The following drug-related adverse reactions in clinical studies were reported commonly (≥1/100 to <1/10) in asthmatic patients treated with montelukast and at a greater incidence than in patients treated with placebo: Adult and adolescent patients 15 years and older (two 12-week studies; n=795): Nervous system disorders:
Paediatric patients 6 to 14 years old (one 8-week study; n=201), (two 56-week studies; n=615): Nervous system disorders:
With prolonged treatment in clinical trials with a limited number of patients for up to 2 years for adults, and up to 12 months for paediatric patients 6 to 14 years of age, the safety profile did not change.
List of adverse reactions:
Adverse reactions reported in post-marketing use are listed, by System Organ Class and specific adverse reaction, as follows. Frequency categories* were estimated based on relevant clinical trials.
Infections and infestations:
Very common: Upper respiratory infection†
Blood and lymphatic system disorders:
Rare: Increased bleeding tendency.
Very rare: Thrombocytopenia.
Immune system disorders:
Uncommon: Hypersensitivity reactions including anaphylaxis.
Very rare: Hepatic eosinophilic infiltration.
Uncommon: Dream abnormalities including nightmares, insomnia, somnambulism, anxiety, agitation including aggressive behaviour or hostility, depression, psychomotor hyperactivity (including irritability, restlessness, tremor§
Rare: Disturbance in attention, memory impairment, tic.
Very rare: Hallucinations, disorientation, suicidal thinking and behaviour (suicidality), obsessive-compulsive symptoms and dysphemia.
Nervous system disorders:
Uncommon: Dizziness, drowsiness, paraesthesia/hypoesthesia, seizure.
Respiratory, thoracic and mediastinal disorders:
Very rare: Churg-Strauss Syndrome (CSS) (see Precautions), pulmonary eosinophilia.
Uncommon: Dry mouth, dyspepsia.
Common: Elevated levels of serum transaminases (ALT, AST).
Very rare: Hepatitis (including cholestatic, hepatocellular and mixed pattern liver injury).
Skin and subcutaneous tissue disorders:
Uncommon: Bruising, urticaria, pruritus.
Very rare: Erythema nodosum, erythema multiforme.
Musculoskeletal, connective tissue and bone disorders:
Uncommon: Arthralgia, myalgia including muscle cramps.
Renal and urinary disorders:
Uncommon: Enuresis in children.
General disorders and administration site conditions:
Uncommon: Asthenia/fatigue, malaise, oedema.
Frequency category: Defined for each adverse experience term by the incidence reported in the clinical trials data base: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000).
This adverse experience, reported as Very Common in the patients who received montelukast, was also reported as Very Common in the patients who received placebo in clinical trials.
This adverse experience, reported as Common in the patients who received montelukast, was also reported as Common in the patients who received placebo in clinical trials.