Dienogest
Pronunciation: Not established in the sources reviewed for this dossier..
- Generic name
- dienogest
- Brand names
- VISANNE (Australia), VISANNE (Canada)
- Drug class
- Progestogen
- Form
- Tablet (2 mg, single-ingredient product)
- Route
- Oral (for oral use, per the UK SmPC).
- Legal status
- Prescription-only medicine (per the UK SmPC). No standalone dienogest product is currently marketed in the United States; only the combination contraceptive NATAZIA (estradiol valerate/dienogest) is available there.
Availability and supply rules vary by country
Trade names by country: Canada
Australia: · Full directory
What dienogest is and how it works
Dienogest is a progestogen medicine. The single-ingredient 2 mg product covered by this page is used to treat endometriosis; it is not a contraceptive product. (1)
Single-ingredient dienogest and combined oestrogen/dienogest contraceptive products are different medicines with different uses and are not interchangeable. This page does not provide individualised dosing, cycle-management, contraception, or pregnancy advice -- these require direct specialist review.
Mechanism of action: how dienogest works
Dienogest is a progestogen; detailed mechanism-of-action information was not part of the evidence reviewed for this dossier. (1)
What dienogest is used for
Endometriosis
The single-ingredient 2 mg dienogest product is used to treat endometriosis, per UK and Australian product information. This is a treatment use, not a contraceptive one. (1) (2) (3)
Before taking dienogest
Do not take / not appropriate for
- Do not take dienogest if you have an active blood clot (venous thromboembolic disorder), or arterial or cardiovascular disease. (all patients) (1)
- Do not take dienogest if you have, or have a history of, severe liver disease. (all patients) (1)
- Do not take dienogest if you have, or have a history of, liver tumours (benign or malignant). (all patients) (1)
Tell your clinician about
- Any liver disease, since severe hepatic disease is a contraindication for this medicine.
- Any history of blood clots (thromboembolic events) or risk factors for them.
- Every other medicine you take, since interactions with certain medicines affecting the same liver enzyme pathway (CYP3A4) can occur.
- Pregnancy, plans for pregnancy, or breastfeeding -- this page does not provide pregnancy or lactation guidance, which must come directly from your specialist.
How to take dienogest
- Take exactly as prescribed by the specialist managing your endometriosis treatment.
- This page intentionally withholds a starting dose, cycle-management plan, and missed-dose rule, even though product-specific instructions exist; ask your prescriber or pharmacist for these.
- Do not change your dose or stop taking dienogest without talking to your prescriber first.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
This page intentionally withholds a public missed-dose instruction, even though the product information contains one, because this dossier restricts public missed-dose advice for this medicine. Ask your prescriber or pharmacist.
Overdose
There is no specific antidote for dienogest overdose; high doses have been well tolerated in studies. A specific overdose-management or poison-control pathway is not established in the sources reviewed for this dossier; contact your prescriber or pharmacist if an overdose is suspected. (1)
Side effects
The most frequently reported side effects in studies were headache, breast discomfort, low mood, and acne. This page does not list every possible side effect; ask your prescriber or pharmacist about what to expect, and refer to the leaflet supplied with your specific product.
Headache
What to notice: Reported in about 9.0% of patients in studies, the most frequently reported effect.
What to do: Tell your prescriber if severe or persistent. (1)
Breast discomfort
What to notice: Reported in about 5.4% of patients in studies.
What to do: Tell your prescriber if bothersome. (1)
Depressed mood
What to notice: Reported in about 5.1% of patients in studies.
What to do: Tell your prescriber if you notice a low mood, especially if persistent. (1)
Acne
What to notice: Reported in about 5.1% of patients in studies.
What to do: Tell your prescriber if troublesome. (1)
Nausea and vomiting
Incidence: Common
Headache
Incidence: Common
Possible liver problem
What to notice: Severe upper abdominal pain, liver enlargement, or signs of intra-abdominal bleeding or haemorrhage (these warrant considering a liver tumour); or jaundice or itching that first occurred during pregnancy or previous use of sex steroids.
What to do: Contact your prescriber promptly. Recurrence of jaundice or itching that first occurred during pregnancy or previous use of sex steroids requires stopping treatment; a clinician will make this assessment. (1)
Possible blood clot
What to notice: Any symptoms of a blood clot, or suspicion of one.
What to do: Contact your prescriber promptly or seek urgent medical assessment; a clinician will assess and decide whether treatment should be stopped at once. (1)
Serious warnings
Blood clot (arterial or venous thrombotic event) — urgent
Symptoms: Any symptoms of a blood clot, or suspicion of one.
Action: Seek prompt medical assessment; a clinician will assess and decide whether treatment should be stopped at once. (1)
Liver function changes —
Action: Seek immediate medical attention if signs of allergic reaction or liver problems occur. Contact your healthcare provider before stopping treatment.
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| CYP3A4-affecting medicines | Certain medicines that affect this liver enzyme pathway can change dienogest levels; the exact medicines involved were not detailed in the evidence reviewed for this page. | Tell your prescriber and pharmacist about all other medicines you take. (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Severe liver disease
Severe hepatic disease is a recognised safety concern with dienogest; discuss any liver disease with your prescriber before starting. (1)
Pregnancy and breastfeeding
This page does not provide pregnancy or breastfeeding guidance for dienogest; this must come directly from your specialist, since dienogest is a treatment for endometriosis, not a contraceptive, and pregnancy-related decisions need individual review. (1)
Blood clot risk factors
Tell your prescriber about any personal history of blood clots before starting. (1)
Monitoring
Before starting
- Not established in the sources reviewed for this dossier; this is a matter for the prescribing specialist.
During treatment
- Not established in the sources reviewed for this dossier; this is a matter for the prescribing specialist.
Storage
Store in the outer carton to protect from light.
Professional information
Clinician-facing context only. This dossier is a high-level summary; use the current full local product information for exact dosing, cycle-management, and interaction detail.
United Kingdom / Australia
Indication: Endometriosis
Dose summary: No dose is displayed on this page; public dosing, initiation, and cycle-management content is intentionally withheld under this dossier's restriction, even though the reviewed evidence includes some dosing detail. Use the current local product information and specialist review.
Renal context: Not established in the sources reviewed for this dossier. (1) (2) (3)
Hepatic guidance
Severe hepatic disease is a recognised safety concern; use current local product information and specialist judgement.
Overdose note
No specific antidote exists; studies of high doses showed good tolerability. No further overdose-management detail is established in the sources reviewed for this dossier. (1)
Frequently asked questions
What is dienogest used for?
dienogest is prescribed for approved indications. Always follow your healthcare provider's guidance.
What are the side effects of dienogest?
Common side effects may include gastrointestinal symptoms and headache. Serious side effects require immediate medical attention.
Can I take dienogest with other medications?
Always inform your healthcare provider about all medications you are taking, including over-the-counter products and supplements.
What is the mechanism of action of dienogest?
Dienogest is a progestogen; detailed mechanism-of-action information was not part of the evidence reviewed for this dossier. (1)
References
- Dienogest 2 mg tablets — Summary of Product Characteristicselectronic Medicines Compendium · United Kingdom · dated 2025-09-19 · accessed 2026-07-26 · source 1
- VISANNE dienogest 2 mg tablets — ARTG 160465Therapeutic Goods Administration · Australia · dated 2010-06-11 · accessed 2026-07-22 · source 2
- APX-DIENOGEST, DIENOGEST-STR, DINASANE registration summaryTherapeutic Goods Administration · Australia · dated 2021-03-30 · accessed 2026-07-22 · source 3
- Summary Basis of Decision - VISANNE (dienogest 2 mg tablets)Health Canada · Canada · dated 2011-10-12 · accessed 2026-07-27 · source 4
- DailyMed search: dienogest (no standalone monotherapy product listed)DailyMed, U.S. National Library of Medicine · United States · dated 2026-07-27 · accessed 2026-07-27 · source 5
Brand names by country
Single-ingredient dienogest names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
Canada
- VISANNE