Dienogest Besins (Dienogest) 2 mg Tablet
Progestogen for the treatment of endometriosis
Quick Facts About Dienogest Besins
Key Takeaways About Dienogest Besins
- Treats endometriosis specifically: Dienogest Besins is designed to reduce endometriosis-related pain by suppressing the growth of ectopic endometrial tissue
- Not a contraceptive: Do not rely on Dienogest Besins for birth control – use non-hormonal methods such as condoms or a copper IUD
- Continuous daily use: Take one 2 mg tablet at the same time every day without breaks between packs
- Bleeding pattern changes are normal: Most women experience changes in menstrual bleeding, including spotting, irregular bleeding, or complete absence of periods
- Important contraindications: Do not use if you have venous thromboembolism, severe liver disease, liver tumors, or hormone-dependent cancers
What Is Dienogest Besins and What Is It Used For?
Dienogest Besins is a progestogen medication containing 2 mg of the active substance dienogest, prescribed specifically for the treatment of endometriosis – a chronic condition where tissue similar to the uterine lining grows outside the uterus, causing pain, inflammation, and other debilitating symptoms.
Endometriosis affects an estimated 10% of women of reproductive age worldwide, according to the World Health Organization (WHO). The condition occurs when endometrial-like tissue implants and grows on organs outside the uterus, most commonly on the ovaries, fallopian tubes, the tissue lining the pelvis, and occasionally on the bowel or bladder. These endometrial implants respond to hormonal cycles, leading to chronic inflammation, pain, and the formation of scar tissue (adhesions).
Dienogest works by acting on progesterone receptors in the body, creating a hormonal environment that suppresses the growth and activity of endometrial tissue. It moderately reduces the production of estrogen (the primary female hormone that stimulates endometrial growth), without completely eliminating it. This mechanism provides effective symptom relief while avoiding the more severe side effects associated with treatments that create a fully estrogen-depleted state, such as GnRH agonists.
Clinical trials have demonstrated that dienogest 2 mg daily is effective in reducing endometriosis-associated pelvic pain, with significant improvement typically seen within the first 12 weeks of treatment. The European Society of Human Reproduction and Embryology (ESHRE) 2022 guidelines recommend progestogens, including dienogest, as a first-line pharmacological treatment option for endometriosis-associated pain.
Dienogest Besins is marketed under various brand names across different countries within the European Economic Area. It is known as Dimetrum in the Netherlands, France, Belgium, and Luxembourg; as Dienogest Besins in the Nordic countries and Cyprus; and as Adienocare in Spain. The medication is manufactured by Cyndea Pharma, S.L. and marketed by Laboratoires Besins International.
Dienogest is also available under other brand names such as Visanne and Endovelle. While the active ingredient and dosage are the same, the inactive ingredients may differ. Always follow your doctor's prescription and do not switch between brands without medical advice.
What Should You Know Before Taking Dienogest Besins?
Before starting Dienogest Besins, it is essential to understand the contraindications, warnings, and precautions. This medication is not suitable for everyone, and certain medical conditions require that you either avoid it entirely or use it with close medical supervision.
Contraindications
Do not take Dienogest Besins if you have any of the following conditions:
- Venous thromboembolism (VTE): An active blood clot in a vein, including deep vein thrombosis (DVT) in the legs or pulmonary embolism (PE) in the lungs
- Severe arterial disease: Current or previous history of heart attack, stroke, angina pectoris, or other cardiovascular conditions affecting blood supply to the heart
- Diabetes with vascular complications: Diabetes mellitus with damage to blood vessels
- Severe liver disease: Current or previous severe hepatic impairment where liver function values have not returned to normal. Symptoms may include jaundice (yellowing of the skin) and generalized itching
- Liver tumors: Current or previous benign or malignant liver tumors
- Hormone-dependent malignancies: Known or suspected sex hormone-dependent cancers, including breast cancer or cancers of the reproductive organs
- Unexplained vaginal bleeding: Any vaginal bleeding that has not been evaluated and diagnosed by a healthcare provider
- Hypersensitivity: Allergy to dienogest or any of the excipients in the tablet
Any of the above conditions develop for the first time while you are taking Dienogest Besins. Seek immediate medical attention if you experience symptoms such as severe leg pain or swelling, sudden chest pain, difficulty breathing, sudden severe headache, vision changes, or weakness or numbness in any part of the body – these may indicate a blood clot.
Warnings and Precautions
Talk to your doctor before taking Dienogest Besins if any of the following apply to you:
- History of venous thromboembolism or a close family member who had blood clots at a young age
- Close relative with breast cancer
- History of depression: Dienogest may worsen depressive symptoms. If you experience significant mood changes, depressed mood, or suicidal thoughts, contact your doctor immediately
- High blood pressure or developing high blood pressure during treatment
- Liver disease developing during treatment: Report any jaundice or generalized itching immediately
- Diabetes or history of gestational diabetes
- Chloasma (brown patches on the skin, especially on the face) – avoid excessive sun exposure and UV radiation
- Lower abdominal pain during treatment: May require further investigation
Dienogest Besins is NOT a contraceptive. While it may reduce your chance of becoming pregnant by affecting ovulation, it is not reliable for birth control. You must not use hormonal contraceptives (pills, patches, or hormonal IUDs) while taking Dienogest Besins. If you wish to prevent pregnancy, use non-hormonal methods such as condoms, a diaphragm, or a copper IUD.
Risk of ectopic pregnancy: If you become pregnant while taking Dienogest Besins, there is a slightly increased risk of ectopic pregnancy (where the embryo implants outside the uterus, usually in a fallopian tube). Inform your doctor before starting treatment if you have a history of ectopic pregnancy or impaired fallopian tube function.
Uterine bleeding: In women with uterine adenomyosis (where endometrial tissue grows into the muscular wall of the uterus) or uterine fibroids (leiomyomas), dienogest may worsen uterine bleeding. Heavy and prolonged bleeding can lead to anemia, which may be severe. If you develop anemia, your doctor will discuss whether you should discontinue treatment.
Blood clot risk (venous and arterial): Some studies suggest a small (but not statistically significant) increased risk of venous thromboembolism with progestogen-only preparations like Dienogest Besins. The risk increases with age, obesity, family history of blood clots, and prolonged immobilization (such as after surgery or a serious injury). If you need surgery, tell your doctor that you are taking Dienogest Besins, as treatment may need to be interrupted. Limited data also suggest a possible association between progestogen-containing preparations and arterial blood clots (heart attack, stroke), particularly in women who smoke, have high blood pressure, or are obese.
Cancer risk: Current data are inconclusive regarding whether dienogest increases breast cancer risk. Breast cancer has been observed slightly more often in women taking hormones, but it is unclear whether this is caused by the treatment or by increased detection through more frequent medical examinations. Regular breast self-examinations are recommended. In rare cases, benign and malignant liver tumors have been reported in women taking hormones.
Bone density: Dienogest moderately reduces estrogen levels, which may affect bone mineral density (BMD). This is particularly relevant for adolescents aged 12 to 18 years, in whom the effect on developing bones requires careful consideration by the prescribing doctor. Adequate calcium and vitamin D intake (through diet or supplements) is recommended for all patients during treatment. If you have additional risk factors for osteoporosis, your doctor will carefully weigh the risks and benefits before prescribing Dienogest Besins.
Pregnancy and Breastfeeding
Do not take Dienogest Besins if you are pregnant or breastfeeding. There is no therapeutic reason to use this medication during pregnancy, and it should be discontinued immediately if pregnancy occurs. If you are planning to become pregnant, discuss with your doctor when to stop treatment, as the original symptoms of endometriosis may return after discontinuation.
How Does Dienogest Besins Interact with Other Drugs?
Several medications can reduce the effectiveness of Dienogest Besins or increase the risk of side effects. Always inform your doctor, dentist, and pharmacist about all medications and supplements you are taking, including herbal products.
Dienogest is primarily metabolized by the cytochrome P450 enzyme CYP3A4 in the liver. Medications that induce (speed up) or inhibit (slow down) this enzyme can significantly alter dienogest blood levels, affecting both its efficacy and safety profile. Additionally, grapefruit juice can inhibit CYP3A4, potentially increasing dienogest levels and the risk of side effects.
| Interacting Drug / Substance | Category | Effect on Dienogest | Clinical Recommendation |
|---|---|---|---|
| Rifampicin (tuberculosis treatment) | CYP3A4 inducer | Significantly reduces dienogest levels | Avoid combination; discuss alternatives with your doctor |
| Phenytoin, Carbamazepine, Oxcarbazepine, Phenobarbital, Primidone, Topiramate, Felbamate (epilepsy) | CYP3A4 inducers | Reduces dienogest levels, may decrease efficacy | Inform your doctor; dose adjustment or alternative therapy may be needed |
| Ritonavir, Efavirenz, Nevirapine (HIV/Hepatitis C) | CYP3A4 inducers / mixed | May reduce or alter dienogest levels | Consult your HIV specialist and gynecologist |
| Ketoconazole (antifungal) | CYP3A4 inhibitor | May increase dienogest levels | Monitor for increased side effects |
| Griseofulvin (antifungal) | CYP3A4 inducer | May reduce dienogest levels | Discuss alternatives with your doctor |
| St. John’s Wort (herbal supplement) | CYP3A4 inducer | Significantly reduces dienogest levels | Do not use St. John’s Wort during treatment |
| Grapefruit juice | CYP3A4 inhibitor | Increases dienogest levels in blood | Avoid grapefruit juice during treatment |
Laboratory Tests
If you need blood tests, inform your doctor or laboratory staff that you are taking Dienogest Besins, as it can affect the results of certain laboratory tests, including hormone levels and liver function markers.
Driving and Using Machines
There is no evidence that Dienogest Besins affects the ability to drive or operate machinery. However, you are responsible for assessing your own fitness to drive, taking into account any side effects (such as dizziness or fatigue) that you may experience during treatment.
What Is the Correct Dosage of Dienogest Besins?
The standard dose of Dienogest Besins for adults is one 2 mg tablet taken once daily at the same time every day, continuously without breaks between packs. Treatment can be started on any day of the menstrual cycle.
Adults
Standard Adult Dosage
Dose: 2 mg (one tablet) once daily
Timing: Take at the same time each day, with a small amount of liquid if needed
Duration: Continuous use – when one blister pack is finished, start the next without a break
Starting: Treatment can be started on any day of the menstrual cycle
With food: Can be taken with or without food
It is important to take Dienogest Besins at approximately the same time each day to maintain steady blood levels of the medication. Continue taking the tablets even during days when you have menstrual bleeding. There is no pill-free interval – begin a new pack immediately after finishing the previous one.
Children and Adolescents
Pediatric Considerations
Before menarche: Dienogest Besins should NOT be used in girls who have not yet had their first menstrual period
Adolescents (12–18 years): The same 2 mg dose applies, but the prescribing doctor must carefully weigh the benefits against the potential risk of reduced bone mineral density
Monitoring: Adolescent patients should be monitored for bone health and adequate calcium and vitamin D intake should be ensured
Elderly
Dienogest Besins is intended for the treatment of endometriosis, which is a condition affecting women of reproductive age. There is no relevant use for this medication in elderly patients.
Missed Dose
If you forget to take a tablet, or if you experience vomiting or severe diarrhea within 3–4 hours of taking the tablet, the active substance may not have been fully absorbed. In these situations:
- Take one tablet as soon as you remember (or as soon as the vomiting or diarrhea subsides)
- Continue with the next tablet at your usual time the following day
- Do not take a double dose to make up for a missed tablet
If you have missed multiple tablets, the effectiveness of Dienogest Besins in managing your endometriosis symptoms may be reduced. Consult your doctor for guidance.
Overdose
There are no reports of serious harmful effects from taking too many Dienogest Besins tablets at once. If accidental overdose occurs, or if a child ingests the medication, contact a healthcare provider or poison control center for assessment and advice. Symptoms of overdose may include nausea, vomiting, and vaginal bleeding.
Your original endometriosis symptoms may return after you stop treatment. Do not discontinue the medication without first discussing it with your doctor, who can advise you on the best approach and any alternative treatments if needed.
What Are the Side Effects of Dienogest Besins?
Like all medicines, Dienogest Besins can cause side effects, although not everyone experiences them. Side effects are most common during the first months of treatment and typically diminish with continued use. Changes in menstrual bleeding patterns (spotting, irregular bleeding, or absence of periods) are expected.
The most frequently reported side effects in clinical trials relate to changes in bleeding patterns, which should be expected during treatment with dienogest. Other common side effects are generally mild to moderate and tend to improve as the body adjusts to the medication. If any side effect becomes severe or persistent, consult your doctor.
Common
May affect up to 1 in 10 users
- Weight gain
- Depressed mood, sleep disturbances, nervousness, decreased libido, or mood changes
- Headache or migraine
- Nausea, abdominal pain, bloating, flatulence, or vomiting
- Acne or hair loss
- Back pain
- Breast discomfort, ovarian cysts, or hot flushes
- Uterine/vaginal bleeding including spotting
- Weakness or irritability
Uncommon
May affect up to 1 in 100 users
- Anemia
- Weight loss or increased appetite
- Anxiety, depression, or mood swings
- Autonomic nervous system imbalance or impaired concentration
- Dry eyes or tinnitus (ringing in the ears)
- Non-specific circulatory problems, unusual palpitations, or low blood pressure
- Shortness of breath
- Diarrhea, constipation, gastrointestinal inflammation, or gingivitis
- Dry skin, excessive sweating, generalized itching, hirsutism, brittle nails, dandruff, dermatitis, photosensitivity, or pigmentation changes
- Bone pain, muscle cramps, or pain/heaviness in arms or legs
- Urinary tract infection
- Vaginal yeast infection, vaginal dryness, vaginal discharge, pelvic pain, atrophic vulvovaginitis, or breast lumps
- Edema (swelling due to fluid retention)
Additional in Adolescents (12–18 years)
Observed in clinical studies
- Decreased bone mineral density – your doctor will monitor this if applicable
Severe pain or swelling in one leg; sudden severe chest pain radiating to the left arm; sudden shortness of breath; sudden severe or unusual headache; partial or complete vision loss or double vision; difficulty speaking; dizziness or fainting; weakness, unusual sensation, or numbness in any part of the body. These may be signs of a blood clot requiring emergency treatment.
Most side effects of Dienogest Besins are manageable and do not require discontinuation of treatment. However, if you experience severe or persistent depression, prolonged heavy bleeding leading to anemia, or symptoms suggestive of a blood clot, contact your healthcare provider promptly. Reporting suspected side effects helps regulatory authorities continuously monitor the benefit-risk balance of medicines.
How Should You Store Dienogest Besins?
Store Dienogest Besins in its original packaging to protect it from light. Keep out of the sight and reach of children. Do not use after the expiry date printed on the package.
The tablets should be stored in the outer carton to protect them from light, as dienogest is light-sensitive. There are no special temperature storage requirements beyond standard room temperature conditions. Check the expiry date (marked as EXP on the packaging) before taking the medication – the expiry date refers to the last day of the stated month.
Do not dispose of medications via wastewater or household waste. Return unused or expired tablets to a pharmacy for safe disposal to protect the environment. Ask your pharmacist about proper medication disposal procedures in your area.
What Does Dienogest Besins Contain?
Each Dienogest Besins tablet contains 2 mg of the active substance dienogest. The tablets are white to pale yellow, round, and marked with “D2” on one side.
Active substance: Dienogest 2 mg per tablet
Inactive ingredients (excipients):
- Lactose monohydrate
- Povidone K30
- Pregelatinized maize starch
- Microcrystalline cellulose
- Crospovidone
- Colloidal anhydrous silica
- Magnesium stearate
Dienogest Besins tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medication.
Tablet description: White to pale yellow round tablets approximately 7 mm in diameter, marked with “D2” on one side and plain on the other.
Pack sizes: Available in blister packs containing 28 tablets per strip. Cartons contain 28, 84, or 168 tablets. Not all pack sizes may be marketed in every country.
Frequently Asked Questions About Dienogest Besins
Dienogest Besins, Visanne, and Endovelle all contain the same active ingredient – dienogest 2 mg – and are used for the same purpose: treating endometriosis. The difference lies in the manufacturer and the inactive ingredients (excipients). Dienogest Besins is manufactured by Laboratoires Besins International, Visanne by Bayer, and Endovelle by other manufacturers. Your doctor or pharmacist can advise on whether switching between brands is appropriate for you. The therapeutic effect is expected to be equivalent across these products.
No. Dienogest Besins is NOT a contraceptive. While it may reduce the likelihood of pregnancy by partially suppressing ovulation, it is not reliable enough to be used as birth control. You must not use any hormonal contraceptives (combined pills, progestogen-only pills, patches, hormonal IUDs, or implants) while taking Dienogest Besins. If you need to prevent pregnancy, use non-hormonal methods such as condoms, a diaphragm, or a copper intrauterine device (IUD).
Most women experience changes in their menstrual bleeding pattern while taking Dienogest Besins. Some women may have spotting or irregular bleeding, especially in the first few months, while others may stop having periods altogether (amenorrhea). These changes are a normal effect of the medication and are generally not harmful. If you experience heavy or prolonged bleeding that concerns you, consult your doctor, as this may need to be evaluated.
Most patients begin to notice improvement in endometriosis-related pain within the first 4 to 12 weeks of treatment. However, the full therapeutic benefit may take several months to achieve. Clinical trials have shown significant pain reduction by 12 weeks, with continued improvement over longer treatment periods. It is important to take the medication consistently every day and not to stop treatment early, even if symptoms improve, unless advised by your doctor.
When you stop taking Dienogest Besins, your endometriosis symptoms (pelvic pain, painful periods, pain during intercourse) may gradually return. Your menstrual cycle will typically resume within a few weeks to months after stopping the medication. Fertility usually returns relatively quickly, although the timeline varies between individuals. Always discuss discontinuation with your doctor, who can help plan the transition and suggest alternative management strategies if needed.
There is no specific interaction between Dienogest Besins and alcohol. However, moderate alcohol consumption is generally recommended for overall health. Heavy alcohol use can affect liver function, and since dienogest is metabolized in the liver, excessive alcohol intake could theoretically alter how the drug is processed. If you have concerns, discuss your alcohol consumption with your prescribing doctor.
References
This article is based on the following peer-reviewed sources and international medical guidelines:
- European Medicines Agency (EMA). Summary of Product Characteristics: Dienogest Besins 2 mg tablets. Last updated 2023.
- European Society of Human Reproduction and Embryology (ESHRE). Endometriosis Guideline. Human Reproduction Open, 2022. DOI: 10.1093/hropen/hoac009.
- Strowitzki T, Marr J, Gerlinger C, et al. Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial. Human Reproduction. 2010;25(3):633–641.
- Vercellini P, Buggio L, Berlanda N, et al. Estrogen-progestins and progestins for the management of endometriosis. Fertility and Sterility. 2016;106(7):1552–1571.
- World Health Organization (WHO). Endometriosis Fact Sheet. Updated March 2023.
- American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin No. 114: Management of Endometriosis. Obstetrics & Gynecology. 2010 (reaffirmed 2022).
- National Institute for Health and Care Excellence (NICE). Endometriosis: diagnosis and management. NICE guideline [NG73]. Updated 2024.
- Schindler AE. Dienogest in long-term treatment of endometriosis. International Journal of Women’s Health. 2011;3:175–184.
- Casper RF. Progestin-only pills may be a better first-line treatment for endometriosis than combined estrogen-progestin contraceptive pills. Fertility and Sterility. 2017;107(3):533–536.
- British National Formulary (BNF). Dienogest. National Institute for Health and Care Excellence. Accessed January 2026.
About iMedic Medical Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, consisting of licensed specialist physicians with expertise in gynecology, reproductive medicine, and clinical pharmacology. Our team follows the GRADE evidence framework and adheres to international guidelines from the WHO, ESHRE, ACOG, and NICE.
All content is independently produced with no commercial funding, pharmaceutical sponsorship, or advertising influence. We are committed to providing accurate, evidence-based medical information that is accessible to everyone.
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