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U.S. Department of Health and Human Services
National Pharmacy & Therapeutics Committee

Rare occurrence of serious liver injury with use of fezolinetant (Veozah®) for hot flashes due to menopause

Fezolinetant (Veozah®) is a nonhormonal prescription medicine approved in May 2023 to reduce the frequency and severity of moderate to severe hot flashes caused by menopause. The medicine is in a drug class called neurokinin 3 (NK3) receptor antagonists. It works to restore the balance between estrogen hormones and a brain chemical called neurokinin B (NKB) by blocking the activities of the NK3 receptor, which plays a role in the brain’s control of body temperature.

A report submitted to the FDA MedWatch System identifies a patient who experienced serious liver injury including symptoms of fatigue, nausea, itching, yellow eyes and skin, light-colored stools, and dark urine within 40 days of starting fezolinetant.

Based on their evaluation of this case, the U.S. Food and Drug Administration (FDA) is warning that fezolinetant can cause rare but serious liver injury. If there are signs and symptoms suggesting liver injury, stopping the medicine could prevent worsening liver injury and potentially return liver function to normal.

Recommendations for Health Care Providers

  • Inform patients about the risk of elevated liver blood test values that may occur during treatment and the rare but serious risk of liver injury.
  • Discuss the signs and symptoms of liver injury and instruct patients to stop fezolinetant immediately and contact their health care provider.
  • Order hepatic laboratory testing (e.g., alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin, and direct bilirubin) at baseline before starting therapy and after 1, 2, 3, 6, and 9 months of treatment.
    • Do not start fezolinetant if the concentration of ALT, AST, or total bilirubin is equal to or exceeds two times the upper limit of normal (ULN).
    • Stop fezolinetant 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.
    • Perform more frequent follow-up hepatic laboratory testing if the transaminases exceed three times the ULN, but the total bilirubin is not more than two times the ULN. If the liver blood test values are elevated, exclude alternative causes of liver injury.

The complete Drug Safety Communication can be viewed on the FDA website.

To help the FDA track safety issues with fezolinetant and other medications, please report adverse events to the MedWatch program and putting "IHS" in the "Reporter" section of the form as recommended in the Indian Health Manual. Instructions for reporting can be found online at the NPTC Pharmacovigilance website