Montelukast has been generally well tolerated. Side effects, which usually were mild, generally did not require discontinuation of therapy.
palpitations, allergic granulomatosis angiitis (Systemic eosinophilia with vasculitis and a clinical presentation consistent with Churg-Strauss. Symptoms may include eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications and/or neuropathy).
Skin and subcutaneous tissue disorders:
angioedema, bruising, erythema nodosum, atopic dermatitis, eczema, infection of skin and/or subcutaneous tissue, rash, urticaria.
abdominal pain, dental pain, diarrhea, gastroenteritis, indigestion, infection of tooth, nausea, pancreatitis, tonsillitis, vomiting.
blood coagulation disorder (increased bleeding tendency).
ALT/ AST levels raised, cholestatic hepatitis.
hypersensitivity reactions, including anaphylaxis, varicella, and viral infection.
asthenia, disorientated, dizziness, headache, hyperactive behavior, hypesthesia, insomnia, paresthesia, seizure, sinus headache, drowsiness, and tremor.
Otalgia, Otitis, Otitis media.
aggressive behavior, agitation, altered behavior, anxiety, depression, dream disorder, feeling nervous, hallucinations, irritability, nightmares, restlessness, sleep disorder, somnambulism, suicidal thinking and behavior (including suicide).
bronchitis, acute, cough, epistaxis, laryngitis, nasal congestion, nasal discharge, pharyngitis, pneumonia, respiratory tract infection, rhinitis, sinusitis, upper respiratory infection, wheezing.
Musculoskeletal and connective tissue disorders:
arthralgia, myalgia including muscle cramps.
fatigue, fever, influenza, malaise, traumatic injury.
Postmarketing Experience: Blood and lymphatic system disorders: