The U.S. faces intermittent shortages of progesterone for menopause and fertility treatments, driven by a surge in demand for Hormone Replacement Therapy (HRT). This follows the FDA's removal of a safety warning in late 2025, which helped triple prescriptions since 2021. While manufacturers like Amneal are increasing capacity, patients face difficulties, prompting a turn to less-regulated compounding pharmacies and raising safety concerns among doctors.
U.S. progesterone supply shortages
- ▪Progesterone shortages are considered milder than those for estrogen patches, partly due to available alternatives and because not all HRT patients require it
- ▪The American Society of Health-System Pharmacists lists oral progesterone from Amneal Pharmaceuticals and Hikma Pharmaceuticals in its shortages database
- ▪The progesterone supply issues follow existing difficulties for patients in filling prescriptions for estrogen patches, another common hormone therapy
- ▪The U.S. Food and Drug Administration does not officially list progesterone as being in shortage
- ▪The U.S. is experiencing intermittent shortages of oral progesterone, which is used in fertility and menopause treatments
Rising HRT demand post-FDA change
- ▪Demand for Hormone Replacement Therapy (HRT) rose sharply after the FDA removed a long-standing safety warning from many such therapies in late 2025
- ▪Progesterone is often prescribed with estrogen to reduce uterine cancer risk and relieve menopause symptoms like hot flashes and mood changes
- ▪Progesterone-containing HRT prescriptions for women aged 45 and older more than tripled between January 2021 and May 2026
- ▪According to health analytics company Truveta, prescribing rates for progesterone-containing HRT have increased by over 19% since the FDA's 2025 label change
Pharmaceutical manufacturer supply responses
- ▪CVS Health reported that manufacturers have been unable to provide sufficient Hormone Replacement Therapy supplies for several months
- ▪Amneal Pharmaceuticals acknowledged increased demand for its progesterone capsules and is increasing manufacturing capacity at its New York facility
- ▪According to an FDA database, nine companies manufacture oral progesterone, though Dr. Reddy's stated it has not done so in the U.S. since 2022
- ▪Michael Ganio of the American Society of Health-System Pharmacists noted that manufacturers have not disclosed a specific cause for the shortages
Compounding pharmacy alternatives
- ▪Compounding pharmacies are permitted to prepare their own drugs when the FDA has declared a shortage or when personalized doses are needed
- ▪Some patients and providers are turning to compounding pharmacies for progesterone and estrogen amid commercial supply issues
Compounded medication safety concerns
- ▪Dr. Gillian Goddard of NYU warned that compounded products could contain incorrect dosages, potentially leading to health issues and costly procedures
- ▪Medical experts caution against using compounded progesterone as it is not subject to the same strict regulatory process as FDA-approved drugs
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