The Food and Drug Administration removed the black box warning from hormone replacement therapies late last year, and recently, the most insured type, the estrogen patch, has been in short supply amid a boom in the therapy’s popularity.

“There’s been a surge in demand for the last two or three years where the utilization of transdermal estrogen has gone up significantly,” said Dr. Robert Kauffman, a professor of obstetrics and gynecology at Texas Tech Physicians of Amarillo.

While doctors and patients report difficulties getting certain doses of estrogen patches, the FDA has not yet included any on its list of drugs in shortage.

The FDA chief, Dr. Marty Makary, said Tuesday that the agency’s move to remove the black box warning label for hormone therapy in November prompted a tremendous increase in demand for estrogen patches, but not enough to cause a shortage.

“The industry has been able to keep up but barely,” Makary said in an interview. “They are recalibrating their distribution and manufacturing to have more robust supply. In the interim, the estrogen patches have not risen to the criteria of being on the shortage list, but it is something to manage.”

Being included on the FDA shortage list is important because it can help trigger actions such as identifying alternative suppliers and extending expiration dates for drugs.

Hormone replacement medications are prescribed to treat hot flashes, mood swings, urinary tract infections, vaginal dryness and difficulty sleeping, as well as to protect against bone fractures. They can either be estrogen-only or progesterone-only or a combination of estrogen and progesterone — the primary female sex hormones.

Is there an estrogen patch shortage?

There’s not one answer.

The American Society of Health-System Pharmacists, a professional organization for pharmacists, includes 14 brands or dosages of estrogen patches in its most current list of drugs in shortage. The group first started including estrogen patches on the list in January.

“Our list is 100% reported by either practitioners, pharmacists, physicians, nurses or patients and caregivers,” said Michael Ganio, the senior director of pharmacy practice and quality at ASHP, which collects data in partnership with the University of Utah Health.

Dr. Lauren Streicher, a professor of obstetrics and gynecology at the Northwestern University Feinberg School of Medicine in Chicago, said estrogen patch shortages always come up when she speaks with groups of women about menopause.

Dr. Kathleen Jordan, the chief medical officer at Midi Health, a telehealth company that specializes in menopause, also said patients are increasingly facing problems when filling estrogen patch prescriptions “due to shortages at the pharmacies.”

“This was happening occasionally last year but has escalated this year,” she said.

Kauffman, the Texas gynecologist, said there’s a shortage in West Texas and colleagues “all over the country” are reporting them as well.

On the other hand, a spokesperson for Alloy Health, a menopause telehealth company, said in an email that it has not noticed an estrogen patch shortage affecting its patients.

Meanwhile, the FDA relies on historic demand data to determine if drug companies are keeping up with demand, so its information on current increases in demand may be lagging, Ganio said. An FDA spokesperson said if the national supply falls into shortage, it’ll be posted on the agency’s drug shortage website.

Swiss generics manufacturer Sandoz told Reuters in April that the company has shipped additional supplies to the U.S. to help pharmacies keep up with demand. NBC News reached out to three estrogen patch manufacturers about the shortage in May: Sandoz, Noven Pharmaceuticals and Amneal Pharmaceuticals — but didn’t receive a response.

A spokesperson from drugmaker Viatris said the company is taking steps to “further expand production long-term,” because demand for estrogen patches has increased.

What is driving demand?

After the highly publicized Women’s Health Initiative study in 2002 linked hormone therapy to increased risk of breast cancer, heart attacks and strokes in postmenopausal women, prescriptions plummeted among menopausal women in the U.S., from 22% to 5% over the next decade. Even after new evidence found the risk was primarily in women who were older when they started hormone therapy, the perception that it was dangerous persisted until recent years.

From 2018 to 2026, the number of women ages 45 to 54 who were prescribed estrogen-based therapies increased by 184%, according to a recent survey by Truveta, a health care analytics company. Prescriptions increased by 20% between July 2025 and February 2026 alone.

Not only has demand surged; there’s been a change in how women use the medications.

Jordan, of Midi Health, said women are using hormone therapy longer than in the past, adding to the increase in demand.

Guidelines used to recommend women only be on hormone therapy for menopause for five to 10 years, and stop by age 60, but newer studies suggest women could benefit from starting hormone therapy earlier — often in their 40s — and stay on it into their 60s, 70s or 80s, Jordan said in an email.

“This means more women going to the pharmacy for refills,” she said.

The refills are typically for estrogen patches — versus other types of hormone therapy such as creams or vaginal rings — because estrogen patches are typically cheaper than the alternatives, have the largest amount of safety data and are more likely to be covered by insurance, Kauffman said.

When will estrogen patch supplies rebound?

It’s unclear.

Although drug companies appear to be ramping up production, some estrogen patches could remain in shortage for years.

Dr. Stephanie Faubion, director of the Mayo Clinic’s Center for Women’s Health, is a bit more optimistic.

“No one knows exactly when the shortage will be over, but companies are increasing production, so things should be better by the end of the year,” Faubion said in an email.

Since pharmaceutical companies typically make drugs and therapies in batches and plan those batches months in advance, some companies may not be able to increase estrogen patch production for a few months, Ganio said.

In the coming months, manufacturers “will certainly try to boost output,” Ganio said.

What are the alternatives?

Some women may be able to switch to a different brand or wear two patches of a lower dose if their regular prescription is unavailable, said Faubion, who is also the medical director of The Menopause Society.

There are also other forms of estrogen: topical creams and gels, oral and vaginal rings. Patches come in two types, one that is changed twice per week and one that is swapped just once, so changing between the two options can also help women stay on estrogen patches even if their usual brand and dose is in short supply, Faubion said.

“I have not had a patient yet that we haven’t found an alternative for,” Faubion said.

The alternatives include:

Oral estrogen

Oral estrogen has been shown to lower harmful LDL cholesterol and increase protective HDL cholesterol, which could make it the best option for women who have high cholesterol, Northwestern’s Streicher said. Women who have a history of blood clots should avoid taking oral estrogen, since it can slightly raise clotting risk.

Vaginal ring

Localized estrogen delivered through a vaginal ring can help women who struggle with vaginal dryness or recurrent urinary tract infections, but a vaginal ring can also deliver systemic estrogen, Streicher said.

Transdermal estrogen

Gels, creams and patches all fall into a category called transdermal estrogen.

“In terms of safety, they are all equal,” Streicher said. However, “the nonpatch options are less likely to be covered by insurance.”