Possible Side Effects of SINGULAIR® (montelukast sodium) for Children
Merck Sharp & Dohme Corp., a subsidiary of Merck and Co., Inc.

POSSIBLE SIDE EFFECTS

What are the possible side effects of SINGULAIR? The side effects of SINGULAIR are usually mild and generally did not cause patients to stop taking their medicine. The side effects in patients treated with SINGULAIR were similar in type and frequency to side effects in patients who were given a placebo (a pill containing no medicine).

The most common side effects with SINGULAIR include:

  • stomach pain
  • stomach or intestinal upset
  • heartburn
  • tiredness
  • fever
  • stuffy nose
  • cough
  • flu
  • upper respiratory infection
  • dizziness
  • headache
  • rash

Less common side effects that have happened with SINGULAIR include:

  • increased bleeding tendency
  • allergic reactions (including swelling of the face, lips, tongue, and/or throat [which may cause trouble breathing or swallowing], hives, itching)
  • drowsiness, pins and needles/numbness, seizures (convulsions or fits)
  • palpitations
  • nosebleed
  • diarrhea, indigestion, inflammation of the pancreas, nausea, vomiting
  • hepatitis
  • bruising
  • joint pain, muscle aches, muscle cramps
  • swelling

Behavior and mood-related changes have been reported, including agitation, aggression or anger, bad or vivid dreams, depression, anxiety, hallucinations (seeing things that are not there), irritability, restlessness, sleepwalking, suicidal thoughts and actions (including suicide), trembling, and trouble sleeping. Tell your doctor if you experience behavior or mood-related changes while taking SINGULAIR.

Rarely, asthmatic patients taking SINGULAIR have experienced a condition that includes certain symptoms that do not go away or that get worse. These occur usually, but not always, in patients who were taking steroid pills by mouth for asthma and those steroids were being slowly lowered or stopped. Although SINGULAIR has not been shown to cause this condition, you must tell your doctor right away if you get one or more of these symptoms:

  • a feeling of pins and needles or numbness of arms or legs
  • a flulike illness
  • rash
  • severe inflammation (pain and swelling) of the sinuses (sinusitis)

These are not all the possible side effects of SINGULAIR. For more information, ask your doctor or pharmacist.

Talk to your child's doctor if you think your child has side effects from taking SINGULAIR.

SINGULAIR is a prescription medicine approved to help control symptoms of asthma in adults and children 12 months and older.

IMPORTANT SAFETY INFORMATION

  • SINGULAIR is not a rescue medication. Always carry a prescribed rescue inhaler for emergencies or sudden symptoms. If your or your child’s asthma symptoms get worse or there is a need to increase the use of fast-acting medicines, call the doctor at once.
  • Side effects vary by age and may include headache, ear infection, sore throat, and upper respiratory infection. Behavior and mood-related changes have been reported, including agitation, aggression or anger, bad or vivid dreams, depression, anxiety, hallucinations (seeing things that are not there), irritability, restlessness, sleepwalking, suicidal thoughts and actions (including suicide), trembling, and trouble sleeping. Tell the doctor if you have, or your child has, these or any other side effects while taking SINGULAIR.
  • SINGULAIR should not be taken by people who are sensitive to any of its ingredients.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please read the Patient Information and discuss it with your doctor. The physician Prescribing Information also is available.

SINGULAIR is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of  Merck & Co., Inc.
20852779(1)-02/10-SNG

 

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