Cyproterone acetate, the anti-androgen component of Diane 35, is combined with ethinylestradiol to treat women with androgen-related acne, excessive hair growth, or other signs of androgenisation. The combination reduces androgen activity and provides hormonal regulation when a clinician considers it appropriate.
Diane 35 tablets contain cyproterone acetate and ethinylestradiol. Together, they suppress androgen effects and provide contraceptive action during treatment. Diane 35 is a prescription-only medicine in the UK and should be started only after an individual assessment of thromboembolic and other risk factors.
Diane 35 is prescribed for women with moderate-to-severe androgen-related symptoms, especially when topical treatment or other approaches have not provided sufficient control. The main clinical targets include:
Diane 35 does not treat every form of acne or every cause of irregular menstruation. A clinician usually considers the pattern of symptoms, menstrual history, examination findings, and risk factors before prescribing it.
Cyproterone acetate reduces androgen stimulation at the receptor level. This can lower sebum output and reduce the hormonal drive behind some forms of acne. The effect on facial or body hair is slower because existing hairs must complete their growth cycle before changes become noticeable.
Patients may need several months before the full dermatological benefit becomes clear. Hair removal methods may still be needed while treatment is working. New hair growth can become finer or slower, but Diane 35 does not permanently remove established hair follicles.
Cyproterone acetate acts in two main ways. It blocks androgen receptors, reducing the ability of testosterone and related hormones to stimulate the skin, hair follicles, and sebaceous glands. It also has progestogenic activity that contributes to suppression of ovarian androgen production.
Ethinylestradiol supports the hormonal action of the combination by suppressing pituitary signals that stimulate the ovaries. Lower ovarian androgen production complements cyproterone acetate’s receptor blockade. The result is reduced androgen activity from both the hormone-production and hormone-receptor sides.
A simple pharmacological pathway is:
Ethinylestradiol → reduced ovarian stimulation → lower androgen production
Cyproterone acetate → androgen-receptor blockade → reduced skin and hair-follicle response
This dual action explains why Diane 35 can help androgen-related acne and hirsutism while also producing predictable withdrawal bleeding during the tablet cycle. Its hormonal effects also prevent ovulation, but treatment selection should be based on the medical indication rather than contraception alone.
The European Medicines Agency reviewed cyproterone acetate and ethinylestradiol medicines in relation to venous thromboembolism risk and their use in androgen-dependent conditions [1]. The MHRA has also stressed that this treatment should be reserved for appropriate clinical indications and reviewed regularly [2].
Diane 35 is not suitable for everyone. Diane 35 is NOT for you if a clinician identifies a contraindication such as a current or previous clot, migraine with aura, or severe uncontrolled hypertension. It should generally be avoided or carefully assessed in people with:
Medicines that can reduce hormonal contraceptive reliability include enzyme-inducing treatments such as certain medicines for epilepsy, tuberculosis, HIV infection, and some herbal preparations containing St John’s wort. Some antibiotics do not reduce contraceptive protection, but enzyme-inducing antibiotics require a specific plan.
Tell the prescriber about anticoagulants, medicines for epilepsy, antiretroviral treatment, medicines for hepatitis C, diabetes treatments, and herbal products. Liver-enzyme induction can lower hormone concentrations, while hormonal treatment can alter the handling of some other medicines.
Diane 35 is NOT for you if a clinician identifies a contraindication such as a current or previous clot, migraine with aura, or severe uncontrolled hypertension.
Some adverse effects are related to hormonal changes and may settle as the body adapts. Possible effects include:
Seek urgent medical assessment for one-sided leg swelling or pain, sudden breathlessness, chest pain, coughing blood, sudden weakness, facial drooping, speech difficulty, severe abdominal pain, or a sudden severe headache. These symptoms can indicate venous thromboembolism, stroke, or another serious complication.
The risk of venous thromboembolism is higher with combined hormonal medicines than without them. It is also affected by age, smoking, obesity, prolonged immobility, surgery, inherited clotting disorders, and a personal or family history of thrombosis. The MHRA’s safety review identified venous thromboembolism as a central risk requiring careful patient selection [3]. The U.S. Food and Drug Administration (FDA) also warns about thromboembolic risks with combined hormonal products.
Mood symptoms deserve attention. Persistent depression, severe anxiety, or thoughts of self-harm require prompt clinical contact. Do not wait for a routine review if mental health symptoms become intense.
A practical detail is often missed: spotting during the first cycles does not necessarily mean that the medicine has failed. Bleeding that becomes heavy, prolonged, or associated with dizziness needs medical assessment.
The active components are:
The amount used and the frequency depend on the purpose of treatment and are agreed with a doctor or pharmacist. Diane 35 is taken orally as tablets according to the prescribed cycle.
Key administration points include:
Crushing or splitting tablets can make accurate dosing harder and is unnecessary for this oral dosage form. A missed dose should not routinely be “replaced” by doubling later doses because the correct action depends on how late the tablet was taken and where the patient is in the cycle.
| Approach | Main action | Typical role |
|---|---|---|
| Diane 35 | Anti-androgen plus oestrogenic hormonal suppression | Androgen-related acne, hirsutism, and associated hormonal symptoms |
| Topical dermatological treatment | Acts mainly at the skin surface | Local acne treatment with limited systemic hormone effects |
| Non-oestrogen anti-androgen approach | Reduces androgen effects through a different systemic pathway | Selected patients when an oestrogen-containing regimen is unsuitable |
Diane 35 may be preferred when acne or hirsutism occurs alongside irregular periods or other signs of androgenisation. A topical approach may be more suitable for mild, localised acne. A non-oestrogen option may be considered when clotting risk, migraine pattern, or other medical factors make combined hormonal treatment unsuitable.
The trade-off is clear: Diane 35 can address several androgen-related symptoms at once, yet it carries oestrogen-related risks that topical treatment does not. The treatment choice therefore depends on the whole clinical picture, not acne severity alone.
Several patterns can reduce benefit or increase risk:
In clinical practice, doctors usually set two expectations early: skin improvement takes time, and risk review is part of every continuation decision. Acne may respond before unwanted facial hair changes, because hair follicles have a longer growth cycle.
A clinician will also distinguish cosmetic improvement from treatment of the underlying hormonal pattern. Diane 35 can reduce androgen-related symptoms, but it does not remove every cause of PCOS, and it does not permanently cure hirsutism.
Treatment reviews often consider blood pressure, new migraine symptoms, smoking status, mood, menstrual pattern, and symptoms of thrombosis. The appearance of new warning signs matters more than simply counting how many tablets remain.
The EMA’s assessment of cyproterone acetate-containing medicines supports restricting higher-exposure cyproterone treatment to appropriate indications because of meningioma risk associated with cumulative exposure [4]. This is one reason clinicians avoid unnecessary long-term use and reassess whether treatment remains needed.
Diane 35 may be prescribed to some post-pubertal adolescents when severe androgen-related acne or hirsutism requires hormonal treatment, but age alone does not determine suitability. The clinician will assess menstrual development, migraine history, blood pressure, clotting risk, and the severity of the indication. MHRA safety guidance published in 2013 supports restricting cyproterone acetate and ethinylestradiol treatment to appropriate clinical use. A parent or guardian may be involved in the decision according to the young person’s circumstances and local clinical practice.
Treatment duration depends on symptom severity, response, adverse effects, and whether the original indication remains present. Acne may require several cycles before a clear change appears, while hirsutism generally takes longer because hair growth is slow. Long-term use is not automatically appropriate; the need for continuation should be reassessed periodically. EMA safety information from 2013 supports using cyproterone-containing combinations only when the expected benefit continues to justify exposure.
Diane 35 is generally not a routine treatment for older adults because cardiovascular and thromboembolic risks increase with age, while new androgen-related symptoms may need investigation for another cause. A clinician would review blood pressure, smoking, migraine, liver health, cancer history, and other medicines before considering treatment. New acne, excess hair, or menstrual changes later in life should receive an appropriate medical assessment. WHO medical eligibility guidance published in 2024 places strong emphasis on age-related vascular risk when considering combined hormonal medicines.
Diane 35 does not usually impair driving or machine operation directly, but headache, dizziness, nausea, visual symptoms, or mood changes can make these activities unsafe for an individual. Do not drive or operate machinery if vision changes, faintness, or severe headache develops. Sudden neurological symptoms require urgent medical assessment rather than simply taking a break from work. MHRA safety information from 2013 highlights the need for prompt evaluation of symptoms that could indicate a serious vascular event.
Diane 35 tablets can generally be taken with or without food, provided they are taken consistently at the prescribed time. Taking a tablet with food may reduce nausea for some people, although food does not remove the risk of serious hormonal adverse effects. Vomiting or severe diarrhoea soon after a dose can interfere with absorption and may require missed-dose precautions. The 2013 EMA product information for cyproterone acetate and ethinylestradiol medicines describes oral administration and the need to consider gastrointestinal absorption problems.
Do not increase the dose or take tablets more frequently when acne, hirsutism, or irregular bleeding persists. The prescriber may need to confirm the diagnosis, review adherence, assess other causes of androgen excess, or choose a different treatment approach. Existing hair may remain even when new growth slows, so the timing of assessment matters. NICE guidance on acne management, reviewed in 2023, supports reassessing treatment when the expected response is absent or inadequate.
The prescriber should review personal or family thrombosis history, migraine with aura, blood pressure, smoking, obesity, planned surgery, liver disease, pregnancy possibility, and medicines that induce liver enzymes. Discuss epilepsy treatment, tuberculosis treatment, HIV or hepatitis C medicines, St John’s wort, anticoagulants, and any previous hormone intolerance. New or unexplained androgenisation may need further investigation before treatment begins. The MHRA’s 2013 safety communication and EMA’s 2013 review both support individual risk assessment before prescribing.
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My jawline acne became less inflamed after the second cycle, and my skin was less oily. I had breast tenderness at first, which settled, but I needed regular reviews because I also smoked.
I used it when hormonal acne was affecting my confidence. The improvement was gradual rather than dramatic, and I remember feeling mildly nauseated during the first weeks.
After a few months, I noticed fewer dark hairs appearing on my chin. Existing hairs still needed removal, so it was helpful but not a complete solution.
My periods became more predictable, but I developed headaches that were different from my usual tension headaches. My prescriber stopped the treatment and reviewed other options.
My skin improved after several cycles, and the oily feeling reduced. I disliked the spotting early on, although it became less troublesome later.
