Diane-35 in the USA: Why It Isn't FDA-Approved, What It Treats, Clot Risk and US Alternatives

Diane-35 is a hormone tablet made by Bayer that combines cyproterone acetate 2 mg, an anti-androgen, with ethinylestradiol 35 micrograms, an oestrogen. It is prescribed in Canada, the UK (as Dianette), Australia, much of Europe and India for acne and excess hair growth in women. It has never been approved in the United States, and no medicine containing cyproterone in any strength appears in the FDA's drug approvals database. That is why many American women search for "Diane-35 USA", often after hearing about it from friends abroad.

This guide explains what Diane-35 is licensed to treat, what its trials showed, why European regulators reviewed it in 2013, how its blood clot risk compares with ordinary birth control pills, who should not take it, what the 2020 meningioma review said about the 2 mg dose, and which FDA-approved options US women can use instead. We sell Diane 35 and Ginette 35, so we have a commercial interest; the evidence is reported as the regulators and studies give it. Every number comes from the sources listed at the end.

The short answer

Diane-35 is not FDA-approved and is not sold in US pharmacies. Elsewhere it is a prescription medicine for moderate to severe acne linked to androgen sensitivity and for hirsutism in women, and for acne only after skin treatments and antibiotics have failed. It also prevents pregnancy, but regulators in the EU, UK and Canada say it should not be prescribed for contraception alone and must not be combined with another hormonal contraceptive. Its main risk is blood clots: European, UK and Canadian product information says the risk is 1.5 to 2 times that of pills containing levonorgestrel, and may be similar to some newer pills. In the US, FDA-approved alternatives include several combined pills with an acne indication, clascoterone cream, and spironolactone, which dermatology guidelines support for acne even though it is not FDA-approved for that use.

What Diane-35 is

Item	Detail
Active ingredients	Cyproterone acetate 2 mg + ethinylestradiol 35 micrograms per active tablet
Maker	Bayer (Diane-35, Dianette); generics exist, such as co-cyprindiol in the UK, Cyestra-35 in Canada and Ginette 35 in India
How it is taken	One tablet daily for 21 days, then 7 tablet-free days (UK Dianette label). Australian "ED" packs add 7 inactive tablets.
Prescription status	Prescription only in Canada, the UK, Australia (Schedule 4) and India
US status	Not approved by the FDA; no cyproterone product in Drugs@FDA

The name sometimes causes confusion. Indian pharmacy listings show it as "Diane 35mg", but the 35 refers to the 35 micrograms of ethinylestradiol, not 35 mg of anything. The anti-androgen dose is 2 mg.

How it works

According to the UK Dianette product information, the tablet blocks androgen receptors and also reduces androgen production, both through feedback on the hormone signals from the brain and by inhibiting enzymes that make androgens. Androgens drive oil production in the skin and the growth of coarse hair, which is why lowering their effect can help acne and hirsutism. The UK label also records that the oestrogen raises sex hormone binding globulin (SHBG) from about 100 to 300 nmol/L, which binds testosterone in the blood. Because it stops ovulation, it works as a contraceptive at the same time.

What it is licensed for, country by country

Country	Licensed use
UK (Dianette)	Moderate to severe acne related to androgen sensitivity (with or without seborrhoea) and/or hirsutism in women of reproductive age. For acne, only after topical therapy or systemic antibiotics have failed.
EU (2013 decision)	Same wording as the UK. Not to be used with other hormonal contraceptives.
Canada (Diane-35)	Women with severe acne with symptoms of androgenization, including seborrhea and mild hirsutism, only when acne has not responded to topical therapy and oral antibiotics. Not to be prescribed for contraception alone.
Australia (Diane-35 ED)	Signs of androgenisation in women, such as severe acne where prolonged oral antibiotics or local treatment have not worked, or mild to moderate idiopathic hirsutism. Also provides contraception in this group.
United States	No approval for any use

Polycystic ovary syndrome (PCOS) is not a licensed indication in these labels, although many women with PCOS have the acne and hair growth that Diane-35 treats. The UK label notes that women prescribed it may already have a higher cardiovascular risk, for example from PCOS.

Why it is not sold in the US

Drugs@FDA lists no approved product containing cyproterone, alone or in combination (searched October 2026). A medicine can only be marketed in the US after the FDA approves an application for it, and none has been approved for cyproterone. We have not found an FDA statement explaining why, so we do not speculate about the reasons. The practical result is that no US pharmacy can legally dispense it.

For US readers, the FDA's personal importation page says that in most circumstances it is illegal for individuals to import unapproved drugs for personal use. The FDA describes limited situations where it may use enforcement discretion for a serious condition, including that effective treatment may not be available in the US and that the product is not commercialized or promoted to US residents. Several FDA-approved options for acne and hirsutism exist in the US, as described below, so talk to a US doctor before considering importation.

How well it works for acne and hirsutism

The Canadian product monograph reports pooled results from three main trials in 1,462 women with acne, seborrhea or hirsutism, covering 23,549 treatment cycles. The monograph does not report a placebo or comparison group for these trials, so some of the improvement may have happened anyway, but they show how quickly each problem responded:

Outcome (Canadian monograph, pooled main trials)	Result
Facial acne improved or healed after 3 months	38% or more
Facial acne improved or healed after 12 cycles	91%
Facial acne completely healed after 12 cycles	68%
Back and chest acne improved or healed after 3 months	35% to 55%
Oily skin and hair improved by cycle 9	61% to 87%
Hirsutism remitted after 36 cycles: face, chest, abdomen	60%, 95%, 82%

The UK label says relief takes at least three months and that the need to continue should be reviewed periodically. The Canadian monograph says Diane-35 should be stopped 3 to 4 cycles after the signs have completely resolved.

How it compares with other pills for acne

A Cochrane review of 31 trials with 12,579 participants (Arowojolu 2012) found that all six combined pills tested against placebo reduced acne lesions. Comparisons between pill types were less clear and data were limited. The review found that pills containing chlormadinone acetate or cyproterone acetate improved acne more than levonorgestrel pills; cyproterone did better than desogestrel in some studies but results conflicted; and a drospirenone pill appeared less effective than cyproterone. The authors concluded that few important and consistent differences were found between pill types, and that how pills compare with other acne treatments is unknown.

In short, cyproterone pills may have a modest edge for acne over some other pills, but the evidence is not strong enough to say it is clearly better than the acne-approved pills available in the US.

The 2013 European review

The French medicines agency, ANSM, decided to suspend Diane-35 and its generics in France after a national review highlighted serious blood clot events and extensive off-label use as a contraceptive only. That triggered an EU-wide review by the European Medicines Agency's safety committee (PRAC).

The PRAC concluded that the benefits outweigh the risks for the licensed skin conditions, provided measures are taken to reduce clot risk. The EU coordination group endorsed this by a majority of 26 to 1 on 29 May 2013, and the European Commission adopted a legally binding decision on 25 July 2013. The conditions were:

• use only for moderate to severe androgen-related acne or hirsutism in women of reproductive age
• for acne, only after topical treatment and antibiotics have failed
• never together with another hormonal contraceptive, because that doubles up the oestrogen and raises clot risk
• educational material and a prescriber checklist on clot risk and symptoms

Australia's regulator, the TGA, issued its own safety advisory on 30 May 2013 saying the risk appeared to be around 1.5 to 2 times that of combined oral contraceptives and might be around 4 times that of women not using them.

Blood clot risk compared with other pills

All combined hormonal pills raise the risk of venous thromboembolism (VTE), meaning clots in the leg veins (deep vein thrombosis) or lungs (pulmonary embolism). The Canadian monograph says VTE is fatal in 1% to 2% of cases and that the excess risk is highest in the first year of use, or when restarting after a break of four weeks or more.

The UK and EU product information state that the risk with Diane-35 is 1.5 to 2 times that of pills containing levonorgestrel, and may be similar to pills containing desogestrel, gestodene or drospirenone. The Canadian monograph gives the same 1.5 to 2 times figure and says it may be similar to desogestrel or drospirenone pills. A large German study of girls and young women published in 2022 found the same pattern:

In that study, cyproterone pills had an adjusted odds ratio of 2.15 (95% CI 1.43 to 3.25) against levonorgestrel pills, in the same range as dienogest, chlormadinone, desogestrel and drospirenone. An earlier UK study of women aged 15 to 39 with acne, hirsutism or PCOS (Seaman 2003) found a rate ratio of 2.20 (95% CI 1.35 to 3.58) against conventional pills, although the authors said confounding by the underlying condition could not be ruled out.

What those relative risks mean in absolute numbers

"Twice the risk" sounds alarming, so it helps to look at the starting rates. The Canadian monograph gives these figures per 10,000 woman-years:

Group (Canadian Diane-35 monograph)	VTE per 10,000 woman-years
Not pregnant, not using estrogen/progestogen combinations	About 4.4
Users of low-estrogen combinations (under 50 mcg ethinylestradiol), from a large cohort study	About 8 to 10
Pregnant or postpartum women	20 to 30 per 10,000 pregnant or postpartum women (the monograph's unit)
Non-fatal VTE in Diane-35 users, published literature (Spitzer 2003)	1.2 to 9.9

So clots are uncommon on any pill, and pregnancy carries a higher risk than the pill. The extra risk still matters for women who already have risk factors, which is why the checks below are important.

What raises the clot risk further

The UK label lists factors that raise the risk of VTE on Dianette: increasing age; smoking, especially over age 35 (women over 35 are strongly advised not to smoke if they want to use it); a parent or sibling with a clot at a relatively young age; prolonged immobilisation, major surgery, leg surgery or major trauma; and obesity with a BMI over 30. It advises stopping at least four weeks before planned major surgery and not restarting until two weeks after full mobility.

Warning signs that need urgent medical help, according to the label, include pain or swelling in one leg, sudden breathlessness, sharp chest pain, coughing for no clear reason, a sudden severe headache, sudden loss of vision, slurred speech, and weakness or numbness on one side of the body.

Who should not take Diane-35

The UK Dianette label lists these contraindications, among others:

• use with another hormonal contraceptive
• a current or past blood clot in a vein (DVT or pulmonary embolism) or artery (heart attack, angina, mini-stroke or stroke)
• severe or multiple risk factors for clots, such as diabetes with blood vessel damage, severe high blood pressure or severe abnormal blood fats
• an inherited or acquired clotting disorder, such as factor V Leiden (APC resistance) or antiphospholipid antibodies
• migraine with focal neurological symptoms (aura)
• severe liver disease until liver tests are normal, or liver tumours
• current or past breast cancer
• meningioma, current or past
• pregnancy or breast-feeding
• certain hepatitis C medicines (ombitasvir/paritaprevir/ritonavir with dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir)

It is not for use in men, after the menopause or before the first period.

The 2020 meningioma review

Meningioma is a usually non-cancerous tumour of the membranes around the brain. In 2020 the EMA reviewed cyproterone after a French study of 253,777 women using high-dose 50 to 100 mg tablets found that the risk rose with the total amount taken. In that study, the rate of meningioma needing surgery or radiotherapy was 4.5 per 100,000 patient-years with less than 3 g in total, and 129.1 per 100,000 with more than 60 g.

The EMA said the risk occurs especially at high doses of 25 mg a day or more, and that available data do not indicate a risk for low-dose 1 mg or 2 mg products combined with ethinylestradiol or estradiol valerate, which includes Diane-35. As a precaution, those low-dose products are now contraindicated in anyone who has or has had a meningioma. For scale, a woman taking Diane-35 for 13 cycles a year takes about 0.55 g of cyproterone a year (2 mg × 21 tablets × 13 cycles), so roughly 3 g after five to six years of continuous use. The French study involved 50 to 100 mg tablets, and the EMA says available data do not indicate a risk for 1 mg or 2 mg combination products.

Other side effects

The UK label lists nausea, abdominal pain, weight gain, headache, depressed or altered mood, and breast pain or tenderness as common side effects (1 in 100 to 1 in 10). Less common effects include vomiting, diarrhoea, migraine, reduced libido, breast enlargement and rash. Changes in bleeding, such as spotting or missed withdrawal bleeds, can occur.

The label also warns that depressed mood and depression are known effects of hormonal contraceptives, that depression can be serious and is a well-known risk factor for suicidal behaviour and suicide, and that women should contact their doctor if they notice mood changes or depressive symptoms, including shortly after starting. Post-marketing reports of severe depression, including very rare reports of suicidal thoughts or behaviour, have been received, though a causal link with Dianette has not been established. The label lists the onset of severe depression as a reason to stop Dianette immediately.

Checks before and during treatment

The UK label says assessment before starting, and at regular intervals afterwards, should include personal and family medical history and an examination guided by the contraindications and warnings, and that pregnancy should be excluded first. The label says this should include a blood pressure measurement and, if the clinician judges it appropriate, breast, abdominal and pelvic examination including cervical cytology. In practice a doctor will also check your weight and smoking status and ask about clots and migraine in you and your family. The label also lists conditions needing close supervision, including diabetes with mild blood vessel damage, controlled high blood pressure, depression, obesity and migraine.

How to take it and missed tablets

Start the first pack on day 1 of your period and take one tablet a day for 21 days, then have 7 tablet-free days, during which a withdrawal bleed usually occurs (UK label). The next pack starts after the 7-day break.

If a tablet is late by less than 12 hours, take it as soon as you remember and contraceptive protection is maintained. If it is more than 12 hours late, the label says to take only the most recent missed tablet, continue the pack and use a non-hormonal method such as condoms for the next 7 days. If this falls in the last 7 tablets of a pack, start the next pack without a break. Vomiting or diarrhoea can also reduce protection. Our missed pill guide explains the seven-day rule in more detail.

Medicines that interact

The UK label warns that enzyme-inducing medicines can cause breakthrough bleeding and contraceptive failure. The label lists examples: the epilepsy medicines phenobarbitone and other barbiturates, primidone, phenytoin, carbamazepine, oxcarbazepine and topiramate; the anti-infectives griseofulvin and rifampicin; and St John's wort. Check any new medicine with a pharmacist. Ethinylestradiol-containing medicines must not be combined with the hepatitis C combinations listed above because of liver enzyme rises in trials.

FDA-approved alternatives in the US

Option	US status for acne or hirsutism
Drospirenone/ethinylestradiol pills (Yaz and generics)	FDA-approved for moderate acne in women at least 14 who want an oral contraceptive
Norgestimate/ethinylestradiol triphasic pills (for example Tri-Estarylla)	FDA-approved for moderate acne in females at least 15 who want an oral contraceptive
Norethindrone acetate/ethinylestradiol with ferrous fumarate (for example Tilia Fe, Tri-Legest Fe)	FDA-approved for moderate acne in females 15 and over who want oral contraception and whose acne has not responded to topical treatment
Clascoterone 1% cream (Winlevi)	FDA-approved topical androgen receptor inhibitor for acne, age 12 and over
Spironolactone	Not FDA-approved for acne; the 2024 American Academy of Dermatology guideline gives it a conditional recommendation

The same AAD guideline gives combined oral contraceptives a conditional recommendation for acne, and strongly recommends benzoyl peroxide, topical retinoids, topical antibiotics and oral doxycycline, with isotretinoin for severe or scarring acne. For facial hirsutism, eflornithine cream (Vaniqa) was once FDA-approved, but Drugs@FDA now lists the brand as discontinued. See our guides to Yaz vs Yasmin, isotretinoin for acne and doxycycline for acne, or browse all treatments on our acne hub.

Diane-35 in Canada, the UK, Australia and India

• Canada. Diane-35 (Bayer, DIN 02233542) and Cyestra-35 (Knight Therapeutics) are listed as marketed prescription products in the Health Canada Drug Product Database (checked October 2026).
• UK. Dianette and co-cyprindiol generics are prescription only. The NHS Drug Tariff price for co-cyprindiol 2000/35 micrograms, 63 tablets (three cycles), has been £8.65 since 1 October 2025. That is what the NHS pays pharmacies, not a retail price.
• Australia. Diane-35 ED is Schedule 4 (prescription only) and is not listed on the PBS, so it is paid for privately.
• India. Diane 35 (Bayer Zydus Pharma) is sold on prescription; one online pharmacy listed an MRP of ₹458.45 for 21 tablets in October 2026.

Contraception while taking it

Diane-35 prevents pregnancy when taken correctly. Pregnancy is a contraindication, and the UK label lists it as a reason to stop immediately. Do not add another hormonal method such as the pill, patch, ring or hormonal IUD at the same time. If you stop Diane-35, you need another method straight away if you want to avoid pregnancy, as the EMA advice to patients points out. Our guide to birth control pills and blood clots compares clot risk across pill types if you are choosing a long-term contraceptive.

Where SafeRxPills fits

We supply Diane 35 (Bayer Zydus) and Ginette 35 (Cipla), both cyproterone acetate 2 mg with ethinylestradiol 35 micrograms, made for the Indian market. Both are prescription medicines. Please take them only after a doctor has checked that you have no contraindications, particularly clot risk factors, and has confirmed that the licensed indications apply to you. US customers should read the FDA importation section above.

Questions to ask your doctor

• Is my acne or hair growth driven by androgens, and do I need tests for PCOS or other hormone causes?
• Have I tried enough topical treatment and antibiotics for my acne first?
• Do I have any risk factors for blood clots, such as smoking, migraine with aura or a family history of clots?
• Would an FDA-approved acne pill, clascoterone or spironolactone suit me instead?
• How long should I take it, and when will we review whether to stop?
• Which contraception should I use if I stop?

Sources

1. DIANE-35 (cyproterone acetate and ethinyl estradiol tablets) Product Monograph. Bayer Inc., Canada. Date of revision March 16, 2017. Indications, Warnings and Precautions, Dosage and Administration, Clinical Trials.
2. Dianette tablets, Summary of Product Characteristics. Bayer plc, UK (electronic Medicines Compendium, accessed October 2026). Sections 4.1 to 4.8, 5.1 and 5.2.
3. European Medicines Agency. Cyproterone- and ethinylestradiol-containing medicines, referral (PRAC recommendation, CMDh position 29 May 2013, European Commission decision 25 July 2013).
4. European Medicines Agency. Cyproterone-containing medicinal products, referral on meningioma risk (PRAC recommendation 13 February 2020; CMDh consensus 26 March 2020).
5. Therapeutic Goods Administration. Safety advisory: Cyproterone, products containing cyproterone with ethinyloestradiol, such as Diane-35 (30 May 2013); healthdirect Australia, Diane-35 ED (ARTG data updated 3 August 2026).
6. Health Canada Drug Product Database: DIANE-35 (DIN 02233542) and CYESTRA-35, accessed October 2026.
7. NHS Business Services Authority / OpenPrescribing: co-cyprindiol 2000 microgram/35 microgram tablets, 63 tablets, Drug Tariff Part VIIIA Category A, price from 1 October 2025.
8. Schink T, Princk C, Braitmaier M, Haug U. Use of combined oral contraceptives and risk of venous thromboembolism in young women: a nested case-control analysis using German claims data. BJOG. 2022;129(13):2107-2116. PMID 35876787.
9. Seaman HE, de Vries CS, Farmer RD. The risk of venous thromboembolism in women prescribed cyproterone acetate in combination with ethinyl estradiol: a nested cohort analysis and case-control study. Hum Reprod. 2003;18(3):522-6. PMID 12615818.
10. Arowojolu AO, Gallo MF, Lopez LM, Grimes DA. Combined oral contraceptive pills for treatment of acne. Cochrane Database Syst Rev. 2012;(7):CD004425. PMID 22786490.
11. Reynolds RV, Yeung H, Cheng CE, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024;90(5):1006.e1-1006.e30. PMID 38300170.
12. US Food and Drug Administration. Drugs@FDA (openFDA), searched for cyproterone, clascoterone and eflornithine, October 2026. Prescribing information for Yaz (Bayer, May 2025), Tri-Estarylla, Tilia Fe, Tri-Legest Fe and Winlevi (January 2025), indications sections.
13. US Food and Drug Administration. Personal Importation (page last updated 18 August 2025).

This guide is for information and does not replace advice from a doctor who knows your medical history. Do not start, stop or switch hormonal medicines without medical advice.