Lumacaftor / Ivacaftor

Common brands: Orkambi, Pulmozyme, Creon, Tobi, 0.9%Saline

Top reporter: Vertex Pharmaceuticals Incorporated

Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC]Recombinant Human Deoxyribonuclease 1 [EPC]Aminoglycoside Antibacterial [EPC]Osmotic Laxative [EPC]Proton Pump Inhibitor [EPC]
8,500
Total Reports
643
Serious Reports
158
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (1.86%)

Patient Demographics

Male
3,783
Female
4,047

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Lumacaftor / Ivacaftor.

# Reaction Reports % of Total
1 INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS 1,461
17.7%
2 HOSPITALISATION 887
10.8%
3 DYSPNOEA 555
6.7%
4 PULMONARY FUNCTION TEST DECREASED 397
4.8%
5 COUGH 394
4.8%
6 INFECTION 369
4.5%
7 CHEST DISCOMFORT 343
4.2%
8 CYSTIC FIBROSIS 326
4.0%
9 PNEUMONIA 269
3.3%
10 MALAISE 224
2.7%
11 NASOPHARYNGITIS 202
2.5%
12 FATIGUE 199
2.4%
13 DIARRHOEA 193
2.3%
14 RESPIRATION ABNORMAL 191
2.3%
15 INFLUENZA 184
2.2%
16 PYREXIA 184
2.2%
17 NAUSEA 183
2.2%
18 CYSTIC FIBROSIS RESPIRATORY INFECTION SUPPRESSION 162
2.0%
19 VOMITING 154
1.9%
20 WEIGHT DECREASED 147
1.8%
21 HEADACHE 146
1.8%
22 ABDOMINAL PAIN UPPER 136
1.7%
23 SINUSITIS 132
1.6%
24 DRUG INEFFECTIVE 124
1.5%
25 FORCED EXPIRATORY VOLUME DECREASED 120
1.5%
26 HAEMOPTYSIS 117
1.4%
27 LIVER FUNCTION TEST INCREASED 115
1.4%
28 LUNG INFECTION 110
1.3%
29 DECREASED APPETITE 107
1.3%
30 DRUG DOSE OMISSION 100
1.2%

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.