KALYDECO: 67 Adverse Event Reports & Safety Profile
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67
Total FAERS Reports
1 (1.5%)
Deaths Reported
25
Hospitalizations
67
As Primary/Secondary Suspect
First Report: 2012 · Latest Report: 201405
What Are the Most Common KALYDECO Side Effects?
#1 Most Reported
Investigation
7 reports (10.4%)
#2 Most Reported
Infective pulmonary exacerbation of cystic fibrosis
7 reports (10.4%)
#3 Most Reported
Ventricular dysfunction
6 reports (9.0%)
All KALYDECO Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosis | 7 | 10.5% | 0 | 6 |
| Investigation | 7 | 10.5% | 0 | 7 |
| Cough | 6 | 9.0% | 1 | 3 |
| Ventricular dysfunction | 6 | 9.0% | 0 | 0 |
| Drug dose omission | 5 | 7.5% | 0 | 5 |
Who Reports KALYDECO Side Effects? Age & Gender Data
Average age: 24.1 years. Most reports from: US. View detailed demographics →
Is KALYDECO Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 3 | 0 | 0 |
| 2013 | 7 | 0 | 6 |
| 2014 | 26 | 1 | 9 |
What Is KALYDECO Used For?
| Indication | Reports |
|---|---|
| Cystic fibrosis | 67 |
Official FDA Label for KALYDECO
Official prescribing information from the FDA-approved drug label.