Drug

Fezolinetant

26 flagged reaction(s) · 1,080 total co-reports · max PRR 42.8

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	Liver Function Test Increased	92	42.8	44.7	signal
2	Alanine Aminotransferase Increased	192	31.0	34.0	signal
3	Hepatic Enzyme Increased	191	27.8	30.5	signal
4	Aspartate Aminotransferase Increased	147	27.4	29.4	signal
5	Gamma-glutamyltransferase Increased	40	17.8	18.2	signal
6	Blood Alkaline Phosphatase Increased	36	14.3	14.5	signal
7	Transaminases Increased	32	14.3	14.5	signal
8	Hot Flush	100	13.1	13.7	signal
9	Brain Fog	18	12.2	12.3	signal
10	Night Sweats	37	11.4	11.6	signal
11	Blood Bilirubin Increased	26	9.5	9.6	signal
12	Glomerular Filtration Rate Decreased	9	7.3	7.4	signal
13	Chromaturia	13	5.7	5.7	signal
14	Therapeutic Response Shortened	18	5.6	5.6	signal
15	Liver Function Test Abnormal	16	5.4	5.4	signal
16	Head Discomfort	9	5.1	5.1	signal
17	Hyperthyroidism	7	4.8	4.8	signal
18	Drug Effective For Unapproved Indication	14	4.7	4.8	signal
19	Therapeutic Product Effect Decreased	20	4.5	4.5	signal
20	Skin Haemorrhage	6	4.1	4.1	signal
21	Nightmare	14	4.0	4.0	signal
22	Contraindicated Product Administered	12	3.9	3.9	signal
23	Initial Insomnia	4	3.9	3.9	signal
24	Disease Recurrence	16	3.3	3.3	signal
25	Libido Decreased	4	3.2	3.2	signal
26	Product Dose Omission In Error	7	2.6	2.6	signal