ROACCUTANE: 11 Adverse Event Reports & Safety Profile
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11
Total FAERS Reports
1 (9.1%)
Deaths Reported
0
Hospitalizations
11
As Primary/Secondary Suspect
First Report: 20081004 · Latest Report: 201303
What Are the Most Common ROACCUTANE Side Effects?
#1 Most Reported
Pregnancy
9 reports (81.8%)
#2 Most Reported
No adverse event
4 reports (36.4%)
#3 Most Reported
Suicidal ideation
1 reports (9.1%)
All ROACCUTANE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Pregnancy | 9 | 81.8% | 0 | 0 |
Who Reports ROACCUTANE Side Effects? Age & Gender Data
Average age: 28.2 years. Most reports from: GB. View detailed demographics →
Is ROACCUTANE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 1 | 1 | 0 |
| 2010 | 1 | 0 | 0 |
| 2013 | 1 | 0 | 0 |
What Is ROACCUTANE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 7 |
Official FDA Label for ROACCUTANE
Official prescribing information from the FDA-approved drug label.