In the U.S.—

In Canada—

• Antianxiety
• antidepressant
• antiobsessional agent
• antipanic agent
• posttraumatic stress disorder therapy agent
• premenstrual dysphoric disorder (PMDD) therapy agent

Sertraline ( SER-tra-leen) is used to treat mental depression, obsessive-compulsive disorder, panic disorder, premenstrual dysphoric disorder, posttraumatic stress disorder, and social anxiety disorder.

Sertraline 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
• Capsules (Canada)
• Tablets (U.S.)
• Oral Concentrate (U.S.)

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 sertraline, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to sertraline. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, dyes, or latex. The dispenser dropper for sertraline oral concentrate contains dry natural rubber.

Pregnancy—Sertraline has not been studied in pregnant women. However, side effects have been reported in babies exposed by their mother during pregnancy. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Sertraline passes into breast milk. Side effects have been reported in a baby exposed during nursing. Before taking this medicine, make sure your doctor knows if you are nursing your baby.

Children—Sertraline has been tested in children 6 to 17 years of age with obsessive-compulsive disorder. In effective doses, this medicine has not been shown to cause different side effects or problems than it does in adults. However, sertraline can cause a decrease in appetite and children who take this medicine for a long time should have their growth and body weight measured by the doctor at regular visits.

Sertraline must be used with caution in children with depression. Studies have shown occurrences of children thinking about suicide or attempting suicide in clinical trials for this medicine. More study is needed to be sure sertraline is safe and effective in children.

Older adults—In studies done to date that have included elderly people, sertraline did not cause different side effects or problems in older people than it did in younger adults. However, this medicine may be removed from the body more slowly in older adults. An older adult may receive a lower dose of sertraline than a younger adult, especially when first starting treatment.

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 sertraline, it is especially important that your health care professional know if you are taking any of the following:

• Astemizole (e.g., Hismanal)—Taking this medicine while you are taking sertraline may lead to a serious change in the rhythm of your heartbeat

• Flecainide (e.g., Tambocor) or
• Propafenone (e.g., Rythmol)—Higher blood levels of these medicines may occur, which may increase the chance of developing unwanted effects. Your doctor may change the dose of these medicines.

• 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], paroxetine [e.g., Paxil]) 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 sertraline 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

• Digitoxin (e.g., Crystodigin) or
• Warfarin (e.g., Coumadin)—Higher or lower blood levels of these medicines or sertraline may occur, which may increase the chance of having unwanted effects. Your doctor may need to change the dose of either these medicines or sertraline

• Disulfiram (e.g., Antabuse)—Disulfiram will react with the alcohol in sertraline oral concentrate and may cause serious problems

• Moclobemide (e.g., Manerex)—The risk of developing serious unwanted effects, including the serotonin syndrome, is increased. Use of moclobemide with sertraline is not recommended. Also, it is recommended that 3 to 7 days be allowed between stopping treatment with moclobemide and starting treatment with sertraline, and it is recommended that 2 weeks be allowed between stopping treatment with sertraline 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 sertraline while you are taking or within 2 weeks of taking an MAO inhibitor. 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. At least 14 days should be allowed between stopping treatment with one medicine (sertraline or the MAO inhibitor) and starting treatment with the other

• Pimozide (e.g., ORAP)—This medicine should not be taken together with sertraline; tell your doctor if you are taking pimozide

• St. John's wort (Hypericum perforatum)—Use of this medicine with sertraline may increase your chance of getting serious side effects.

• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—Higher blood levels of these medicines may occur, which may increase the chance of developing unwanted effects. Your doctor may check the blood level of the tricyclic antidepressant, and may change the dose of either these medicines or sertraline. Also, taking sertraline with amitriptyline, clomipramine, or imipramine may increase the chance of developing the serotonin syndrome

• Bleeding problems, abnormal or
• Purpura, or history of (purplish or brownish-red discoloration of skin)—Sertraline may make these problems worse.

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

• Dehydration or
• Hyponatremia (condition in which your body has too little sodium)—Sertraline may make these problems worse, especially in older adults.

• Heart attack, recent or
• Heart disease, unstable—The medicine has not been studied in patients with these medical problems.

• Kidney disease—It is not known whether the chance of side effects will be increased

• Liver disease—Higher blood levels of sertraline may occur, increasing the chance of side effects. Your doctor may want you to take a lower dose or to take your doses less often than a person without liver disease

• Mania (history of)—May be activated

• Weight loss—Sertraline may cause weight loss. This weight loss is usually small, but if a large weight loss occurs, it may be harmful in some patients

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.

Sertraline may be taken with or without food on a full or empty stomach. This medicine should be taken once a day in the morning or at night. If your doctor tells you to take it a certain way, follow your doctor's instructions.

If you are taking the oral concentrate, mix it with 4 ounces of water, ginger ale, lemon-lime soda, lemonade or orange juice. Take it right away after mixing.

You may have to take sertraline for 4 weeks or longer before you begin to feel better. Your doctor should check your progress at regular visits during this time. Also, if you are taking this medicine for depression, you may need to keep taking it for 6 months or longer to help prevent the return of the depression.

Dosing—

The dose of sertraline 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 sertraline. If your dose is different, do not change it unless your doctor tells you to do so.

Also, the number of capsules or tablets that you take depends on the strength of the medicine and the medical problem for which you are taking sertraline.

• For oral dosage forms (capsules, oral solution or tablets):
  • Adults:
    • For mental depression or obsessive-compulsive disorder: To start, usually 50 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may increase your dose gradually if needed. However, the dose usually is not more than 200 mg a day.
    • For panic disorder, posttraumatic stress disorder, or social anxiety disorder: To start, usually 25 mg once a day, taken either in the morning or evening. Your doctor may increase your dose gradually if needed. However, the dose usually is not more than 200 mg a day.
    • For premenstrual dysphoric disorder: To start, 50 mg once a day throughout your menstrual cycle or just during the premenstrual time. Your doctor may increase your dose if needed. However, the dose usually is not more than 150 mg a day throughout your menstrual cycle or 100 mg a day if you are only taking it during your premenstrual time.
  • Children:
    • For mental depression, posttraumatic stress disorder, or panic disorder: Use and dose must be determined by the doctor.
    • For obsessive-compulsive disorder:
      • Children younger than 6 years old: Use and dose must be determined by the doctor.
      • Children 6 to 12 years old: To start, usually 25 mg once a day, taken either in the morning or evening. Your doctor may increase your dose gradually if needed. However, the dose usually is not more than 200 mg a day.
      • Children 13 to 17 years old: To start, usually 50 mg once a day, taken either in the morning or evening. Your doctor may increase your dose gradually if needed. However, the dose usually is not more than 200 mg a day.
  • Older adults:
    • For mental depression, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, or social anxiety disorder (using capsules or tablets): To start, usually 12.5 to 25 mg once a day, taken either in the morning or evening. Your doctor may increase your dose gradually if needed.

Missed dose—

Because sertraline may be given to different patients at different times of the day, you and your doctor should discuss what to do about any missed doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• 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.

Do not take sertraline with or within 14 days of taking an MAO inhibitor (furazolidone, phenelzine, procarbazine, selegiline, tranylcypromine). Do not take an MAO inhibitor within 14 days of taking sertraline. If you do, you may develop extremely high blood pressure or convulsions (seizures).

Avoid drinking alcoholic beverages while taking sertraline.

This medicine may cause some people to become drowsy, to have trouble thinking, or to have problems with movement. Make sure you know how you react to sertraline before you drive, use machines, or do anything else that could be dangerous if you are not alert or well-coordinated.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely. This is to decrease the chance of having discontinuation symptoms such as agitation, anxiety, dizziness, feeling of constant movement of self or surroundings, headache, increased sweating, nausea, trembling or shaking, trouble in sleeping or walking, or unusual tiredness.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. One rare, but very serious, effect that may occur is the serotonin syndrome. This syndrome (group of symptoms) is more likely to occur shortly after an increase in sertraline dose.

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

• More common
  • Decreased sexual desire or ability;  failure to discharge semen (in men) 
  
  

• Less common or rare
  • Aggressive reaction;  breast tenderness or enlargement;  fast, pounding, irregular, or slow heartbeat;  fast talking and excited feelings or actions that are out of control;  fever;  inability to sit still;  increase in body movements ;  loss of bladder control;  low blood sodium (confusion, convulsions [seizures], drowsiness, dryness of mouth, increased thirst, lack of energy);  muscle spasm or jerking of all extremities;  nose bleeds ;  red or purple spots on skin;  restlessness;  serotonin syndrome (diarrhea, fever, increased sweating, mood or behavior changes, overactive reflexes, racing heartbeat, restlessness, shivering or shaking);  skin rash, hives, or itching;  sudden loss of consciousness ;  unusual or sudden body or facial movements or postures ;  unusual secretion of milk (in females) 
  
  

• Incidence not known
  • Abdominal or stomach pain;  bleeding gums;  blindness;  blistering, peeling, loosening of skin;  bloating;  bloody, black, tarry stools;  blood in urine;  blue-yellow color blindness;  blurred vision;  chest pain or discomfort ;  chills;  clay-colored stools ;  coma;  cough or hoarseness ;  darkened urine;  decreased urine output;  decreased vision;  depressed mood;  difficulty in breathing;  difficulty in speaking;  difficulty swallowing ;  drooling;  dry skin and hair;  eye pain;  fainting ;  feeling cold;  feeling of discomfort;  feeling that others can hear your thoughts;  feeling that others are watching you or controlling your behavior;  feeling, seeing, or hearing things that are not there;  fixed position of eye ;  general feeling of discomfort, illness, tiredness, or weakness;  hair loss;  high fever;  high or low blood pressure;  hoarseness or husky voice;  hostility ;  increased coagulation times;  indigestion;  inflammation of joints;  irritability;  joint or muscle pain;  large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, and sex organs;  lethargy;  light-colored stools;  lightheadedness ;  loss of appetite;  loss of balance control;  loss of bladder control;  lower back or side pain;  muscle aches ;  muscle cramps and stiffness;  muscle trembling, jerking or stiffness;  muscle twitching ;  painful or difficult urination;  pains in stomach, side, or abdomen, possibly radiating to the back;  pale skin;  palpitations;  puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue;  rapid weight gain;  rash;  red, irritated eyes;  red skin lesions often with a purple center;  redness, soreness or itching skin;  right upper abdominal pain and fullness;  seizures;  severe mood or mental changes;  severe muscle stiffness ;  shortness of breath;  shuffling walk;  sore throat;  sores, ulcers, or white spots in mouth or on lips;  sores, welting or blisters;  stiffness of limbs;  stupor;  sweating;  swelling of face, ankles, or hands;  swollen lymph glands;  swollen or painful glands;  talking or acting with excitement you cannot control;  tightness in chest;  troubled breathing;  twisting movements of body;  twitching ;  uncontrolled movements, especially of face, neck, and back;  unexplained bleeding or bruising;  unpleasant breath odor;  unusual behavior ;  unusual tiredness or weakness;  upper right abdominal pain;  vomiting of blood;  weight gain;  wheezing;  yellow eyes and skin 
  
  

• Symptoms of overdose--may be more severe than side effects occurring at regular doses or several may occur together
  • Actions that are out of control;  agitation;  anxiety;  bloating;  blurred vision;  change in consciousness;  chest pain or discomfort;  chills;  coma;  confusion;  confusion as to time or place or person holding false beliefs that cannot be changed by fact;  constipation;  convulsions (seizures);  darkened urine;  decreased awareness or responsiveness;  dizziness or fainting;  drowsiness;  fever;  hallucinations;  headache;  indigestion;  irritability;  lightheadedness;  loss of appetite;  loss of consciousness;  nausea;  nervousness;  pains in stomach, side, or abdomen, possibly radiating to the back;  pounding in ears;  seeing, hearing, or feeling things that are not there;  serotonin syndrome (diarrhea, fever, increased sweating, mood or behavior changes, overactive reflexes, racing heartbeat, restlessness, shivering or shaking);  severe sleepiness;  shakiness in legs, arms, hands, feet;  shortness of breath;  slow or irregular heartbeat;  sweating ;  trembling or shaking of hands or feet;  unusual excitement, or restlessness;  unusual tiredness or weakness;  unusually fast heartbeat ;  unusually large pupils;  vomiting;  yellow eyes or skin 
  
  

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 or weight loss;  diarrhea or loose stools;  dizziness;  drowsiness;  dryness of mouth;  headache;  heartburn;  increased sweating;  nausea;  sleepiness or unusual drowsiness;  stomach or abdominal cramps, gas, or pain;  trembling or shaking;  trouble in sleeping 
  
  

• Less common
  • Agitation, anxiety, or nervousness;  bladder pain;  burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings;  changes in vision, including blurred vision;  cloudy urine;  constipation;  difficult, burning, or painful urination;  flushing or redness of skin, with feeling of warmth or heat;  frequent urge to urinate;  increased appetite;  pain or tenderness around eyes and cheekbones;  stuffy or runny nose;  vomiting 
  
  

• Incidence not known
  • flushed, dry skin;  fruit-like breath odor;  increased hunger;  increased thirst;  increased urination;  redness or other discoloration of skin;  severe sunburn;  swelling of breasts (in women);  unexplained weight loss;  unusual secretion of milk (in women) 
  
  

After you stop taking sertraline or when your dose is decreased, 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;  agitation;  anxiety;  burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings ;  dizziness;  electric shock sensations;  failure to discharge semen (in men);  feeling of constant movement of self or surroundings;  headache;  increased sweating;  nausea;  sleepiness or unusual drowsiness ;  trembling or shaking;  trouble in sleeping;  trouble in walking;  unusual tiredness 

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, sertraline is used in certain patients with the following medical conditions:

• Premature ejaculation