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ATC Codes: None found

Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2
Oropharyngeal pain Oropharyngeal pain 22% 18.3% x x
Headache Headache 17% - 23.9% 16.3% x x
Upper respiratory tract infection Upper respiratory tract infection 16% - 22% 13.5% x x
Nasal congestion Nasal congestion 16% - 20.2% 15.4% x x
Abdominal pain Abdominal pain 15.6% 12.5% x x
Gastrointestinal pain Abdominal pain 15.6% 12.5% x x
Nasopharyngitis Nasopharyngitis 14.7% 11.5% x x
Diarrhoea Diarrhoea 12.8% 9.62% x x
Dermatitis Rash 10% - 12.8% 6.73% x x
Rash Rash 10% - 12.8% 6.73% x x
Nausea Nausea 10% - 11.9% 10.6% x
Dizziness Dizziness 5% - 9.17% 0.962% x x
Rhinitis Rhinitis 6% x x
Arthralgia Arthralgia 5% x
Musculoskeletal discomfort Arthralgia 5% x
Myalgia x
Breast disorder Breast disorder x
Pleuritic pain Pleuritic pain x
Infection Infection x x
Connective tissue disorder Connective tissue disorder x
Ear pain Ear pain x
Gastrointestinal disorder Gastrointestinal disorder x
Gynaecomastia Gynaecomastia x
Hypoglycaemia Hypoglycaemia x
Breast mass Breast mass x
Mastitis Mastitis x
Mediastinal disorder Mediastinal disorder x x
Nervous system disorder Nervous system disorder x x
Sinus headache Sinus headache x
Tinnitus Tinnitus x
Vestibular disorder Vestibular disorder x
Wheezing Wheezing x
Aspartate aminotransferase increased Aspartate aminotransferase increased x
Sinus congestion Sinus congestion x x
Skin disorder Unspecified disorder of skin and subcutaneous tissue x x
Myalgia Myalgia x
Hepatic enzyme increased Hepatic enzyme increased x
Hyperaesthesia Nipple pain x
Nipple pain Nipple pain x
Nipple disorder Nipple disorder x
Transaminases increased Transaminases increased x x
Pharyngeal erythema Pharyngeal erythema x x
Musculoskeletal chest pain Musculoskeletal chest pain x
Blood glucose increased Blood glucose increased x
Blood bilirubin increased Bilirubin total increased x
Ear congestion Ear congestion x
Infestation Infestation NOS x x
Ear discomfort Ear discomfort x
Tympanic membrane hyperaemia Tympanic membrane hyperaemia x


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


Side effects:30
Source:FDA Structured Product Label

ivacaftor / ivacaftor

Side effects:33

Color scheme:


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