FDA Boxed Warning: Veozah (fezolinetant) Liver Injury Risk

Tier 1: Established: peer-reviewed research or government health authority
Publisher: U.S. Food and Drug Administration · Published: December 16, 2024 · Accessed: August 11, 2026

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Claims this source supports

• Veozah (fezolinetant) is a nonhormonal prescription medicine approved in May 2023 to reduce the frequency and severity of moderate to severe hot flashes caused by menopause.
• On December 16, 2024, FDA added a Boxed Warning - its most prominent warning - to Veozah's prescribing information to highlight the known risk of rare but serious liver injury.
• The warning followed a postmarketing report of serious liver injury in a patient who took Veozah for about 40 days; the patient's liver blood test values were significantly elevated and symptoms included fatigue, nausea, decreased appetite, itching, jaundice, pale feces, and dark urine. After stopping the medicine, symptoms gradually went away and blood test values slowly returned to normal.
• Health care professionals should conduct hepatic laboratory testing before prescribing Veozah, then every month for the first three months after patients start treatment, and then at months 6 and 9 of treatment.
• Do not start Veozah if ALT, AST, or total bilirubin is equal to or exceeds two times the upper limit of normal; stop Veozah if transaminases exceed five times the ULN, or if transaminases exceed three times the ULN and total bilirubin is more than two times the ULN.
• Patients should stop taking Veozah immediately and contact the prescriber if they experience signs or symptoms that suggest liver problems: feeling more tired than usual, nausea, vomiting, unusual itching, light-colored stools, yellowing of the eyes or skin (jaundice), dark urine, swelling in the stomach or belly area, or pain in the right upper abdomen.