Drug · FAERS side-effect profile with label screen
14%Azelaic Acid side effects: what 790 FDA adverse event reports show
Drug class
Not stated in label
Who reports
790 reports · 53% serious · 72 with death outcome · 86% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Clear Skin Solution Fade Acne Marks Soothing & Oil Control Apply proper amount to facial acne gently after morning and night cleansing, massage until absorbed.
FDA label, Indications and Usage
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
Reporting / coding artifact 3Lab value / disease marker 2No label text to screen 35
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 42 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Taste disorder | 83 | 110.2 89.9–135.2ROR 123.1 · χ² 8,848 / p <1e-300 | 107.1 EB05 89.2 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 238.0 · 90% clinician | no trial data cached |
| Folliculitis | 36 | 92.7 67.3–127.6ROR 97.1 · χ² 3,165 / p <1e-300 | 88.2 EB05 66.6 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 117.2 · 97% clinician | no trial data cached |
| Wound infection | 31 | 75.8 53.7–107.1ROR 78.9 · χ² 2,209 / p <1e-300 | 72.4 EB05 53.4 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 87.5 · 97% clinician | no trial data cached |
| Epilepsy | 85 | 74.0 60.5–90.5ROR 82.8 · χ² 6,044 / p <1e-300 | 72.7 EB05 60.6 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 80.1 · 91% clinician | no trial data cached |
| Back injury | 27 | 66.3 45.7–96.0ROR 68.6 · χ² 1,667 / p <1e-300 | 63.3 EB05 45.7 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 90.9 · 96% clinician | no trial data cached |
| Bursitis | 30 | 66.1 46.5–93.9ROR 68.6 · χ² 1,854 / p <1e-300 | 63.4 EB05 46.5 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 83.7 · 97% clinician | no trial data cached |
| Synovitis | 44 | 64.8 48.6–86.4ROR 68.5 · χ² 2,695 / p <1e-300 | 62.9 EB05 48.8 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 73.0 · 98% clinician | no trial data cached |
| Pemphigus | 30 | 64.1 45.1–91.1ROR 66.6 · χ² 1,798 / p <1e-300 | 61.6 EB05 45.2 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 69.2 · 97% clinician | no trial data cached |
| Hypercholesterolaemia | 22 | 61.1 40.4–92.3ROR 62.8 · χ² 1,239 / p 1e-271 | 58.0 EB05 40.4 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 69.9 · 95% clinician | no trial data cached |
| Red blood cell sedimentation rate increased | 25 | 59.9 40.7–88.1ROR 61.8 · χ² 1,387 / p <1e-300 | 57.3 EB05 40.8 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious PRR 73.1 · 96% clinician | no trial data cached |
| Helicobacter infection | 21 | 54.7 35.9–83.5ROR 56.2 · χ² 1,053 / p 3e-231 | 52.2 EB05 36.0 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 62.3 · 95% clinician | no trial data cached |
| Pericarditis | 34 | 54.2 39.0–75.3ROR 56.6 · χ² 1,720 / p <1e-300 | 52.6 EB05 39.4 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 58.8 · 97% clinician | no trial data cached |
| Joint range of motion decreased | 22 | 43.7 28.9–66.0ROR 44.9 · χ² 875 / p 2e-192 | 42.2 EB05 29.3 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.0 · 95% clinician | no trial data cached |
| Sleep disorder due to a general medical condition | 26 | 42.7 29.2–62.3ROR 44.1 · χ² 1,016 / p 3e-223 | 41.4 EB05 29.7 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.5 · 92% clinician | no trial data cached |
| Hand deformity | 21 | 42.6 27.9–65.0ROR 43.7 · χ² 811 / p 9e-179 | 41.1 EB05 28.3 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.9 · 95% clinician | no trial data cached |
| Laryngitis | 16 | 39.1 24.1–63.6ROR 39.9 · χ² 556 / p 3e-123 | 37.5 EB05 24.5 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Poor quality product administered | 14 | 36.4 21.6–61.1ROR 37.0 · χ² 446 / p 2e-99 | 34.7 EB05 22.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Wound | 36 | 34.4 25.0–47.3ROR 36.0 · χ² 1,133 / p 1e-248 | 33.8 EB05 25.5 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.1 · 92% clinician | no trial data cached |
| Fibromyalgia | 31 | 33.9 24.0–47.8ROR 35.2 · χ² 956 / p 3e-210 | 33.2 EB05 24.5 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.0 · 97% clinician | no trial data cached |
| Contraindicated product administered | 36 | 31.7 23.0–43.6ROR 33.1 · χ² 1,039 / p 3e-228 | 31.2 EB05 23.5 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 42.5 · 94% clinician | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 93 | 30.8 25.4–37.3ROR 34.7 · χ² 2,657 / p <1e-300 | 30.6 EB05 25.7 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 52.9 | no trial data cached |
| Irritable bowel syndrome | 24 | 29.8 20.1–44.2ROR 30.7 · χ² 640 / p 2e-141 | 29.2 EB05 20.6 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.8 · 96% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 25 | 29.7 20.2–43.7ROR 30.6 · χ² 664 / p 9e-147 | 29.1 EB05 20.7 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.6 · 96% clinician | no trial data cached |
| Obesity | 17 | 28.3 17.7–45.3ROR 28.9 · χ² 420 / p 1e-93 | 27.5 EB05 18.1 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.4 | no trial data cached |
| Night sweats | 34 | 28.0 20.2–38.9ROR 29.2 · χ² 859 / p 3e-189 | 27.6 EB05 20.7 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.8 | no trial data cached |
| Autoimmune disorder | 10 | 27.7 15.0–51.3ROR 28.1 · χ² 231 / p 1e-52 | 26.3 EB05 15.0 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.0 | no trial data cached |
| Migraine | 90 | 25.2 20.7–30.6ROR 28.3 · χ² 2,072 / p <1e-300 | 25.0 EB05 21.0 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.8 | no trial data cached |
| Drug intolerance | 87 | 24.0 19.7–29.2ROR 26.8 · χ² 1,900 / p <1e-300 | 23.9 EB05 19.9 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 41.2 | no trial data cached |
| Prescribed overdose | 17 | 23.3 14.6–37.3ROR 23.8 · χ² 341 / p 2e-76 | 22.7 EB05 14.9 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.9 | no trial data cached |
| Hepatic cirrhosis | 16 | 22.7 14.0–36.9ROR 23.2 · χ² 311 / p 8e-70 | 22.1 EB05 14.3 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.8 | no trial data cached |
| C-reactive protein increased | 31 | 22.6 16.0–31.9ROR 23.5 · χ² 620 / p 5e-137 | 22.3 EB05 16.4 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 25.4 · 97% clinician | no trial data cached |
| Systemic lupus erythematosus | 30 | 22.5 15.8–32.0ROR 23.3 · χ² 595 / p 8e-132 | 22.2 EB05 16.3 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.9 · 93% clinician | no trial data cached |
| Gait inability | 28 | 22.4 15.6–32.3ROR 23.2 · χ² 553 / p 2e-122 | 22.1 EB05 16.0 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.1 · 96% clinician | no trial data cached |
| Ear pain | 16 | 21.8 13.4–35.5ROR 22.3 · χ² 298 / p 6e-67 | 21.2 EB05 13.7 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.0 | no trial data cached |
| Type 2 diabetes mellitus | 27 | 21.2 14.6–30.7ROR 21.9 · χ² 500 / p 4e-111 | 20.9 EB05 15.0 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.1 · 96% clinician | no trial data cached |
| Stomatitis (mouth sores) | 47 | 20.6 15.6–27.1ROR 21.8 · χ² 857 / p 1e-188 | 20.4 EB05 15.9 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.6 · 98% clinician | no trial data cached |
| Psoriatic arthropathy | 31 | 20.4 14.5–28.9ROR 21.2 · χ² 555 / p 6e-123 | 20.2 EB05 14.9 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.8 · 97% clinician | no trial data cached |
| Respiratory disorder | 23 | 20.3 13.6–30.4ROR 20.9 · χ² 404 / p 4e-90 | 20.0 EB05 13.9 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.2 · 95% clinician | no trial data cached |
| Impaired healing | 25 | 20.2 13.7–29.7ROR 20.8 · χ² 437 / p 2e-97 | 19.9 EB05 14.1 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 26.3 · 96% clinician | no trial data cached |
| Osteoarthritis | 32 | 20.0 14.2–28.1ROR 20.8 · χ² 559 / p 7e-124 | 19.7 EB05 14.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.2 · 91% 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 | 97 | 12.5 10.4–15.1ROR 14.1 · χ² 1,027 / p 2e-225 | 12.4 EB05 10.4 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.3 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 93 | 30.8 25.4–37.3ROR 34.7 · χ² 2,657 / p <1e-300 | 30.6 EB05 25.7 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 52.9 | no trial data cached |
| Paraesthesia (tingling/numbness) | 92 | 15.5 12.8–18.8ROR 17.4 · χ² 1,240 / p 7e-272 | 15.4 EB05 12.9 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.1 | no trial data cached |
| Hypoaesthesia (numbness) | 90 | 15.9 13.1–19.4ROR 17.8 · χ² 1,253 / p 1e-274 | 15.9 EB05 13.3 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.1 · 90% clinician | no trial data cached |
| Migraine | 90 | 25.2 20.7–30.6ROR 28.3 · χ² 2,072 / p <1e-300 | 25.0 EB05 21.0 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.8 | no trial data cached |
| Memory impairment | 89 | 17.2 14.1–20.9ROR 19.2 · χ² 1,347 / p 4e-295 | 17.1 EB05 14.3 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.7 | no trial data cached |
| Drug intolerance | 87 | 24.0 19.7–29.2ROR 26.8 · χ² 1,900 / p <1e-300 | 23.9 EB05 19.9 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 41.2 | no trial data cached |
| Epilepsy | 85 | 74.0 60.5–90.5ROR 82.8 · χ² 6,044 / p <1e-300 | 72.7 EB05 60.6 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 80.1 · 91% clinician | no trial data cached |
| Taste disorder | 83 | 110.2 89.9–135.2ROR 123.1 · χ² 8,848 / p <1e-300 | 107.1 EB05 89.2 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 238.0 · 90% clinician | no trial data cached |
| Rheumatoid arthritis | 50 | 11.7 9.0–15.3ROR 12.5 · χ² 482 / p 3e-107 | 11.4 EB05 8.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.5 · 94% clinician | no trial data cached |
| Sleep disorder | 50 | 19.0 14.5–24.8ROR 20.2 · χ² 835 / p 8e-184 | 18.8 EB05 14.8 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.7 · 90% clinician | no trial data cached |
| Maternal exposure during pregnancy | 47 | 14.1 10.7–18.6ROR 15.0 · χ² 563 / p 1e-124 | 13.9 EB05 10.8 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 17.4 | no trial data cached |
| Stomatitis (mouth sores) | 47 | 20.6 15.6–27.1ROR 21.8 · χ² 857 / p 1e-188 | 20.4 EB05 15.9 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.6 · 98% clinician | no trial data cached |
| Synovitis | 44 | 64.8 48.6–86.4ROR 68.5 · χ² 2,695 / p <1e-300 | 62.9 EB05 48.8 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 73.0 · 98% clinician | no trial data cached |
| Product quality issue | 42 | 8.3 6.2–11.1ROR 8.7 · χ² 262 / p 3e-59 | 7.8 EB05 5.9 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 29.3 | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
✓ 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 14%Azelaic Acid?
In FDA FAERS, the most frequently co-reported reaction terms for 14%Azelaic Acid are abdominal pain upper, gastrooesophageal reflux disease, paraesthesia, hypoaesthesia, migraine, 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 14%Azelaic Acid have an FDA boxed warning?
No. The FDA label retrieved for 14%Azelaic Acid has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that 14%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 534252e4-9428-4cc7-e063-6394a90ae0fc, effective 20260602; matched on
openfda.generic_name.exact:"14%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, fieldpatient.drug.openfda.generic_name.exact, 82 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.