Андрокур

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Андрокур

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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 Андрокур

Androcur is a medicine whose active ingredient is cyproterone acetate (CPA), which is classified as a synthetic steroidal anti-androgen with progestational properties. An anti-androgen works by blocking the effects of androgens (male sex hormones like testosterone) in the body, which are produced in both males and, to a lesser extent, females.

Mechanism of Action

Cyproterone acetate's therapeutic effect is achieved through two primary mechanisms: it antagonizes (blocks) androgen receptors in target tissues, and its progestational activity causes a negative feedback loop to the pituitary gland. This dual action prevents androgens from binding to their receptors and suppresses the release of Luteinizing Hormone (LH), which in turn reduces the body's overall production of androgens.

Approved Uses

Androcur is prescribed for several conditions that are caused or aggravated by high androgen levels:

  • In men: It is used for the anti-androgen treatment of inoperable prostate cancer and to reduce an abnormally increased sex drive. In prostate cancer, cyproterone acetate helps slow or stop the growth of cancer cells that rely on androgens.
  • In women: It is used to manage moderately severe to severe symptoms of androgenisation (excessive male hormone effects), such as excessive hairiness (hirsutism), scalp hair loss, severe acne, and oily skin.

What side effects are possible with Андрокур?

Possible Side Effects and Safety Information

The officially documented safety profile for cyproterone acetate (Androcur) is categorized based on the frequency and system-organ class affected, as defined in regulatory labeling.

Very Common side effects, occurring in more than one in ten patients, primarily involve the reproductive system and general systemic effects, including decreased libido and erectile dysfunction in men, inhibition of ovulation in women, and general tiredness.

Common effects, reported in up to one in ten patients, include depressive moods, weight changes associated with fluid retention, gynaecomastia (breast enlargement) in men, hot flushes, and sweating.

Serious Adverse Reactions and Safety Constraints

Regulatory documents emphasize specific, clinically significant risks. Hepatic toxicity (liver damage), including severe hepatic failure and the development of benign and malignant liver tumours, is a major constraint, especially at higher doses. The medication is also associated with a documented, rare risk of thromboembolic events (blood clots) and the formation of meningioma (a type of brain tumor), particularly with long-term use at doses of 25 mg or more.

Safety constraints dictate that the medicine is contraindicated in individuals with pre-existing severe hepatic impairment, a history of liver tumours or meningioma, and a history of or risk for thromboembolic events. Furthermore, the drug should not be used in women who are pregnant due to the risk of fetal harm. Regular liver function monitoring is required during treatment.

Overdose and Emergency Response

The official regulatory information concerning an overdose of cyproterone acetate (Androcur) focuses on mandated emergency actions rather than a description of a specific acute toxic syndrome. Official prescribing documents state that no specific acute symptoms or clinical signs following a single oral overdose event are documented.

Overdose Outcomes and Required Actions

Immediate medical attention must be sought in all cases of suspected overdose due to the potential for severe consequences documented in high-dose exposures. Although a specific overdose syndrome is not detailed, regulatory bodies note the risks associated with excessive exposure. These risks include the potential for severe liver toxicity, such as hepatic failure. Furthermore, cases resulting in fatal outcomes have been reported when high dosages, particularly 100 mg and above, were administered, primarily in men with advanced prostatic carcinoma.

Management and Antidote Status

In the event of an overdose, the required management is strictly defined as symptomatic and supportive treatment. Regulatory labeling explicitly confirms that there is no specific antidote known for cyproterone acetate. Consequently, management focuses on providing comprehensive support to address any emerging clinical manifestations.

Therapeutic Uses of Андрокур

This medication is used in situations involving certain distressing symptoms, consistent with designated therapeutic areas.

Addressing Androgen-Driven Skin and Hair Symptoms

This therapeutic domain is relevant for easing symptoms associated with conditions that present with significant manifestations of androgenisation, such as excessive body and facial hair (hirsutism), persistent severe acne, and related seborrhoea (oily skin) or androgenetic alopecia (scalp hair loss). The treatment provides support that helps ease the overall symptom burden and may assist with managing symptoms that interfere with daily comfort.

Palliative and Adjunctive Therapy for Advanced Prostate Carcinoma

The medication is applicable within clinical settings that involve acute or disruptive symptom patterns related to advanced, inoperable prostatic carcinoma in men. It supports the patient during difficult episodes by easing distress. The medication may be used during phases when symptoms may intensify temporarily, such as to support the mitigation of a tumor flare when initiating other hormonal cancer therapies, and is relevant for easing symptoms associated with the progression of the hormone-sensitive condition.

It is relevant in conditions characterized by periods of heightened symptoms, including those associated with prostatic carcinoma, severe acne, hirsutism, androgenetic alopecia, seborrhoea, and an abnormally increased sex drive.

Control of Abnormally Increased Sexual Urge

In adult men, this treatment is relevant in contexts marked by increased discomfort or tension related to a medically determined, abnormally increased sex drive or sexual deviations. It offers symptomatic relief that helps patients cope more steadily. This therapeutic use may assist with managing symptoms that interfere with daily comfort.

Quick Fact: Relief for Androgenisation Symptoms The medication is commonly used to help with symptom clusters related to hormonal activity in women, particularly when symptoms like excessive hair growth or severe acne are difficult to manage with conventional treatments.

Eligibility and Restrictions for Use

Official Regulatory Eligibility for Андрокур (Cyproterone Acetate)

This section outlines the population eligibility rules for using cyproterone acetate, strictly based on official government regulatory documents.

Contraindicated Populations

Use of this medicine is absolutely contraindicated and must be avoided in patients who have a history of or current meningioma (a type of brain tumor) or thromboembolic processes (blood clots). Non-eligibility also applies to patients with uncorrected liver disease (including specific syndromes like Dubin-Johnson or Rotor), severe chronic depression, severe diabetes mellitus with vascular changes, or known hypersensitivity to the drug or its excipients.

Age and Physiological Restrictions

Category Regulatory Status
Pediatric (Male) Not recommended for children and adolescents under 18 years due to insufficient safety data and the potential for interference with growth and endocrine function.
Pregnancy/Lactation Contraindicated in women who are pregnant or breastfeeding due to the risk of feminization of a male fetus and safety concerns for the infant.

Conditional Eligibility

For the treatment of androgenisation symptoms in women (such as severe acne or hirsutism), regulatory labeling dictates that the medicine should only be used after less restrictive treatments, such as topical therapy or systemic antibiotics, have failed or cannot be used.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents describe interactions with cyproterone acetate (the active ingredient in Androcur) based on metabolic pathways and pharmacodynamic effects.

Pharmacokinetic and Exposure Alterations

Cyproterone acetate is primarily metabolized by the CYP3A4 enzyme. Co-administration with other substances that affect this enzyme can significantly alter the medicine's concentration in the body.

Interacting Substance Category Official Regulatory Outcome
Potent CYP3A4 Inhibitors (e.g., Ketoconazole, Ritonavir) May increase the plasma concentration (exposure) of cyproterone acetate due to reduced clearance.
Potent CYP3A4 Inducers (e.g., Rifampicin, St John's Wort) May decrease the plasma concentration (exposure) of cyproterone acetate due to increased clearance.

Pharmacodynamic and Lifestyle Interactions

The medicine's effects can interfere with or be affected by other products based on shared physiologic outcomes, which necessitates caution.

  • Antidiabetic Agents and Insulin: Co-administration may reduce the therapeutic efficacy of these agents by interfering with blood sugar control, which is officially documented.
  • Thromboembolic Risk: The risk of blood clots is officially noted as being increased when cyproterone acetate is combined with other medicines associated with this risk.
  • Alcohol: Consumption may reduce the anti-androgenic effect when the medicine is used for the management of an abnormally increased sex drive.

In patients with hepatic impairment, a condition-specific interaction is noted where clearance is reduced, which may lead to officially documented increased exposure of the medicine.

Mechanism of Action

Андрокур (cyproterone acetate) exerts its pharmacodynamic activity through a dual mechanism involving both peripheral receptor blockade and central suppression of sex hormone production.

Androgen Receptor Antagonism

Cyproterone acetate functions as a competitive antagonist at the androgen receptor (AR), a nuclear receptor located within target tissues such as the prostate, sebaceous glands, and hair follicles. The drug molecule binds to the AR, directly preventing endogenous androgens, primarily testosterone and its more potent metabolite dihydrotestosterone (DHT), from binding and initiating the downstream transcriptional cascades. This AR blockade inhibits the androgen-dependent gene expression necessary for cellular proliferation and functional maintenance in androgen-sensitive tissues.


Antigonadotropic Effect

Simultaneously, cyproterone acetate exhibits significant progestogenic activity, acting as an agonist at the progesterone receptor (PR). Activation of the PR mediates a negative feedback signal on the hypothalamic-pituitary axis. This central action leads to a decrease in the release of luteinizing hormone-releasing hormone (LHRH) from the hypothalamus and, consequently, reduced secretion of pituitary luteinizing hormone (LH). The resulting systemic hypogonadotropic state causes a diminished synthesis and secretion of testosterone by the testes, resulting in reduced circulating androgen concentrations. The combination of peripheral AR antagonism and central androgen suppression culminates in significant systemic antiandrogen modulation.

Dosage and Administration Information

Official Administration Guidelines

Administration Scope

Element Official Instructions (Label-Based)
Route of administration: The medicine is available for oral use (tablets) and intramuscular (IM) injection (depot solution).
Dosing schedule (Adults): Prostate Carcinoma (Men): Oral dose ranges from 200 mg to 300 mg daily, typically divided. Reduction of Sex Drive (Men): Starting dose is often 50 mg twice daily, with a gradual reduction to the lowest effective dose for maintenance. Androgenisation (Women): Oral dose is typically 50 mg to 100 mg daily.
Timing in relation to meals: Oral tablets must be taken after meals with some liquid.
Preparation requirements: Tablets must be swallowed whole; the IM injection is administered slowly into a muscle.
Age-group administration rules: Use is not recommended in male children and adolescents below 18 years of age. Female patients may use the medicine after completion of puberty.
Missed-dose rules: If a dose is forgotten, it should be taken as soon as possible on the same day; do not take a double dose.
Special procedural conditions: Treatment for prostate cancer should not be discontinued once improvement occurs. Dose adjustments (upward or downward) must be made gradually over several weeks.

Instruction Classifications (High-Level)

Classification Parameter
Administration method type: Oral and Intramuscular.
Frequency pattern: Daily (divided dosing), Weekly (IM injection), or Cyclic (e.g., 10 days of the cycle for women).
Use-context constraints: Post-meal intake is required for oral administration; treatment for women of childbearing potential is cyclic and involves a fixed duration (e.g., Day 1 to Day 10).

Resulting Procedural Structure

Official step sequence:

  • The prescribed oral dose is taken daily, either once or divided into 2 or 3 doses, or the IM injection is administered weekly, depending on the indication.
  • Oral tablets must be ingested after a meal and swallowed whole, preferably at the same time each day.
  • For female patients, the use must follow a specified cyclic pattern beginning on the first day of the menstrual cycle.
  • Any change in dose or discontinuation of the medicine requires a gradual reduction (tapering) rather than an abrupt stop.

Connection to the overall use protocol (2–4 sentences): The official usage protocol defines administration through highly specific, indication-dependent patterns, requiring either continuous daily use or a time-restricted cyclic regimen. Adherence to the instruction to take the oral form after meals is a fundamental condition of use, while the procedural mandate for gradual dose reduction structures how the long-term medicine is initiated and maintained.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Cyproterone Acetate (Андрокур)

This section summarizes the types of research that have been conducted to evaluate cyproterone acetate across its approved uses, focusing on what was studied and what remains uncertain based on the scientific literature.


Evidence for Use in Androgen-Dependent Skin and Hair Symptoms (Women)

Research exploring the use of cyproterone acetate for moderately severe to severe symptoms of androgenisation—such as excessive body and facial hair (hirsutism), persistent severe acne, and related scalp hair lossincludes Randomized Controlled Trials (RCTs) and systematic reviews. The studies examined the medicine in women of reproductive age. Outcomes monitored included standardized clinical scores and laboratory measurements of hormone levels. When comparisons were made to other treatments, findings were sometimes mixed, and comparative evidence is limited.

The research base for this indication is characterized by a mix of study types. Follow-up durations were typically limited to intermediate periods (e.g., six to twelve months), meaning that limited information for long-term outcomes and the durability of any reported change is established.

Evidence for Use in Advanced Prostatic Carcinoma (Men)

The research for advanced, inoperable prostatic carcinoma includes large-scale clinical trials and comprehensive meta-analyses. Studies explored the use of this medicine in research contexts involving combination regimens with other hormonal cancer treatments. These long-term studies monitored outcomes such as overall survival and mortality. Large-scale, long-duration trials have been conducted, but research exploring long-term survival patterns has shown mixed findings across anti-androgen agents. Results apply only to the populations studied.

What Remains Uncertain and Key Research Gaps

Evidence quality varies across studies, and several research limitations have been identified. For androgenisation symptoms, sample sizes were modest in comparative trials. For controlling sex drive, the available research is primarily composed of non-randomized designs, and certainty remains low. Generally, long-term effects are not fully established for the non-cancer indications, and comparative evidence against the newest treatments is often lacking.

Frequently Asked Questions (FAQ)

Common questions about Андрокур (FAQ)

Q: What is the difference between Андрокур and other anti-androgen medicines?

Official information describes this drug as having a dual action. It works by directly blocking androgen receptors in the body's tissues, and simultaneously, it acts on the brain to suppress the production of hormones. This combination of peripheral blockage and central hormone suppression is a key distinguishing feature from some other types of anti-androgen medicines.

Q: Can Андрокур be used as a long-term treatment?

The duration of treatment is dependent on the specific condition being treated. For conditions like severe androgenisation, regulatory guidance suggests re-evaluating the need to continue the medicine periodically, with withdrawal often considered after symptoms have satisfactorily resolved. For the treatment of prostate cancer, the drug is generally prescribed for long-term use according to regulatory specifications.

Q: What signs or symptoms might indicate a serious reaction to the medication?

Official patient safety information describes signs of serious adverse reactions. These potential signs may include yellowing of the skin or eyes (potentially indicating liver problems), sudden severe pain in the stomach, or symptoms described as being related to a blood clot, such as sudden shortness of breath or throbbing pain and swelling in an arm or leg.

Q: Is it safe to use herbal or dietary supplements while taking Андрокур?

Official warnings note that certain herbal remedies, such as St John's Wort, are known to interact with this medication. These substances can cause the drug to be cleared more quickly from the body, which could decrease its intended effectiveness. Official regulatory documentation notes that the use of herbal supplements carries the potential for similar drug interactions.

Q: Can taking antibiotics change how effective Андрокур is?

Regulatory documents indicate that the medicine can interact with certain antibiotics and antifungals. Specifically, drugs that affect the CYP3A4 enzyme can alter the level of the medicine in the blood. This means some antibiotics could potentially change the concentration of Андрокур in your body.

Q: Will the effects of Андрокур stop immediately after treatment ends?

No, the effects do not stop immediately upon cessation. Official guidelines specify that the discontinuation of the medicine requires a gradual reduction, often referred to as tapering, rather than an abrupt stop. This procedure is described as necessary to manage the body's adjustment as the hormonal effects of the drug slowly reverse.

Q: Is hair loss a known side effect of Андрокур?

Official patient safety documents indicate that hair loss, or alopecia, is listed as a less common side effect of the medicine. It is important to note that the drug is also prescribed for the treatment of certain types of androgen-related scalp hair loss.

Q: Does the medication affect bone mineral density over time?

According to official documentation, there is a risk that long-term use may cause a decrease in bone mineral density. This risk is particularly noted in patients receiving higher doses and could potentially lead to conditions like osteoporosis.

Q: Is Андрокур recommended for people with pre-existing heart problems?

Official patient information describes that the medicine may be used with caution, or is contraindicated, in certain people with pre-existing cardiac disease. This is due to regulatory concerns regarding the potential for the medicine to exacerbate circulation problems or increase the documented risk of developing blood clots.

Q: How long does it typically take to notice the effects of Андрокур?

Official drug information suggests that the time required to notice the therapeutic effects will vary based on the treated condition. For androgen-related symptoms, studies indicate that the time to relief of symptoms is typically at least three months.

Q: What is the expected time frame for visible changes to hair or skin to appear?

For androgen-related symptoms affecting the hair and skin, regulatory documentation indicates that complete relief of symptoms like acne may be expected within a few months. In some severe cases of androgenisation, treatment may be required for a longer duration to see the full clinical benefit.

Q: Are there any restrictions on driving or operating machinery while using Андрокур?

Due to the officially documented risk of drowsiness or reduced alertness, regulatory advice suggests a restriction on activities. Regulatory documents state that driving or operating heavy machinery is to be avoided until the patient knows how the drug affects their individual level of alertness.

Q: What does 'contraindication' mean in the context of who should not use this drug?

A contraindication is a term used in official drug labeling to describe a specific condition or factor that absolutely forbids the use of the medicine. Regulatory bodies list these conditions because the potential for harm outweighs any possible benefit.

How should Андрокур be stored and disposed of?

How to Store and Dispose of Андрокур?

This information details the storage and disposal requirements for Androcur (Cyproterone Acetate) based strictly on official regulatory documentation.

Storage and Handling Requirements

Requirement Official Instruction
Temperature & Environment Store below 30, C in a cool dry place, away from heat, moisture, and direct light. Keep from freezing.
Prohibited Locations Do not store in environments like the bathroom, near a sink, or on a window-sill.
Packaging Keep the tablets in the original pack until the time of use.
Child Safety Keep this medication out of the sight and reach of children.

Disposal Instructions

While some official product documents state “No special requirements” for disposal, general pharmaceutical guidance advises against flushing unused or expired medicine into wastewater (e.g., down the sink or toilet) or disposing of it in household garbage where pharmaceutical take-back programs are available.

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

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