Dienogest

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Dienogest

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Dienogest

Property Description
Active ingredient Dienogest (DNG)
Form Oral tablet
Pharmacological class Progestin (Progestogen)
Common use Hormonal regulation, Contraception
Origin Synthetic (19-nortestosterone derivative)

What Type of Medicine is Dienogest?

Dienogest is classified as a potent, orally active synthetic steroid that belongs to the progestin (progestogen) pharmacological class. It functions as a fourth-generation or hybrid progestin, structurally identified as a 19-nortestosterone derivative. This unique structure is clinically recognized for combining strong progestogenic activity with beneficial antiandrogenic activity, differentiating it from older progestins by exhibiting a profile of superior metabolic neutrality. This selective action is characterized by its specific pharmacological mechanism.

Dienogest's Pharmaceutical Form and Composition

The active ingredient, Dienogest, is consistently provided as an oral tablet, establishing the route of administration as oral. The medication is available in two distinct types of preparations: as a single-ingredient product (monotherapy), marketed under various names, or as a component in a combination product, typically paired with an estrogen, such as Estradiol Valerate. As an oral tablet, its composition includes the active ingredient and necessary solid pharmaceutical excipients that act as the base/vehicle.

What is the General Purpose of Dienogest's Action?

The general purpose of Dienogest is to modulate the female reproductive cycle by acting as a powerful selective progesterone receptor agonist. This specific action creates a hormonal environment that suppresses the growth and activity of hormone-responsive cells, which is the basis of its therapeutic effect. This physiological action allows the compound to serve the broad therapeutic purpose of regulating cyclical hormonal activity, making it suitable for general applications, including effective contraception and stabilizing hormone-driven conditions.

Regulatory References

  1. Public Assessment Report for Visanne (Dienogest)

What side effects are possible with Dienogest?

Possible side effects and safety information

The safety profile of Dienogest, a synthetic progestin, is formally classified by regulatory authorities based on system-organ classes and frequency of occurrence.

Frequency-Classified Adverse Reactions

The most frequent category of adverse reactions relates to the reproductive system. Very Common effects include changes in menstrual bleeding patterns, such as irregular uterine bleeding, spotting, or the eventual absence of menstruation (amenorrhea).

Common reactions often observed include systemic effects like headache, depressed mood, nausea, abdominal pain, acne, breast discomfort, fatigue, and weight increase. Less common effects may involve alopecia, migraine, dizziness, and ovarian cysts.

Documented Safety Constraints and Serious Risks

Regulatory documents list specific high-level safety constraints for use. The medication is contraindicated in individuals with active venous thromboembolic disorders, severe hepatic disease, a history of hepatic tumors, or known or suspected sex hormone-dependent malignancies.

Although rare, officially documented serious adverse reactions include thromboembolic events and the potential for benign or malignant liver tumors. Additionally, severe uterine bleeding is noted as a risk that may lead to secondary anemia.

Specific population notes indicate that use over 12 months in adolescent patients (12 to <18 years) was associated with a decrease in Bone Mineral Density (BMD) in the lumbar spine, which partially recovers after treatment cessation.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents for Dienogest consistently detail a low-risk profile concerning acute overdose. The information provided is based solely on documented reports and regulatory statements from sources like the FDA and national drug agencies.

Documented Manifestations and Severity

Acute overdose with Dienogest is generally not expected to result in serious or life-threatening health issues. Regulatory agencies note that even accidental ingestion by children has resulted in no serious ill effects. Similarly, clinical reports involving daily doses up to 10 to 15 times the recommended therapeutic amount have been reported as very well tolerated over extended periods.

The manifestations officially documented following acute overdose are typically non-severe:

  • Nausea
  • Withdrawal bleeding (metrorrhagia)

Management and Required Actions

No specific antidote is known for Dienogest. Due to the drug's low acute toxicity and lack of documented severe effects, the required medical approach is limited to symptomatic and supportive treatment.

Because of the documented low severity, immediate emergency services contact is not explicitly mandated in the official labeling. However, if any individual is concerned about taking an excessive number of tablets, the regulatory guidance is to contact a doctor or other healthcare professional for assessment, particularly if the documented manifestations of nausea or bleeding occur.

Therapeutic Uses of Dienogest

Dienogest is commonly used in the long-term management of specific hormone-sensitive gynecological conditions, offering support to ease chronic symptoms and assist with maintaining functional stability. Dienogest is applied across therapeutic areas that involve symptomatic management of heavy menstrual bleeding and hormonal contraception. In combination products, its uses include preventing pregnancy and managing heavy menstrual flow. It is also considered relevant for use as a monotherapy for endometriosis.


Management of Endometriosis-Related Pain

This domain covers the treatment of symptoms related to physical discomfort, including chronic pelvic pain, intense menstrual cramping (dysmenorrhea), and pain during intercourse (dyspareunia) associated with endometriosis. The therapeutic benefit supports symptomatic relief that helps ease the impact of symptoms on routine activities and general comfort, contributing to improved day-to-day functioning. It may be part of management used following surgery to assist with managing recurrent manifestations.

Dienogest is relevant in clinical settings marked by increased discomfort and is used across domains where additional symptomatic support is needed.

Quick Fact: Supportive Management for Chronic Pelvic Discomfort


Controlling Heavy Menstrual Bleeding

Dienogest is relevant in clinical settings marked by abnormal uterine bleeding (AUB), specifically where excessively heavy or prolonged flow (menorrhagia) creates noticeable physiological strain. The benefit helps address cycle regulation and reduction in bleeding volume. This assists patients with maintaining a sense of stability when symptoms are more noticeable and supports general well-being during symptomatic phases.


Addressing Androgen-Related Skin Symptoms

When used as part of a combination product (with an estrogen), Dienogest is applied in addressing specific hormone-driven skin manifestations. This is used in cases where symptoms cluster into patterns like acne, hirsutism, or excessive oiliness. The benefit contributes to easing the burden of these common, distressing manifestations, which may support improved comfort during symptomatic periods.

Eligibility and Restrictions for Use

Official Population Eligibility for Dienogest

Dienogest is strictly intended for women of reproductive age, including adolescents after menarche. Use is defined by regulatory eligibility rules that specify absolute prohibitions and conditional restrictions.

Absolute Contraindications

The medicine must not be used by individuals with active venous thromboembolic disorder or a history of arterial or cardiovascular disease, including diabetes mellitus with vascular involvement. It is also strictly contraindicated for patients with severe hepatic disease (as long as liver function is abnormal), a history of liver tumors, sex hormone-dependent malignancies, and known or suspected pregnancy. Undiagnosed vaginal bleeding also prohibits use.

Age and Use Restrictions

Use is not indicated in children prior to menarche or in the geriatric population (postmenopausal women). While use is permitted in adolescents, it requires careful consideration of the documented risk of decreased Bone Mineral Density (BMD). Lactation is generally not recommended or is contraindicated. Patients with a history of extrauterine pregnancy require individual risk assessment before starting treatment.

What should I know about interactions with other medicines?

Dienogest Interactions with other medicines and products

The official interaction profile for Dienogest is defined by substances that modulate its clearance, which occurs primarily through the Cytochrome P450 3A4 (CYP3A4) enzyme system.

Pharmacokinetic Interactions and Restrictions

Classification Official Statements and Constraints
Contraindicated Combinations Co-administration with strong CYP3A4 inducers (e.g., Carbamazepine, Phenytoin, Rifampicin, Bosentan, Nevirapine) is formally restricted for Dienogest-containing oral contraceptives due to the documented risk of decreased drug exposure and potential loss of efficacy.
Exposure-Altering Substances Strong CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole) may increase Dienogest plasma concentrations by reducing its metabolic clearance. Inducers cause a subsequent decrease in exposure.
Dietary and Herbal Modifiers The herbal product St. John’s wort is classified as a potent CYP3A4 inducer that reduces Dienogest exposure. Grapefruit/Grapefruit juice may also increase plasma concentrations by inhibiting first-pass CYP3A4 metabolism.

Procedural and Population Constraints

Regulatory documentation notes that a clearance period is necessary following the cessation of a strong CYP3A4 inducer before initiating therapy to mitigate the risk of reduced efficacy. Furthermore, use is contraindicated in patients with hepatic impairment (existing or history) because steroid hormones may be poorly metabolized when liver function is impaired, directly affecting the drug's clearance. Dienogest-containing products may also cause interference with certain laboratory tests, including those for coagulation and thyroid function.

Mechanism of Action

Modulating Hormonal Regulation via Receptor Agonism

Dienogest's primary mechanism involves acting as an agonist at the Progesterone Receptor (PR). Through PR activation in the pituitary gland and hypothalamus, the drug mediates the moderate suppression of the Hypothalamic-Pituitary-Ovarian (HPO) axis). This action decreases the release of gonadotropins (LH and FSH), which results in a reduction in ovarian estrogen (E2) production. This establishes a local hypoestrogenic environment that facilitates the drug's subsequent peripheral effects.

Inducing Local Tissue Regression and Atrophy

Binding to PRs in target cells initiates a cascade that triggers decidualization (cellular maturation) and subsequent atrophy (shrinkage/breakdown) of the tissue. This mechanism includes anti-proliferative effects, suppressing the cells' ability to divide and grow. Dienogest also acts as a modulator to suppress the local release of pro-inflammatory mediators (cytokines and prostaglandins) and inhibits angiogenesis (new blood vessel growth), which collectively results in the inhibition of trophic support for the affected tissue.

Dosage and Administration Information

How to Use Dienogest 2 mg Tablets

This section outlines the administration instructions for single-ingredient Dienogest 2 mg tablets. This information focuses strictly on the procedural use of the medication and does not cover therapeutic indications, mechanisms of action, or safety information.

Dosing and Administration

Administration Scope Instruction
Route of Administration Oral use (by mouth).
Standard Dosing Schedule One 2 mg tablet taken once daily.
Regimen Type Continuous administration. Tablet-taking must be continuous—every day, without a break, and independent of menstrual bleeding.
Initiation Tablet-taking may be started on any day of the menstrual cycle.
Administration Conditions The tablet should be swallowed whole with some liquid. It may be taken with or without food, but should preferably be taken at the same time each day.

Management of Missed Doses

If a tablet is missed, the patient is to take only one tablet as soon as it is remembered, then continue the next day at the usual scheduled time. If vomiting or severe diarrhea occurs within 3 to 4 hours of taking the tablet, the tablet is considered unabsorbed; a single replacement tablet should be taken.

Population-Specific Rules

  • Adolescents: The 2 mg daily dose is indicated for use in adolescents who have passed menarche.
  • Hepatic Impairment: The medication is contraindicated in patients with present or past severe liver disease, making dose adjustment irrelevant for this group.

Recent Clinical Evidence

Research evidence / Overview of studies for Dienogest

Evidence for use in Endometriosis-Associated Pain

Research has explored Dienogest in conditions characterized by fluctuating or episodic manifestations of pain linked to endometriosis. The primary goal of these studies was to monitor outcomes related to physical discomfort and research examined patient-reported experiences over defined time intervals, typically ranging from three to 12 months. Studies comparing Dienogest to a placebo examined patient-reported outcomes. Findings suggest patterns related to how symptoms evolved in the observed populations during the study period. Comparative evidence exploring Dienogest against other hormonal treatments is more limited, and studies monitored varying outcomes related to physical discomfort.


Long-term studies and follow-up

Studies have monitored Dienogest usage for extended periods, with some research following patients for up to five years, primarily focusing on how symptoms evolved in the observed populations. Research monitored outcomes related to physical discomfort over time. Studies report how symptoms evolved in the observed populations, and findings indicate patterns where changes measured during the study period were maintained throughout the study duration. Evidence also explored the risk of symptom recurrence after the study medication was stopped. Some studies observed differences in the rate of symptom recurrence in the groups studied, but long-term effects are not fully established.


Evidence in special populations

Studies have evaluated the use of Dienogest in groups where clinical evidence may be limited, such as adolescents. Research in this group examined symptom intensity and patient-reported experiences. Findings indicated that the study period was associated with observed changes in endometriosis-associated pain scores. Research exploring these special populations also examined temporary physiological imbalance, particularly focusing on bone accretion. Changes in bone mineral density (BMD) were observed in some studies. Limited information is available for certain groups, such as those with comorbid conditions like adenomyosis.


What is still uncertain about Dienogest

Key research limitations exist, including that the results apply primarily to the populations studied, and comparative evidence against all other established treatments is lacking. Studies monitored varying outcomes related to various fertility-related outcomes. Research is ongoing to identify which patients may be more likely to have certain patterns observed during the study, such as associations between pre-treatment characteristics and how symptoms evolved. Overall, research provides context but not individual predictions, and findings describe group patterns, not personal outcomes.

Frequently Asked Questions (FAQ)

Common questions about Dienogest (FAQ)


Q: What is the main medical condition that Dienogest is approved to treat?

According to official product information, the primary indication for Dienogest as a monotherapy (a single-ingredient drug) is the treatment of pain associated with endometriosis.

Official information suggests that Dienogest prescribed after surgery for endometriosis may also help to reduce the risk of the condition recurring.


Q: Does Dienogest directly target and reduce the size of endometriosis lesions?

Regulatory studies suggest that Dienogest may suppress the growth of endometriotic deposits in the body.

Its mechanism includes triggering shrinkage (atrophy) and suppressing the division and growth of the affected tissue, which may lead to a reduction in lesion size.


Q: Is Dienogest considered a progestin-only medication?

Dienogest is the progestin component of the drug. The formulation indicated for endometriosis is a progestin-only monotherapy, meaning it contains no estrogen.


Q: Can Dienogest affect the effectiveness of other medications, such as antibiotics or antifungals?

Dienogest is metabolized by the CYP3A4 enzyme system, and substances that interact with this system can affect its concentration in the body.

Official documents warn that certain liver enzyme inducers—including some antibiotics (like rifampicin/rifabutin) and antifungals (like griseofulvin)—may potentially reduce the effectiveness of Dienogest.


Q: What usually happens to a person's menstrual cycle after they stop taking Dienogest?

Clinical data suggests the menstrual cycle generally returns to normal in most women within two months of stopping treatment.

Ovulation usually resumes shortly after the medication is discontinued.


Q: Is Dienogest used for purposes other than endometriosis and heavy menstrual bleeding?

Dienogest monotherapy is indicated for endometriosis-associated pain.

Dienogest, in combination with an estrogen, is also indicated for use as an oral contraceptive to prevent pregnancy, and to treat heavy menstrual bleeding in women who choose an oral contraceptive.


Q: Are there different strengths or dosages of Dienogest available?

Dienogest is available as a 2 mg monotherapy tablet for endometriosis.

In combination oral contraceptives, it is also available in different strengths (e.g., 2 mg or 3 mg) with estradiol valerate.


Q: Is it necessary to have certain medical tests, like pelvic exams or blood work, while using Dienogest?

Regular medical monitoring is recommended while using this medication.

This monitoring may include breast examinations, gynecological check-ups, and certain laboratory tests, such as blood work, to monitor the patient's condition.


Q: How is Dienogest different from a combined oral contraceptive (COC) pill?

Dienogest monotherapy (2 mg for endometriosis) is a progestin-only drug and is not a form of contraception. Combined oral contraceptive pills, on the other hand, contain both a progestin and an estrogen and are indicated specifically for pregnancy prevention.

Official guidance states that a separate non-hormonal barrier method is recommended to prevent pregnancy while using the monotherapy formulation.


Q: How long do initial side effects like spotting usually last when starting Dienogest?

Irregular vaginal bleeding, which includes spotting or breakthrough bleeding, is a common and expected effect when initiating treatment with Dienogest.

According to official patient information, this side effect is typically observed within the first three months of use.


Q: What is the typical time frame for patients to notice pain relief after starting Dienogest?

Clinical trials suggest that improvement in pain intensity is typically reported progressively, with continued decrease in pain severity observed during long-term therapy.

The time to notice relief can vary between individuals.


Q: Will taking Dienogest inhibit ovulation?

Dienogest at the approved dose (2 mg per day) is associated with inhibition of ovulation in most users.

This physiological action of suppressing the reproductive cycle is a key part of how the medication works to relieve endometriosis symptoms.


Q: Does Dienogest cause a change in libido or sexual interest?

Official regulatory documents list decreased libido (loss of sexual interest) as a commonly reported side effect in clinical trials of Dienogest.


Q: Is smoking tobacco a risk factor to consider before starting Dienogest?

Official product warnings state that smoking is a risk factor and is generally discouraged while taking Dienogest.

This is due to an increased risk of serious adverse effects on the heart and blood vessels.


Q: Does Dienogest have any reported effects on cholesterol or lipid levels?

Official information notes the potential for effects on carbohydrate and lipid metabolism.

Therefore, close monitoring may be necessary for individuals with prediabetes, diabetes, or uncontrolled high cholesterol (dyslipidemia).


Q: Does Dienogest provide protection against sexually transmitted diseases?

No. Official patient information clearly states that Dienogest does not provide any protection against HIV/AIDS or other sexually transmitted diseases (STDs).


Q: Is there a possibility of experiencing hot flashes while taking Dienogest?

Yes, hot flashes (sometimes called hot flushes) have been reported as a side effect.

Regulatory documents classify hot flashes as an uncommon to rare occurrence in patients using the medication.


Q: Why might a person need to use a non-hormonal barrier method while taking Dienogest?

Dienogest monotherapy is not officially indicated as a contraceptive.

Patients are recommended to use a non-hormonal barrier method, such as condoms, to prevent pregnancy while using the medication for endometriosis.


Q: What is the relationship between taking Dienogest and sun exposure or skin discoloration (melasma)?

The medication may cause yellowish-brown pigmentation patches on the skin, particularly on the face (chloasma/melasma).

Official patient information advises avoiding sun exposure or UV radiation while taking Dienogest.


Q: Do studies support the use of Dienogest to prevent the recurrence of endometriosis after surgery?

Official information suggests that Dienogest prescribed after surgery for endometriosis may help reduce the risk of the condition recurring.

Research has explored this usage in patients who have undergone surgery for the condition.


Q: Is it normal to feel bloated or experience fluid retention with Dienogest?

Yes, abdominal distension (bloating) and edema (fluid retention or swelling) have been reported as side effects.

These effects are listed as common or uncommon occurrences in official regulatory documents.


Q: Is there any research on the effect of Dienogest on fertility after treatment is stopped?

Clinical data suggests that long-term fertility is generally not impaired, with ovulation typically resuming shortly after treatment cessation.

Hormonal changes during follow-up indicate that the reproductive cycle returns to normal after the medication is discontinued.

How should Dienogest be stored and disposed of?

How to Store and Dispose of Dienogest

Official regulatory documents define specific requirements for the storage, handling, and disposal of Dienogest tablets to maintain product stability and ensure public safety.


Storage Conditions

Requirement Official Instruction
Temperature The medicinal product does not need any specific storage condition.
Protection Store in the original package or outer carton to protect from light.
Safety Keep this medicine out of the sight and reach of children.
Stability Do not use this medicine after the expiry date stated on the packaging.

Disposal Requirements

Disposal of unused or expired Dienogest must comply with local regulations.

  • Wastewater and Household Waste: Do not throw away any medicine via wastewater or household trash.
  • Regulatory Compliance: Any unused medicinal product should be disposed of in accordance with local requirements.
  • Guidance: Patients are instructed to ask their pharmacist for information on how to properly dispose of medicines they no longer use.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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