LOW-VOLUME · FEMALE-LED
azelaic acid Side Effects
azelaic acid (also sold as Finacea, Azelex) is a LOW-VOLUME FAERS extract #496 of 524 by FAERS report count. Still opens on FEMALE-LED: 84% of sex-coded reports are female (589 F / 110 M).
Data updated 2026-05-15
- 826
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
azelaic acid reporting skew - 84% of sex-coded reports are female (589 F / 110 M). Volume band LOW-VOLUME #496 of 524 by FAERS report count; caseload SIGNAL.
Thinner FAERS extract for azelaic acid (Finacea) (826 reports #496 of 524 by FAERS report count). 84% of sex-coded reports are female (589 F / 110 M). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2004–2025). Stamps SIGNAL · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
PAIN leads 109 of 826 reports
FEMALE-LED reporters · age peak 18-44
Female-led reporters (84% of sex-coded rows)
Age peak 18-44 (246 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (55 reports, 6.7%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| GASTROOESOPHAGEAL REFLUX DISEASE | 28 |
| HYPOAESTHESIA | 27 |
| VOMITING | 27 |
| PARAESTHESIA | 26 |
| RHEUMATIC FEVER | 26 |
| ABDOMINAL PAIN UPPER | 25 |
| BLEPHAROSPASM | 25 |
| EPILEPSY | 25 |
| MEMORY IMPAIRMENT | 25 |
| RASH | 25 |
| STOMATITIS | 25 |
| PAIN | 24 |
| RHEUMATOID ARTHRITIS | 24 |
| SYNOVITIS | 24 |
| TASTE DISORDER | 24 |
| MIGRAINE | 23 |
Reactions in Hospitalization Reports
Hospitalization mid-share (150, 18.2%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| VOMITING | 34 |
| PAIN | 32 |
| RASH | 32 |
| GASTROOESOPHAGEAL REFLUX DISEASE | 31 |
| ABDOMINAL PAIN UPPER | 30 |
| HYPOAESTHESIA | 29 |
| MIGRAINE | 29 |
| MEMORY IMPAIRMENT | 28 |
| PARAESTHESIA | 28 |
| RHEUMATIC FEVER | 28 |
| BLEPHAROSPASM | 27 |
| EPILEPSY | 27 |
| RHEUMATOID ARTHRITIS | 27 |
| STOMATITIS | 27 |
| DYSPNOEA | 26 |
| SWELLING | 26 |
| SYNOVITIS | 26 |
How to read azelaic acid FAERS figures (SIGNAL · DEATH-HEAVY · HOSP-MID)
FAERS holds 826 voluntary reports linked to azelaic acid (Finacea, Azelex), 2004-2025. Death is listed on 55 (6.7%). Hospitalization appears on 150 (18.2%). Top co-reported indication: Product Used For Unknown Indication.
Sparse extract - named reactions and FEMALE-LED skew still differ by drug; not a complete safety profile.
Read with azelaic acid
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 834 FAERS cases (Δ 8 heavier vs azelaic acid); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 799 FAERS cases (Δ 27 lighter vs azelaic acid); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 863 FAERS cases (Δ 37 heavier vs azelaic acid); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 774 FAERS cases (Δ 52 lighter vs azelaic acid); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 55.4 pp vs azelaic acid's DEATH-HEAVY): CASELOAD · HOSP-MID.
azelaic acid stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload SIGNAL and the label guide.