How SINGULAIR Works: 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:

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 and itching)
• drowsiness, pins and needles/numbness, and seizures (convulsions or fits)
• palpitations
• nose bleed
• diarrhea, indigestion, inflammation of the pancreas, nausea, and vomiting
• hepatitis
• bruising
• joint pain, muscle aches, and muscle cramps
• swelling

Behavior and mood-related changes have been reported: agitation including aggressive behavior or anger, bad/vivid dreams, depression, feeling anxious, hallucinations (seeing things that are not there), irritability, restlessness, sleepwalking, suicidal thoughts and actions (including suicide), tremor, 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 flu like 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 doctor if you think you have side effects from taking SINGULAIR.

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.

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