Verified
My inflammatory acne became less frequent after the third cycle. The first month brought breast tenderness and mild nausea, which settled when I took the tablet after dinner.
08 Oct 2026
Active ingredient: Cyproterone acetate, Ethinylestradiol
Diane 35
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Diane 35 is a prescription hormonal medicine for women with androgen-related acne or hirsutism who also need contraception. Its anti-androgenic action reduces sebum production and excess hair growth while suppressing ovulation.
Description
Diane 35 is a prescription combined hormonal tablet containing cyproterone acetate and ethinylestradiol. It belongs to the class of combined hormonal preparations with anti-androgenic activity and is used for androgen-related acne and hirsutism in women who also require hormonal contraception.
Composition
Each Diane 35 tablet contains:
| Active ingredient | Amount per tablet | Pharmacological role |
|---|---|---|
| Cyproterone acetate | The dose is stated on the pack — follow the leaflet | Anti-androgenic progestin |
| Ethinylestradiol | The dose is stated on the pack — follow the leaflet | Oestrogen component |
Cyproterone acetate blocks androgen receptors and reduces the effect of testosterone and related hormones on the skin and hair follicles. It also suppresses gonadotrophin release when combined with ethinylestradiol. Ethinylestradiol strengthens ovulation suppression and raises sex hormone-binding globulin, which reduces the amount of biologically active free testosterone.
This fixed-dose combination is classified as a combined hormonal preparation with anti-androgenic activity. The formulation and its recognised indications are described in European regulatory material for cyproterone acetate and ethinylestradiol medicines [2].
Diane 35 is not intended to be combined with another hormonal contraceptive. Using two oestrogen-containing contraceptive methods together can increase hormonal exposure and clotting risk.
Role of cyproterone acetate and ethinylestradiol
The two ingredients work through different but complementary pathways. Cyproterone acetate reduces androgen signalling in target tissues. Ethinylestradiol suppresses ovarian hormone production and increases binding proteins that carry sex hormones in the bloodstream.
This explains why the effect on acne is not immediate. The medicine changes the hormonal environment first; the skin then needs time to produce less oil and form fewer blocked follicles.
Dosage and usage
The usual regimen is:
- Take one tablet daily for 21 consecutive days.
- Start the next seven-day tablet-free interval after the 21 tablets.
- Begin the next course after the seven-day interval, even if bleeding has not completely stopped.
- Take the tablet at approximately the same time each day.
- Swallow it with water; food is not required for absorption.
A missed tablet can reduce contraceptive reliability. The correct action depends on how many hours have passed and where the missed tablet occurred in the 21-day cycle. A missed tablet late in the pack can require shortening the tablet-free interval or starting the next pack without a break.
Taking Diane 35 at the same time as brushing your teeth or another established evening routine can reduce missed-dose errors. A late dose is easier to manage when the delay is recognised promptly.
Vomiting or severe diarrhoea soon after taking a tablet can prevent absorption and should be managed like a missed tablet.
How it works
Cyproterone acetate blocks androgen receptors and reduces androgen stimulation at the receptor level. Ethinylestradiol lowers circulating free testosterone through increased sex hormone-binding globulin and suppresses gonadotrophin release. Diane 35 suppresses ovulation by reducing the release of follicle-stimulating hormone and luteinising hormone from the pituitary gland. The medicine also thickens cervical mucus, making it more difficult for sperm to pass through the cervix.
Indications
Diane 35 combines an anti-androgenic progestin with an oestrogen. Its main therapeutic role is the treatment of moderate-to-severe acne, oily skin, and hirsutism linked to androgen activity. Hirsutism means excessive terminal hair growth in areas such as the face, chest, or abdomen.
The medicine also provides contraceptive protection when taken correctly. Its contraceptive effect must not be treated as a reason to use Diane 35 for mild acne alone. European regulatory guidance limits cyproterone acetate and ethinylestradiol combinations to women with clinically significant androgen-related symptoms, especially when other acne treatments have not produced enough improvement [1].
Clinical applications for acne and hirsutism
Androgens stimulate sebaceous glands and can increase sebum production. Excess sebum contributes to blocked pores, inflammatory acne, and persistent skin oiliness.
Improvement is gradual. New inflammatory lesions may become less frequent after several cycles, while unwanted facial or body hair usually requires longer treatment because existing hairs must pass through their natural growth cycle.
The medicine is usually considered when topical treatment, standard acne therapy, or other clinically suitable options have not achieved adequate control. Acne that is mild, short-lived, or unrelated to androgen sensitivity may not justify the vascular risks associated with a combined hormonal preparation.
Comparison
Cyproterone acetate belongs to a group of progestins with anti-androgenic properties. Other progestins have different receptor profiles and are selected according to the person’s contraceptive needs, acne pattern, bleeding preferences, and vascular risk.
| Progestin type | Anti-androgenic profile | Common clinical focus |
|---|---|---|
| Cyproterone acetate | Strong anti-androgenic activity | Androgen-related acne and hirsutism |
| Desogestrel or gestodene | Low direct anti-androgenic activity | Contraception in selected patients |
| Drospirenone | Anti-androgenic and antimineralocorticoid activity | Contraception and some androgen-related symptoms |
These categories are not interchangeable on a tablet-for-tablet basis. A different progestin may offer a different balance of acne benefit, bleeding control, contraindications, and clotting risk. The choice should be based on the clinical indication rather than cosmetic preference alone.
Contraindications
Diane 35 should not be taken together with another hormonal contraceptive. This includes combined pills, contraceptive patches, vaginal rings, and other products containing oestrogen or progestin.
Combining methods does not provide proportionally better contraception. It increases exposure to reproductive hormones and may increase the risk of venous thromboembolism. A separate non-hormonal method may be appropriate in some circumstances, such as during a transition directed by a prescriber.
- A current or previous deep-vein thrombosis, pulmonary embolism, stroke, or heart attack.
- Known thrombophilia or a strong personal or family clotting history.
- Migraine with aura.
- Severe liver disease or liver tumours.
- Unexplained vaginal bleeding.
- Hormone-sensitive breast cancer or another oestrogen-sensitive malignancy.
- Pregnancy or suspected pregnancy.
- Severe diabetes with vascular complications.
- Uncontrolled high blood pressure.
- A planned major operation requiring prolonged immobility.
- Allergy to cyproterone acetate, ethinylestradiol, or an excipient in the tablet.
Some medicines can reduce contraceptive protection. These include carbamazepine, phenytoin, phenobarbital, primidone, rifampicin, rifabutin, some antiretroviral medicines, and the herbal antidepressant St John’s wort. Other medicines may alter potassium levels, liver enzymes, or bleeding patterns.
When this is not for you
NOT for you if you have
- A current or previous deep-vein thrombosis, pulmonary embolism, stroke, or heart attack.
- Known thrombophilia or a strong personal or family clotting history.
- Migraine with aura.
- Severe liver disease or liver tumours.
- Unexplained vaginal bleeding.
- Hormone-sensitive breast cancer or another oestrogen-sensitive malignancy.
- Pregnancy or suspected pregnancy.
- Severe diabetes with vascular complications.
- Uncontrolled high blood pressure.
- A planned major operation requiring prolonged immobility.
- Allergy to cyproterone acetate, ethinylestradiol, or an excipient in the tablet.
Side effects
Diane 35 may not be suitable for everyone. Possible unwanted effects include mild digestive discomfort or an allergic or skin reaction to a component. Use requires caution during pregnancy, in people with a known allergy, and when taking interacting medicines; follow the leaflet and consult a healthcare professional if concerning symptoms occur.
Common mistakes
The most frequent problems arise from incorrect timing, unrecognised interactions, or unsuitable combination therapy.
- Starting Diane 35 for mild acne without discussing non-hormonal or topical options.
- Taking it with another combined hormonal contraceptive.
- Stopping after one or two cycles because acne has not improved yet.
- Restarting after a prolonged break without reassessing clotting risks.
- Smoking while using an oestrogen-containing tablet.
- Forgetting to mention migraine with aura or a previous clot.
- Assuming antibiotics never affect contraception; enzyme-inducing antibiotics such as rifampicin and rifabutin are important exceptions.
- Treating a late tablet as harmless when several tablets have been missed.
- Ignoring sudden breathlessness, chest pain, or one-sided leg swelling.
- Continuing treatment through major surgery without discussing temporary interruption.
Keep a complete medicine list, including epilepsy treatment, tuberculosis treatment, HIV medicines, and herbal products. St John’s wort is easy to overlook and can reduce hormonal contraceptive reliability.
What doctors say
In clinical practice, prescribers often explain that Diane 35 treats a hormonal driver of acne rather than acting like a rapid spot treatment. Skin improvement usually needs several cycles, and stopping after a few weeks can make the treatment appear ineffective.
A doctor will usually ask about smoking, migraines, blood pressure, previous clots, family history, liver disease, and all current medicines. These questions are central to deciding whether the vascular risk is acceptable.
One practical issue is treatment overlap. Patients sometimes begin Diane 35 while continuing a separate combined contraceptive because they assume the added hormones will improve acne faster. That approach increases exposure without providing a safe advantage.
Another frequent clinical observation is that hirsutism improves more slowly than acne. Hair-removal methods may still be required while the hormonal treatment reduces new growth.
Frequently asked questions
Is Diane 35 used mainly for contraception?
Diane 35 provides contraception, but its principal therapeutic role is androgen-related acne and hirsutism. EMA restrictions describe it as a treatment for these conditions when other options have not been sufficient, rather than a first-choice contraceptive for every patient. This regulatory approach remains relevant in 2026. Its use should match the medical indication and the person’s risk profile. A prescriber should also review thromboembolic risk before treatment begins.
How long does Diane 35 take to improve acne?
Visible acne improvement often develops over several treatment cycles rather than within days. NICE acne guidance published in 2021 supports allowing adequate time for hormonal and topical treatments to work while monitoring adverse effects. Ongoing new lesions, scarring, or severe inflammation require a review of the treatment plan. Do not increase the dose to accelerate the response.
Can Diane 35 be taken with another contraceptive?
Diane 35 should not be combined with another hormonal contraceptive. EMA and PRAC assessments have linked combined hormonal exposure with increased thromboembolic risk, and the warning remains clinically relevant in 2026. This includes another pill, a patch, or a vaginal ring. A prescriber should direct any change between contraceptive methods.
What symptoms require urgent medical attention?
Sudden breathlessness, chest pain, coughing blood, unilateral leg swelling, sudden weakness, facial drooping, or speech difficulty require urgent assessment. WHO guidance published in 2015 identifies smoking, hypertension, obesity, and immobility as relevant contributors to vascular disease. These symptoms should not be managed by simply skipping the next tablet. Emergency evaluation is needed.
Can Diane 35 be used during pregnancy?
Diane 35 should not be used during pregnancy. A missed withdrawal bleed does not always mean pregnancy, but pregnancy becomes more plausible after missed tablets, vomiting, interacting medicines, or unprotected intercourse during a vulnerable interval. SAHPRA guidance published in 2024 requires pregnancy to be excluded before treatment is started or restarted. Persistent uncertainty needs prompt clinical assessment.
Does Diane 35 treat unwanted hair immediately?
No. Cyproterone acetate reduces androgen stimulation, but existing hairs remain until their growth cycle ends. EMA clinical information published in 2013 describes anti-androgenic treatment as a gradual approach to hirsutism rather than an immediate hair-removal method. Cosmetic hair-removal techniques may still be needed while new growth becomes less noticeable.
What happens after stopping Diane 35?
The contraceptive effect ends when treatment is stopped, and ovulation may return. Acne or hirsutism can recur if the underlying androgen sensitivity remains. WHO contraceptive guidance published in 2015 recognises that fertility may return after combined hormonal contraception, although individual timing varies. A replacement contraceptive plan is needed if pregnancy prevention remains important.
Do you offer anonymous delivery?
Your order will be securely packed and shipped within 24 hours. This is exactly what your package will look like (images of an actual item sent). It has the size and look of a regular private letter (24x11x0.7 cm) and its contents cannot be seen.
Diane 35: Reviews and Experiences
3.4
Based on 4 reviews
Verified
Facial hair growth slowed, but the change was gradual. I still used hair-removal treatment, and the benefit was easier to judge after several months than after the first pack.
14 Oct 2026
Verified
I stopped after a few weeks because of spotting and headaches. The symptoms were not severe, but the treatment did not feel suitable, so my prescriber reviewed other options.
15 Sept 2026
Verified
The skin improvement was useful, but remembering the daily tablet was difficult during travel and late shifts. A routine alarm helped prevent missed doses.
27 Sept 2026
Sources
- European Medicines Agency (2013). Cyproterone acetate and ethinylestradiol-containing medicines — referral under Article 31 of Directive 2001/83/EC.
- European Medicines Agency (2013). Cyproterone acetate and ethinylestradiol-containing medicines — Pharmacovigilance Risk Assessment Committee assessment report.
