Azelaic Acid side effects: what 938 FDA adverse event reports show

Azelaic Acid · 89 reaction terms · 2,592 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

938 reports · 53% serious · 74 with death outcome · 85% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Limitations of Use Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.

FDA label, Indications and Usage

What it is

Azelaic Acid Gel, 15%, is a white to yellowish white opaque gel which contains azelaic acid, a naturally-occurring saturated dicarboxylic acid. It is for topical use.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 3Lab value / disease marker 2Not in label — unassessed 32

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 49 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Taste disorder	83	92.9 75.6–114.1ROR 101.8 · χ² 7,427 / p <1e-300	90.6 EB05 75.4 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious PRR 203.3 · 90% clinician	no trial data cached
Folliculitis	37	80.3 58.5–110.1ROR 83.5 · χ² 2,809 / p <1e-300	76.9 EB05 58.3 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 102.9 · 95% clinician	no trial data cached
Wound infection	31	63.9 45.2–90.3ROR 66.0 · χ² 1,852 / p <1e-300	61.4 EB05 45.3 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 74.7 · 97% clinician	no trial data cached
Epilepsy	85	62.4 50.9–76.4ROR 68.5 · χ² 5,065 / p <1e-300	61.4 EB05 51.2 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 68.4 · 91% clinician	no trial data cached
Back injury	28	57.9 40.2–83.4ROR 59.6 · χ² 1,506 / p <1e-300	55.7 EB05 40.4 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 80.7 · 96% clinician	no trial data cached
Bursitis	30	55.7 39.1–79.2ROR 57.5 · χ² 1,553 / p <1e-300	53.7 EB05 39.4 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 71.5 · 97% clinician	no trial data cached
Synovitis	44	54.6 40.9–72.8ROR 57.2 · χ² 2,257 / p <1e-300	53.3 EB05 41.3 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 62.4 · 98% clinician	no trial data cached
Pemphigus	30	54.0 38.0–76.8ROR 55.8 · χ² 1,505 / p <1e-300	52.2 EB05 38.3 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 59.1 · 97% clinician	no trial data cached
Hypercholesterolaemia	22	51.5 34.0–77.8ROR 52.7 · χ² 1,037 / p 1e-227	49.3 EB05 34.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 59.7 · 95% clinician	no trial data cached
Red blood cell sedimentation rate increased	25	50.4 34.2–74.3ROR 51.8 · χ² 1,161 / p 1e-254	48.6 EB05 34.6 · IC025 +4.0 3/3 methods agree	Lab value / disease marker	serious PRR 62.5 · 96% clinician	no trial data cached
Helicobacter infection	21	46.1 30.2–70.4ROR 47.1 · χ² 880 / p 9e-194	44.3 EB05 30.6 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 53.2 · 95% clinician	no trial data cached
Pericarditis	34	45.6 32.8–63.5ROR 47.3 · χ² 1,439 / p <1e-300	44.5 EB05 33.3 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 50.3 · 97% clinician	no trial data cached
Joint range of motion decreased	22	36.8 24.3–55.6ROR 37.7 · χ² 730 / p 4e-161	35.7 EB05 24.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 51.3 · 95% clinician	no trial data cached
Sleep disorder due to a general medical condition	26	36.0 24.6–52.5ROR 37.0 · χ² 848 / p 9e-187	35.1 EB05 25.1 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 56.8 · 92% clinician	no trial data cached
Hand deformity	21	35.9 23.5–54.8ROR 36.7 · χ² 677 / p 1e-149	34.8 EB05 24.0 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 42.7 · 95% clinician	no trial data cached
Laryngitis	16	33.0 20.3–53.6ROR 33.5 · χ² 464 / p 3e-103	31.8 EB05 20.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=16	no trial data cached
Poor quality product administered	14	30.6 18.2–51.5ROR 31.1 · χ² 372 / p 4e-83	29.5 EB05 18.6 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Fibromyalgia	33	30.4 21.7–42.5ROR 31.5 · χ² 908 / p 8e-200	29.9 EB05 22.3 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 43.7 · 97% clinician	no trial data cached
Wound	37	29.8 21.7–40.8ROR 30.9 · χ² 1,000 / p 1e-219	29.3 EB05 22.2 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 38.7	no trial data cached
Contraindicated product administered	37	27.4 20.0–37.6ROR 28.5 · χ² 916 / p 2e-201	27.1 EB05 20.5 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 37.3 · 95% clinician	no trial data cached
Gastrooesophageal reflux disease (acid reflux)	95	26.5 21.9–32.1ROR 29.4 · χ² 2,310 / p <1e-300	26.3 EB05 22.2 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 46.2	no trial data cached
Irritable bowel syndrome	25	26.2 17.8–38.5ROR 26.8 · χ² 580 / p 2e-128	25.7 EB05 18.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 36.3 · 96% clinician	no trial data cached
Glossodynia (burning tongue/mouth pain)	25	25.0 17.0–36.8ROR 25.7 · χ² 552 / p 2e-122	24.6 EB05 17.5 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 36.4 · 96% clinician	no trial data cached
Obesity	17	23.8 14.9–38.2ROR 24.2 · χ² 349 / p 4e-78	23.2 EB05 15.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 30.2	no trial data cached
Night sweats	34	23.6 17.0–32.8ROR 24.5 · χ² 714 / p 1e-157	23.3 EB05 17.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 39.1	no trial data cached
Autoimmune disorder	10	23.4 12.6–43.3ROR 23.6 · χ² 192 / p 6e-44	22.1 EB05 12.3 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 27.3	no trial data cached
Migraine	93	21.9 18.1–26.6ROR 24.2 · χ² 1,842 / p <1e-300	21.8 EB05 18.3 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 44.9	no trial data cached
Drug intolerance	87	20.2 16.5–24.7ROR 22.2 · χ² 1,575 / p <1e-300	20.1 EB05 16.8 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 35.2	no trial data cached
Prescribed overdose	17	19.6 12.3–31.5ROR 20.0 · χ² 282 / p 1e-63	19.1 EB05 12.4 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 36.6	no trial data cached
Hepatic cirrhosis	16	19.1 11.8–31.1ROR 19.4 · χ² 257 / p 4e-58	18.5 EB05 11.8 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 21.2	no trial data cached
C-reactive protein increased	31	19.0 13.5–26.9ROR 19.7 · χ² 513 / p 8e-114	18.8 EB05 13.8 · IC025 +3.3 3/3 methods agree	Lab value / disease marker	serious PRR 21.7 · 97% clinician	no trial data cached
Systemic lupus erythematosus	30	19.0 13.3–27.0ROR 19.5 · χ² 493 / p 2e-109	18.7 EB05 13.7 · IC025 +3.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 21.3 · 93% clinician	no trial data cached
Gait inability	28	18.9 13.1–27.2ROR 19.5 · χ² 457 / p 9e-102	18.6 EB05 13.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 25.7 · 96% clinician	no trial data cached
Ear pain	16	18.4 11.3–29.9ROR 18.7 · χ² 246 / p 1e-55	17.8 EB05 11.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 32.4	no trial data cached
Osteoarthritis	34	17.9 12.9–24.9ROR 18.5 · χ² 526 / p 1e-116	17.7 EB05 13.1 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 21.9 · 91% clinician	no trial data cached
Respiratory disorder	24	17.9 12.0–26.5ROR 18.3 · χ² 366 / p 7e-82	17.5 EB05 12.2 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 24.2 · 91% clinician	no trial data cached
Type 2 diabetes mellitus	27	17.9 12.3–25.9ROR 18.4 · χ² 413 / p 3e-92	17.6 EB05 12.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 20.6 · 96% clinician	no trial data cached
Impaired healing	26	17.7 12.1–25.9ROR 18.2 · χ² 393 / p 8e-88	17.4 EB05 12.3 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 23.4 · 96% clinician	no trial data cached
Stomatitis (mouth sores)	47	17.3 13.1–22.9ROR 18.2 · χ² 708 / p 3e-156	17.2 EB05 13.4 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 27.8 · 98% clinician	no trial data cached
Psoriatic arthropathy	31	17.2 12.2–24.4ROR 17.8 · χ² 458 / p 6e-102	17.0 EB05 12.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 23.7 · 97% clinician	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Abdominal pain upper	100	10.9 9.0–13.1ROR 12.1 · χ² 895 / p 5e-197	10.7 EB05 9.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 21.4	no trial data cached
Gastrooesophageal reflux disease (acid reflux)	95	26.5 21.9–32.1ROR 29.4 · χ² 2,310 / p <1e-300	26.3 EB05 22.2 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 46.2	no trial data cached
Paraesthesia (tingling/numbness)	93	13.2 10.9–16.0ROR 14.5 · χ² 1,042 / p 9e-229	13.1 EB05 10.9 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 24.9	no trial data cached
Migraine	93	21.9 18.1–26.6ROR 24.2 · χ² 1,842 / p <1e-300	21.8 EB05 18.3 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 44.9	no trial data cached
Hypoaesthesia (numbness)	91	13.6 11.2–16.5ROR 14.9 · χ² 1,054 / p 2e-231	13.5 EB05 11.3 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 23.4	no trial data cached
Memory impairment	90	14.6 12.0–17.8ROR 16.1 · χ² 1,135 / p 4e-249	14.5 EB05 12.1 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 28.3	no trial data cached
Drug intolerance	87	20.2 16.5–24.7ROR 22.2 · χ² 1,575 / p <1e-300	20.1 EB05 16.8 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 35.2	no trial data cached
Epilepsy	85	62.4 50.9–76.4ROR 68.5 · χ² 5,065 / p <1e-300	61.4 EB05 51.2 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 68.4 · 91% clinician	no trial data cached
Taste disorder	83	92.9 75.6–114.1ROR 101.8 · χ² 7,427 / p <1e-300	90.6 EB05 75.4 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious PRR 203.3 · 90% clinician	no trial data cached
Rheumatoid arthritis	50	9.9 7.5–12.9ROR 10.4 · χ² 392 / p 1e-87	9.5 EB05 7.4 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 13.2 · 94% clinician	no trial data cached
Sleep disorder	50	16.0 12.2–20.9ROR 16.8 · χ² 688 / p 5e-152	15.8 EB05 12.4 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 25.3 · 90% clinician	no trial data cached
Maternal exposure during pregnancy	47	11.9 9.0–15.7ROR 12.5 · χ² 460 / p 2e-102	11.6 EB05 8.9 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 14.8	no trial data cached
Stomatitis (mouth sores)	47	17.3 13.1–22.9ROR 18.2 · χ² 708 / p 3e-156	17.2 EB05 13.4 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 27.8 · 98% clinician	no trial data cached
Product quality issue	44	7.3 5.5–9.7ROR 7.6 · χ² 234 / p 4e-53	6.9 EB05 5.3 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 25.0	no trial data cached
Synovitis	44	54.6 40.9–72.8ROR 57.2 · χ² 2,257 / p <1e-300	53.3 EB05 41.3 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 62.4 · 98% clinician	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Taste disorder — n=83, PRR 92.9
Folliculitis — n=37, PRR 80.3
Wound infection — n=31, PRR 63.9
Epilepsy — n=85, PRR 62.4
Back injury — n=28, PRR 57.9
Bursitis — n=30, PRR 55.7
Synovitis — n=44, PRR 54.6
Pemphigus — n=30, PRR 54.0
Hypercholesterolaemia — n=22, PRR 51.5
Helicobacter infection — n=21, PRR 46.1

✓ A hand-written Bradford Hill causality assessment exists for this drug: Zoledronic acid (bisphosphonates) ↔ Osteonecrosis of the jaw.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Azelaic Acid?

In FDA FAERS, the most frequently co-reported reaction terms for Azelaic Acid are abdominal pain upper, gastrooesophageal reflux disease, paraesthesia, migraine, hypoaesthesia, memory impairment. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Azelaic Acid have an FDA boxed warning?

No. The FDA label retrieved for Azelaic Acid has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Azelaic Acid causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 0b5ab22e-c78a-4429-9a76-a4ba2d11fcde, effective 20211223; matched on openfda.generic_name.exact:"AZELAIC ACID")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 89 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.