Fezolinetant
فزولینتانت
🚻 Genito Urinary System And Sex HormonesNeurokinin-3 receptor antagonist (menopausal hot flushes)
Market / country: 🇺🇸 USA
Veozah (US)
🧮 Dose calculator
Menopausal vasomotor symptoms · Regimen source: FDA Veozah · 2.1
- • Liver tests before starting; do not start if ALT or AST ≥2× ULN or bilirubin ≥2× ULN. Monitor monthly for 3 months, then at 6 and 9 months. Swallow whole. FDA Veozah · 2.1FDA Veozah · Boxed Warning
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Cirrhosis; severe renal impairment or ESRD; concomitant CYP1A2 inhibitors. FDA Veozah · 4
Warnings
- • Boxed warning: hepatotoxicity; stop immediately with signs of liver injury. FDA Veozah · Boxed Warning
Important interactions
- • CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) — contraindicated. FDA Veozah · 4
Formulations
- 45 mg tablet — tablet 🇺🇸 USA FDA Veozah · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Veozah · 8.1
“Risk Summary There are no data on VEOZAH use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Veozah · 8.2
“Risk Summary There are no data on the presence of fezolinetant in human milk, the effects on the breastfed child, or the effects on milk production.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Veozah · 8.4
“The efficacy and safety of VEOZAH in individuals less than 18 years of age have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Veozah · 8.5
“There have not been sufficient numbers of geriatric women involved in clinical trials utilizing VEOZAH to determine whether those over 65 years of age differ from younger women in their response to VEOZAH.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA216578
- DailyMed (FDA label)FDA Veozah
- MedlinePlus (NIH)Fezolinetant
- WHO ATC/DDDG02CX06
- Darooyab (Iran)Fezolinetant
🇮🇷 Registered in Iran Darooyab · G-5576/Fezolinetant
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 Veozah · 3FDA Veozah · 2.1FDA Veozah · Boxed WarningFDA Veozah · 4FDA Veozah · 8.1FDA Veozah · 8.2FDA Veozah · 8.4FDA Veozah · 8.5FDA Veozah · 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-5576/Fezolinetant
- Clinical review⚠ Unverified