OpenClaim

Azelaic Side Effects

The most commonly reported side effects of azelaic include off label use, gastrooesophageal reflux disease, and abdominal pain upper, based on 3,003 FDA adverse event reports from 2004 to 2025. 15.6% of reports found the drug to be ineffective.

Azelaic side effects

Percentages show how often each reaction appears relative to total reports for azelaic.

1
Drug Ineffective15.6%467
2
Off Label Use12.4%373
3
Gastrooesophageal Reflux Disease12.3%369
4
Abdominal Pain Upper12.2%365
5
Pain12.0%359
6
Paraesthesia11.9%358
7
Hypoaesthesia11.7%352
8
Blepharospasm11.2%337
9
Taste Disorder11.0%329
10
Epilepsy10.9%328
11
Drug Intolerance10.8%324
12
Vomiting10.7%322
13
Product Use In Unapproved Indication9.7%292
14
Memory Impairment9.7%291
15
Rash9.4%281

These are voluntary reports and do not establish that azelaic caused these reactions.

Report severity

46.8%Serious1,404 reports
17.7%Hospitalizations531 reports
15.1%Fatal453 reports

Seriousness is determined by the reporter, not by OpenClaim.

Azelaic drug interactions

Other drugs that appear in adverse event reports alongside azelaic. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Erenumab-aooe16.8%506
2
Naproxen16.7%503
3
Cyclobenzaprine-hydrochloride16.6%497
4
Lamotrigine16.5%495
5
Pantoprazole-sodium16.5%494
6
Buprenorphine16.5%494
7
Hydromorphone-hydrochloride16.3%489
8
Betamethasone16.3%488
9
Desoximetasone16.3%488
10
Mirabegron16.1%484
11
Candesartan-cilexetil16.1%482
12
Cetirizine-hydrochloride16.0%481
13
Levomilnacipran15.9%476
14
Topiramate15.5%465
15
Atomoxetine-hydrochloride15.4%463

Taken alongside

1
Ergocalciferol13.0%389
2
Acetaminophen12.2%367
3
Fluticasone9.4%283
4
Calcium9.2%276
5
Albuterol7.9%237
6
Levothyroxine-sodium7.3%219
7
Cetirizine-hydrochloride7.2%215
8
Metronidazole7.1%212
9
Omeprazole7.0%211
10
Pantoprazole-sodium7.0%209
11
Doxycycline6.9%206
12
Lisinopril6.8%205
13
Ibuprofen6.3%190
14
Lorazepam6.3%189
15
Prednisone5.9%177

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports azelaic side effects

75.2% of azelaic adverse event reports involve female patients and 13.9% involve male patients. The largest age group is adult at 75%. These figures reflect who reports side effects, not underlying risk.

Sex

Female75.2%
Male13.9%
Unknown10.9%

Age group

< 20.4%
2–110.2%
12–172.0%
18–6475.1%
65+22.2%

What is azelaic used for

Conditions and purposes for which patients were taking azelaic when the adverse event was reported.

AcneAcne CysticAcne PustularAdverse EventAcneAcute Myeloid LeukaemiaBlood Pressure AbnormalBreast Cancer MetastaticChloasmaChloasmaCystDermal CystDermatitisDermatitis ContactDrug Use For Unknown Indication

Showing 15 of 87 indications

Azelaic brand names and reporting trend

Azelaic is sold under the brand name Azelex.

Brand names

Azelex875

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking azelaic with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.