Flibanserin: Side Effects, Uses & Monitoring
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 interperson
- Data source
- FDA labeling via NIH DailyMed (label 3819daf3…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
No structured frequency data available in current labeling. Consult the official label.
Labeled uses (from FDA prescribing information)
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. 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. • ADDYI is not indicated to enhance sexual performance.
Frequently Asked Questions
What is Flibanserin used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Flibanserin?
Current labeling for this ingredient does not include a structured frequency table that we can reproduce. Review the official label linked below.
Does Flibanserin require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Flibanserin.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.