PULMICORT: 78 Adverse Event Reports & Safety Profile
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78
Total FAERS Reports
1 (1.3%)
Deaths Reported
13
Hospitalizations
78
As Primary/Secondary Suspect
1
Life-Threatening
First Report: 1999 · Latest Report: 20140518
What Are the Most Common PULMICORT Side Effects?
#1 Most Reported
Off label use
43 reports (55.1%)
#2 Most Reported
Intentional product misuse
8 reports (10.3%)
#3 Most Reported
Tremor
6 reports (7.7%)
All PULMICORT Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 43 | 55.1% | 0 | 0 |
| Intentional product misuse | 8 | 10.3% | 0 | 1 |
| Cough | 6 | 7.7% | 0 | 0 |
| Dyspnoea | 6 | 7.7% | 0 | 1 |
| Tremor | 6 | 7.7% | 0 | 1 |
| Asthma | 5 | 6.4% | 0 | 4 |
Who Reports PULMICORT Side Effects? Age & Gender Data
Average age: 46.8 years. Most reports from: US. View detailed demographics →
Is PULMICORT Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 0 | 1 |
| 2002 | 1 | 0 | 0 |
| 2008 | 1 | 0 | 0 |
| 2010 | 2 | 0 | 0 |
| 2012 | 2 | 0 | 2 |
| 2013 | 12 | 0 | 5 |
| 2014 | 9 | 0 | 0 |
What Is PULMICORT Used For?
| Indication | Reports |
|---|---|
| Asthma | 16 |
| Bronchopulmonary dysplasia | 12 |
| Bronchitis | 8 |
| Cystic fibrosis | 6 |
Official FDA Label for PULMICORT
Official prescribing information from the FDA-approved drug label.