What the label lists and what reports show
Flibanserin side effects
Flibanserin's FDA label: “Most common adverse reactions (incidence ≥2%) are dizziness, somnolence, nausea, fatigue, insomnia, urinary tract infection, anxiety, sinusitis, constipation and dry mouth.” FAERS holds 1,994 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dizziness (331 reports).
- No generic listed
- Boxed warning
Check it at the source: the flibanserin FDA label on DailyMed (effective December 22, 2025, Sprout Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ADDYI?ADDYI can cause serious side effects, including: • See “What is the most important information I should know about ADDYI?” • Sleepiness is a common side effect of ADDYI and can be serious. Taking ADDYI can increase your risk of sleepiness if taken during waking hours, if you drink alcohol, or take certain medicines or herbal supplements. • Low blood pressure and fainting (loss of consciousness) can happen when you take ADDYI even if you do not drink alcohol or take other medicines or herbal supplements. Your risk of low blood pressure and fainting (loss of consciousness) is increased if ADDYI is taken during waking hours, if you drink alcohol within 2 hours of taking ADDYI, or if you take certain medicines or herbal supplements. […]
Source: FDA drug label, Sprout Pharmaceuticals, Inc., effective December 22, 2025 (SPL set 3819daf3-e935-2c53-c527-e1d57922f394), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥2%) are dizziness, somnolence, nausea, fatigue, insomnia, urinary tract infection, anxiety, sinusitis, constipation and dry mouth.
Table 2 Common Adverse Reactions Adverse reactions reported in ≥2% of patients who received ADDYI 100 mg once daily at bedtime and at a higher incidence than placebo-treated patients in premenopausal women or…
| Adverse Reaction | Placebo (N=1556) | ADDYI (N=1543) | Placebo (N=797) | ADDYI (N=801) |
|---|---|---|---|---|
| Dizziness | 2.2% | 11.4% | 3.3% | 7.9% |
| Somnolence | 2.9% | 11.2% | 1.8% | 7.7% |
| Nausea | 3.9% | 10.4% | 3.9% | 6.6% |
| Fatigue | 5.5% | 9.2% | 3.9% | 3.0% |
| Insomnia | 2.8% | 4.9% | 3.4% | 5.7% |
| Dry mouth | 1.0% | 2.4% | 1.3% | 2.4% |
| Urinary tract infection | 2.4% | 2.3% | 3.0% | 3.2% |
| Anxiety | 1.0% | 1.8% | 1.6% | 2.6% |
| Sinusitis | 3.5% | 2.9% | 2.1% | 2.5% |
| Constipation | 0.4% | 1.6% | 1.8% | 2.5% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail in other sections of the labeling: • Hypotension and syncope [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5) ] • CNS depression [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence ≥2%) are dizziness, somnolence, nausea, fatigue, insomnia, urinary tract infection, anxiety, sinusitis, constipation and dry mouth. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sprout Pharmaceuticals, Inc. at 1-844-746-5745, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The approved 100 mg ADDYI dosage at bedtime was administered to 2,997 premenopausal women with acquired, generalized HSDD in clinical trials, of whom 1,672 received treatment for at least 6 months, 850 received treatment for at least 12 months, and 88 received treatment for at least 18 months [see Clinical Studies (14) ]. …
Source: FDA drug label, Sprout Pharmaceuticals, Inc., effective December 22, 2025 (SPL set 3819daf3-e935-2c53-c527-e1d57922f394), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,994 reports list flibanserin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 22 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 15 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Flibanserin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions