Aspira Adverse Reactions

Montelukast has been generally well-tolerated. Side effects, which usually were mild, generally did not require discontinuation of therapy.
Cardiovascular Effects: Palpitations, allergic granulomatous 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 SC tissue, rash, urticaria.
Gastrointestinal Effects: Abdominal pain, dental pain, diarrhea, gastroenteritis, indigestion, infection of tooth, nausea, pancreatitis, tonsillitis, vomiting.
Hematologic Effects: Blood coagulation disorder (increased bleeding tendency).
Hepatic Effects: Raised alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels, cholestatic hepatitis.
Immunologic Effects: Hypersensitivity reactions, including anaphylaxis, varicella and viral infection.
Neurologic Effects: Asthenia, disoriented, dizziness, headache, hyperactive behavior, hypesthesia, insomnia, paresthesia, seizure, sinus headache, drowsiness and tremor.
Ophthalmic Effects: Conjunctivitis, myopia.
Otic Effects: Otalgia, otitis, otitis media.
Psychiatric Effects: Aggressive behavior, agitation, altered behavior, anxiety, depression, dream disorder, feeling nervous, hallucinations, irritability, nightmares, restlessness, sleep disorder, somnambulism; suicidal thinking and behavior (including suicide).
Renal Effects: Pyuria.
Respiratory Effects: Acute bronchitis, cough, epistaxis, laryngitis, nasal congestion and discharge, pharyngitis, pneumonia, respiratory tract infection, rhinitis, sinusitis, upper respiratory infection, wheezing.
Musculoskeletal and Connective Tissue Disorders: Arthralgia, myalgia including muscle cramps.
Others: Fatigue, fever, influenza, malaise, traumatic injury.