PENTASA: 49 Adverse Event Reports & Safety Profile
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49
Total FAERS Reports
6 (12.2%)
Deaths Reported
15
Hospitalizations
49
As Primary/Secondary Suspect
1
Life-Threatening
First Report: 201102 · Latest Report: 201405
What Are the Most Common PENTASA Side Effects?
#1 Most Reported
Off label use
15 reports (30.6%)
#2 Most Reported
Death
5 reports (10.2%)
#3 Most Reported
Crohn's disease
5 reports (10.2%)
All PENTASA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 15 | 30.6% | 0 | 2 |
| Crohn's disease | 5 | 10.2% | 0 | 2 |
| Death | 5 | 10.2% | 5 | 0 |
Who Reports PENTASA Side Effects? Age & Gender Data
Average age: 40.5 years. Most reports from: US. View detailed demographics →
Is PENTASA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 1 | 0 | 1 |
| 2012 | 1 | 0 | 0 |
| 2013 | 10 | 1 | 4 |
| 2014 | 12 | 2 | 4 |
What Is PENTASA Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 24 |
| Crohn's disease | 15 |
| Colitis ulcerative | 5 |
Official FDA Label for PENTASA
Official prescribing information from the FDA-approved drug label.