Montelukast Side Effects

Brand Names: Singulair

Please note - some side effects for Montelukast may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Montelukast - for the Consumer

Montelukast

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Montelukast:

Cough; dizziness; headache; indigestion; nausea; stomach upset or pain; stuffy nose; tiredness; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); aggressive behavior; agitation; chest pain; dark urine; disorientation; fever; flu-like symptoms; hallucinations; irregular heartbeat; mental or mood changes; new or worsening wheezing or other breathing problems; numbness or tingling of the hands or feet; seizures; severe or persistent stomach pain; severe sinus inflammation; suicidal thoughts or actions; swelling; tremor; unusual bruising or bleeding; upper respiratory tract infection; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Montelukast Chewable Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Montelukast Chewable Tablets:

Cough; dizziness; headache; indigestion; nausea; stomach upset or pain; stuffy nose; tiredness; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); aggressive behavior; agitation; chest pain; dark urine; disorientation; fever; flu-like symptoms; hallucinations; irregular heartbeat; mental or mood changes; new or worsening wheezing or other breathing problems; numbness or tingling of the hands or feet; seizures; severe or persistent stomach pain; severe sinus inflammation; suicidal thoughts or actions; swelling; tremor; unusual bruising or bleeding; upper respiratory tract infection; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Montelukast Granules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Montelukast Granules:

Cough; dizziness; headache; indigestion; nausea; stomach upset or pain; stuffy nose; tiredness; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); aggressive behavior; agitation; chest pain; dark urine; disorientation; fever; flu-like symptoms; hallucinations; irregular heartbeat; mental or mood changes; new or worsening wheezing or other breathing problems; numbness or tingling of the hands or feet; seizures; severe or persistent stomach pain; severe sinus inflammation; suicidal thoughts or actions; swelling; tremor; unusual bruising or bleeding; upper respiratory tract infection; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects have included headache (18% to 20%) and dizziness (2%). Isolated and rare reports of somnolence have been associated with the use of higher than recommended doses. Seizures have been reported very rarely. Paresthesias, hypoesthesia, and drowsiness and have been reported in postmarketing experiences.

Respiratory

Respiratory system side effects have included influenza (4%), cough (3%), and nasal congestion (2%). In some studies, upper respiratory tract infection (28%) and worsened asthma (4% to 11%) were associated with the use of this drug. However, many patients with asthma have some or all of these symptoms, and a causal relationship has not been proven. Rhinorrhea, sinusitis, otitis, influenza, epistaxis, and pneumonia have also been reported.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain, dyspepsia, or infectious gastroenteritis in up to 3% of patients. Diarrhea has been associated with the use of higher than recommended doses.

General

In general, montelukast is well tolerated. Asthenia, fatigue, or fever has been associated with the use of this drug in approximately 2% of patients. Varicella has also been reported.

Dermatologic

Dermatologic side effects have included rash, eczema, urticaria, and dermatitis.

Churg-Strauss syndrome has been reported in association with montelukast therapy.

Hepatic

Postmarketing experience has reported rare cases of cholestatic hepatitis, hepatocellular liver injury and mixed pattern liver injury.

Hepatic side effects have included elevated hepatic serum transaminases in approximately 2% of patients. Pancreatitis has been reported very rarely. Jaundice with elevated liver enzymes are described in a 42 year old man several months after starting montelukast therapy. Serum enzymes completely normalized 4 months after drug withdrawal.

Other

Churg-Strauss syndrome is a rare granulomatous eosinophilic condition that involves the upper and lower airways and manifests as rhinitis, sinusitis and asthma. If untreated the syndrome may progress to systemic vasculitis, peripheral neuropathy and potentially fatal cardiac complications. In most cases, the condition emerged during withdrawal of oral corticosteroid therapy. A causative role for leukotriene receptor antagonists has not been ruled out.

Other side effects have included isolated cases of Churg-Strauss syndrome, a rare systemic vasculitis associated with asthma.

Musculoskeletal

Musculoskeletal side effects have included myalgia, muscle cramps, and muscle aches. Postmarketing experience has reported arthralgia.

Hematologic

Hematologic side effects have included increased bleeding tendencies and bruising. Thrombocytopenia has also been reported.

Ocular

Ocular side effects have included conjunctivitis.

Psychiatric

Psychiatric side effects have included agitation including aggressive behavior, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. Postmarketing reports include agitation, hostility, insomnia, and somnambulism.

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis, erythema nodosum, pruritus, urticaria, and very rarely hepatic eosinophilic infiltration. Postmarketing reports have included angioedema.

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