Dianette

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Dianette on Prescriptsy

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Dianette is a branded combined hormonal preparation containing cyproterone acetate 2 mg and ethinylestradiol 35 micrograms.

It is licensed in the United Kingdom for the treatment of severe acne vulgaris in women that has not responded to prolonged courses of oral antibiotic therapy, and for moderately severe hirsutism.

Dianette is the original branded version of co-cyprindiol, and several generic alternatives are also available.

While Dianette provides effective contraception as a secondary benefit, it is not licensed as a contraceptive and must not be prescribed for that purpose alone.

Severe acne remains a significant clinical problem in the UK, particularly among women in whom androgen-driven sebum production is the dominant pathological factor.

When topical treatments and oral antibiotics have failed to achieve adequate control, anti-androgen therapy offers a targeted approach that addresses the hormonal root cause.

Similarly, moderately severe hirsutism, affecting an estimated 5 to 10% of women, can cause considerable psychological distress and reduced quality of life.

Dianette is a well-established treatment option for both conditions.

This page provides a comprehensive clinical overview of Dianette, covering its mechanism of action, clinical evidence, dosing, side effects, important safety warnings, and how to obtain a prescription in the UK.

Important safety information about Dianette

Before reading further, note the following essential safety points. Dianette is a prescription-only medicine (POM) in the UK and must only be used under medical supervision.

• Dianette carries a higher risk of venous thromboembolism (blood clots) than most standard combined oral contraceptive pills. Your prescriber must assess your individual VTE risk before starting treatment.
• Do not take Dianette if you have a personal or strong family history of blood clots, a known clotting disorder, uncontrolled hypertension, migraine with aura, or if you smoke and are over 35.
• Treatment should continue only as long as necessary to control the skin condition, typically no longer than 3 to 4 cycles after resolution of acne or hirsutism.
• Do not take Dianette at the same time as another hormonal contraceptive.
• Stop Dianette and seek immediate emergency medical attention if you develop sudden chest pain, severe leg pain or swelling, unexplained breathlessness, sudden visual disturbance, or an unusually severe headache.

Understanding androgen-driven acne and hirsutism in women

Androgens, principally testosterone and its active metabolite dihydrotestosterone (DHT), stimulate the sebaceous glands in the skin to produce sebum.

In women with androgen-sensitive skin, even normal circulating androgen levels can lead to excess sebum production, blocked pores, bacterial proliferation, and the inflammatory lesions of acne.

This androgen-driven pattern is often characterised by acne affecting the lower face, jawline, chin, and neck, and by persistence into adulthood beyond the typical teenage years.

Hirsutism is the growth of excess terminal (thick, dark) hair in androgen-sensitive areas including the upper lip, chin, chest, abdomen, and lower back.

It results from androgenic stimulation of vellus hair follicles, converting them to terminal hairs.

The severity is assessed clinically using the modified Ferriman-Gallwey scoring system, with scores of 15 or above generally considered moderately severe to severe.

While polycystic ovary syndrome (PCOS) is the most common underlying cause, many women have idiopathic hirsutism with normal androgen levels and regular menstrual cycles.

In both conditions, treatments that target only the surface symptoms (topical creams, antibiotics, physical hair removal) may provide incomplete relief. Anti-androgen therapy such as Dianette addresses the hormonal mechanism driving the pathology, offering a more fundamental therapeutic approach.

How Dianette works: mechanism of action

Dianette contains two active substances that work synergistically to reduce the effects of androgens on the skin.

Cyproterone acetate is a potent steroidal anti-androgen. It competitively blocks androgen receptors in the skin and sebaceous glands, preventing testosterone and DHT from binding and activating these receptors.

This directly reduces sebum production and slows androgen-dependent hair growth.

Cyproterone acetate also acts as a progestogen, suppressing the midcycle luteinising hormone (LH) surge and thereby reducing ovarian androgen production.

Furthermore, it inhibits 5-alpha reductase activity in the skin, reducing the local conversion of testosterone to the more potent DHT.

Ethinylestradiol serves two key functions. First, it stimulates hepatic production of sex hormone-binding globulin (SHBG), a carrier protein that binds circulating testosterone and renders it biologically inactive.

During treatment, SHBG levels may increase two to threefold, substantially reducing free testosterone available to act on skin structures.

Second, ethinylestradiol provides cycle control and, together with cyproterone acetate, suppresses ovulation, conferring reliable contraceptive efficacy when taken correctly.

The combined anti-androgenic effect of these two components reduces sebum production by up to 50% over several months of treatment, leading to clearing of existing acne lesions and prevention of new ones.

Hirsutism responds more slowly, with gradual thinning and slowing of androgen-dependent hair growth typically becoming apparent after 6 to 12 months of continuous use.

Clinical evidence and prescribing guidance

Dianette has been available in the UK since 1985 and has been used by millions of women worldwide.

Randomised controlled trials and large observational studies demonstrate reductions in inflammatory and non-inflammatory acne lesion counts of 60 to 80% over 6 months of treatment.

It is particularly effective for acne patterns that suggest androgen involvement, including adult female acne, hormonal flares, and acne resistant to prolonged courses of tetracycline-class antibiotics.

NICE Clinical Knowledge Summaries on acne vulgaris position co-cyprindiol (Dianette) as a treatment option for women with moderate to severe acne that has not responded to topical retinoids, benzoyl peroxide, and oral antibiotics.

The British Association of Dermatologists (BAD) guidelines similarly recognise anti-androgen therapy as an option for women with acne resistant to conventional treatments.

For hirsutism, the Royal College of Obstetricians and Gynaecologists (RCOG) and the Endocrine Society recommend combined oral contraceptives with anti-androgenic progestogens as first-line pharmacological treatment. Dianette, with its dedicated anti-androgen component, is a well-established choice within this category.

The MHRA has issued specific safety communications regarding VTE risk with co-cyprindiol preparations including Dianette, advising that the preparation should be prescribed only for its licensed anti-androgen indications and withdrawn once the condition has resolved.

Dosage and administration

Take one Dianette tablet daily for 21 consecutive days, at approximately the same time each day, followed by a 7-day tablet-free interval.

A withdrawal bleed similar to a menstrual period usually occurs during the break. Begin the next 21-day pack after the 7-day interval regardless of whether bleeding has stopped.

First-time users should start on day 1 of the menstrual cycle (the first day of natural bleeding). Contraceptive protection begins immediately if started on day 1.

If started later in the cycle (up to day 5), additional barrier contraception (such as condoms) is recommended for the first 7 days.

Clinical improvement in acne typically becomes apparent after 2 to 3 months, with full benefit at approximately 6 months.

Treatment for hirsutism generally requires 6 to 12 months before a clinically meaningful reduction in hair growth is observed.

Once the condition has cleared or reached an acceptable level, continue Dianette for a further 3 to 4 complete cycles, then discontinue.

If ongoing hormonal contraception is needed, switch to a standard combined oral contraceptive with a lower VTE risk profile.

Missed tablets

If a tablet is missed by fewer than 12 hours, take it as soon as you remember and continue as normal. Contraceptive protection is maintained.

If more than 12 hours late, take the missed tablet immediately, continue with the rest of the pack, and use additional barrier contraception for the next 7 days.

If those 7 days extend beyond the last tablet in the pack, start the next pack immediately without a tablet-free interval.

Side effects of Dianette

Common side effects

Side effects are broadly similar to those of combined hormonal contraceptives.

Commonly reported effects include headache, nausea, breast tenderness and fullness, mood changes (including low mood, irritability, and anxiety), reduced libido, weight gain (usually modest), and breakthrough bleeding or spotting, particularly in the first 2 to 3 cycles.

Many of these settle with continued use as the body adjusts to the hormonal combination.

Uncommon and rare side effects

Less common effects include migraine, fluid retention, chloasma (brown patches on the face, worsened by sun exposure), changes in cervical secretions, contact lens intolerance, and abdominal bloating.

Rare but serious adverse effects include venous thromboembolism (deep vein thrombosis, pulmonary embolism), arterial thromboembolism (ischaemic stroke, myocardial infarction), liver dysfunction including hepatitis and cholestatic jaundice, and liver tumours (both benign hepatic adenoma and, very rarely, hepatocellular carcinoma).

The MHRA has noted that high-dose cyproterone acetate therapy (at doses far exceeding the 2 mg in Dianette) is associated with meningioma development. While the relevance to the low dose in Dianette is unclear, unnecessary long-term use should be avoided.

When to seek urgent medical advice

Stop taking Dianette and seek emergency care (call 999 or attend A&E) if you experience sudden severe chest pain or tightness, unexplained breathlessness, pain or swelling in one leg (particularly the calf), sudden severe headache unlike your normal headaches, sudden partial or complete loss of vision, slurred speech, or weakness or numbness on one side of the body.

These may be signs of a blood clot, stroke, or heart attack requiring immediate treatment.

Contact your GP or NHS 111 for persistent headaches, significant mood disturbance, jaundice (yellowing of skin or eyes), or any new symptoms that concern you.

Report any suspected adverse reactions to the MHRA via the Yellow Card scheme at yellowcard.mhra.gov.uk .

Warnings and precautions

Venous thromboembolism risk

Dianette carries a higher risk of VTE than most standard combined oral contraceptive pills. The estimated incidence is approximately 1.5 to 2 times that of levonorgestrel-containing COCs.

The risk is highest in the first year of use and on restarting after a break of 4 weeks or more.

Key risk factors include obesity (BMI above 30), smoking, immobility, recent surgery, family history of VTE in a first-degree relative under 45, and inherited thrombophilia.

Your prescriber must conduct a thorough risk assessment before initiation and should reassess at each repeat prescription.

Dianette should be stopped at least 4 weeks before planned elective surgery or any period of prolonged immobilisation. Do not restart until you are fully mobile.

If emergency immobilisation occurs (for example after a fracture), seek medical advice about discontinuation and alternative contraception.

Cardiovascular considerations

Dianette should not be used in women with uncontrolled hypertension, known ischaemic heart disease, a history of stroke or transient ischaemic attack, valvular heart disease with complications, or atrial fibrillation.

Women who develop migraine with aura during treatment must stop immediately.

Migraine with aura is a recognised independent risk factor for ischaemic stroke, and the combination with oestrogen-containing preparations significantly increases this risk.

Liver function

Dianette is contraindicated in women with active liver disease, a history of liver tumours, or a history of cholestatic jaundice during pregnancy or previous combined hormonal contraceptive use.

If jaundice, hepatitis, or generalised pruritus develops during treatment, stop Dianette and do not restart until liver function has normalised.

Drug interactions

Enzyme-inducing medicines reduce the efficacy of Dianette.

These include rifampicin, rifabutin, certain anticonvulsants (carbamazepine, phenytoin, phenobarbital, primidone, topiramate, oxcarbazepine, eslicarbazepine), some HIV antiretrovirals, and the herbal remedy St John's Wort.

If you require any of these medicines, discuss alternative acne treatment and additional contraceptive measures with your clinician.

Lamotrigine levels may be reduced by ethinylestradiol, potentially affecting seizure control, so this combination requires specialist input.

Dianette versus standard combined oral contraceptives for acne

Several combined oral contraceptives contain progestogens with mild anti-androgenic properties, including drospirenone (Yasmin), dienogest, and norgestimate. These may provide modest improvement in mild to moderate acne.

However, Dianette offers the most potent anti-androgenic effect due to cyproterone acetate and is reserved for cases where standard treatments have been insufficient.

The trade-off is a higher VTE risk, which is why Dianette is not recommended as a first-choice contraceptive and should be used only for its licensed dermatological and endocrine indications.

How to get a Dianette prescription in the UK

Dianette is a prescription-only medicine available on the NHS.

Your GP can prescribe it following a clinical assessment of your acne or hirsutism, including a review of treatments previously tried, blood pressure measurement, BMI assessment, smoking status, and evaluation of VTE risk factors.

A comprehensive medical and family history is essential before prescribing.

Dermatology referral may be appropriate for severe, scarring, or treatment-resistant acne. Your dermatologist can initiate Dianette or consider alternatives such as oral isotretinoin.

For hirsutism, referral to endocrinology or gynaecology may be warranted if polycystic ovary syndrome or another underlying hormonal condition is suspected.

Authorised online prescribers registered with the General Pharmaceutical Council (GPhC) may also prescribe Dianette following a structured clinical consultation that includes thorough eligibility and risk assessment.

The standard NHS prescription charge in England is currently 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Living with acne and hirsutism: practical advice

While Dianette addresses the hormonal driver of these conditions, supportive measures can enhance treatment outcomes.

Use a gentle, non-comedogenic cleanser and avoid abrasive scrubs or harsh exfoliants, which can worsen inflammation.

Apply non-oily moisturiser and broad-spectrum sunscreen daily, especially as chloasma risk is increased during hormonal treatment.

Avoid picking, squeezing, or extracting spots, as this increases the risk of permanent scarring and secondary infection.

For hirsutism, Dianette slows new androgen-dependent hair growth but does not remove existing terminal hairs.

Physical removal methods including shaving, waxing, threading, depilatory creams, electrolysis, and laser hair reduction can be used alongside pharmacological treatment.

Laser and intense pulsed light (IPL) treatment for hirsutism may be available on the NHS in some areas; ask your GP or dermatologist about local availability and referral criteria.

When to seek medical advice

Contact your GP or NHS 111 if your acne worsens despite treatment, if you develop new or troublesome mood symptoms, or if you have questions about your medication.

Seek emergency care (call 999 or attend A&E) if you develop signs of a blood clot or stroke as described in the warnings section.

Report any suspected adverse reactions via the MHRA Yellow Card scheme at yellowcard.mhra.gov.uk .

Sources

• Dianette, Summary of Product Characteristics (EMC)
• Co-cyprindiol, British National Formulary (BNF)
• NICE CKS: Acne vulgaris
• Acne, NHS
• British Association of Dermatologists, Acne
• MHRA Yellow Card Scheme