What the label lists and what reports show
Azelaic acid side effects
Azelaic acid's FDA label: “The most common adverse reactions are burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%).” FAERS holds 939 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pain (129 reports).
- Generic listed
Check it at the source: the azelaic acid FDA label on DailyMed (effective November 11, 2021, Sandoz Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions are burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%).
Table 1: Adverse Events Occurring in ≥1% of Subjects in the Rosacea Trials by Treatment Group and Maximum Intensity Subjects may have >1 cutaneous adverse event; thus, the sum of the frequencies of preferred terms may…
| Reaction | Mild N=99 (22%) | Moderate N=61 (13%) | Severe N=27 (6%) | Mild N=46 (14%) | Moderate N=30 (9%) | Severe N=5 (2%) |
|---|---|---|---|---|---|---|
| Burning/stinging/tingling | 71 (16%) | 42 (9%) | 17 (4%) | 8 (2%) | 6 (2%) | 2 (1%) |
| Pruritus | 29 (6%) | 18 (4%) | 5 (1%) | 9 (3%) | 6 (2%) | 0 (0%) |
| Scaling/dry skin/xerosis | 21 (5%) | 10 (2%) | 5 (1%) | 31 (9%) | 14 (4%) | 1 (<1%) |
| Erythema/irritation | 6 (1%) | 7 (2%) | 2 (<1%) | 8 (2%) | 4 (1%) | 2 (1%) |
| Contact dermatitis | 2 (<1%) | 3 (1%) | 0 (0%) | 1 (<1%) | 0 (0%) | 0 (0%) |
| Edema | 3 (1%) | 2 (<1%) | 0 (0%) | 3 (1%) | 0 (0%) | 0 (0%) |
| Acne | 3 (1%) | 1 (<1%) | 0 (0%) | 1 (<1%) | 0 (0%) | 0 (0%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most common adverse reactions are burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two vehicle-controlled and one active-controlled U.S. clinical trials, treatment safety was monitored in 788 subjects who used twice-daily azelaic acid gel for 12 weeks (N=333) or 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks. In all three trials, the most common treatment-related adverse events were: burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). In the active-controlled trial, overall adverse reactions (including burning, stinging/tingling, dryness/tightness/scaling, itching, and erythema/irritation/redness) were 19.4% (24/124) for azelaic acid gel compared to 7.1% (9/127) for the active comparator gel at 15 weeks. …
Source: FDA drug label, NDA021470 (Leo Pharma As), as published by Sandoz Inc., effective November 11, 2021 (SPL set 66178511-5c1a-4ecd-bc98-2ceb54e710ac), via openFDA; the full label on DailyMed
What do FAERS reports show?
939 reports list azelaic acid among the medicines taken, each a report of something that happened, not proof the medicine caused it; 74 are coded as a death and 173 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 1 is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Azelaic acid: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions