POSSIBLE SIDE EFFECTS

What are the possible side effects of SINGULAIR?

SINGULAIR may cause serious side effects.

Behavior and mood-related changes have been reported. Tell your healthcare provider right away if you or your child have any of these symptoms while taking SINGULAIR:

Increase in certain white blood cells (eosinophils) and possible inflamed blood vessels throughout the body (systemic vasculitis). Rarely, this can happen in people with asthma who take SINGULAIR. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered.

Tell your healthcare provider 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)

The most common side effects with SINGULAIR include:

• upper respiratory infection
• fever
• headache
• sore throat
• cough
• stomach pain
• diarrhea
• earache or ear infection
• flu
• runny nose
• sinus infection

Other side effects 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)
• dizziness, drowsiness, pins and needles/numbness, seizures (convulsions or fits)
• palpitations
• nosebleed, stuffy nose
• diarrhea, heartburn, indigestion, inflammation of the pancreas, nausea, stomach or intestinal upset, vomiting
• hepatitis
• bruising, rash
• joint pain, muscle aches, and muscle cramps
• tiredness, swelling

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of SINGULAIR. For more information ask your healthcare provider or pharmacist.

ADDITIONAL SAFETY INFORMATION

• You or your child should not take SINGULAIR for relief right away from a sudden asthma attack. Always have your or your child's rescue inhaler medicine with you for asthma attacks. Tell your healthcare provider right away if your or your child's asthma symptoms get worse or if you need, or your child needs, to use rescue inhaler medicine more often for asthma attacks.
• Do not stop taking or lower the dose of your other asthma medicines unless your health care provider tells you to.
• If you have asthma and aspirin makes your asthma symptoms worse, continue to avoid taking aspirin and talk with your healthcare provider.
• Parents or guardians of a child with phenylketonuria: Note that cherry chewable tablets contain phenylalanine, a component of aspartame.
• 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 healthcare provider.
The physician Prescribing Information also is available.

This site is intended only for residents of the United States, its territories, and Puerto Rico.
For non-US health care professionals, click here.