Is Dydrogesterone Banned in the US? A Look at Its Status and Alternatives

October 7, 2025 •

4 min read

Dydrogesterone is a synthetic progestogen used in over 100 countries, but it is not currently marketed in the United States [1.2.3]. So, is dydrogesterone banned in the US? The simple answer is no; it was withdrawn for commercial reasons, not due to safety or efficacy concerns [1.3.1, 1.3.2].

Quick Summary

Dydrogesterone is not banned in the US but was withdrawn from the market for commercial reasons. This article explores its regulatory history, medical uses abroad, and compares it to progesterone alternatives available in the United States.

Key Points

Not Banned, Commercially Withdrawn: Dydrogesterone is not banned in the US; it was withdrawn from the market for commercial reasons, not due to safety or effectiveness concerns [1.3.1, 1.3.2].
FDA Stance: The FDA determined in 2017 that the drug was not withdrawn for safety, which allows for potential future approval of generic versions [1.2.1].
Global Use: It is approved and used in over 100 countries for menstrual disorders, endometriosis, infertility support, and hormone replacement therapy [1.2.3, 1.4.6].
Mechanism: Dydrogesterone is a selective progestogen with high oral bioavailability that acts on the uterine lining without typically inhibiting ovulation [1.4.6].
US Alternatives: The most common alternative to dydrogesterone in the US is micronized progesterone (Prometrium), available in oral and vaginal forms [1.6.1, 1.6.7].
Safety Profile: Generally well-tolerated, but recent observational studies have raised questions about a potential association with certain birth defects, warranting further research [1.7.1, 1.7.2].
Key Differences: Compared to micronized progesterone, dydrogesterone is often cited for better oral absorption and a lower incidence of sedative side effects [1.5.5].

The Regulatory Journey of Dydrogesterone in the US

Dydrogesterone, a synthetic hormone belonging to the progestin class, has a peculiar history in the United States [1.2.2]. While it is not explicitly banned, it is also not available for prescription. The medication was first registered in the US in 1961 [1.2.3]. However, in 1997, the new drug application (NDA) holder, Solvay Pharmaceuticals, withdrew the product from the market [1.3.1].

This withdrawal was not prompted by safety issues. In fact, a 2017 notice from the Food and Drug Administration (FDA) confirmed that the drug, previously marketed as Gynorest, was not withdrawn for reasons of safety or effectiveness [1.2.1, 1.3.4]. The decision was purely commercial, as the registered indications were no longer considered commercially viable by the company [1.3.1]. This determination by the FDA means that the path is clear for other manufacturers to seek approval for generic versions (Abbreviated New Drug Applications or ANDAs), provided all other regulatory requirements are met [1.2.5]. As of now, however, it remains on the "Discontinued Drug Product List" and is not marketed [1.2.1, 1.6.2].

What is Dydrogesterone and How Does It Work?

Dydrogesterone is a stereoisomer of progesterone, meaning it has a similar chemical structure but a different spatial arrangement [1.4.1]. This unique structure allows it to be highly selective for progesterone receptors, mimicking the effects of natural progesterone with high oral bioavailability [1.4.6, 1.5.5]. Its mechanism of action involves acting directly on the uterus to help regulate the healthy growth and shedding of the uterine lining [1.4.3].

Unlike some other progestins, dydrogesterone is noted for its lack of androgenic, estrogenic, or corticoid side effects [1.4.3]. It also typically does not inhibit ovulation at standard therapeutic doses, which makes it suitable for treating certain conditions in women who are trying to conceive [1.4.6, 1.4.7]. Its main active metabolite is 20α-dihydrodydrogesterone (DHD) [1.4.6].

Common Uses Outside the United States

In the more than 100 countries where it is licensed, dydrogesterone (often under the brand name Duphaston) is used to treat a wide range of conditions related to progesterone deficiency [1.2.3, 1.4.6]. These include:

Menstrual Disorders: Treatment for irregular, painful, or absent menstrual periods (dysmenorrhea, amenorrhea), and premenstrual syndrome (PMS) [1.4.6, 1.4.8].
Endometriosis: It helps relieve pain and cause the atrophy of ectopic endometrial tissue without inhibiting ovulation [1.4.2, 1.4.7].
Infertility and Pregnancy Support: It is used for luteal phase support in assisted reproductive technology (ART) cycles, and to manage threatened or recurrent miscarriages associated with progesterone insufficiency [1.4.6, 1.4.8].
Menopausal Hormone Therapy (HRT): It is often combined with an estrogen to protect the endometrium from hyperplasia (abnormal thickening) in women with an intact uterus [1.4.6, 1.4.8].

Safety Profile and Side Effects

Dydrogesterone is generally considered well-tolerated [1.4.4]. Common side effects can include headaches, nausea, breast tenderness, and menstrual irregularities [1.4.6]. While many clinical trials have found its safety profile to be favorable, particularly in comparison to other progestins, some recent observational studies have raised concerns [1.7.6]. A 2025 analysis of a WHO global safety database noted a disproportionately higher reporting of birth defects, specifically hypospadias and congenital heart defects, in pregnancies exposed to dydrogesterone compared to progesterone [1.7.1, 1.7.2]. Researchers emphasize that this is a potential safety signal that requires further investigation to establish causality, and other studies have not found evidence of congenital malformations associated with its use [1.7.1, 1.7.7].

Comparison: Dydrogesterone vs. US-Available Alternatives

Since dydrogesterone is not available in the US, clinicians prescribe other progestogens to achieve similar therapeutic goals [1.6.1]. The most common alternative is micronized progesterone (Prometrium), which is structurally identical to the progesterone produced by the body [1.6.7].


Feature	Dydrogesterone (Not in US)	Micronized Progesterone (US Alternative)	Other Progestins (e.g., Medroxyprogesterone)
Administration	Oral tablets [1.4.6]	Oral capsules, vaginal gels/suppositories [1.5.1, 1.6.7]	Oral tablets, injectables [1.6.2]
Bioavailability	High oral bioavailability (28%) [1.4.3, 1.4.6]	Poor oral bioavailability, improved by micronization but still variable; better via vaginal route [1.5.5, 1.6.6]	Variable by type and route
Side Effects	Generally well-tolerated; non-sedating [1.4.4, 1.4.6]	Can cause drowsiness, dizziness, bloating due to metabolites [1.5.5, 1.6.7]	Side effect profile varies; some may have androgenic effects (e.g., mood changes, acne) [1.6.7]
Ovulation	Does not typically inhibit ovulation at therapeutic doses [1.4.6]	Does not inhibit ovulation when used for luteal phase support	Some types, particularly in contraceptives, are designed to inhibit ovulation [1.6.2]
Patient Preference	Studies often report high patient satisfaction due to oral route and tolerability [1.5.3, 1.5.7]	Vaginal route can be messy or inconvenient for some patients; oral route can cause sedation [1.5.1, 1.6.7]	Varies widely based on the specific drug and administration method

Conclusion

Dydrogesterone is not banned in the United States; rather, it was voluntarily withdrawn from the market for commercial reasons over two decades ago [1.3.1]. The FDA has stated this withdrawal was not related to safety or efficacy, leaving the door open for future generic applications [1.2.1]. While it remains a widely used medication globally for conditions like endometriosis, infertility, and menstrual disorders, patients in the US are treated with alternatives [1.4.6, 1.6.1]. The primary alternative is micronized progesterone, which, along with other synthetic progestins like medroxyprogesterone acetate, serves the needs of patients requiring progesterone support [1.6.2, 1.6.7]. The choice between these alternatives depends on the specific clinical indication, desired route of administration, and individual patient tolerance.

Disclaimer: This article is for informational purposes only and does not constitute medical advice. Consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.

For more information on progestogens approved in the US, you can visit the FDA's website.

Frequently Asked Questions

Duphaston (dydrogesterone) is not sold in the USA because its manufacturer withdrew it from the market for commercial reasons, not because of a ban for safety or ineffectiveness [1.3.1]. It is currently on the FDA's discontinued drug list [1.2.1].

No, dydrogesterone is not illegal. It is a drug that was previously approved but is no longer commercially available in the US market [1.3.1, 1.6.2]. The FDA has determined it was not withdrawn for safety reasons [1.3.2].

There is no direct equivalent, but the most commonly used alternative for similar indications is micronized progesterone (brand name Prometrium) [1.6.1, 1.6.7]. Other progestins like medroxyprogesterone acetate may also be used depending on the condition [1.6.2].

It is used for a variety of conditions related to progesterone deficiency, including painful or irregular periods, endometriosis, premenstrual syndrome, infertility, threatened miscarriage, and as part of menopausal hormone therapy [1.4.6].

Dydrogesterone is often well-tolerated with fewer sedative side effects than oral micronized progesterone [1.4.4, 1.5.5]. However, some recent pharmacovigilance studies have suggested a potential link to a higher reporting of certain birth defects that requires more investigation [1.7.1].

Yes. Because the FDA determined its withdrawal was not for safety or effectiveness reasons, the agency can approve Abbreviated New Drug Applications (ANDAs) for generic dydrogesterone if a manufacturer applies and meets all legal and regulatory requirements [1.2.5].

At typical therapeutic dosages used for conditions like luteal phase support or endometriosis, dydrogesterone does not inhibit ovulation, which is one of its distinguishing features from some other progestins [1.4.6, 1.4.7].