Drug

12%azelaic Acid

82 flagged reaction(s) · 2,453 total co-reports · max PRR 110.2

Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.

	Reaction	Co-reports (a)	PRR	ROR	Signal
1	Taste Disorder	83	110.2	123.1	signal
2	Folliculitis	36	92.7	97.1	signal
3	Wound Infection	31	75.8	78.9	signal
4	Epilepsy	85	74.0	82.8	signal
5	Back Injury	27	66.3	68.6	signal
6	Bursitis	30	66.1	68.6	signal
7	Synovitis	44	64.8	68.5	signal
8	Pemphigus	30	64.1	66.6	signal
9	Hypercholesterolaemia	22	61.1	62.8	signal
10	Red Blood Cell Sedimentation Rate Increased	25	59.9	61.8	signal
11	Helicobacter Infection	21	54.7	56.2	signal
12	Pericarditis	34	54.2	56.6	signal
13	Joint Range Of Motion Decreased	22	43.7	44.9	signal
14	Sleep Disorder Due To A General Medical Condition	26	42.7	44.1	signal
15	Hand Deformity	21	42.6	43.7	signal
16	Laryngitis	16	39.1	39.9	signal
17	Poor Quality Product Administered	14	36.4	37.0	signal
18	Wound	36	34.4	36.0	signal
19	Fibromyalgia	31	33.9	35.2	signal
20	Contraindicated Product Administered	36	31.7	33.1	signal
21	Gastrooesophageal Reflux Disease	93	30.8	34.7	signal
22	Irritable Bowel Syndrome	24	29.8	30.7	signal
23	Glossodynia	25	29.7	30.6	signal
24	Obesity	17	28.3	28.9	signal
25	Night Sweats	34	28.0	29.2	signal
26	Autoimmune Disorder	10	27.7	28.1	signal
27	Migraine	90	25.2	28.3	signal
28	Drug Intolerance	87	24.0	26.8	signal
29	Prescribed Overdose	17	23.3	23.8	signal
30	Hepatic Cirrhosis	16	22.7	23.2	signal
31	C-reactive Protein Increased	31	22.6	23.5	signal
32	Systemic Lupus Erythematosus	30	22.5	23.3	signal
33	Gait Inability	28	22.4	23.2	signal
34	Ear Pain	16	21.8	22.3	signal
35	Type 2 Diabetes Mellitus	27	21.2	21.9	signal
36	Stomatitis	47	20.6	21.8	signal
37	Psoriatic Arthropathy	31	20.4	21.2	signal
38	Respiratory Disorder	23	20.3	20.9	signal
39	Impaired Healing	25	20.2	20.8	signal
40	Osteoarthritis	32	20.0	20.8	signal
41	Prescribed Underdose	15	19.9	20.3	signal
42	Therapeutic Product Effect Decreased	33	19.7	20.5	signal
43	Sleep Disorder	50	19.0	20.2	signal
44	Inflammation	36	18.6	19.4	signal
45	Liver Injury	16	17.5	17.9	signal
46	Memory Impairment	89	17.2	19.2	signal
47	Sciatica	10	16.7	16.9	signal
48	Lower Limb Fracture	12	16.7	16.9	signal
49	Blister	35	16.6	17.3	signal
50	Blood Cholesterol Increased	29	16.5	17.1	signal
51	Liver Function Test Increased	13	16.2	16.4	signal
52	Hypoaesthesia	90	15.9	17.8	signal
53	Paraesthesia	92	15.5	17.4	signal
54	Pulmonary Fibrosis	11	15.3	15.5	signal
55	Arthropathy	30	14.3	14.8	signal
56	Maternal Exposure During Pregnancy	47	14.1	15.0	signal
57	Wheezing	30	13.4	13.9	signal
58	Neck Pain	28	13.3	13.7	signal
59	Application Site Pain	11	13.3	13.4	signal
60	Joint Stiffness	13	13.1	13.3	signal
61	Abdominal Pain Upper	97	12.5	14.1	signal
62	Treatment Failure	38	12.3	12.8	signal
63	Rheumatoid Arthritis	50	11.7	12.5	signal
64	Coeliac Disease	4	10.8	10.9	signal
65	Insurance Issue	6	10.7	10.8	signal
66	Injury	28	10.5	10.9	signal
67	Product Prescribing Issue	8	10.4	10.5	signal
68	Skin Irritation	18	10.4	10.6	signal
69	Foot Deformity	4	9.6	9.6	signal
70	Basal Cell Carcinoma	5	8.5	8.5	signal
71	Product Quality Issue	42	8.3	8.7	signal
72	Drug Effect Less Than Expected	4	7.5	7.6	signal
73	Skin Burning Sensation	20	7.5	7.6	signal
74	Product Packaging Quantity Issue	3	7.3	7.3	signal
75	Incorrect Product Administration Duration	5	6.5	6.6	signal
76	Exposure During Pregnancy	15	6.4	6.5	signal
77	Acne	16	5.6	5.7	signal
78	Dermatitis Atopic	10	5.3	5.4	signal
79	Application Site Erythema	5	5.0	5.1	signal
80	Complication Of Device Removal	3	4.7	4.7	signal
81	Abortion Spontaneous	5	3.3	3.3	signal
82	Device Dislocation	4	2.4	2.5	no signal