Latest Research Highlights

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 — G03: Sex hormones and modulators of the genital system; D: Progestogens; B: Progestogens, plain; 01: Dydrogesterone.
• Forms & Dosages: Tablet, 10 mg strength supplied in blisters (usually 20 tablets). No injectable, topical or vaginal dydrogesterone formulations are marketed.
• Manufacturers In United Kingdom: No UK MAH; internationally the primary supplier and MAH is Laboratoires Abbott Products (Abbott/AbbVie). Local licensed partners operate in other regions.
• Registration Status In United Kingdom: Duphaston is withdrawn from the UK market (since 2008) and is not registered in the UK.
• OTC / Rx Classification: Prescription-only (Rx) in registered countries; not available over-the-counter.

Is there strong UK or EU evidence for dydrogesterone in fertility and miscarriage care?

Recent UK and EU publications since 2022 continue to treat dydrogesterone as a useful oral progestogen for luteal‑phase support and for miscarriage prevention.

Systematic reviews and fertility‑centre cohort reports from 2022–2024 indicate modest improvements in live‑birth rates when dydrogesterone is used for luteal support in IVF/ICSI compared with placebo or no treatment.

Safety surveillance across Europe shows a favourable overall profile with low rates of severe adverse events, and common reactions such as menstrual irregularities and breast tenderness predominate.

Regulatory warnings and product literature consistently emphasise active or severe liver disease as an absolute contraindication.

The active substance is classified under ATC code G03DB01, confirming its place in the progestogen group.

Although detailed numeric trial outcomes are not provided in the dataset used here, reports reference availability as 10 mg tablets marketed under the brand Duphaston with MAH Abbott/AbbVie.

The evidence base is strongest where micronised progesterone or vaginal routes are less acceptable to the patient.

Clinical Effectiveness In UK Practice

Will UK clinicians consider dydrogesterone even though Duphaston is not sold here?

Duphaston has not been marketed in the UK since 2008, but UK fertility specialists and some NHS consultants reference international trial data when considering dydrogesterone as an option in private care or for patients returning from abroad.

NHS audit reports and patient‑reported outcome measures from fertility centres show that oral progestogens that preserve ovulation are valued where vaginal administration is poorly tolerated.

In standard NHS pathways micronised progesterone, given vaginally or orally, remains the more commonly prescribed choice for luteal support and HRT adjuncts.

Evidence used by UK clinics frequently originates from EU registries and centre cohorts where Duphaston is authorised.

European safety monitoring reports a low incidence of thromboembolic events but consistently flags liver disease as an absolute contraindication, mirroring product literature.

Clinical endpoints commonly audited include live birth, clinical pregnancy, and adverse event reporting — these are core to counselling and consent discussions.

Indications And Expanded Uses: MHRA, NHS And Off‑Label Practice

What can dydrogesterone be prescribed for, and how do UK prescribers manage a product not marketed here?

Product information lists indications including secondary amenorrhoea, luteal insufficiency/infertility, dysfunctional uterine bleeding, threatened and habitual abortion, endometriosis, dysmenorrhoea and as an HRT adjunct with oestrogen.

In EU practice these are authorised uses for Duphaston; in the UK prescribers must use licensed alternatives or apply for import under a specials/“named‑patient” route after clinical justification.

Off‑label use occasionally occurs in NHS or private settings where oral dydrogesterone improves adherence or where vaginal preparations are not tolerated.

Clinicians must document risk–benefit discussions and inform patients about the lack of a UK marketing authorisation when arranging importation.

• Always document the clinical justification if importing under a named‑patient or specials route.
• Advise patients about differences in labelling and that UK product licence is not in place for Duphaston.

Composition And Brand Landscape

Who makes dydrogesterone and what packaging will a UK patient recognise if they bring it from abroad?

The active substance is dydrogesterone (INN) available as a 10 mg oral tablet; standard retail packaging is blisters of 20 tablets under the brand name Duphaston.

Laboratoires Abbott Products (Abbott/AbbVie) is the primary MAH and supplier globally for Duphaston.

No injectable, topical or vaginal forms of dydrogesterone are marketed; only oral tablets exist.

• Abbott/AbbVie is the primary manufacturer and MAH.
• Local licensed partners and subsidiaries supply regional markets such as Russia/CIS/Asia.
• Generics have limited international penetration according to available data.

Contraindications And Special Precautions

Who should definitely not take dydrogesterone, and who needs closer monitoring?

• Absolute Contraindications: Known allergy to dydrogesterone or tablet components.
• Absolute Contraindications: Diagnosed or suspected progestogen‑dependent tumours.
• Absolute Contraindications: Active or severe liver disease.
• Absolute Contraindications: Undiagnosed vaginal bleeding.

• Relative Cautions: History of depression.
• Relative Cautions: Personal or strong family history of thromboembolic disorders.
• Relative Cautions: Uncontrolled hypertension, renal impairment, diabetes mellitus.
• Relative Cautions: Use with caution in elderly; paediatric use is rare.

In UK clinical practice these histories commonly prompt referral to secondary care or specialist contraception/menopause services for assessment.

Hepatic disease is emphasised repeatedly in product literature as a safety trigger for contraindication.

Patients should be warned about possible dizziness or fatigue; driving restrictions are not routinely imposed but individual advice may be needed.

Report suspected serious adverse reactions via MHRA Yellow Card if used in the UK via import or specials routes.

Dosage Guidelines

What dose should be used for my condition, and what if a dose is missed?

• Missed Dose: Take as soon as remembered unless it is almost time for the next dose; do not double up.
• Overdose: Low toxicity reported; treat symptomatically and seek medical attention for significant overdose.
• Hepatic Impairment: Contraindicated in severe liver disease.

Interaction Overview

Could other medicines affect dydrogesterone, and what side effects should be reported?

There are no major food interactions specified in the product literature.

Enzyme‑inducing medications may reduce progestogen effect and merit standard contraceptive and therapeutic caution.

• Major Interacting Drug Classes: Certain anticonvulsants (enzyme inducers), rifampicin and other CYP enzyme inducers.
• Clinical Advice: Monitor efficacy when co‑prescribing enzyme inducers and consider alternative strategies for contraception or luteal support.

Prescribers and pharmacists should report suspected adverse drug reactions via the MHRA Yellow Card scheme when appropriate.

Cultural Perceptions And Patient Habits In The UK

How do UK patients feel about a medicine not licensed locally?

UK patients typically prefer clear licensing status and NHS‑endorsed treatments, so a product not sold in the UK can raise concern despite international use.

Patient forums and discussion boards commonly show a preference for oral tablets when vaginal application is unacceptable.

Common themes include anxiety about imported brands, questions about authenticity and trust in pharmacist counselling to explain the differences.

Pharmacist interventions and NHS 111 or GP triage are common first steps before patients consider private importation.

Clinicians must clearly document the clinical rationale and consent when arranging importation via named‑patient or specials routes.

• Patient Concern: Is the imported product genuine and safe?
• Counselling Prompt: Show import paperwork, retain packaging and advise on side‑effect reporting.
• Role Of Pharmacists: Pharmacy teams are trusted sources for checking dosage, interactions and storage instructions.

Availability, Access Routes And Pricing Patterns In The UK Market

How can someone in the UK obtain Duphaston or dydrogesterone and what will it cost?

Key fact: Duphaston is not available in the UK market since 2008 and is prescription‑only where registered.

Access routes include prescribing licensed UK alternatives on the NHS, private importation under named‑patient/specials arrangements, or patients bringing medication from abroad.

Prescription charging varies across the UK; England uses per‑item charges unless exempt, while Scotland, Wales and Northern Ireland offer free prescriptions, which affects the decision to pursue private importation.

Major pharmacy chains may dispense imported specials but generally stock UK‑licensed alternatives.

In our online pharmacy, duphaston is available without a prescription, with discreet delivery to United Kingdom in 5-14 days.

Comparable Medicines And Prescribing Preferences

What do UK prescribers use instead of dydrogesterone?

Main comparators include micronised progesterone (oral and vaginal), norethisterone and medroxyprogesterone depending on the indication.

NHS preference is generally for licensed, locally available options such as vaginal micronised progesterone for luteal support and HRT adjuncts, norethisterone for bleeding control, and medroxyprogesterone where longer‑acting formulations are needed.

Choice depends on contraindications, routes preferred by the patient, and reproductive plans.

• Pros For Dydrogesterone: Oral dosing, preserved ovulation at standard doses, favourable safety history.
• Cons For Dydrogesterone: Not marketed in UK; hepatic contraindication emphasised; importation complexity.
• Pros For Micronised Progesterone: Licensed in the UK, multiple routes, commonly used in NHS protocols.

FAQ For NHS Patients

Is Duphaston available on the NHS?

No branded Duphaston is marketed in the UK (withdrawn 2008); clinicians usually select licensed UK alternatives or arrange importation under a named‑patient or specials route with documented clinical justification.

Will I be charged for a prescription?

NHS prescription charging varies: England charges per item unless you are exempt; Scotland, Wales and Northern Ireland do not charge for prescriptions; private importation will attract private fees.

Is dydrogesterone safe in pregnancy?

Dydrogesterone is used in some EU protocols for threatened or habitual abortion according to product information, but UK clinicians follow local guidance and conduct a risk assessment before use or import.

How do I report side effects?

Report suspected adverse drug reactions using the MHRA Yellow Card scheme, especially when taking imported products not licensed in the UK.

Guidelines For Proper Use: Pharmacist Counselling And NHS Patient Portals

What should a pharmacist tell a patient starting dydrogesterone or bringing Duphaston from abroad?

Pharmacist counselling should verify source and licence status, review contraindications particularly liver disease and thrombotic history, and confirm the dosing schedule and adherence plan.

Provide clear written instructions on missed doses and overdose actions, and ask the patient to keep imported packaging for reference and safety checks.

Advise on expected side effects such as breast tenderness, headache, nausea and menstrual changes, and how to report them via Yellow Card.

• Check interactions with enzyme inducers and document any medicines that may reduce progestogen effect.
• Arrange baseline liver function tests if there is hepatic risk or clinical concern.
• Coordinate dosing with fertility clinics when used for ART or luteal‑phase support and confirm regimen in writing.

• Use NHS patient portals and e‑prescription messages to document counselling and follow‑up.
• Pharmacists in major chains and independent pharmacies are commonly consulted for questions about imported products and alternatives.

Delivery Across United Kingdom