Androcur: Uses, Dosage & Side Effects
A steroidal antiandrogen and progestogen used to block androgen effects in men and women
Androcur (cyproterone acetate) is a steroidal antiandrogen medication that blocks the effects of androgens (male sex hormones). It belongs to the progestogen class and works by competitively inhibiting androgen receptors and suppressing gonadotropin release from the pituitary gland. In men, Androcur is used to reduce sex drive in cases of sexual deviations or abnormally high libido when other treatments are considered inappropriate. In women, it is prescribed for severe hirsutism (excessive body hair growth) when lower doses or alternative therapies have been inadequate. Androcur requires a prescription and close medical supervision due to its significant risk profile, including the potential for hepatotoxicity and meningioma development.
Quick Facts: Androcur
Key Takeaways
- Androcur (cyproterone acetate) is a potent antiandrogen that blocks androgen receptors and reduces testosterone levels, used in men for sex drive reduction and in women for severe hirsutism.
- Prolonged use, particularly at doses of 25 mg/day or higher, has been associated with the development of meningiomas (usually benign brain tumours). Treatment must be discontinued if meningioma is diagnosed.
- Hepatotoxicity, including liver failure and fatal cases, has been reported especially at doses of 100 mg or higher. Regular liver function monitoring is mandatory throughout treatment.
- Androcur must never be used during pregnancy as it can cause feminization of a male foetus. Women of childbearing age should use combined oral contraceptives concurrently.
- The medication should not be discontinued abruptly. Your physician will gradually reduce the dose over several weeks to prevent symptom recurrence.
What Is Androcur and What Is It Used For?
Androcur (cyproterone acetate) is a hormonal antiandrogen that blocks the effects of androgens (male sex hormones). It is used in men to reduce sex drive in cases of sexual deviations and in women to treat severe hirsutism (excessive body hair growth).
Androcur contains the active substance cyproterone acetate, a synthetic steroidal compound with both antiandrogen and progestogenic properties. Androgens are sex hormones produced primarily in men but also, in lower quantities, in women. By blocking androgen receptors and suppressing androgen production, Androcur effectively reduces the biological activity of these hormones throughout the body.
The mechanism of action of cyproterone acetate is twofold. First, it competitively inhibits the binding of dihydrotestosterone (DHT) to androgen receptors in target tissues, preventing androgens from exerting their effects. Second, its progestogenic activity suppresses the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) from the pituitary gland, which in turn reduces gonadal production of testosterone. This dual action makes it a particularly effective antiandrogen agent.
Use in Men
In men, Androcur lowers the concentration of testosterone in the blood, which leads to a reduced sex drive. It is used for the suppression of sex drive in cases of sexual deviations and/or abnormally increased libido. However, it is important to note that Androcur 50 mg should only be used when a physician has determined that other interventions are inappropriate for the individual patient.
The treatment typically involves long-term use and may be combined with psychotherapy. When treatment goals have been achieved, the physician will gradually reduce the dose rather than stopping abruptly, as sudden discontinuation may lead to a return of symptoms. Within a few weeks of starting treatment, sperm production is inhibited, and this effect is reversible upon discontinuation over a period of several months.
Use in Women
In women of childbearing age, Androcur has beneficial effects on conditions driven by androgens, such as severe hirsutism (excessive body or facial hair growth in a male pattern). The drug is indicated only when satisfactory results have not been achieved with lower doses of cyproterone acetate or with alternative treatments. This positions Androcur as a second-line therapy for hirsutism that has proven resistant to other approaches.
When prescribed for women, Androcur is typically administered alongside a combined oral contraceptive (containing both progestogen and oestrogen). This concurrent treatment serves two purposes: it stabilizes the menstrual cycle and provides contraceptive protection, as the antiandrogen effects of cyproterone acetate could be harmful to a developing male foetus. The combined hormonal effect suppresses ovarian function, and these changes are reversible after treatment discontinuation.
Other androgen-dependent conditions that may benefit from cyproterone acetate include severe acne resistant to other treatments and androgenetic alopecia in women, though lower-dose formulations are typically used for these indications first. The 50 mg formulation of Androcur is reserved for more severe presentations.
What Should You Know Before Taking Androcur?
Before starting Androcur, your physician must evaluate you for contraindications including liver disease, history of meningioma, thromboembolic disease, and pregnancy. Regular monitoring of liver function and blood counts is required throughout treatment.
Androcur carries significant risks that require careful patient selection and ongoing monitoring. Before initiating treatment, your physician should conduct a thorough medical examination. For women, this includes a gynaecological examination (including breast examination and cervical smear), and pregnancy must be excluded. Understanding the contraindications and precautions is essential for safe use of this medication.
Contraindications
Androcur must not be used if any of the following conditions apply. These contraindications are absolute and apply to both men and women unless otherwise specified.
Do Not Take Androcur If You Have:
- Allergy to cyproterone acetate or any other ingredient in the formulation
- Liver disease of any kind, including hepatic impairment
- Hereditary liver disorders with impaired bilirubin excretion (Dubin-Johnson syndrome or Rotor syndrome)
- Liver tumours (current or history of), whether benign or malignant
- Meningioma (current or history of) — a usually benign brain tumour
- Wasting diseases that cause severe weight loss
- Severe chronic depression
- Thromboembolic disorders (current or history of), particularly blood clots in the veins
- Severe diabetes with vascular complications
- Sickle cell anaemia
Additional contraindications for women: Androcur must not be used during pregnancy or breastfeeding. It is also contraindicated in women who experienced jaundice, persistent itching, or herpes during a previous pregnancy. If your physician has prescribed a combined oral contraceptive alongside Androcur, you should also read the patient information leaflet for that product carefully.
Warnings and Precautions
Meningioma Risk
Cyproterone acetate has been associated with the development of meningiomas (usually benign brain tumours). The risk increases particularly with prolonged use over several years and at doses of 25 mg/day or higher. If you are diagnosed with meningioma, your physician will discontinue treatment immediately. Report any of the following symptoms promptly: visual changes (double vision or blurred vision), hearing loss or ringing in the ears, loss of smell, worsening headaches, memory loss, seizures, or weakness in the arms or legs.
Liver toxicity: Liver function disorders, some of them serious (jaundice, hepatitis, and liver failure), have been observed in patients treated with Androcur. Fatal cases have been reported at doses of 100 mg or higher, mostly in men with advanced prostate cancer. Liver function abnormalities are dose-related and typically develop several months after treatment initiation. Your physician will monitor your liver function before and during treatment, especially if symptoms of hepatotoxicity appear.
Thromboembolic events: Blood clots have been reported in patients using Androcur, though a direct causal relationship has not been definitively established. The risk is higher in patients with a history of thromboembolic events or advanced tumour disease. Tell your physician if you have ever had deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke.
Anaemia: Anaemia has been reported during Androcur treatment, particularly in men. Your physician will monitor your red blood cell count during the course of therapy. The effect of Androcur on sex drive may be diminished by concurrent alcohol consumption.
Diabetes: If you have diabetes, your dose of insulin or oral antidiabetic medication may need to be adjusted during Androcur treatment. This requires careful monitoring by your physician, as cyproterone acetate can affect glucose metabolism.
Adrenal function: Data from animal studies indicate that high doses of Androcur may suppress adrenal hormone production. Your physician may therefore conduct adrenal function tests during treatment, particularly at higher doses.
Breathlessness: A sensation of breathlessness may occur during treatment with high-dose Androcur. This should be reported to your physician promptly.
Children and adolescents: Androcur is not recommended for use in children and adolescents under 18 years of age, as safety and efficacy have not been established in this population. It must not be given before puberty is complete, as it may have adverse effects on growth and hormonal development.
Pregnancy and Breastfeeding
Pregnancy and Breastfeeding
Androcur must not be used during pregnancy or breastfeeding. The antiandrogen effects of cyproterone acetate may cause feminization of a male foetus. Pregnancy must be excluded before starting treatment, and women of childbearing age must use effective contraception throughout the treatment period. If your physician prescribes a combined oral contraceptive concurrently, follow the dosing instructions for both medications precisely.
Driving and Operating Machinery
Androcur can cause fatigue and decreased energy, which may impair your ability to concentrate. You should exercise caution when driving vehicles or operating machinery during treatment. Assess your own fitness for these activities based on your individual response to the medication, and discuss any concerns with your physician.
Lactose Content
Each Androcur 50 mg tablet contains 105.5 mg of lactose monohydrate. If you have been told by your physician that you have an intolerance to some sugars, consult your physician before taking this medicine.
How Does Androcur Interact with Other Drugs?
Androcur interacts with statins (increasing muscle toxicity risk), antifungals, HIV antivirals, and enzyme-inducing drugs like rifampicin and phenytoin. High doses of Androcur may inhibit liver enzymes, affecting the metabolism of other medications.
It is important to tell your physician about all medications you are taking, including prescription drugs, over-the-counter medicines, and herbal remedies. Cyproterone acetate is metabolized primarily in the liver, and several drug interactions have been identified that may affect its efficacy or increase the risk of adverse effects.
Major Interactions
Statins (HMG-CoA reductase inhibitors): When statins used for lowering blood cholesterol are taken concurrently with Androcur, there is an increased risk of myopathy (muscle disease) and rhabdomyolysis (severe muscle breakdown). This effect may be potentiated at higher doses of Androcur. Patients receiving both medications should be monitored for muscle pain, tenderness, or weakness, and creatine kinase levels should be checked if myopathy is suspected.
Enzyme inhibitors: Medications that inhibit liver enzymes may increase cyproterone acetate levels in the blood, potentially intensifying both therapeutic and adverse effects. These include:
- Ketoconazole, itraconazole, clotrimazole (antifungal medications)
- Ritonavir (antiviral medication for HIV)
Enzyme Inducers
Certain medications increase the activity of liver enzymes, which may reduce the effectiveness of Androcur by accelerating its metabolism. These include:
- Rifampicin (antibiotic for tuberculosis)
- Phenytoin (antiepileptic medication)
- St John’s Wort (herbal preparation) — may significantly reduce cyproterone acetate effectiveness
Effect of Androcur on Other Medications
At high doses (100 mg three times daily), cyproterone acetate can inhibit certain hepatic enzymes, potentially altering the metabolism and effectiveness of other medications. This enzyme inhibition is dose-dependent and may not be clinically significant at the standard 50 mg dose used for most indications. However, your physician should be aware of all concurrent medications to assess potential interactions.
| Interacting Drug | Drug Category | Type of Interaction | Clinical Significance |
|---|---|---|---|
| Statins (e.g. atorvastatin, simvastatin) | Lipid-lowering agents | Increased myopathy/rhabdomyolysis risk | High — Monitor muscle symptoms |
| Ketoconazole | Antifungal | CYP3A4 inhibitor; may increase CPA levels | Moderate |
| Itraconazole | Antifungal | CYP3A4 inhibitor; may increase CPA levels | Moderate |
| Ritonavir | HIV antiviral | CYP3A4 inhibitor; may increase CPA levels | Moderate |
| Rifampicin | Anti-tuberculosis | CYP3A4 inducer; may decrease CPA levels | High — May reduce efficacy |
| Phenytoin | Antiepileptic | CYP3A4 inducer; may decrease CPA levels | Moderate |
| St John’s Wort | Herbal supplement | CYP3A4 inducer; may decrease CPA levels | Moderate — Avoid concurrent use |
Alcohol: Concurrent alcohol consumption may reduce the effectiveness of Androcur in suppressing sex drive in men. Patients should be counselled about this interaction, particularly those being treated for sexual deviation, as reduced therapeutic efficacy could have clinical and social implications.
What Is the Correct Dosage of Androcur?
Dosage varies by indication. For sex drive reduction in men: typically 50 mg twice daily, adjustable up to 100 mg three times daily. For hirsutism in women: 100 mg daily on days 1–10 of the menstrual cycle, combined with an oral contraceptive. Tablets should be taken with liquid after a meal.
Androcur tablets should be taken with a small amount of liquid after a meal to improve absorption and reduce gastrointestinal discomfort. The dose is determined by your physician and tailored individually to your clinical situation. Do not exceed the maximum daily dose prescribed by your physician, and never change the dose without medical guidance. If you feel that the effect of Androcur is too strong or too weak, discuss this with your physician.
Dosage for Men — Sex Drive Reduction
Men: Standard Dosing Regimen
- Starting dose: 1 tablet (50 mg) twice daily
- Dose escalation: May be increased to 2 tablets (100 mg) twice daily, or even 2 tablets (100 mg) three times daily for a short period, as determined by the physician
- Maintenance dose: Once the desired therapeutic response is achieved, reduce to the lowest effective dose, generally ½ tablet (25 mg) twice daily
- Maximum daily dose: 300 mg (do not exceed)
- Dose tapering: When adjusting the maintenance dose or discontinuing treatment, the physician will gradually reduce the daily dose by ½ to 1 tablet over intervals of several weeks
For a stable effect, long-term treatment is necessary and may be combined with psychotherapy.
Dosage for Women — Severe Hirsutism
Women: Cyclical Dosing Regimen
- Day 1–10 of cycle: 1 tablet (50 mg) twice daily (total 100 mg/day)
- Day 1–21 of cycle: Combined oral contraceptive (as prescribed)
- Timing: Start both medications on the first day of menstrual bleeding
- Cycle length: 28 days — restart both medications exactly 4 weeks after the previous cycle began
- Dose reduction: Once satisfactory results are achieved, the Androcur dose may be reduced to 1–½ tablet daily (50–25 mg) on days 1–10
A menstruation-like withdrawal bleed may occur during the pill-free interval or placebo days. A new cycle begins on the same day of the week regardless of whether bleeding has stopped.
Special Populations
Elderly Patients (65 years and older)
For men, there are no data suggesting that dose adjustment is needed for elderly patients. For women, Androcur is intended for use in women of childbearing age, and treatment in postmenopausal women has not been studied.
Hepatic Impairment
Androcur is contraindicated in patients with liver disease. Do not use if you have hepatic impairment of any kind.
Renal Impairment
There are no data suggesting that dose adjustment is required for patients with renal impairment.
Missed Dose
If you forget to take a dose of Androcur, do not take a double dose to compensate. Simply continue with your regular dosing schedule. In women, a missed dose may result in intermenstrual bleeding.
Women taking Androcur with an oral contraceptive: If you forget to take the oral contraceptive at the usual time, it must be taken within 12 hours. If more than 12 hours have elapsed, the contraceptive protection may be compromised for that cycle. Follow the instructions in the oral contraceptive’s patient information leaflet, and consult your physician if your monthly withdrawal bleed does not occur. Pregnancy must be excluded before continuing treatment.
Overdose
There are no reports of harmful effects following acute overdose with Androcur. In the event of an overdose, contact your physician, hospital, or poison control centre for assessment. There is no specific antidote; treatment would be symptomatic and supportive.
Do Not Stop Abruptly
Your symptoms may worsen if you stop taking Androcur on your own without medical guidance. Never discontinue treatment without first consulting your physician. If you wish to stop treatment, your physician will devise a gradual dose reduction plan over several weeks.
| Indication | Starting Dose | Maintenance Dose | Maximum Dose |
|---|---|---|---|
| Sex drive reduction (men) | 50 mg twice daily | 25 mg twice daily | 300 mg/day |
| Severe hirsutism (women) | 50 mg twice daily (days 1–10) | 25–50 mg daily (days 1–10) | 100 mg/day |
What Are the Side Effects of Androcur?
Common side effects include reduced libido, erectile dysfunction, gynaecomastia, fatigue, weight changes, and depression. Serious risks include hepatotoxicity (including liver failure), meningioma, and thromboembolic events. Seek immediate medical attention if you develop jaundice, severe abdominal pain, or symptoms of blood clots.
Like all medicines, Androcur can cause side effects, although not everyone experiences them. Some side effects are serious and require immediate medical attention. The side effect profile differs between men and women, as detailed below.
Seek Immediate Medical Attention If You Experience:
- Signs of liver damage: General malaise, fever, nausea, vomiting, loss of appetite, generalised itching, yellowing of the skin or eyes, light-coloured stools, dark urine
- Severe abdominal pain that does not resolve quickly (may indicate liver tumours with internal bleeding)
- Signs of blood clots: Calf swelling, chest pain, shortness of breath, or sudden weakness
Side Effects in Men
Very Common
May affect more than 1 in 10 people
- Temporary inhibition of sperm production (reversible)
- Decreased sex drive (reduced libido)
- Erectile dysfunction (inability to achieve or maintain erection)
Common
May affect up to 1 in 10 people
- Hepatotoxicity, including jaundice, hepatitis, liver failure
- Weight gain or weight loss
- Depression
- Temporary restlessness
- Gynaecomastia (breast enlargement, sometimes with nipple tenderness)
- Fatigue and decreased energy
- Hot flushes
- Sweating
- Shortness of breath
Uncommon
May affect up to 1 in 100 people
- Skin rash
Rare
May affect up to 1 in 1,000 people
- Allergic reactions (hypersensitivity)
- Meningioma (usually benign brain tumour)
Very Rare
May affect up to 1 in 10,000 people
- Benign and malignant liver tumours
Frequency Not Known
Cannot be estimated from available data
- Intra-abdominal haemorrhage (internal bleeding)
- Thromboembolic events (blood clots)
- Osteoporosis (bone density loss with long-term treatment)
- Anaemia
During Androcur treatment in men, sex drive and erectile function are reduced and testicular function is inhibited. These changes reverse after treatment is discontinued. Sperm production is inhibited within a few weeks and gradually recovers over several months after stopping the medication. Gynaecomastia (breast enlargement) is common and usually resolves after treatment ends, though not always completely. Long-term treatment may cause osteoporosis, similar to other antiandrogen therapies.
Side Effects in Women
Rare
May affect up to 1 in 1,000 people
- Meningioma (usually benign brain tumour)
Frequency Not Known
Cannot be estimated from available data
- Benign and malignant liver tumours
- Allergic reactions (hypersensitivity)
- Weight gain or weight loss
- Depression
- Temporary restlessness
- Decreased or increased sex drive
- Thromboembolic events (blood clots)
- Shortness of breath
- Intra-abdominal haemorrhage (internal bleeding)
- Hepatotoxicity, including jaundice, hepatitis, liver failure
- Skin rash
- Inhibition of ovulation
- Breast tenderness
- Spotting (intermenstrual bleeding)
- Fatigue
In women, treatment with Androcur in combination with a combined oral contraceptive suppresses ovarian function, meaning ovulation is prevented and the woman cannot become pregnant during treatment. When both medications are discontinued, ovarian function returns to normal. If your physician has prescribed a combined oral contraceptive alongside Androcur, you should also consider the side effects listed in that product’s patient information.
If you experience small, irregular breakthrough bleeding during the three weeks of combined tablet-taking, do not stop taking either medication. Contact your physician if the bleeding is persistent or recurrent.
Missed menstrual bleeding: If your monthly withdrawal bleed fails to occur, temporarily discontinue both Androcur and the oral contraceptive and consult your physician. Pregnancy must be excluded before a new treatment cycle can begin.
How Should You Store Androcur?
Store Androcur out of the sight and reach of children. Do not use after the expiry date stated on the packaging. Dispose of unused medication responsibly through a pharmacy take-back programme.
Androcur tablets should be stored in their original packaging at room temperature, protected from excessive heat and moisture. Keep the medication out of the sight and reach of children at all times. Do not use the medicine after the expiry date printed on the carton; the expiry date refers to the last day of the month indicated.
Unused or expired Androcur tablets should not be disposed of via household waste or flushed down the drain. Return them to a pharmacy for safe disposal through an approved medication take-back programme. This protects the environment from potential contamination by hormonal substances, which is particularly important for antiandrogen medications like cyproterone acetate.
If you notice any visible changes in the appearance of the tablets (discolouration, crumbling, or unusual odour), do not take them and return the pack to your pharmacist for assessment.
What Does Androcur Contain?
Each Androcur tablet contains 50 mg of the active substance cyproterone acetate, along with inactive ingredients including lactose monohydrate (111 mg), maize starch, povidone, colloidal silicon dioxide, and magnesium stearate.
Understanding the full composition of your medication is important, especially if you have known allergies or intolerances to certain excipients. Below is the complete list of ingredients in Androcur 50 mg tablets.
Active Substance
Cyproterone acetate 50 mg — the pharmacologically active ingredient responsible for the antiandrogen and progestogenic effects of the medication. Cyproterone acetate is a synthetic derivative of 17-hydroxyprogesterone with potent antiandrogenic activity.
Inactive Ingredients (Excipients)
- Lactose monohydrate (111 mg) — a sugar used as a filler/binder. Patients with lactose intolerance should consult their physician before taking this medication.
- Maize starch — used as a disintegrant to help the tablet break down in the gastrointestinal tract
- Povidone 25,000 — a binding agent that helps hold the tablet together
- Colloidal anhydrous silicon dioxide — a flow agent used during manufacturing
- Magnesium stearate — a lubricant that prevents the tablet mixture from sticking to equipment during manufacturing
Appearance and Packaging
Androcur 50 mg tablets are white to slightly yellow, with a score line on one side and the letters “BV” embossed within a hexagon on the other side. The tablets can be divided into two equal halves along the score line, facilitating dose adjustment. Each pack contains 50 tablets, available in either a coloured glass bottle or blister packaging. Not all pack types may be available in all markets.
Marketing Authorisation Holder
Advanz Pharma Limited, Dublin, Ireland. The tablets are manufactured by Bayer Weimar GmbH und Co KG, Weimar, Germany, and Bayer AG, Berlin, Germany.
Frequently Asked Questions About Androcur
Medical References and Sources
This article is based on current medical research and international guidelines. All claims are supported by scientific evidence from peer-reviewed sources.
- European Medicines Agency (EMA). “Cyproterone acetate-containing medicinal products — Article 31 referral.” EMA/141014/2020. EMA Referral Decision EMA review of meningioma risk with cyproterone acetate products. Evidence level: Regulatory assessment
- Gil M, et al. (2011). “Risk of meningioma among users of high doses of cyproterone acetate as compared with the general population.” British Journal of Clinical Pharmacology, 72(6):965–968. doi:10.1111/j.1365-2125.2011.04031.x Epidemiological study demonstrating increased meningioma risk with high-dose CPA. Evidence level: 2B
- Martin KA, et al. (2018). “Evaluation and Treatment of Hirsutism in Premenopausal Women: An Endocrine Society Clinical Practice Guideline.” Journal of Clinical Endocrinology & Metabolism, 103(4):1233–1257. doi:10.1210/jc.2018-00241 International clinical practice guideline for hirsutism management. Evidence level: 1A
- Hammerstein J. (1990). “Antiandrogens: Clinical Aspects.” In: Orfanos CE, Happle R (eds) Hair and Hair Diseases. Springer, Berlin. Comprehensive review of cyproterone acetate pharmacology and clinical applications. Evidence level: Expert review
- World Health Organization (WHO). “WHO Model List of Essential Medicines — 23rd List (2023).” WHO Essential Medicines List International reference for essential medicine classifications. Evidence level: Regulatory
- Bayer AG. “Androcur (cyproterone acetate) Summary of Product Characteristics.” Updated November 2024. Regulatory-approved product information. Evidence level: SmPC
- Brahm J, et al. (2020). “Hepatotoxicity of Cyproterone Acetate: A Systematic Review.” Frontiers in Medicine, 7:590. doi:10.3389/fmed.2020.00590 Systematic review of hepatotoxicity data for cyproterone acetate. Evidence level: 1A
Evidence grading: This article uses the GRADE framework (Grading of Recommendations Assessment, Development and Evaluation) for evidence-based medicine. Evidence level 1A represents the highest quality of evidence, based on systematic reviews of randomized controlled trials. Regulatory assessments from EMA and national agencies are also considered authoritative sources.