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: See table.
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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.
Post-marketing Experience: Adverse reactions reported in post-marketing use are listed by System Organ Class and specific adverse experience term as follows. Frequency categories were estimated based on relevant clinical trials.
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).
Infections and infestations: Very common: Upper respiratory infection@.
Blood and lymphatic system disorders: Rare: Increased bleeding tendency.
Immune system disorders: Uncommon: Hypersensitivity reactions including anaphylaxis.
Very rare: Hepatic eosinophilic infiltration.
Psychiatric disorders: 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.
Very rare: Hallucinations, disorientation, suicidal thinking and behaviour (suicidality).
Nervous system disorders: Uncommon: Dizziness, drowsiness, paraesthesia/hypoesthesia, seizure.
Cardiac disorders: Rare: Palpitations.
Respiratory, thoracic and mediastinal disorders: Uncommon: Epistaxis.
Very rare: Churg-Strauss Syndrome (CSS) (see Precautions).
Very rare: Pulmonary eosinophilia.
Gastrointestinal disorders: Common: Diarrhoea**, nausea**, vomiting**.
Uncommon: Dry mouth, dyspepsia.
Hepato-biliary disorders: Common: Elevated levels of serum transaminases (ALT, AST).
Very Rare: Hepatitis (including cholestatic, hepatocellular, and mixed-pattern liver injury).
Skin and subcutaneous tissue disorders: Common: Rash**.
Uncommon: Bruising, urticaria, pruritus.
Very Rare: Erythema nodosum, erythema multiforme.
Musculoskeletal and connective tissue disorders: Uncommon: Arthralgia, myalgia including muscle cramps.
General disorders and administration site conditions: Common: Pyrexia**.
Uncommon: Asthenia/fatigue, malaise, oedema.
@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.
§ Frequency Category: Rare.
Adverse Drug Reactions: Inform doctors about unexpected reactions after using drugs.