NIKP-Montelukast Adverse Reactions

Montelukast has been generally well tolerated. Side effects, which usually were wild, generally did not require discontinuation of therapy. The overall incidence of side effects reported with Montelukast was comparable to placebo.
Pediatric Patients 6 to 14 Years of Age with Asthma: Montelukast has been evaluated in approximately 475 pediatric patients 6 to 14 years of age. The safety profile in pediatric patients is generally similar to the adult safety profile and to placebo.
In an 8-week, placebo-controlled clinical study, the only adverse experience reported as drug related in >1% of patients treated with Montelukast and at a greater incidence than in patients treated with placebo was headache. The incidence of headache was not significantly different in the two treatment groups.
In studies evaluating growth rate, the safety profile in these pediatric patients was consistent with the safety profile previously described for Montelukast.
Cumulatively, 263 pediatric patients 6 to 14 years of age were treated with Montelukast for at least 3 months and 164 for 6 months or longer. With prolonged treatment, the adverse experience profile did not change.
Pediatric Patients 2 to 14 Years of Age with Seasonal Allergic Rhinitis: Montelukast has been evaluated in 280 pediatric patients 2 to 14 years of age and older with perennial allergic rhinitis in a 2-week, placebo-controlled, clinical study. Montelukast administered once daily in the evening was generally well tolerated with a safety profile similar to that of placebo. In this study, no adverse experiences reported as drug related ≥1% of patients treated with Montelukast and at a greater incidence of somnolence was similar to that of placebo.
Post marketing Experience: The following side effects have been reported in post marketing use: Infections and infestations: upper respiratory infection.
Blood and lymphatic system disorders: increased bleeding tendency, thrombocytopenia.
Immune system disorders: hypersensitivity reactions including anaphylaxis, hepatic eosinophilic infiltration.
Psychiatric disorders: agitation including aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, dysphemia (stuttering), hallucinations, insomnia, memory impairment, obsessive-compulsive symptoms, psychomotor hyperactivity (including irritability, restlessness and tremor), somnambulism, suicidal thinking and behavior (suicidality), tic.
Nervous system disorders: dizziness, drowsiness, paraesthesia/hypoesthesia, seizure.
Cardiac disorders: palpitations.
Respiratory, thoracic and mediastinal disorders: epistaxis, pulmonary eosinophilia.
Gastrointestinal disorders: diarrhea, dyspepsia, nausea, vomiting.
Hepatobiliary disorders: increased ALT and AST, hepatitis (including cholestatic, hepatocellular, and mixed-pattern liver injury).
Skin and subcutaneous tissue disorders: angioedema, bruising, erythema multiforme, erythema nodosum, pruritus, rash, urticaria.
Musculoskeletal and connective tissue disorders: arthralgia, myalgia including muscle cramps.
Renal and urinary disorders: enuresis in children.
General disorders and administration site conditions: asthenia/fatigue, edema, pyrexia.