ASACOL: 30 Adverse Event Reports & Safety Profile
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30
Total FAERS Reports
0
Deaths Reported
11
Hospitalizations
30
As Primary/Secondary Suspect
1
Disabilities
First Report: 2009 · Latest Report: 20140303
What Are the Most Common ASACOL Side Effects?
#1 Most Reported
Diarrhoea
4 reports (13.3%)
#2 Most Reported
Exposure via father
3 reports (10.0%)
#3 Most Reported
Exposure during pregnancy
3 reports (10.0%)
All ASACOL Side Effects by Frequency
No side effect data available.
Who Reports ASACOL Side Effects? Age & Gender Data
Average age: 46.4 years. Most reports from: US. View detailed demographics →
Is ASACOL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 2 | 0 | 2 |
| 2011 | 3 | 0 | 0 |
| 2012 | 2 | 0 | 1 |
| 2013 | 14 | 0 | 6 |
| 2014 | 2 | 0 | 1 |
What Is ASACOL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 10 |
| Colitis ulcerative | 8 |
Official FDA Label for ASACOL
Official prescribing information from the FDA-approved drug label.