The U.S. Food and Drug Administration has approved changes to the labeling of six menopausal hormone therapy (HRT) products, also known as hormone replacement therapy, to provide clearer information about potential risks. Most notably, warnings about cardiovascular disease, breast cancer, and probable dementia have been removed from the “boxed warning”—the FDA’s most prominent safety alert.

A Shift Based on Evolving Science

“This decision reflects our commitment to follow the science wherever it leads and to correct course when the evidence demands it,” Health and Human Services Secretary Robert F. Kennedy, Jr. said. “By removing these boxed warnings, we ensure that women receive accurate information about hormone therapy—free from exaggeration or fear. A healthcare system worthy of public trust tells the truth, updates its guidance as science evolves, and respects women’s ability to make informed choices about their own health.”

The FDA began reviewing the warnings in November 2025, leading to requests for labeling changes from 29 drug companies. The first six products to receive approved labeling changes represent all four categories of HRT used by women experiencing menopause:

  • Systemic combination therapy (estrogen and progestogen)
  • Systemic estrogen-alone therapy
  • Systemic progestogen-alone therapy for women with a uterus using systemic estrogen
  • Topical vaginal estrogen therapy

“With today’s action, we are delivering on our promise to make sure women have accurate, scientifically grounded information about the potentially life-changing benefits of HRT,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Women face symptoms of menopause that can last for years, and our efforts will help these women make well-informed medical decisions.”

Understanding Menopause and HRT

Menopause is a natural stage of life, but its symptoms can significantly impact a woman’s quality of life. Common symptoms include hot flashes and night sweats (vasomotor symptoms or VMS), changes in the vagina, vulva, and urinary tract due to lower estrogen levels, and osteoporosis, which increases the risk of fractures.

The FDA has approved hormone therapies to treat moderate-to-severe hot flashes, vaginal dryness, and to prevent bone loss. Studies also indicate that women who begin HRT within 10 years of menopause (typically before age 60) may experience a reduction in all-cause mortality and fractures. Despite these potential benefits, HRT remains underutilized. In 2020, approximately 41 million U.S. women were between 45 and 64 years old, yet only about 2 million women aged 46–65 received a hormone therapy prescription.

Today’s action aims to empower women, in consultation with their healthcare providers, to make informed decisions about managing menopause symptoms. Women are encouraged to review the updated drug label, available here, for detailed information on the benefits and risks of these products.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, biological products, and medical devices. The agency also safeguards the nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and regulates tobacco products.