Drug

Flibanserin

36 flagged reaction(s) · 2,048 total co-reports · max PRR 31.7

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	Middle Insomnia	56	31.7	32.6	signal
2	Adverse Reaction	17	13.5	13.6	signal
3	Therapeutic Response Unexpected	56	13.1	13.4	signal
4	Presyncope	27	11.7	11.9	signal
5	Adverse Drug Reaction	99	11.6	12.2	signal
6	Impaired Driving Ability	12	11.1	11.2	signal
7	Drug Ineffective For Unapproved Indication	50	9.4	9.7	signal
8	Somnolence	168	8.8	9.5	signal
9	Intentional Dose Omission	21	8.1	8.2	signal
10	Libido Decreased	9	7.6	7.7	signal
11	Therapeutic Product Effect Decreased	32	7.6	7.7	signal
12	Initial Insomnia	7	7.2	7.2	signal
13	Dizziness	331	7.0	8.2	signal
14	Product Use In Unapproved Indication	154	6.6	7.1	signal
15	Brain Fog	9	6.5	6.5	signal
16	Vertigo	34	5.9	6.0	signal
17	Mood Altered	15	5.8	5.8	signal
18	Insomnia	142	5.6	6.0	signal
19	Sluggishness	5	5.2	5.2	signal
20	Euphoric Mood	5	5.1	5.1	signal
21	Menstruation Delayed	5	5.1	5.1	signal
22	Breast Pain	5	4.9	4.9	signal
23	Abnormal Dreams	13	4.9	4.9	signal
24	Restless Legs Syndrome	8	4.6	4.6	signal
25	Drug Ineffective	561	4.5	5.8	signal
26	Feeling Abnormal	101	4.4	4.6	signal
27	Sedation	10	4.0	4.1	signal
28	Anger	13	4.0	4.0	signal
29	Adverse Event	31	3.5	3.6	signal
30	Irritability	20	3.5	3.5	signal
31	Impaired Work Ability	7	3.4	3.4	signal
32	Vaginal Discharge	3	3.1	3.1	no signal
33	Menstruation Irregular	6	2.4	2.4	no signal
34	Withdrawal Syndrome	9	2.2	2.2	signal
35	Drug Effective For Unapproved Indication	4	1.4	1.4	no signal
36	Device Expulsion	3	0.5	0.5	no signal