Ivacaftor

Common brands: Kalydeco, Pulmozyme, Creon, Albuterol, Tobi

Top reporter: Vertex Pharmaceuticals Incorporated

Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC]Recombinant Human Deoxyribonuclease 1 [EPC]Aminoglycoside Antibacterial [EPC]Proton Pump Inhibitor [EPC]Osmotic Laxative [EPC]
7,803
Total Reports
3,204
Serious Reports
322
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (4.13%)

Patient Demographics

Male
3,152
Female
4,188

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Ivacaftor.

# Reaction Reports % of Total
1 HOSPITALISATION 1,331
21.9%
2 INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS 606
10.0%
3 PNEUMONIA 265
4.4%
4 INFECTION 253
4.2%
5 LOWER RESPIRATORY TRACT INFECTION 250
4.1%
6 MALAISE 250
4.1%
7 DEATH 226
3.7%
8 COUGH 221
3.6%
9 CYSTIC FIBROSIS 215
3.5%
10 HEADACHE 195
3.2%
11 NASOPHARYNGITIS 170
2.8%
12 INFLUENZA 161
2.7%
13 DYSPNOEA 143
2.4%
14 PULMONARY FUNCTION TEST DECREASED 137
2.3%
15 OFF LABEL USE 122
2.0%
16 HAEMOPTYSIS 115
1.9%
17 ABDOMINAL PAIN UPPER 113
1.9%
18 VOMITING 113
1.9%
19 EXPOSURE DURING PREGNANCY 110
1.8%
20 DRUG DOSE OMISSION 108
1.8%
21 SINUSITIS 105
1.7%
22 DIARRHOEA 103
1.7%
23 WEIGHT DECREASED 102
1.7%
24 FATIGUE 101
1.7%
25 WEIGHT INCREASED 96
1.6%
26 ANXIETY 95
1.6%
27 ABDOMINAL PAIN 94
1.5%
28 DRUG INTERACTION 92
1.5%
29 NAUSEA 92
1.5%
30 DEPRESSION 81
1.3%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.