the past 2 weeks. Do not start taking an MAO inhibitor within 2 weeks of stopping paroxetine. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, severe convulsions, or the serotonin syndrome.

Paroxetine has not been shown to add to the effects of alcohol. However, use of alcohol is not recommended in patients who are taking paroxetine.

Paroxetine may cause some people to become drowsy or have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see clearly.

Along with its needed effects, a medicine may cause some unwanted effects. One rare but serious unwanted effect that may occur with paroxetine use is the serotonin syndrome. This syndrome (group of symptoms) is more likely to occur shortly after the dose of paroxetine is increased.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Less common
  • Agitation;  chest congestion;  chest pain;  chills;  cold sweats;  confusion;  difficulty breathing;  dizziness, faintness, or lightheadedness when getting up from a lying or sitting position;  fast, pounding, or irregular heartbeat or pulse;  muscle pain or weakness;  skin rash 
  
  

• Rare
  • Absence of or decrease in body movements;  bigger, dilated, or enlarged pupils [black part of eye];  difficulty in speaking;  inability to move eyes;  incomplete, sudden, or unusual body or facial movements;  increased sensitivity of eyes to light;  low blood sodium (confusion, convulsions [seizures], drowsiness, dryness of mouth, increased thirst, lack of energy);  red or purple patches on skin;  serotonin syndrome (confusion, diarrhea, fever, poor coordination, restlessness, shivering, sweating, talking and acting with excitement you cannot control, trembling or shaking, twitching) ;  talking, feeling, and acting with excitement and activity you cannot control 
  
  

• Incidence not determined
  • Back, leg, or stomach pains;  bleeding gums;  blindness;  blistering, peeling, loosening of skin;  bloated, full feeling ;  bloody or black, tarry stools;  bloody urine;  blue-yellow color blindness;  blurred vision;  coma;  constipation;  cough or hoarseness;  dark urine;  decreased frequency or amount of urine ;  decreased vision;  depression ;  difficulty opening the mouth;  difficulty swallowing;  electric shock sensations ;  epileptic seizure that will not stop;  excessive muscle tone;  eye pain;  fainting;  fixed position of eye;  fluid-filled skin blisters;  general body swelling;  general feeling of tiredness or weakness ;  headache;  high fever;  hives;  inability to move arms and legs ;  inability to sit still;  increased blood pressure;  increased sweating;  increased thirst;  incremental or ratchet-like movement of muscle;  indigestion;  itching skin;  joint pain;  lab results that show problems with liver;  light-colored stools;  lockjaw;  loss of appetite;  loss of bladder control;  low blood pressure;  lower back or side pain;  muscle spasm, especially of neck and back;  muscle tension or tightness;  nausea;  need to keep moving;  nosebleeds;  painful knees and ankles;  painful or difficult urination;  painful or prolonged erection of the penis;  pale skin;  puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue ;  raised red swellings on the skin, the buttocks, legs, or ankles;  red irritated eyes;  rigid muscles;  seizure or coma late in pregnancy;  sensitivity to the sun;  skin redness or soreness;  skin sores, welts or blisters;  skin thinness;  sore throat;  sores, ulcers, or white spots on lips or in mouth;  swelling of breasts;  swollen or painful glands;  shortness of breath;  slow heart rate;  slow movement;  slow reflexes;  spasms of throat;  stiff muscles;  stomach pain;  sudden numbness and weakness in the arms and legs;  swelling of face, fingers, lower legs;  tightness in chest;  unexpected or excess milk flow from breasts;  unusual bleeding or bruising;  unusual or decreased blood cell production;  unusual tiredness or weakness;  vomiting;  weight gain;  wheezing;  yellowing of the eyes or skin 
  
  

• Symptoms of overdose
  • Dizziness;  drowsiness;  dryness of mouth;  flushing of face;  irritability;  large pupils;  nausea;  racing heartbeat;  trembling or shaking;  vomiting 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Acid or sour stomach;  belching;  decreased appetite;  decreased sexual ability or desire;  excess air or gas in stomach or intestines;  heartburn;  nervousness;  pain or tenderness around eyes and cheekbones ;  passing gas;  problems in urinating;  runny or stuffy nose;  sexual problems, especially ejaculatory disturbances;  sleepiness or unusual drowsiness;  stomach discomfort, upset, or pain;  sweating;  trauma;  trembling or shaking;  trouble in sleeping 
  
  

• Less common
  • Abnormal dreams;  anxiety;  bladder pain;  body aches or pain;  change in sense of taste;  changes in vision;  cloudy urine;  confusion ;  congestion;  difficulty in focusing eyes;  difficulty in moving;  discouragement, feeling sad or empty;  drugged feeling;  dryness of throat;  excessive muscle tone;  fainting or loss of consciousness;  fast or irregular breathing;  feeling of unreality;  feeling of warmth or heat;  flushing or redness of skin, especially on face and neck;  frequent urge to urinate;  headache, severe and throbbing;  heavy bleeding;  increase in body movements;  increased appetite;  irritability;  itching, pain, redness, or swelling of eye or eyelid;  itching of the vagina or genital area;  lack of emotion;  loss of interest or pleasure;  loss of memory;  lump in throat;  menstrual changes;  menstrual pain or cramps;  muscle twitching or jerking;  pain during sexual intercourse;  problems with memory;  problems with tooth;  rhythmic movement of muscles;  sense of detachment from self or body;  severe sunburn;  slow heartbeat;  sneezing;  thick, white vaginal discharge with no odor or with a mild odor;  tightness in throat;  tingling, burning, or prickling sensations;  trouble concentrating;  voice changes;  watering of eyes;  weight loss;  yawn 
  
  

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any of the following side effects:

• Abnormal dreams;  actions that are out of control;  agitation, confusion, or restlessness ;  burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings;  crying ;  depersonalization;  diarrhea ;  dizziness or light-headedness;  dysphoria;  electric shock sensations;  euphoria;  fear;  feeling unwell or unhappy;  headache;  increased sweating;  irritability;  mental depression;  muscle pain;  nausea or vomiting;  nervousness;  paranoia;  quick to react or overreact emotionally;  rapidly changing moods;  runny nose;  talking, feeling, and acting with excitement;  trembling or shaking;  trouble in sleeping;  unusual drowsiness, dullness or feeling of sluggishness;  unusual tiredness or weakness;  vision changes 

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.