Elexacaftor, Tezacaftor, / Ivacaftor

Common brands: Trikafta, Pulmozyme, Creon, Albuterol, Walgreens

Top reporter: Vertex Pharmaceuticals Incorporated

Recombinant Human Deoxyribonuclease 1 [EPC]Osmotic Laxative [EPC]Aminoglycoside Antibacterial [EPC]Proton Pump Inhibitor [EPC]Provitamin D2 Compound [EPC]
12,133
Total Reports
6,109
Serious Reports
229
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (1.89%)

Patient Demographics

Male
4,305
Female
6,003

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Elexacaftor, Tezacaftor, / Ivacaftor.

# Reaction Reports % of Total
1 INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS 792
6.8%
2 HEADACHE 758
6.5%
3 ANXIETY 592
5.1%
4 COUGH 588
5.0%
5 RASH 565
4.9%
6 PRODUCTIVE COUGH 523
4.5%
7 FATIGUE 518
4.4%
8 WEIGHT INCREASED 501
4.3%
9 CYSTIC FIBROSIS 488
4.2%
10 ABDOMINAL PAIN UPPER 468
4.0%
11 DEPRESSION 433
3.7%
12 HOSPITALISATION 419
3.6%
13 PNEUMONIA 383
3.3%
14 DIARRHOEA 381
3.3%
15 INFECTION 337
2.9%
16 MENTAL DISORDER 329
2.8%
17 NAUSEA 322
2.8%
18 INSOMNIA 321
2.8%
19 DYSPNOEA 305
2.6%
20 INFLUENZA 293
2.5%
21 CONSTIPATION 271
2.3%
22 PRODUCT DOSE OMISSION ISSUE 254
2.2%
23 NASOPHARYNGITIS 251
2.2%
24 ABDOMINAL PAIN 235
2.0%
25 DIZZINESS 230
2.0%
26 COVID-19 228
2.0%
27 FEELING ABNORMAL 227
1.9%
28 OFF LABEL USE 218
1.9%
29 HEPATIC ENZYME INCREASED 211
1.8%
30 BRAIN FOG 207
1.8%

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.