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
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- tiredness
- fever
- stuffy nose
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- cough
- flu
- upper respiratory infection
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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)
- behavior and mood-related changes (agitation including aggressive
behavior, bad/vivid dreams, depression, feeling anxious, hallucinations [seeing things that are not there], irritability, restlessness, suicidal thoughts and actions [including suicide], tremor, and trouble sleeping)
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- drowsiness, pins and needles/numbness, and seizures (convulsions or fits)
- palpitations
- nosebleed
- diarrhea, indigestion, inflammation of the pancreas, nausea, and vomiting
- hepatitis
- bruising
- joint pain, muscle aches, and muscle cramps
- swelling
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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
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- rash
- severe inflammation (pain and swelling) of the sinuses (sinusitis)
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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.
SINGULAIR for asthma
SINGULAIR helps prevent asthma symptoms before they start by providing effective 24-hour control in a once-a-day tablet. LEARN MORE. |
SINGULAIR for indoor and outdoor allergies
SINGULAIR works differently to help provide relief from indoor and outdoor allergy symptoms. SINGULAIR is the only indoor and outdoor allergy medicine that blocks leukotrienes — an underlying cause of allergy symptoms. LEARN MORE. |
SINGULAIR is a prescription medicine approved to help control symptoms of asthma in adults and children 12 months and older and for relief of symptoms of indoor and outdoor allergies (outdoor allergies in adults and children as young as 2 years and indoor allergies in adults and children as young as 6 months).
IMPORTANT SAFETY INFORMATION: SINGULAIR is not a rescue medication. Always carry a prescribed rescue inhaler for emergencies or sudden symptoms. For asthma, SINGULAIR should be taken once a day, in the evening as prescribed, whether or not you have asthma symptoms. If your asthma symptoms get worse or you need to increase the use of your rescue inhaler, call your doctor at once.
Side effects are generally mild and vary by age, and may include headache, ear infection, sore throat, and upper respiratory infection. Check with your doctor if you are pregnant or nursing.
SINGULAIR should not be taken by people who are sensitive to any of its ingredients.
SINGULAIR has not been studied as a treatment option for both conditions in the same person.
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.