Prescription medicine
Flibanserin Brand names: Addyi
Flibanserin (Addyi) is a prescription medicine with an FDA approval on record since 2015. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the flibanserin FDA label on DailyMed (effective December 22, 2025, Sprout Pharmaceuticals, Inc.); the NDA 22526 record on Drugs@FDA; every flibanserin label on DailyMed.
Highlights of the record
FDA label of December 22, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
HYPOTENSION and SYNCOPE IN CERTAIN SETTINGS Interaction with Alcohol The use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope [see Warnings and Precautions (5.1) ]. Counsel patients to wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or to skip their ADDYI dose if they have consumed three or more standard alcoholic drinks that evening. Contraindicated with Strong or Moderate CYP3A4 Inhibitors The concomitant use of ADDYI and moderate or strong CYP3A4 inhibitors increases flibanserin concentrations, which can cause severe hypotension and syncope [see Warnings and Precautions (5.2) ]. Therefore, the use of moderate or strong CYP3A4 inhibitors is contraindicated in patients taking ADDYI [see Contraindications (4) ]. Contraindicated in Patients with Hepatic Impairment The use of ADDYI in patients with hepatic impairment increases flibanserin concentrations, which can cause severe hypotension and syncope [see Warnings and Precautions (5.5) ]. Therefore, ADDYI is contraindicated in patients with hepatic impairment [see Contraindications (4) ]. WARNING: HYPOTENSION and SYNCOPE IN CERTAIN SETTINGS See full prescribing information for complete boxed warning.
Use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope. […]
Used for
From the label: indications and usageADDYI 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.
Forms and strengths
- 100 mg
Film-coated tablet.
On the market
- Earliest approval on file
- August 18, 2015 Addyi, Sprout Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 9, 2028 Addyi tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,994 through July 30, 2026
What is flibanserin used for?
From the label: indications and usageADDYI 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. Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner. Limitations of Use
ADDYI is not indicated in men. […]
Source: FDA drug label (ADDYI), Sprout Pharmaceuticals, Inc., effective December 22, 2025 (SPL set 3819daf3-e935-2c53-c527-e1d57922f394), via openFDA; the full label on DailyMed
What does the patient leaflet for flibanserin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ADDYI?Your risk of severe low blood pressure and fainting (loss of consciousness) is increased: • if you drink alcohol close to the time you take your ADDYI dose, • if you take ADDYI with certain medicines, or • if you have liver problems and you take ADDYI. To lower your risk of low blood pressure and fainting (loss of consciousness): • Do not drink alcohol close to the time you take your ADDYI dose. • After taking ADDYI at bedtime do not drink alcohol until the following day. Examples of 1 standard alcoholic drink include: o one 12-ounce regular beer o 5 ounces of wine o 1.5 ounces of distilled spirits or shot • Tell your doctor about other medicines you take. Do not take or start taking any prescription or over-the-counter medicines, or herbal supplements without first talking to your doctor. Your doctor will tell you if it is safe to take other medicines or herbal supplements while you are taking ADDYI. • Do not take ADDYI if you have liver problems. If you take ADDYI and you feel lightheaded or dizzy, lie down right away. Get emergency medical help or ask someone to get emergency medical help for you if the symptoms do not go away or if you feel like you could faint (lose consciousness). If you faint (lose consciousness), tell your doctor as soon as you can.
From the patient leaflet: What should I avoid while taking ADDYI?Do not drink alcohol close to the time you take your ADDYI dose because this increases your risk of severe low blood pressure and fainting (loss of consciousness). • Do not drive, operate machinery, or do things that require clear thinking until at least 6 hours after you take ADDYI and until you know how ADDYI affects you. • Do not drink grapefruit juice if you take ADDYI. Drinking grapefruit juice during your treatment with ADDYI increases your risk of severe low blood pressure and fainting (loss of consciousness). • You should not take the herbal supplements St. John’s Wort, ginkgo, or resveratrol or certain over-the-counter medicines such as cimetidine until you talk to your doctor. Taking ADDYI with these herbal supplements and over-the-counter medicine may increase your risk of low blood pressure, fainting (loss of consciousness), and sleepiness.
From the patient leaflet: How should I store ADDYI?Store ADDYI at room temperature between 68°F to 77°F (20°C to 25°C). Keep ADDYI and all medicines out of the reach of children.
Source: FDA drug label (ADDYI), Sprout Pharmaceuticals, Inc., effective December 22, 2025 (SPL set 3819daf3-e935-2c53-c527-e1d57922f394), via openFDA; the full label on DailyMed
Is there a generic for flibanserin (Addyi)?
No generic flibanserin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 1 patent for Addyi tablets, the last expiring on May 9, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2028 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the flibanserin label say about other medicines?
The flibanserin label names 25 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name flibanserin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atazanavir | drug interactions | Examples of moderate CYP3A4 inhibitors; Amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, and grapefruit juice |
| Carbamazepine | drug interactions | CYP3A4 Inducers Examples Carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapetine, St. John's Wort Clinical Implications The concomitant use of ADDYI with CYP3A4 inducers substantially decreases flibanserin exposure compared to the use of ADDYI alone. |
| Cimetidine | drug interactions | Examples; Oral contraceptives, cimetidine, fluoxetine, ginkgo, ranitidine |
| Ciprofloxacin | drug interactions | Examples of moderate CYP3A4 inhibitors; Amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, and grapefruit juice |
| Clarithromycin | drug interactions | Examples of strong CYP3A4 inhibitors; Ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan |
| Digoxin | drug interactions | Examples; Digoxin, sirolimus |
| Diltiazem | drug interactions | Examples of moderate CYP3A4 inhibitors; Amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, and grapefruit juice |
| Diphenhydramine | drug interactions | Examples; Diphenhydramine, opioids, hypnotics, benzodiazepines |
| Erythromycin | drug interactions | Examples of moderate CYP3A4 inhibitors; Amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, and grapefruit juice |
| Fluconazole | drug interactions | Examples of moderate CYP3A4 inhibitors; Amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, and grapefruit juice |
| Fluoxetine | drug interactions | Examples; Oral contraceptives, cimetidine, fluoxetine, ginkgo, ranitidine |
| Fosamprenavir | drug interactions | Examples of moderate CYP3A4 inhibitors; Amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, and grapefruit juice |
| Itraconazole | drug interactions | Examples of strong CYP3A4 inhibitors; Ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan |
| Ketoconazole | drug interactions | Examples of strong CYP3A4 inhibitors; Ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan |
Every other medicine the flibanserin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Nefazodone | drug interactions | Examples of strong CYP3A4 inhibitors; Ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and … |
| Nelfinavir | drug interactions | Examples of strong CYP3A4 inhibitors; Ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and … |
| Phenobarbital | drug interactions | CYP3A4 Inducers Examples Carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapetine, St. John's Wort Clinical Implications The concomitant use of ADDYI with CYP3A4 inducers … |
| Phenytoin | drug interactions | CYP3A4 Inducers Examples Carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapetine, St. John's Wort Clinical Implications The concomitant use of ADDYI with CYP3A4 inducers … |
| Posaconazole | drug interactions | Examples of strong CYP3A4 inhibitors; Ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and … |
| Ranitidine | drug interactions | Examples; Oral contraceptives, cimetidine, fluoxetine, ginkgo, ranitidine |
| Rifabutin | drug interactions | CYP3A4 Inducers Examples Carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapetine, St. John's Wort Clinical Implications The concomitant use of ADDYI with CYP3A4 inducers … |
| Rifampin | drug interactions | CYP3A4 Inducers Examples Carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapetine, St. John's Wort Clinical Implications The concomitant use of ADDYI with CYP3A4 inducers … |
| Ritonavir | drug interactions | Examples of strong CYP3A4 inhibitors; Ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and … |
| Sirolimus | drug interactions | Examples; Digoxin, sirolimus |
| Verapamil | drug interactions | Examples of moderate CYP3A4 inhibitors; Amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, and grapefruit juice |
Other labels that name flibanserin
Source: FDA drug label (ADDYI), 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 for flibanserin?
The FDA Adverse Event Reporting System holds 1,994 reports that list flibanserin among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Flibanserin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other