Progestogen (selective) — endometriosis 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: Zalkya, Visanne

Dienogest is a progestogen used in the management of endometriosis-associated pelvic pain.

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 produces a hypo-oestrogenic, hyper-progestogenic environment that induces decidualisation and subsequent atrophy of endometriotic lesions, reducing associated pain.

Prescribing in practice

Exclude pregnancy before starting and counsel that, although ovulation is often suppressed, it is not licensed as a contraceptive, so a non-hormonal method should be used.
Changes in menstrual bleeding pattern, including spotting or amenorrhoea, are very common during treatment.
Use with caution in women with a history of depression, as mood changes can occur.

Monitoring

Monitor blood pressure and review bleeding pattern and symptom control; assess bone health considerations with prolonged use.

Counselling the patient

Take the tablet at the same time each day, including through any bleeding.
Use a non-hormonal contraceptive method, as this is not a contraceptive.
Report persistent low mood or significant changes in mood.

Evidence & guidelines

Dienogest is recommended in NICE guidance on endometriosis as a hormonal treatment option for managing endometriosis-related pain.

Reference: NICE NG73; RCOG endometriosis; ESHRE; 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.

Pathways