Dianette

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Dianette

Dianette: Dual Identity as a Combined Hormonal Agent

Property Description
Active Ingredients Cyproterone acetate, Ethinyl Estradiol
Form Film-coated tablets
Pharmacological Class Estrogen-Progestogen Combination / Hormonal Agent
Common Use Hormonal contraception and antiandrogenic action
Origin Synthetic compound

Dianette is a synthetic, fixed-dose combination product classified by the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) system under the group Antiandrogens and Estrogens (G03HB01). This medication is identified as a dual-purpose medication—an Oral contraceptive that simultaneously possesses significant Antiandrogenic properties. The preparation is administered orally as film-coated tablets for systemic effect. Its primary classification as a hormonal agent distinguishes it from standard oral contraceptives, which typically lack the potent antiandrogenic component, making it reserved for women requiring specific hormonal management.

Composition and Active Ingredients: Cyproterone and Ethinyl Estradiol

The pharmacological activity is due to its two synthetic active ingredients: the progestogen Cyproterone acetate and the estrogen Ethinyl Estradiol. Cyproterone acetate is the core antiandrogen, a steroid derivative that acts as an antagonist, directly binding to and blocking the androgen receptor. Cyproterone acetate actively intervenes in the body's response to androgens, a mechanism recognized for its targeted efficacy in managing androgen-driven symptoms. Ethinyl Estradiol serves as the estrogenic component, contributing to cycle stability.

General Therapeutic Purpose and Mechanism Principle

The general purpose of this medication is intrinsically two-fold: to provide reliable hormonal contraception and to exert a powerful corrective influence on elevated or sensitive androgen levels. Formulations containing Cyproterone acetate effectively manage androgen-related symptoms alongside providing contraceptive coverage. This means the medication offers two major benefits simultaneously: pregnancy prevention and hormonal neutralization. This synergy defines the preparation's unique utility in the management of specific hormonal conditions in women of reproductive age.

What side effects are possible with Dianette?

Possible Side Effects and Safety Information for Dianette

Adverse Reaction Scope

The most clinically significant and serious risks associated with Dianette (cyproterone acetate/ethinylestradiol) are Venous Thromboembolism (VTE) and Arterial Thromboembolism (ATE), which include deep vein thrombosis, pulmonary embolism, stroke, and myocardial infarction. The risk of VTE is known to be elevated with this medicine, estimated to be 1.5 to 2 times higher than with combined oral contraceptives containing levonorgestrel.

Common adverse reactions (occurring in 1/100 to <1/10 users) include nausea, abdominal pain, headache, depressed mood, mood alterations, breast pain, breast tenderness, and weight gain. Uncommon reactions (1/1000 to <1/100) include vomiting, diarrhoea, migraine, and fluid retention. Serious post-marketing reports include liver disturbances (e.g., tumours) and a slightly increased risk of breast cancer and cervical cancer with long-term use, consistent with other combined hormonal contraceptives.

Safety Restrictions and Monitoring

Dianette is not indicated for use solely as an oral contraceptive. Treatment is restricted to women with severe acne or moderately severe hirsutism that has not responded to other therapies. Use should be discontinued 3 to 4 menstrual cycles after the treated condition has completely resolved. Concomitant use with any other hormonal contraceptive is contraindicated due to the significantly increased risk of thromboembolism.

The risk of VTE is highest during the first year of use or when restarting after a break of at least one month. Smoking and increasing age (especially over 35 years) are major additional risk factors for thrombosis. Immediate medical attention and discontinuation are required for suspected signs of thrombosis, unexplained severe headaches, sudden visual/perceptual disturbances, jaundice, or onset of severe depression.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information describes the clinical presentation of acute overdose with Dianette (cyproterone acetate and ethinyl estradiol) as generally consisting of a limited set of manifestations. Due to the composition of the product, the acute overdose profile is considered to have low toxicity.

Documented Manifestations and Emergency Actions

The documented symptoms following the ingestion of a large dose include gastrointestinal and hormonal effects. These manifestations include nausea and vomiting.

In women and girls who have reached puberty, withdrawal bleeding or spotting may occur following the ingestion of an overdose. Symptoms such as nausea and vomiting may also occur in girls not yet having their period (pre-pubertal children) if tablets are accidentally taken.

In all suspected cases of overdose, regulatory guidance mandates that the individual seek immediate medical attention or contact emergency services. Medical help is required for any confirmed or suspected overdosage.

Management and Antidote Information

Regulatory documentation confirms that no specific antidote is known for the overdose of this combination product. As a result, the official procedure documented for the management of an overdose is that treatment should be symptomatic and supportive, addressing any clinical signs that develop.

Therapeutic Uses of Dianette

What Dianette Treats: Main Uses and Benefits

Dianette is a medication generally used with two distinct therapeutic roles, is commonly used to help with situations involving certain distressing symptoms related to androgen sensitivity. This approach helps address symptom clusters associated with hormonal dermatological conditions, and is generally used for hormonal contraception.

The medication is applied in addressing specific indications, including moderate to severe acne vulgaris, pronounced seborrhoea (excessive skin oiliness), and moderately severe hirsutism (excessive hair growth). The use is considered relevant in conditions where symptoms may intensify temporarily, and is applied when skin disturbances present with significant symptomatic burden.

This combined utility is applicable within clinical settings that involve acute or disruptive symptom patterns, and assists with maintaining functional stability when patients require hormonal contraception.

“This preparation may assist with maintaining functional stability by managing chronic, recurrent manifestations, contributing to improved day-to-day comfort.”


Key Therapeutic Focus
Dianette is commonly used to help with conditions presenting with symptoms related to systemic imbalance, specifically managing skin and hair issues linked to hormonal activity.

Regulatory References

  1. MHRA guidance on Co-cyprindiol (Dianette)

Eligibility and Restrictions for Use

Dianette's eligibility is strictly defined by regulatory guidelines and is limited to women of reproductive age who meet a dual requirement: having a specific androgen-related condition (such as severe acne or moderately severe hirsutism) and needing simultaneous hormonal contraception. The medicine is not licensed for use solely as a contraceptive.

Populations Contraindicated for Use

The medicine is subject to several absolute contraindications. It is strictly prohibited for individuals with a current or history of venous or arterial thromboembolism (blood clots), known thrombophilia, or severe vascular risk factors, including severe hypertension or diabetes with vascular symptoms. Dianette is also contraindicated for patients with current or history of specific hormone-sensitive malignancies (e.g., breast cancer), liver tumours, or meningioma. Concomitant use with any other hormonal contraceptive is explicitly forbidden.

Age and Conditional Restrictions

The drug is not intended for use before menarche or after menopause. It is strictly prohibited during known or suspected pregnancy and while breastfeeding (lactation). Furthermore, use is conditional: treatment is limited in duration and must be discontinued three to four menstrual cycles after the underlying androgen-related condition has resolved. Regulatory documentation also requires the medicine to be temporarily stopped prior to major surgery or prolonged immobilization.

What should I know about interactions with other medicines?

The official interaction profile for Dianette centers on preventing combinations that result in adverse safety risks or reduced efficacy. Co-administration is strictly contraindicated with other combined hormonal contraceptives due to the documented, elevated risk of Venous Thromboembolism. Prohibitions also extend to specific direct-acting antiviral medicines used for Hepatitis C (such as Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir), as co-use may cause significant liver enzyme elevations (ALT). Use is also contraindicated in patients with a current or history of meningioma.

The pharmacokinetic stability is affected by co-administered drugs that modify liver enzymes. Hepatic enzyme inducers—including certain anticonvulsants (e.g., Rifampicin, Carbamazepine) and the herbal product St. John’s Wort—reduce the plasma concentrations of both active components. This officially documented effect may lead to a loss of contraceptive efficacy. Conversely, certain hepatic enzyme inhibitors may increase the systemic exposure of Ethinyl Estradiol.

Mandatory administration rules apply to the contraindicated Hepatitis C therapies, requiring Dianette to be discontinued before treatment initiation and only restarted 2 weeks following completion of the regimen. Additionally, the estrogen component may induce or exacerbate symptoms of hereditary and acquired angioedema.

Mechanism of Action

Dianette is a combined hormonal preparation containing cyproterone acetate (a progestin and antiandrogen) and ethinylestradiol (an estrogen). The mechanism involves two primary pathways, modulating androgen and gonadotropin signaling.

Cyproterone acetate acts as an antagonist at the androgen receptor (AR) in target tissues like the skin, competitively inhibiting the binding of endogenous androgens such as testosterone and dihydrotestosterone. Concurrently, its progestogenic activity contributes to central antigonadotropic effects at the hypothalamus-pituitary-ovarian axis. This suppresses the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to a reduction in endogenous ovarian androgen synthesis.

Ethinylestradiol acts as an agonist at the estrogen receptor and exerts its influence through the hepatic synthesis pathway. Specifically, it elevates the plasma concentration of sex hormone-binding globulin (SHBG). This systemic increase in SHBG results in a greater fractional binding of circulating androgens, consequently reducing the free circulating plasma levels of androgens, which are the biologically active fraction. The combined actions modify the systemic hormonal environment to achieve net androgen-level modulation and AR blockade in peripheral tissues.

Dosage and Administration Information

Dianette, an oral film-coated tablet containing 2 mg cyproterone acetate and 0.035 mg ethinylestradiol, is administered in a strict cyclic pattern.

Official Dosing and Cycle

Administration is strictly by oral use only, and the medicine is indicated solely for women of reproductive age. The standardized regimen follows a 21/7 cycle:

  • Daily Dose: One tablet is taken every day at approximately the same time.
  • Cycle Pattern: Tablets are taken for 21 consecutive days, followed by a mandatory 7-day tablet-free interval. Each new pack is started after this 7-day break.
  • Starting a Course: The first course of administration must begin on Day 1 of the woman's natural menstrual cycle (the first day of bleeding).

Duration and Administration Constraints

The length of administration is not open-ended. The need for continued treatment is assessed periodically by a physician. Treatment should be withdrawn three to four cycles after the treated condition has completely resolved. The preparation must not be used solely for the purpose of hormonal contraception.

Handling of Missed Timing

If the administration time for a tablet is delayed by less than 12 hours, the tablet should be taken immediately to maintain efficacy. If the delay is more than 12 hours, contraceptive protection may be reduced, requiring specific procedures to minimize the risk of a gap in hormonal coverage.

Recent Clinical Evidence

Dianette: Recent Clinical Evidence

Evidence for Use in Moderate to Severe Acne and Seborrhoea

The evidence landscape for this medication in moderate to severe acne and excessive skin oiliness (seborrhoea) includes Randomized Controlled Trials (RCTs) and systematic reviews. Investigators monitored outcomes related to inflammatory states, tracking changes in the number of acne lesions and overall acne severity using clinical grading scales. Research also examined shifts in hormonal levels, such as androgens and Sex Hormone-Binding Globulin (SHBG). Trials reported measurements of change in lesion counts over several treatment cycles, with observations often indicating a change in lesion counts. Some comparative trials described patterns observed when this combination was evaluated alongside other treatments.


Evidence for Use in Moderately Severe Hirsutism

For the indication of moderately severe hirsutism (excessive hair growth), research explored this medication in controlled studies, including trials where it was evaluated alongside other antiandrogenic treatments. Research examined conditions where symptoms may vary in intensity, using specialized clinical scoring systems, like the Ferriman-Gallwey Score, as the main outcome measurement. Trials reported how symptoms evolved in the observed populations, with measurements of change in hair growth scores generally tracked over a long time—typically six months to a year. This extended follow-up duration reflects the observed time interval needed for assessing changes in hair growth. Research describes concurrent patterns related to serum androgen and SHBG levels.


Long-Term Outcomes and Uncertainties

Clinical trials generally involved follow-up durations that were limited, ranging from short- to intermediate-term. Data on the long-term effects are not fully established regarding the continuous maintenance of the measured outcomes over many years. Furthermore, some evidence derived from observational settings reports patterns of symptom recurrence after the medication is discontinued. The evidence base contributes to the broader landscape but has acknowledged limitations, including variability in study designs and instances where certainty remains low for some long-term outcomes.

Key Studies & References Management options for people with acne vulgaris and polycystic ovary syndrome (NICE Evidence Review)

Frequently Asked Questions (FAQ)

Common questions about Dianette (FAQ)


Q: How is Dianette's mechanism of action different from a standard birth control pill?

Official product information indicates that Dianette contains cyproterone acetate, which has significant anti-androgenic effects. This specific component, in addition to the estrogen, is a characteristic when describing its use for androgen-related conditions, unlike some combined pills that may be used primarily for contraception.


Q: Does Dianette help with symptoms of Polycystic Ovary Syndrome (PCOS) such as hirsutism?

Regulatory documents state that this medicine is indicated for treating moderately severe hirsutism (excessive hair growth) and severe acne. These are known symptoms often associated with conditions like Polycystic Ovary Syndrome (PCOS) that involve high androgen levels.


Q: How long does it typically take for Dianette to show noticeable improvement in acne?

Studies and official information indicate that it often takes several months of continuous treatment before initial improvement in acne becomes noticeable. The timing for assessment and discontinuation is typically evaluated by a physician after the condition has completely resolved.


Q: What happens to skin or hair growth when a person stops taking Dianette?

Evidence derived from observational settings, according to official documents, reports patterns where the original symptoms (acne or hirsutism) may recur after the medication is discontinued. Treatment duration is limited, and its continued need is periodically assessed.


Q: Does Dianette cause weight gain, or is it usually water retention?

Official product information lists weight gain as a common side effect of the medicine. Separately, fluid retention is listed as an uncommon adverse reaction, which can be one factor contributing to changes in body weight.


Q: What effect can Dianette have on a person's libido or sex drive?

According to official reports, changes in libido (sex drive) are a reported adverse reaction associated with the use of the medicine. Any persistent or concerning changes should be discussed with a healthcare professional.


Q: Is it common to experience changes in breast size while using Dianette?

Breast enlargement is a reported finding associated with the use of the drug, according to official information. Common adverse reactions also include general breast pain and tenderness.


Q: Is it normal to have spotting or breakthrough bleeding in the first few months of taking Dianette?

Breakthrough bleeding or spotting between periods is a known pattern when the body is adjusting to combined hormonal preparations, particularly during the initial cycles of use. This is often described as a temporary adjustment phenomenon as the body adapts to the new hormone levels.


Q: Can Dianette affect cholesterol levels or blood pressure?

Severe hypertension (very high blood pressure) is listed as an absolute contraindication for using the medicine. Additionally, clinical studies of oral contraceptives have described a tendency toward increased systolic blood pressure and higher serum total cholesterol levels.


Q: Does Dianette interact with common painkillers or anti-inflammatory drugs?

The official interaction profile focuses on medicines that affect liver enzymes, such as certain anticonvulsants. Specific combinations involving oral contraceptives and nonsteroidal anti-inflammatory drugs (NSAIDs) have been associated with changes in blood levels of certain electrolytes, which is a factor considered in prescribing.


Q: Is Dianette safe to take if a person has a family history of certain cancers?

Official safety information mentions that having a family history of certain conditions, such as confirmed idiopathic venous thromboembolism (VTE) or breast cancer, is a factor to be assessed. Contraindications primarily relate to a personal history of hormone-sensitive malignancies.


Q: Can Dianette be taken if a person has a history of migraines with aura?

Regulatory documents state that a history of migraines with focal neurological symptoms, such as aura, is listed as a specific contraindication for combined hormonal preparations like this one.


Q: Does vomiting or severe diarrhea reduce the effectiveness of Dianette?

Official guidance states that if vomiting or severe diarrhoea occurs, the absorption of the active ingredients may be incomplete. This can potentially reduce the contraceptive effectiveness of the tablets.


Q: How long after taking Dianette is it considered absorbed by the body?

Pharmacokinetic studies indicate that the active ingredients generally reach their maximum concentrations in the bloodstream approximately 30 minutes to 3 hours after the tablet is taken.


Q: Can Dianette affect the use of contact lenses?

According to the official product information, adverse reactions have included contact lens intolerance in some users. This may present as difficulty or discomfort while wearing contact lenses.

How should Dianette be stored and disposed of?

Storage Conditions

D Requirement
Temperature Store at a temperature not above 30°C or not above 25°C, depending on the specific authorized formulation.
Packaging Keep the tablets in the original container (blister strip and outer carton) and do not use after the expiry date.
Child Safety The medicine must be kept out of the sight and reach of children.

Disposal Instructions

Official regulations require that unused or expired Dianette must not be disposed of via household waste or wastewater to protect the environment. Patients must return the unwanted product to a pharmacist for proper disposal through established pharmaceutical waste channels. There are no special requirements for handling this product as hazardous waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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