Drug

Omaveloxolone

36 flagged reaction(s) · 882 total co-reports · max PRR 22.4

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	Hepatic Enzyme Increased	123	22.4	24.1	signal
2	Blood Cholesterol Increased	82	21.8	22.8	signal
3	Hepatic Cytolysis	21	21.3	21.5	signal
4	Blood Triglycerides Increased	22	15.4	15.6	signal
5	Cardiomyopathy	17	14.2	14.4	signal
6	Alanine Aminotransferase Increased	64	12.9	13.4	signal
7	Liver Function Test Increased	22	12.8	12.9	signal
8	Prescribed Underdose	20	12.4	12.6	signal
9	Cardiogenic Shock	13	11.3	11.4	signal
10	Brain Fog	13	11.0	11.1	signal
11	Aspartate Aminotransferase Increased	41	9.6	9.8	signal
12	Urosepsis	7	9.4	9.4	signal
13	Coordination Abnormal	10	8.8	8.9	signal
14	Speech Disorder	37	8.7	8.9	signal
15	Atrial Fibrillation	65	8.2	8.5	signal
16	Gastroenteritis Viral	12	8.2	8.3	signal
17	Hyperthyroidism	9	7.7	7.7	signal
18	Motor Dysfunction	6	7.3	7.4	signal
19	Product Use Complaint	8	6.4	6.4	signal
20	Cold Sweat	9	6.3	6.3	signal
21	Product Dose Omission In Error	13	6.0	6.0	signal
22	Muscle Spasticity	6	6.0	6.0	signal
23	Ejection Fraction Decreased	7	5.6	5.6	signal
24	Cardiac Failure	36	5.5	5.6	signal
25	Accident	5	5.2	5.2	signal
26	Musculoskeletal Disorder	8	5.2	5.2	signal
27	Choking	8	5.1	5.1	signal
28	Underdose	28	4.7	4.8	signal
29	Laboratory Test Abnormal	11	4.6	4.6	signal
30	Product Dose Omission Issue	106	4.6	4.8	signal
31	Pharyngitis Streptococcal	4	4.6	4.6	signal
32	Cardiac Disorder	32	4.2	4.3	signal
33	Hunger	4	3.7	3.7	signal
34	Diabetic Ketoacidosis	7	3.6	3.6	signal
35	Blood Glucose Fluctuation	3	3.4	3.4	no signal
36	Menstruation Irregular	3	1.4	1.4	no signal