Dydrogesterone

Progestogens — pregnadiene derivatives

ATC code: G03DB01

Brand names: Duphaston

Updated 12 Jul 2026 · Methodology

Indications

Endometrial protection during estrogen MHT

First line

Per NAMS 2022 and IMS 2016, dydrogesterone 5–10 mg daily or 10 mg for 14 days per month provides endometrial protection during estrogen MHT. The breast cancer and VTE risk profile of dydrogesterone is closer to micronized progesterone than to synthetic progestins such as medroxyprogesterone acetate. Fixed combination with estradiol is available as Femoston.

Sources

Luteal phase support in ART

First line

The Lotus I and Lotus II trials showed oral dydrogesterone 30 mg daily was as effective as vaginal micronized progesterone in ART. The primary endpoint was clinical pregnancy; comparable live birth rates were confirmed in an individual-patient meta-analysis. conditionally endorses oral dydrogesterone as an alternative; vaginal progesterone remains the standard for luteal phase support.

Sources

ICD-10: Z31.8 · ICD-11: QA30

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

Threatened miscarriage

Not recommended

Dydrogesterone is an oral progestogen approved for threatened and recurrent miscarriage in the EU, Asia, and Russia. The evidence is conflicting: meta-analyses and some professional recommendations suggest a possible reduction in miscarriage risk (especially with recurrent loss), whereas recommends vaginal micronized progesterone (from the PRISM trial) rather than dydrogesterone for bleeding with a previous miscarriage, and the quality of dydrogesterone data is rated as limited. The decision is individualized with an obstetrician.

Sources

ICD-10: O20.0 · ICD-11: JA40.0

Irritable bowel syndrome

Not recommended

Dydrogesterone has variable evidence for dysmenorrhea and endometriosis. For pain unrelated to menstrual cycle or endometriosis, dydrogesterone is not indicated. Common Russian prescriptions for Duphaston for «hormonal imbalance», «cycle disturbance» without workup, or «luteal-phase progesterone deficiency on blood levels» lack international evidence and often mask missed differential diagnoses.

Dydrogesterone is labeled for dysmenorrhea, not «any lower abdominal pain».

Sources

ICD-10: K58.8 · ICD-11: DD91.0Z

How to read tiers A–F

AStrong evidence – first or second line in international guidelines
BRecommended in selected cases
CStudy data contradict each other
DBenefit not proven, no documented harm
FDocumented harm, or risk without benefit

Mechanism of action

Semi-synthetic progestogen, a progesterone isomer at the double bond. Selectively binds progesterone receptors with no estrogenic, androgenic, or mineralocorticoid activity. Unlike micronized progesterone, lacks sedative and anxiolytic effects (no allopregnanolone metabolite) — taken at any time of day.

Safety

Contraindications

Hypersensitivity
Undiagnosed vaginal bleeding
Progestogen-dependent (or suspected) tumors
Severe hepatic disease

Serious adverse effects

Hepatotoxicity (rare)
Venous thromboembolism (lower risk than synthetic progestins and oral estrogens)
Allergic reactions

Common adverse effects

Headache
Breast tenderness
Breakthrough bleeding
Nausea
Mood changes

Pregnancy: can you take Dydrogesterone?

Use in the first and second trimesters for ART or recurrent loss indications is acceptable. Without specific indication, routine pregnancy use is unjustified.

Breastfeeding: can you take Dydrogesterone?

Transfers into milk in minimal amounts. Compatible with breastfeeding.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Take with or without food at any time of day. Dydrogesterone lacks sedation — convenient for daytime use, unlike micronized progesterone. MHT dose: 5–10 mg daily or 10 mg on days 14–28. ART luteal support: 30 mg daily in three divided doses.

Common myths

Myth: 'Duphaston should be taken for any lower abdominal cramping in pregnancy'. Fact: in patients without recurrent loss, evidence is lacking. Cramping and spotting more often reflect physiological processes than embryonic chromosomal abnormality.

Myth: 'progesterone deficiency is diagnosed by a luteal blood test'. Fact: the laboratory diagnosis of «progesterone deficiency» does not exist in international gynecology. Progesterone levels vary throughout the day and menstrual cycle. Endocrine causes of anovulatory infertility are diagnosed with other approaches — follicle tracking, hormone panels by clinical picture, extended workup as indicated.

Myth: 'in anovulatory cycles with progesterone deficiency, take Duphaston in the second phase'. Fact: in anovulation, luteal-phase progesterone is physiologically low because no corpus luteum formed. A progestogen does not treat the cause of anovulation. Management requires identifying the cause (PCOS, hypothalamic dysfunction, hyperprolactinemia, thyroid dysfunction, etc.).

Label mentions6 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

antidiabéticosclass named in the label
«Debido a que la progesterona puede influir en el control de la diabetes, podría ser necesario un ajuste en la dosis de los medicamentos antidiabéticos.»
AEMPS, section 4.5 · Open on CIMA
antiepilépticosclass named in the label
«Por lo tanto, el metabolismo de disrogesterona y DHD puede aumentar cuando se utiliza concomitantemente con sustancias conocidas por inducir la actividad enzimática CYP, como los anticonvulsivantes…»
AEMPS, section 4.5 · Open on CIMA
Carbamazepine
«Por lo tanto, el metabolismo de disrogesterona y DHD puede aumentar cuando se utiliza concomitantemente con sustancias conocidas por inducir la actividad enzimática CYP, como los anticonvulsivantes…»
AEMPS, section 4.5 · Open on CIMA
Phenobarbital
«Por lo tanto, el metabolismo de disrogesterona y DHD puede aumentar cuando se utiliza concomitantemente con sustancias conocidas por inducir la actividad enzimática CYP, como los anticonvulsivantes…»
AEMPS, section 4.5 · Open on CIMA
Phenytoin
«Por lo tanto, el metabolismo de disrogesterona y DHD puede aumentar cuando se utiliza concomitantemente con sustancias conocidas por inducir la actividad enzimática CYP, como los anticonvulsivantes…»
AEMPS, section 4.5 · Open on CIMA
Ritonavir
«Aunque el ritonavir y el nelfinavir son conocidos por actuar como potentes inhibidores de las enzimas del citocromo, tienen propiedades de inducción enzimática cuando se utilizan concomitantemente…»
AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Dydrogesterone used for?

Dydrogesterone is evaluated for the following indications with varying evidence strength: Endometrial protection during estrogen MHT (evidence tier A), Luteal phase support in ART (evidence tier B), Threatened miscarriage (evidence tier C). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Dydrogesterone?

Common side effects of Dydrogesterone (≥ 1 in 100): Headache, Breast tenderness, Breakthrough bleeding, Nausea, Mood changes. See the Safety section for uncommon and serious reactions.

Is Dydrogesterone safe during pregnancy?

Use in the first and second trimesters for ART or recurrent loss indications is acceptable. Without specific indication, routine pregnancy use is unjustified.

Is Dydrogesterone compatible with breastfeeding?

Transfers into milk in minimal amounts. Compatible with breastfeeding.

Who should not take Dydrogesterone?

Dydrogesterone is contraindicated in: Hypersensitivity; Undiagnosed vaginal bleeding; Progestogen-dependent (or suspected) tumors; Severe hepatic disease. Full list in the Safety section.

Duphaston should be taken for any lower abdominal cramping in pregnancy

in patients without recurrent loss, evidence is lacking. Cramping and spotting more often reflect physiological processes than embryonic chromosomal abnormality.

progesterone deficiency is diagnosed by a luteal blood test

the laboratory diagnosis of «progesterone deficiency» does not exist in international gynecology. Progesterone levels vary throughout the day and menstrual cycle. Endocrine causes of anovulatory infertility are diagnosed with other approaches — follicle tracking, hormone panels by clinical picture, extended workup as indicated.

in anovulatory cycles with progesterone deficiency, take Duphaston in the second phase

in anovulation, luteal-phase progesterone is physiologically low because no corpus luteum formed. A progestogen does not treat the cause of anovulation. Management requires identifying the cause (PCOS, hypothalamic dysfunction, hyperprolactinemia, thyroid dysfunction, etc.).

Official sources

Direct links to regulator labels. Open in a new tab.

AEMPS / CIMALabel dated 04/17/2026

Other drugs in this group

Estradiol, Estradiol + Nomegestrol acetate, Estradiol valerate + Dienogest, Ethinylestradiol, Ethinylestradiol + Desogestrel, Follitropin alfa, Norethisterone, Ulipristal acetate