Flibanserin
فلیبانسرین
🚻 Genito Urinary System And Sex HormonesSerotonin 1A agonist / 2A antagonist
Market / country: 🇺🇸 USA
Addyi (US)
🧮 Dose calculator
Hypoactive sexual desire disorder (premenopausal women) · Regimen source: FDA Addyi · 2.1
- • Bedtime only (risk of hypotension and fainting). Stop if no improvement after 8 weeks. FDA Addyi · 2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Moderate or strong CYP3A4 inhibitors; hepatic impairment; hypersensitivity. FDA Addyi · 4
Warnings
- • Boxed warning: hypotension and syncope with alcohol; wait at least 2 h after 1–2 drinks or skip that night’s dose. FDA Addyi · Boxed WarningFDA Addyi · 5.1
Formulations
- 100 mg tablet — tablet 🇺🇸 USA FDA Addyi · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Addyi · 8.1
“Risk Summary There are no studies of ADDYI in pregnant women to inform whether there is a drug-associated risk in humans.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Addyi · 8.2
“Risk Summary Flibanserin is excreted in rat milk.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Addyi · 8.4
“ADDYI is not indicated for use in pediatric patients.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Addyi · 8.5
“ADDYI is not indicated for the treatment of HSDD in geriatric patients [see Warnings and Precautions (5.1 . 5.2 , and 5.4 )] .”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA022526
- DailyMed (FDA label)FDA Addyi
- MedlinePlus (NIH)Flibanserin
- WHO ATC/DDDG02CX02
- Darooyab (Iran)Flibanserin
🇮🇷 Registered in Iran Darooyab · G-5564/Flibanserin
Dosage forms with Iranian generic codes, per Darooyab.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Addyi · 3FDA Addyi · 2.1FDA Addyi · 2FDA Addyi · 4FDA Addyi · Boxed WarningFDA Addyi · 5.1FDA Addyi · 8.1FDA Addyi · 8.2FDA Addyi · 8.4FDA Addyi · 8.5FDA Addyi · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-5564/Flibanserin
- Clinical review⚠ Unverified