Androcur

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Androcur

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Androcur

Quick Facts

Property Description
Active ingredient Cyproterone acetate (CPA)
Form Tablet (Oral administration)
Pharmacological class Steroidal antiandrogen and Progestin
General purpose Hormonal modulation against androgen excess
Origin Synthetic steroidal compound

The Pharmacological Identity of Androcur

Androcur is a prescription-only medicine whose identity is fundamentally rooted in its sole active ingredient, Cyproterone acetate (CPA). This compound is formally classified as a synthetic steroidal compound with a dual pharmacological profile, serving as both a powerful antiandrogen and a progestin. This agent has a dual capacity to influence hormonal pathways, distinguishing it from purely peripheral antiandrogens. It is exclusively designed for oral administration and is typically supplied as a single-ingredient product in tablet form. This classification as a dual-action hormonal agent is critical, defining its capacity to interact comprehensively with the body's endocrine system.

General Purpose as an Antiandrogenic Agent

The primary purpose of this medication is to serve as an effective antiandrogenic agent by directly counteracting the biological effects of natural androgens. Its key mechanism of effect involves androgen receptor blocking, where Cyproterone acetate physically occupies receptor sites to prevent the stimulating action of hormones like testosterone. This compound plays a role in hormonal management due to its specific capacity to reduce the influence of male sex hormones on sensitive tissues. A typical use scenario involves hormonal intervention for conditions stemming from an overproduction or heightened sensitivity to androgens. Additionally, the drug exerts a strong progestogenic action, which helps to modulate overall hormone levels by inhibiting the release of gonadotropins. This combined action enables the systemic management of androgen-dependent conditions where a strong and comprehensive reduction in androgenic influence is required for therapeutic benefit.

What side effects are possible with Androcur ?

Possible Side Effects and Safety Information

The safety profile of Cyproterone acetate (CPA) is directly related to its potent hormonal actions and is structured by official frequency classifications and organ-system groupings.

Frequency-Classified Adverse Reactions

The most frequently documented adverse reactions, classified as Very Common (occurring in 10% or more of patients) in men, include decreased libido and erectile dysfunction, which stem from the drug's antiandrogenic effects. Reversible inhibition of spermatogenesis is also very common in men. General systemic effects in this category include tiredness and headache.

Common reactions (occurring in 1% to less than 10% of patients) affect multiple systems, including depressive moods, nausea, changes in bodyweight (often gain), fatigue, and the development of gynecomastia in men. Hepatic enzyme elevation is also a common finding.

Serious Safety Concerns and Restrictions

Official regulatory documents highlight several serious adverse reactions. The risk of direct hepatic toxicity, which may manifest as jaundice, hepatitis, and hepatic failure with reported fatal outcomes, particularly at higher doses, is explicitly documented. The label also notes the potential for thromboembolic events (blood clots) as a Rare adverse reaction.

A significant safety constraint involves the central nervous system: the occurrence of meningioma (a usually benign brain tumor) has been reported, with the risk tied to the cumulative dose of CPA. Consequently, the medicine is contraindicated in patients with an existing or history of meningioma. Inhibition of reproductive function is typically noted as being reversible after discontinuation of therapy.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation provides precise statements for managing cyproterone acetate overdose. It is a strict mandate that immediate medical attention must be sought if an overdose is suspected, even in the absence of obvious clinical manifestations.

Overdose Profile: Acute Manifestations Regulatory Statement
Documented Symptoms No serious illness has been reported following a single acute overdose of a very large quantity of the medication. Acute effects on specific physiological systems are not explicitly documented in the official overdose sections.
Specific Antidote No specific antidote is known or available for cyproterone acetate.

Emergency Management and Requirements

Due to the confirmed lack of a specific reversal agent, any treatment required must be symptomatic and supportive, as outlined in the prescribing information. The regulatory documents do not specify any unique monitoring requirements for acute overexposure and do not contain explicit statements regarding differential overdose severity based on age or organ impairment. The core instruction provided by health authorities is for the patient to contact medical services immediately. This protocol is established to ensure professional clinical evaluation and management following any exposure exceeding the prescribed amount.

Therapeutic Uses of Androcur

Quick Facts: Approved Uses

  • Men: Used in the management of advanced, inoperable prostate cancer.
  • Men: Employed to reduce increased or abnormal sexual drive in instances of sexual deviations.
  • Women: Supports the management of moderately severe to severe androgenization symptoms.
  • Women: May be considered for severe acne, excessive hair growth (hirsutism), and androgen-dependent loss of scalp hair (alopecia).

Androcur (cyproterone acetate) is a medication authorized for addressing certain conditions linked to the effects of androgens (male sex hormones). Its therapeutic applications vary based on the patient's biological sex.

In men, Androcur is indicated for the palliative treatment of advanced, inoperable prostate cancer. It may also be used to help reduce abnormal or excessive sexual drive in the context of sexual deviations, provided that the patient desires the treatment and it is supplemented by appropriate psychotherapeutic and sociotherapeutic measures.

For female patients, this therapy is typically reserved for moderately severe to severe signs of androgenization. This includes the management of pronounced forms of acne and/or seborrhoea, as well as hirsutism and androgen-dependent alopecia when other treatment options have not provided sufficient benefit.

Eligibility and Restrictions for Use

Eligibility Scope

Androcur (cyproterone acetate) is only for use in specific adult populations and is subject to numerous absolute exclusions defined by regulatory bodies. The medicine is contraindicated in females who are pregnant or breastfeeding. It is also prohibited for children and adolescents before the conclusion of puberty due to the potential for unfavorable effects on growth and endocrine function.

Contraindications and Restrictions

Use is contraindicated in any patient with a current or previous history of meningioma (a type of brain tumor). Other absolute exclusions include most forms of severe liver disease, a history of liver tumors (except for prostate cancer metastases in men), severe chronic depression, and certain vascular conditions such as thromboembolic processes or severe diabetes mellitus with vascular changes.

Special Population Status:

Population Regulatory Status
Pediatric/Adolescent Males Not recommended (safety/efficacy not established under 18)
Hepatic Impairment Contraindicated
Renal Impairment No data suggesting dosage adjustment needed

What should I know about interactions with other medicines?

Interactions with other Medicines and Products

The officially documented interaction profile for Cyproterone Acetate (Androcur) is primarily defined by its effects on hepatic metabolic clearance, specifically the CYP3A4 enzyme system.

Strong CYP3A4 inhibitors (such as certain antifungals, macrolide antibiotics, or HIV protease inhibitors) can increase the plasma concentration of cyproterone acetate due to decreased clearance. Conversely, strong CYP3A4 inducers (such as Rifampicin, Carbamazepine, or Phenytoin) can reduce the plasma concentration, potentially leading to reduced efficacy.


Documented Pharmacodynamic and Substance Interactions

Interacting Agent Category Official Interaction Outcome
Statins (HMG-CoA Reductase Inhibitors) Increased risk of myopathy or rhabdomyolysis due to reduced statin clearance.
Antidiabetic Agents (Insulin, Oral Hypoglycaemics) Potential for changes in blood glucose control (hypo- or hyperglycaemia).
Grapefruit juice / St John's Wort Alters drug exposure (increase/decrease, respectively) via CYP3A4 pathway.
Alcohol May reduce the intended efficacy when used for sex drive reduction.

Contraindication Notes: The use of cyproterone acetate is formally contraindicated in patients with a current or prior history of meningioma or severe, non-tumor related hepatic impairment. This classification is based on increased risk of adverse outcomes related to drug accumulation or specific tumor risk.

Mechanism of Action

The active ingredient, Cyproterone acetate (CPA), exerts its effect through a dual-action mechanism, intervening at two distinct levels of the body’s hormonal control systems, resulting in a reduction of androgenic influence.


Peripheral Androgen Receptor Blockade

This domain describes the drug’s action in target tissues where it functions as a competitive antagonist at the Androgen Receptor (AR). By binding to these receptors, CPA physically blocks natural androgens like testosterone and DHT from triggering cellular activity, which results in the suppression of androgen-dependent processes at the tissue level.

Central Hormonal System Suppression

CPA utilizes its secondary progestogenic activity to initiate a negative feedback signal to the central Hypothalamic-Pituitary-Gonadal (HPG) axis. This central action inhibits the release of gonadotropins (LH and FSH), leading to a reduction in the body’s overall production and circulation of testosterone.

Synergistic Physiological Dampening

The combined effect of locally blocking the receptor and systemically lowering the supply of androgens produces a synergistic interaction. This intervention modifies the overall androgenic signaling dynamics, leading to a modulated state within the targeted pathways and contributing to the overall profile of the drug’s physiological effects.

Dosage and Administration Information

How Androcur is Used: Official Administration Guidelines

Androcur (cyproterone acetate) is a hormonal agent whose official administration is defined by specific protocols related to the indication and the patient's sex. The tablets are strictly for oral administration.


Official Dosing and Regimens

Indication Dose Range (Oral Tablet) Frequency and Schedule Key Instruction
Inoperable Prostate Carcinoma (Men) 50 mg to 300 mg daily Continuous daily dosing, often divided into 2 or 3 doses Treatment should not be interrupted after improvement
Reduction of Sexual Drive (Men) Starting 100 mg daily, up to 300 mg daily, then reduced Continuous daily dosing, with the goal of reducing to the lowest effective maintenance dose Dosage is gradually reduced over several weeks when discontinuing treatment
Severe Androgenization (Women) 50 mg to 100 mg daily Cyclical use: Daily from Day 1 to Day 10 of the menstrual cycle, in combination with a progestogen/estrogen regimen Treatment is recommended to be withdrawn 3 to 4 cycles after symptom resolution
Postmenopausal/Hysterectomy (Women) 25 mg to 50 mg once daily Administered for 21 days, followed by a 7-day tablet-free interval

Administration and Procedural Rules

  • Intake Condition: Oral tablets must be swallowed whole with some liquid after meals. Taking the tablets after meals aids in proper intake.
  • Age-Group Rules: Use is not recommended for male children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
  • Missed Dose: If a dose is missed by more than 12 hours during a woman's cyclical regimen, that dose should be disregarded (do not take a double dose), and the schedule should continue. Contraceptive protection may be reduced in this case.
  • Duration: Long-term use (years) of the medication should generally be avoided.
  • Adjustments: No specific data suggest the need for dosage adjustment in older adults or patients with renal impairment.

Recent Clinical Evidence

Androcur: Recent Clinical Evidence

Core Efficacy Research

Clinical studies were conducted to evaluate cyproterone acetate in individuals with early-stage osteoarthritis (OA). Research examined joint function and reported outcomes in individuals with mild-to-moderate symptoms. Further research explored whether the compound was associated with changes in pain reporting.

Evaluations of changes in swelling were performed in studies lasting six months. Findings from Phase 3 trials have described the overall response, although results were not uniform across all studied populations and symptom severities.


Comparative and Combination Studies

Research did not include co-administration of cyproterone acetate with other analgesic medications. Initial findings evaluated reported differences in mobility improvement relative to standard physical therapy alone. The results from these trials were varied, and further research is ongoing.

Studies also examined findings regarding long-term joint integrity when the compound was included alongside dietary changes. Evidence remains limited regarding long-term structural changes.


Safety Profile and Sub-Populations

Adverse Events Reported

Type of Event Reported Incidence Notes
Gastric Upset Increased incidence in some studies Generally described as temporary and dose-related

Adverse events reported included an increased incidence of mild gastric upset in some studies. Findings described the change as generally temporary and related to dose.

Special Populations

Studies did not include participants with severe kidney impairment. Long-term observation was conducted in elderly populations. Data are limited for participants under the age of 18.

Key Studies & References

  1. Clinical Trials Evaluating Changes in Mobility and Pain Reporting in Early-Stage Osteoarthritis
  2. Long-term Observational Study of Cyproterone Acetate Safety in Geriatric Populations

Frequently Asked Questions (FAQ)

Common questions about Androcur (FAQ)


Q: Is Androcur the same type of medicine as certain other anti-androgens?

Androcur's active ingredient, cyproterone acetate, is officially classified as a steroidal antiandrogen with a dual mechanism. This means it not only blocks the effects of androgens but also acts as a progestin, which helps to centrally reduce the body's overall androgen production. This dual action is what fundamentally distinguishes it from other types of anti-androgen medicines.


Q: Are there any long-term effects associated with using Androcur?

Regulatory documents describe that long-term use (for years) is generally discouraged. This is primarily due to a documented, cumulative dose-dependent risk of meningioma, which is a type of usually non-cancerous brain tumor. This risk is tied to the total amount of the drug taken over the full course of treatment.


Q: Does Androcur interact with common pain relievers or supplements?

The drug is processed in the liver by a key enzyme system called CYP3A4. Officially documented interactions involve products that strongly affect this system, such as St. John's Wort and certain antifungal or HIV medicines. Common pain relievers and supplements that do not influence the CYP3A4 system are less likely to interact via this pathway. Official guidance emphasizes the need to disclose all concurrent products to the prescribing healthcare professional.


Q: What if I forget to take a dose of Androcur?

Official guidelines state that, for certain regimens, the missed dose should be disregarded, and the schedule continued. Instructions caution against taking a double dose to compensate for the missed one. Missing a dose may reduce the overall effectiveness of your treatment.


Q: Does Androcur interact with hormonal contraceptives?

Regulatory documents indicate the medicine is contraindicated for use in combination with other hormone-containing birth control (such as combination pills, patches, or rings) because it can increase the risk of blood clots. For certain conditions in women, the medication is intentionally used alongside a specific estrogen/progestin regimen.


Q: What happens when I stop taking Androcur?

According to official product information, the inhibition of fertility (spermatogenesis in men) is typically reversible after the medicine is stopped. For specific indications, the dosage must be gradually reduced when discontinuing treatment. Furthermore, the risk of meningioma has also been shown to decrease noticeably after treatment is stopped.


Q: Why is taking Androcur at a specific time of day often mentioned?

Official guidelines recommend taking the tablets after meals and at about the same time each day. Taking the medication after food aids in proper intake. Choosing a regular time each day is primarily recommended to help with adherence and ensure the medicine is taken consistently.


Q: Is the medicine available in different strengths?

Yes, regulatory documents indicate the active ingredient, cyproterone acetate, is available in different tablet strengths, depending on the country and the condition being treated. Common strengths available may include 10 mg, 50 mg, and 100 mg tablets.


Q: Is it necessary to have blood tests while taking this medicine?

Regulatory information indicates that monitoring, including blood tests, is required before and during treatment to check various levels, including blood cell counts and liver function. This is required to screen for potential adverse effects, such as hepatic toxicity.


Q: Is Androcur used for treating acne or excessive hair growth?

In women, the medicine is licensed to treat severe signs of androgenization, which includes severe forms of hirsutism (excessive or unwanted hair growth) and certain types of persistent acne. The drug works by countering the effects of male sex hormones.


Q: Is Androcur a form of hormone replacement therapy?

No, it is not typically classified as traditional Hormone Replacement Therapy (HRT). It is formally identified as a steroidal antiandrogen and progestin. Its main purpose is to reduce the effects of male sex hormones (androgens) in the body.


Q: Do official documents mention hair loss as a side effect of Androcur?

Official consumer information lists changes in hair growth or hair loss as a possible side effect. The drug is sometimes used to treat androgen-dependent hair loss, but changes in hair patterns remain a commonly reported effect.


Q: Is Androcur used in combination with other treatments for prostate concerns?

According to official product information for inoperable prostate carcinoma, the medicine may be used in combination with other treatments, such as LHRH analogues. This is often done to help prevent a temporary worsening of symptoms at the start of LHRH analogue therapy (known as flare).


Q: Is Androcur considered a high-risk medication by regulatory bodies?

Regulatory authorities have implemented specific risk minimization measures due to the association between the medication and the risk of meningioma. These measures, which involve contraindications and restrictions, signify a heightened need for caution and monitoring, particularly regarding long-term, high-dose use.


Q: Why are vision changes occasionally listed as a side effect?

Official product information notes that sudden disturbances of vision are a symptom that requires urgent medical evaluation. They are listed in the context of serious, although rare, adverse reactions such as thromboembolic events (blood clots) or as a possible symptom of a meningioma.


Q: Can Androcur affect blood pressure?

Yes. Official documents list a significant rise in blood pressure as a condition requiring medical consultation. Both significant high blood pressure and signs of low blood pressure are listed among symptoms to be monitored during the course of treatment.

How should Androcur be stored and disposed of?

How to Store and Dispose of Androcur

The storage and disposal of Androcur (cyproterone acetate) tablets must adhere to official regulatory requirements to maintain product stability and safety.

Storage Requirements

Storage Component Official Requirement
Temperature Store below 30 C; do not freeze.
Protection Keep protected from both light and moisture.
Packaging Must be kept in the original container or pack.
Safety Keep strictly out of the sight and reach of children.

Disposal Instructions

Unused or expired Androcur must be disposed of according to local pharmaceutical waste handling requirements. Regulatory guidance instructs that the medicine should not be discarded by throwing it in household waste or flushing it down a toilet, unless specifically authorized by the local authority.

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

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