Reported signals
isotretinoin
Registration status unknownDrugalgemeen
48,237
reports (FAERS)
56.3%
reported as serious
323
fatal reports (0.7%)
0
signals above threshold
2026-07
last updated
Signal ranking · ROR
What stands out in the reports.
No disproportionate signals with sufficient data to plot. This may indicate the substance has too few reports, or that reported effects are in line with background rates.
Interpretation
Summary not yet available — will be auto-generated.
Label versus report
On the label
No signals currently mapped to the label.
Newly reported
No novel signals above threshold.
Recall history · 0 on record
No recalls on record.
Compare within ALGEMEEN
Source & citation
HealthProves. isotretinoin — reported signals. Retrieved 2026-07-05. Source: openFDA (FAERS). healthproves.com/isotretinoin/
FAERS48,237 records
Retrieved2026-07-05
MethodROR / disproportionality