Quick answers
- What is Flibanserin used for?
- The FDA-approved label (Addyi, Sprout Pharmaceuticals, Inc., December 22, 2025) says: “ADDYI is indicated for the treatment of women less than 65 years of age with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to: • A co-existing medical or psychiatric condition, • Problems within the relationship, or • The effects of a medication or other drug substance. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Flibanserin have a boxed warning?
- Yes. The FDA label for Addyi has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Flibanserin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Flibanserin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Flibanserin?
- 1 company lists prescription products of Flibanserin in the FDA NDC Directory, including Sprout Pharmaceuticals, Inc..
What Flibanserin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ADDYI is indicated for the treatment of women less than 65 years of age with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to: • A co-existing medical or psychiatric condition, • Problems within the relationship, or • The effects of a medication or other drug substance. …
— FDA label: Addyi, Sprout Pharmaceuticals, Inc., effective December 22, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Addyi |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Sprout Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022526 ADDYI | Sprout Pharms | August 18, 2015 | 9, latest December 13, 2025 2025: Efficacy · 2025: REMS · 2021: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1665514, 1666391 |
|---|---|
| SPL set ID of the quoted label | 3819daf3-e935-2c53-c527-e1d57922f394 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA022526 |
| Active ingredients (FDA) | FLIBANSERIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Addyi, Sprout Pharmaceuticals, Inc., effective December 22, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →