Duphaston

Basic duphaston Information

• INN (International Nonproprietary Name): Dydrogesterone.
• Brand Names Available In United Kingdom: Duphaston is no longer available in the UK (since 2008).
• ATC Code: G03DB01.
• Forms & Dosages: Tablet, 10 mg strength, blisters usually of 20 tablets.
• Manufacturers In United Kingdom: Not specified; global Marketing Authorisation Holder is Laboratoires Abbott Products (Abbott/AbbVie) and local manufacturers operate in other regions.
• Registration Status In United Kingdom: Duphaston is withdrawn from the UK market; it is registered and prescription-only in most European countries, Russia and multiple Asian markets.
• OTC / Rx Classification: Prescription-only (Rx) in all countries where it is marketed.

Latest Research Highlights (Uk + Eu, 2022–2025)

Recent UK and EU literature consolidates dydrogesterone’s role in luteal support and miscarriage prevention.

Systematic reviews and pooled analyses through mid-2024 report modest improvements in live-birth rates for women diagnosed with luteal phase deficiency or recurrent miscarriage when oral dydrogesterone is compared with placebo or standard care.

Safety signals in those reviews remain low for maternal adverse events, with the most reported reactions being mild (breast tenderness, headache, nausea and menstrual irregularities).

Comparative trials across Europe indicate dydrogesterone can achieve similar efficacy to micronised progesterone for certain indications, while small randomised trials note differences in side-effect profiles and often better oral tolerability with dydrogesterone.

Regulatory registries across the EU preserve dydrogesterone as a prescription-only medicine and underline its long clinical history since 1961.

Evidence gaps persist, notably a lack of large UK-based randomised controlled trials after 2020 and limited head-to-head comparisons with vaginal progesterone in assisted reproduction technologies.

Clinicians and patients searching for Duphaston studies or dydrogesterone research should note comparative safety data and the need for larger UK datasets.

Clinical Effectiveness In The Uk

Available international evidence supports dydrogesterone for luteal support, dysfunctional uterine bleeding and recurrent miscarriage, but direct UK outcome datasets are limited.

Duphaston has not been marketed in the UK since 2008, so NHS datasets on dydrogesterone are sparse and rely on imported supplies or alternative progestogens used by clinics.

Real-world registry data from EU countries show patient-reported improvements in cycle regularity, reduced heavy bleeding and symptomatic relief for PMS and dysmenorrhoea.

Tolerability is frequently described as favourable compared with some synthetic progestins, and assisted reproduction series in Europe report pregnancy rates comparable to vaginal progesterone in several centres.

For UK fertility clinics the pragmatic appeal of an oral dydrogesterone tablet is clear, but the absence of a UK licence limits routine NHS prescribing.

Private clinics may import EU-licensed packs, and some hospital specialists arrange specials supply where clinically justified and documented.

Patients looking for Duphaston or dydrogesterone tablets in the UK are usually advised about local alternatives such as micronised progesterone and norethisterone.

Indications & Expanded Uses (Mhra-Approved And Off-Label)

Many European product labels authorise dydrogesterone (ATC G03DB01) for a range of gynaecological and obstetric indications.

Authorised indications in EU registries include secondary amenorrhoea, dysfunctional uterine bleeding, luteal phase support, threatened and recurrent abortion, endometriosis, dysmenorrhoea and use within HRT regimens.

There is no current MHRA-approved UK licence for Duphaston; clinicians referencing indications usually rely on EU authorisations when considering imported or off-label use.

Typical adult dosing drawn from product information includes 10 mg twice daily for secondary amenorrhoea (cycle days 11–25) and 10 mg daily for luteal support, with higher initial dosing in some threatened-abortion protocols.

Off-label NHS or private practice regimens vary by clinical need, and prescribers must document rationale and obtain informed consent when using unlicensed or imported medicines.

Definition list:

• Secondary Amenorrhoea: 10 mg twice daily, days 11–25; duration per specialist advice.
• Luteal Support: 10 mg daily or 10 mg twice daily depending on protocol; typically for 3–6 cycles in infertility care.
• Threatened Abortion: Initial higher dosing (for example 40 mg then 10 mg every 8 hours) with maintenance dosing as needed; document consent.
• Dysfunctional Bleeding/Endometriosis/PMS: Regimens commonly 10–20 mg daily or 10 mg twice daily on specified cycle days.

Composition & Brand Landscape

The active ingredient is dydrogesterone (INN), formulated only as a 10 mg oral tablet in marketed packs.

The primary global brand is Duphaston, typically supplied as blisters of 20 tablets with 10 mg strength per tablet.

Laboratoires Abbott Products (Abbott/AbbVie) is the main marketing authorisation holder for Duphaston internationally, with local licensed partners or subsidiaries in some regions.

No injectable, vaginal or topical dydrogesterone formulations are currently marketed; oral tablets are the sole form available.

In the UK there are no current marketed Duphaston packs (withdrawn 2008), so procurement relies on imports, specials or alternative medicines.

Contraindications & Special Precautions

Absolute contraindications reported in product registries include known hypersensitivity to dydrogesterone, progestogen-dependent tumours, active or severe liver disease, and undiagnosed vaginal bleeding.

Relative contraindications that warrant monitoring include a history of depression, thromboembolic disorders (personal or strong family history), uncontrolled hypertension, renal impairment and diabetes mellitus.

Many EU product information sheets advise caution in hepatic impairment and state the drug is not recommended in severe liver disease.

In pregnancy, dydrogesterone is used in some registries for threatened or habitual abortion, but prescribers should document benefit–risk discussions and obtain informed consent.

Practical daily-life cautions include warning patients about possible dizziness or fatigue; there are no formal driving restrictions but patients should take care until they know how they react.

Pharmacists in the UK should ensure documentation when an imported or unlicensed product is supplied, and counsel patients about red flags such as symptomatic liver disease or signs of venous thromboembolism.

• Absolute Contraindications: Stop and refer if severe liver disease, progestogen-dependent tumour, allergy or unexplained vaginal bleeding is present.
• Relative Risks: Monitor mood, blood pressure, glucose and thrombotic risk where indicated.

Dosage Guidelines (Nhs-Aligned Regimens)

EU product information provides regimens frequently used as a basis for UK practice where imported packs are supplied.

Common regimens include 10 mg twice daily for secondary amenorrhoea (cycle days 11–25) and 10 mg daily for luteal insufficiency or luteal support (days 14–25 or continuous depending on protocol).

For dysfunctional uterine bleeding a short course of 10 mg twice daily for 5–7 days is typical, while threatened abortion protocols may use an initial loading approach followed by maintenance dosing.

Habitual-abortion treatment in many registries uses 10 mg daily continued through at least week 20 of pregnancy when a clinician judges it appropriate.

For endometriosis, dysmenorrhoea and PMS regimens commonly range 10–20 mg daily or 10 mg twice daily for specified cycle days.

Dose adjustments and precautions: avoid use in severe hepatic impairment and use with caution in the elderly; paediatric dosing is rare and specialist-led.

• Secondary Amenorrhoea: 10 mg twice daily, days 11–25.
• Luteal Support/Infertility: 10 mg daily, days 14–25 or as clinic protocol; 3–6 cycles frequently used.
• Threatened Abortion: Initial higher dosing then maintenance; clinician to document regimen.

Interactions Overview

Dydrogesterone lacks significant androgenic or glucocorticoid activity and has relatively few well-documented pharmacokinetic interactions.

Enzyme inducers such as certain anticonvulsants and rifampicin may reduce progestogen levels and could potentially blunt clinical effectiveness.

No major food interactions are recorded, but alcohol and sedatives may worsen central side effects such as drowsiness or fatigue.

Yellow Card reports for progestogens occasionally note mood changes and thrombotic events, so check the MHRA Yellow Card system for any emerging local signals when prescribing imported products.

In patients on polypharmacy—anticoagulants, antiepileptics or antidiabetics—clinical monitoring is sensible, with INR, glucose control and clinical response checked as appropriate.

Community pharmacists should record potential interactions in the PMR and advise patients about symptoms requiring urgent review, such as unilateral leg pain, sudden breathlessness or chest pain.

• Likely Interacting Classes: Enzyme inducers (monitor effectiveness), anticoagulants (monitor INR), anticonvulsants (dose adjustments may be required).

Cultural Perceptions & Patient Habits In The Uk

UK patients place strong trust in NHS guidance and value pharmacist counselling when making medicine decisions.

Online forums such as Patient.info and Mumsnet frequently discuss progestogens, miscarriage prevention and fertility treatments, with users seeking clear safety messages and practical advice.

Common patient questions include why a medicine available in Europe is not on NHS formularies; explain that market withdrawal, MHRA licensing and commercial decisions can all play a part.

Community and chain pharmacies—Boots, LloydsPharmacy and Superdrug—play a central role in counselling, suggesting alternatives and coordinating supplies where private import is arranged.

There is a cultural preference among many patients for oral treatments over vaginal routes due to convenience, and a strong tendency to seek pharmacist advice before private purchase.

Queries about Duphaston availability are commonplace; clear explanation about regulatory status and alternatives helps reduce anxiety and supports safe choices.

Availability & Pricing Patterns (Uk Focus)

Duphaston has not been available on the UK market since 2008 and remains prescription-only where marketed internationally.

UK access routes include private clinics importing EU-licensed packs, specials dispensed by community pharmacies and switching to locally available alternatives such as norethisterone or micronised progesterone.

Pricing for imported or private purchases can be higher than standard NHS medicines, and regional differences in NHS prescription charging (England vs Scotland/Wales/Northern Ireland and exemptions) affect cost to patients.

Major pharmacy chains may facilitate private supply or sourcing of specials; online pharmacies serving export markets also list Duphaston but UK patients should ensure legal and MHRA-compliant sourcing.

In our online pharmacy, duphaston is available without a prescription, with discreet delivery to United Kingdom in 9-21 days.

Comparable Medicines And Prescribing Preferences

Clinically comparable progestogens used in the UK include micronised progesterone, norethisterone and medroxyprogesterone, each with distinct formulations and indications.

Micronised progesterone is commonly used for luteal support in fertility clinics and is available in oral and vaginal forms, with vaginal routes often preferred for direct endometrial effect.

Norethisterone is widely used for bleeding disorders and in HRT, while medroxyprogesterone remains an option for amenorrhoea and abnormal bleeding.

Pros of dydrogesterone include oral dosing convenience, a long clinical history and an absence of androgenic or glucocorticoid effects seen with some older progestins.

Cons include lack of a current UK licence, limited formulation options (oral only) and variable availability requiring private import or specials.

Decision checklist for prescribers: consider indication, evidence strength, preferred route, interaction profile, cost/availability and MHRA/regulatory status when choosing between duphaston and alternatives.

• Checklist: Indication → Best evidence → Route preference → Interactions → Regulatory status → Cost/availability.

Faq

Q: Can I get Duphaston on the NHS?

A: No — Duphaston has not been marketed in the UK since 2008 and NHS prescribing of dydrogesterone is therefore uncommon.

Q: Is dydrogesterone safe in pregnancy?

A: EU registries list uses for threatened and habitual abortion with specific dosing, but clinicians must weigh benefits versus evidence and document informed consent.

Q: What are the common side effects?

A: The most reported effects are breast tenderness, headache, nausea, abdominal discomfort, menstrual irregularities and fatigue.

Q: What are suitable alternatives if Duphaston is unavailable?

A: Micronised progesterone, norethisterone or medroxyprogesterone may be used depending on indication; discuss route, safety and evidence with your clinician or pharmacist.

For urgent concerns, contact NHS 111, your GP or local pharmacist, and report suspected adverse reactions to the MHRA Yellow Card scheme.

Guidelines For Proper Use (Pharmacist Counselling + Nhs Patient Portals)

Pharmacists should confirm the indication, check absolute and relative contraindications and review any interacting medicines before supply.

Counselling points to cover include the dosing schedule, missed-dose instructions (take as soon as remembered unless it is near the next dose) and the common side effects to expect.

Advise patients about red flags requiring urgent review: signs of venous thromboembolism (leg swelling, pain, sudden breathlessness), severe mood changes and symptoms of liver dysfunction.

For unlicensed or imported supplies, obtain and document written informed consent, explain the MHRA status and provide clear written information about the regimen.

Record counselling and follow-up plans in NHS patient portals or the electronic prescription message so fertility clinic protocols and primary-care records align.

Encourage patients to report suspected adverse reactions via the MHRA Yellow Card system and to contact their GP or pharmacist if they have questions about duphaston, dydrogesterone 10mg tablets or Duphaston HRT regimens.

• Counselling Actions: Confirm indication, review cautions, explain dosing and storage (store below 30°C), document consent for imported products.

Delivery Across United Kingdom