ROACUTAN: 14 Adverse Event Reports & Safety Profile
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14
Total FAERS Reports
0
Deaths Reported
1
Hospitalizations
14
As Primary/Secondary Suspect
First Report: 201306 · Latest Report: 201307
What Are the Most Common ROACUTAN Side Effects?
#1 Most Reported
Pregnancy
7 reports (50.0%)
#2 Most Reported
Exposure during pregnancy
2 reports (14.3%)
#3 Most Reported
Vocal cord disorder
1 reports (7.1%)
All ROACUTAN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Pregnancy | 7 | 50.0% | 0 | 0 |
Who Reports ROACUTAN Side Effects? Age & Gender Data
Average age: 26.0 years. Most reports from: BR. View detailed demographics →
Is ROACUTAN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 2 | 0 | 0 |
What Is ROACUTAN Used For?
| Indication | Reports |
|---|---|
| Acne | 8 |
| Product used for unknown indication | 6 |
Official FDA Label for ROACUTAN
Official prescribing information from the FDA-approved drug label.