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ATC Code: R03DC01

Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2 3
Headache Headache 12.9% 11.7% x x x
Infection Infection 3.5% 3.4% x x x
Nausea Nausea 3.1% 2% x x x
Diarrhoea Diarrhoea 2.8% 2.1% x x x
Pain Pain 1.9% 1.7% x x x
Abdominal pain Abdominal pain 1.8% 1.1% x x x
Gastrointestinal pain Abdominal pain 1.8% 1.1% x x x
Asthenia Asthenia 1.8% 1.6% x x x
Fatigue x
Dizziness Dizziness 1.6% 1.5% x x x
Body temperature increased Body temperature increased 1.6% 1.1% x x x
Injury Accidental injury 1.6% 1.5% x x x
Myalgia Myalgia 1.6% 1.5% x x x
Musculoskeletal discomfort Myalgia 1.6% 1.5% x x x
Arthralgia x x x
Back pain Back pain 1.5% 1.2% x x x
Vomiting Vomiting 1.5% 1.1% x x x
Dyspepsia Dyspepsia 1.3% 1.2% x x x
Digestion impaired x
Agranulocytosis Agranulocytosis x x x
Angioedema Angioedema x x x
Arthralgia Arthralgia x x x
Blister Blister x x x
Dermatitis bullous Blister x x x
Allergic granulomatous angiitis Allergic granulomatous angiitis x x x
Leukocytoclastic vasculitis Allergic granulomatous angiitis x x x
Contusion Contusion x x x
Oedema Oedema x x x
Eosinophilia Eosinophilia x x x
Dermatitis Rash x x x
Rash Rash x x x
Fatigue Fatigue x
Haematemesis Haematemesis x
Blood disorder Blood disorder x
Haemoptysis Haemoptysis x
Haemorrhage Haemorrhage x x x
Haemoglobin Haemorrhage x x x
Hepatitis Hepatitis x x x
Hyperbilirubinaemia Hyperbilirubinaemia x x x
Hypersensitivity Hypersensitivity x x x
Jaundice Jaundice x
Neutropenia Neutropenia x
Hypoaesthesia Numbness x
Sensory loss Numbness x
Pruritus Pruritus x x
Sinusitis Sinusitis x
Swelling Swelling x
Thrombocytopenia Thrombocytopenia x
Urticaria Urticaria x x
Vasculitis Vasculitis x x x
Hepatic failure Hepatic failure x x x
Hepatic function abnormal Hepatic function abnormal x x
Liver injury Liver injury x
Traumatic liver injury Liver injury x
Malaise Malaise x x
Discomfort Malaise x x
Discomfort x
Feeling abnormal Malaise x x
Ill-defined disorder Malaise x x
Gastrointestinal disorder Digestion impaired x
Abdominal discomfort Upset stomach x
Hepatotoxicity Hepatotoxicity x x
Oropharyngeal discomfort Throat sore x
Oropharyngeal pain Throat sore x
Rectal haemorrhage Rectal haemorrhage x
Hepatitis fulminant Hepatitis fulminant x x x
Increased tendency to bruise Increased tendency to bruise x
Neuropathy peripheral Neuropathy x x x
Vasculitic rash Vasculitic rash x x x
Influenza like illness Influenza like illness x
Liver function test abnormal Raised liver function tests x x x
Insomnia Insomnia x x
Eosinophilic pneumonia Eosinophilic pneumonia x x


Information about indications was extracted from the indications and usage sections of the labels.

Zafirlukast / Accolate

Side effects:37


Side effects:40
Source:FDA Structured Product Label


Side effects:54
Source:Health Canada

Color scheme:


    frequent (1% to 100%)
    infrequent (0.1% to 1%)
    rare (<0.1%)
    no frequency information
    not found on label