Progestogen (4th Generation, Anti-Endometriotic) Pregnancy: Must not be administered to pregnant women, because there is no need to treat endometriosis during pregnancy. There is limited data from use in pregnant women; animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Lactation: treatment during lactation is not recommended — it is unknown whether dienogest is excreted in human milk, and data in animals have shown excretion in rat milk.

Dienogest

Brand names: Visanne, Zalkya

Dienogest is an oral progestogen used to treat the pain associated with endometriosis.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 2 mg (one tablet) daily, taken continuously without any break

Route: Oral

Frequency: Once daily, preferably at the same time each day; tablets must be taken continuously without regard to vaginal bleeding, and when a pack is finished the next one is started without interruption

Fetched label is 'Dienogest 2 mg tablets' (UK SPC); the indication reflected in the label is endometriosis. The tablet can be taken with or without food, with some liquid as needed. Treatment can be started on any day of the menstrual cycle. Any hormonal contraception needs to be stopped prior to initiation. Dienogest 2 mg tablets is NOT a contraceptive — if contraception is required, a non-hormonal method should be used (e.g. barrier method). Missed tablets: efficacy may be reduced by missed tablets, vomiting and/or diarrhoea (if occurring within 3-4 hours after tablet taking). In the event of one or more missed tablets, take one tablet only as soon as remembered, then continue the next day at the usual time; a tablet not absorbed due to vomiting or diarrhoea should likewise be replaced by one tablet. Contraindicated in patients with present or past severe hepatic disease. No dosage adjustment indicated in renal impairment. There is no relevant indication for use in the geriatric population. Ovulation is inhibited in the majority of patients, and the menstrual cycle returns to normal within 2 months after cessation. Paediatric (non per-kg, so not expressed as a mg/kg dose): not indicated in children prior to menarche; safety and efficacy of dienogest were investigated in an uncontrolled clinical trial over 12 months in 111 adolescent women aged 12 to under 18 years with clinically suspected or confirmed endometriosis. Verify any under-18 use against a children's formulary.

Dose adjustments

Renal

There are no data suggesting the need for a dosage adjustment in patients with renal impairment.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Active venous thromboembolic disorder
Arterial and cardiovascular disease, past or present (e.g. myocardial infarction, cerebrovascular accident, ischaemic heart disease)
Diabetes mellitus with vascular involvement
Presence or history of severe hepatic disease as long as liver function values have not returned to normal
Presence or history of liver tumours (benign or malignant)
Known or suspected sex hormone-dependent malignancies
Undiagnosed vaginal bleeding
Hypersensitivity to the active substance or to any of the excipients

Side effects

Changes in menstrual bleeding pattern — spotting, irregular, infrequent, frequent or prolonged bleeding, or amenorrhoea (experienced by the majority of patients)
Headache (9.0%) and migraine
Breast discomfort (5.4%)
Depressed mood (5.1%), sleep disorder, nervousness, loss of libido, altered mood
Acne (5.1%)
Nausea, abdominal pain, flatulence, abdominal distension; weight increase; anaemia

Clinical monograph

How it works

It exerts a strong progestogenic effect on the endometrium and downregulates ovarian oestrogen production, inducing decidualisation and atrophy of ectopic endometriotic tissue.

Prescribing in practice

Irregular or unscheduled vaginal bleeding is common, especially early on; investigate any new or persistent unexpected bleeding to exclude other pathology.
Long-term progestogen exposure may reduce bone mineral density, so weigh this in younger women and those with additional risk factors.
It is not a licensed contraceptive in this indication, so advise non-hormonal contraception, and avoid in active venous thromboembolism and known or suspected hormone-dependent malignancy.

Monitoring

Review symptom control and bleeding patterns, monitor blood pressure, and consider bone health with prolonged use.

Counselling the patient

Irregular bleeding or spotting is common and usually settles with continued use.
Use a non-hormonal method of contraception while taking it.
Report any persistent or heavy unexpected bleeding.

Evidence & guidelines

Dienogest is an established second-line therapy for endometriosis-associated pain, recognised within NICE endometriosis guidance among hormonal treatment options.

Reference: GARDA trial (Strowitzki et al. Fertil Steril 2010); ESHRE Endometriosis Guideline (2022); NICE NG73; SPC Visanne; Schindler et al. Maturitas 2011; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators