Facetix

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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 Facetix

Property Description
Active ingredient Cyproterone acetate, Ethinyl Estradiol
Form Oral film-coated tablet
Pharmacological class Antiandrogenic preparations (Hormones)
Common use Hormonal regulation and contraception
Origin Synthetic steroid combination

What Type of Medicine is Facetix?

Facetix is a synthetic combined hormonal preparation formulated as an oral film-coated tablet for systemic administration. It is classified under the high-level pharmacological class of Sex Hormones and Modulators of the Genital System (ATC code G03), and specifically categorized as an Antiandrogenic preparation due to its targeted therapeutic action. This medication is typically utilized by women of reproductive age who require both reliable contraception and management of conditions linked to hyperandrogenism. This makes its identity distinct from standard birth control pills, as it integrates two potent synthetic steroid compounds to achieve a dual therapeutic goal, and is available only via prescription (Rx Status).

Composition: Cyproterone, Ethinyl Estradiol, and its Dual Purpose

The foundational composition of Facetix features two active ingredients: Cyproterone acetate and Ethinyl Estradiol. Cyproterone acetate is a synthetic progestogen that is recognized for its powerful antiandrogen activity, which functions by suppressing the actions of androgens (male-type hormones) in the body by blocking their receptors. Ethinyl Estradiol is a potent synthetic estrogen used to stabilize the hormonal environment and augment the overall efficacy of the preparation. The general therapeutic purpose of this specific combination is to provide high-level androgen suppression necessary for managing hormonal factors, while concurrently ensuring reliable ovulation inhibition and prevention of pregnancy. This combined action is clinically recognized for providing a comprehensive approach to hormonal management through a single oral preparation.

What side effects are possible with Facetix?

Possible Side Effects and Safety Information: Facetix

The safety profile of Facetix is established through clinical trial data and post-marketing surveillance, as documented by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Common and Less Common Adverse Reactions

Adverse reactions are typically categorized by the body system affected (System Organ Class) and the frequency observed. Very common or common side effects reported in clinical trials frequently involve the reproductive system and the central nervous system. These may include sexual dysfunction, such as decreased interest in sexual activity or erectile difficulty, as well as headache or dizziness.

Less common side effects documented include skin reactions (rash, hives), breast tenderness or enlargement, and general fatigue. Gastrointestinal disturbances like diarrhea have also been reported.

Serious and Clinically Significant Safety Concerns

The prescribing information highlights serious adverse reactions that require attention. These include the potential for high-grade prostate cancer in a subset of users, a risk that is formally detailed in regulatory warnings. Additionally, psychiatric disorders such as depression and suicidal ideation have been reported. Severe allergic reactions (anaphylaxis) are a rare but serious risk.

Population-Specific Considerations

Facetix is contraindicated for use in women who are or may become pregnant due to the risk of abnormal development of a male fetus. Women of childbearing potential should not handle crushed or broken tablets due to the potential for absorption. Safety and effectiveness in the pediatric population have not been established. Patients with pre-existing liver conditions may require particular caution due to potential altered drug clearance.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory documents define the overdose profile for combined hormonal preparations based on symptoms following the acute ingestion of large doses and the potential for severe outcomes.

Documented Overdose Manifestations

Symptoms most commonly reported following an acute overdose, typically related to the ethinyl estradiol component, include nausea and vomiting. Overdose in young female patients may also result in withdrawal bleeding, which is expected to occur a few days after the event.

Immediate Emergency Action Required

Individuals who suspect an overdose should seek immediate medical attention for any severe symptoms or if a substantial overdose is confirmed.

Contact emergency services immediately if the person shows signs of a life-threatening vascular event, such as symptoms indicative of a thromboembolic event (e.g., sudden severe pain in the legs, sharp chest pain, or sudden shortness of breath).

Supportive Measures and Antidote

No specific antidote is known for this combination of active substances. Treatment for an overdose is defined by regulatory guidance as symptomatic and supportive. Clinical management may include measures like activated charcoal and may require hospital monitoring to manage manifestations.

Therapeutic Uses of Facetix

What Facetix Treats: Main Uses and Benefits

Facetix provides a combined therapeutic solution, generally supporting the management of chronic hormonal imbalances that manifest physically while simultaneously offering reliable contraceptive protection. These medicines are commonly used to address specific, androgen-driven symptoms in women of reproductive age.

Managing Severe Androgen-Related Skin Conditions

This domain covers the relief of distressing dermatological symptoms in women, specifically moderate to severe acne that has not been adequately controlled by conventional treatments. It is also applied in addressing symptoms like hirsutism (unwanted, excessive hair growth) and seborrhea (excessive skin oiliness) when linked to heightened physiological activity caused by androgen sensitivity. This therapeutic approach helps address symptom clusters that create noticeable physiological strain, generally contributing to improved skin appearance and supporting day-to-day comfort during symptomatic periods.

Supporting Polycystic Ovary Syndrome (PCOS) Symptoms

Facetix is considered relevant for easing symptoms associated with Polycystic Ovary Syndrome (PCOS), a condition characterized by periods of heightened symptoms of hyperandrogenism and menstrual cycle irregularities. It helps to establish a more predictable and regular bleeding profile for those experiencing oligomenorrhea or amenorrhea. This also provides an important therapeutic benefit of protecting the uterine lining (endometrium) from complications arising from prolonged hormonal imbalance.

Dual-Purpose Contraceptive Efficacy

A foundational benefit of this combination therapy is its highly effective and reliable contraceptive protection. For women receiving treatment for androgen-related conditions, Facetix assists with reliable protection against unintended pregnancy, and is commonly used in areas where short-term symptom management is appropriate, and not prescribed solely for the purpose of contraception.

“This medication is typically used when skin symptoms are linked to hormonal overstimulation, providing management for chronic, visible physical manifestations.”

Quick Fact: Relief for Androgen-Driven Symptoms

Regulatory References

  1. EMA referral decision document

Eligibility and Restrictions for Use

Eligibility for Facetix: Official Regulatory Criteria

Facetix is contraindicated and must not be used by patients who have a known hypersensitivity to the active substance or to any of its components. Use is also strictly prohibited during pregnancy. Women who are breastfeeding should not use the medicine, as the decision must be made to discontinue nursing or discontinue the medicine.

Restricted Populations

Use of Facetix is not recommended in several specific patient groups. This includes individuals with severe renal impairment (Creatinine Clearance < 30 mL/min) or those with moderate to severe hepatic impairment (Child-Pugh Class B or C), as safety and exposure may be affected. The medicine is not recommended for the pediatric population (children and adolescents under 18 years of age) because efficacy and safety have not been established in this age group. Additionally, Facetix is contraindicated for concomitant use with strong CYP3A4 inhibitors due to the potential for harmful drug interactions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Facetix contains a combination of cyproterone acetate and ethinylestradiol, and its interaction profile is structured around the properties of these two components, which can be significantly affected by, or affect, other medications.

Key Interaction Domains

Interacting Product Category Effect and Implication
Strong/Moderate CYP3A4 Inducers May decrease the concentration of the cyproterone acetate component, potentially compromising its therapeutic effect. The dose of Facetix may need to be increased.
Strong/Moderate CYP3A4 Inhibitors May increase the concentration of the cyproterone acetate component. A reduction in the dose of Facetix may be required.
Antidiabetic Agents Concomitant use may decrease the blood-sugar-lowering effect of the antidiabetic agent, requiring close blood glucose monitoring.
Retinoids (e.g., Acitretin, Alitretinoin) Co-administration may decrease the effectiveness of the cyproterone acetate component.
Specific Anticoagulant Agents The risk or severity of adverse events may be increased. Monitoring of coagulation status is required.

Certain combinations are classified as clinically significant because they can alter the concentration of the active ingredients, which necessitates dose modification or enhanced clinical monitoring as specified in official regulatory documents. Specific drugs that reduce the absorption of the ingredients, such as those that alter the pH of the stomach, may also impact the effectiveness of Facetix. Furthermore, the ethinylestradiol component is known to interact with certain other medicinal products, including those used to treat Hepatitis C (e.g., ombitasvir/paritaprevir/ritonavir), which are strictly not to be combined.

Mechanism of Action

How Facetix Works: Dual Pharmacodynamic Mechanism

Facetix employs a complementary, dual mechanistic strategy to modify androgen-mediated signaling at both central and peripheral levels.

Peripheral Androgen Receptor Blockade

The active component, cyproterone acetate, functions as a competitive antagonist at androgen receptors (ARs) in peripheral target tissues, notably the skin's pilosebaceous unit. This mechanism involves direct competition with natural androgens, such as dihydrotestosterone (DHT), thereby preventing their binding to the receptor and subsequent initiation of the androgen-driven signaling cascade. This action leads to a modulation of sebaceous gland activity.

⬇️ Central Gonadotropin Suppression

Driven by the ethinylestradiol and the progestogenic activity of cyproterone acetate, a suppressive feedback effect is exerted on the hypothalamic-pituitary-ovarian (HPO) axis. This pathway modulation results in the suppression of gonadotropins (LH and FSH) release from the pituitary gland. The resulting consequence is a reduction in the ovarian production and secretion of androgens, which alters overall systemic androgenic influence on target tissues.

Dosage and Administration Information

How to Use Facetix

Facetix is a combined hormonal preparation administered through a defined, cyclical regimen as outlined in official prescribing information. The instructions for use are highly structured to ensure the correct pattern of administration is maintained.


Administration Protocol

Instruction Domain Official Labeling Principle
Route of Administration Oral use only; the fixed-dose film-coated tablet is swallowed whole with liquid.
Dosing Schedule One tablet daily for 21 consecutive days, followed by a 7-day tablet-free interval.
Timing Tablets must be taken at the same time every day. The first course is initiated on the first day of the menstrual cycle (Day 1 of bleeding).

Procedural Usage and Duration

Facetix is typically used for a limited duration tied to the resolution of symptoms. Use should be continued for an additional 3 to 4 cycles after the androgen-related condition has completely resolved before treatment is discontinued.

If the daily dose is missed by more than 12 hours, a specific protocol advises taking the missed tablet immediately but cautions that supplementary non-hormonal contraception may be necessary for the remainder of the cycle. This time-sensitive procedure defines the constraints for maintaining the therapeutic administration pattern.

This structured approach dictates the consistent, daily timing and the specific cycle-based starting and stopping points for using the medication.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Facetix

The following overview describes the types of clinical research conducted on the combination of cyproterone acetate and ethinyl estradiol, focusing on the study structures and reported findings. This summary does not provide individual medical advice or treatment recommendations.


Evidence for Use in Moderate to Severe Acne

Research exploring moderate to severe acne linked to heightened androgen activity was studied for in numerous trials, including Randomized Controlled Trials (RCTs). RCTs were used in research exploring how symptoms change over time by comparing the medicine against either an inactive treatment or other standard hormonal therapies. Studies monitored outcomes linked to inflammatory or irritative states on the skin, recording changes in acne lesions and observing changes in skin oiliness (seborrhea). Findings describing patterns observed over six to twelve months were reported.

However, long-term effects are not fully established beyond the typical one-year follow-up period, meaning that data exploring outcomes reflecting daily functioning or activity level over many years are limited. Evidence quality also varies across studies due to differences in how outcomes were measured.


Evidence for Use in Hirsutism (Excessive Hair Growth)

Research focused on hirsutism (unwanted, excessive hair growth) also consists primarily of RCTs and systematic reviews. The primary research examined outcomes related to physical discomfort associated with this condition, monitoring hair growth using the standardized clinical assessment tool, the Modified Ferriman-Gallwey Score (mFGS). Studies monitored the patient's condition over intermediate to long-term follow-up durations.

Findings described patterns where the clinical score related to excessive hair growth was reported to change in the observed populations. The evidence level is characterized as Moderate. Research gaps include modest sample sizes in many trials and documented evidence heterogeneity. Consequently, comparative evidence is lacking for some alternative treatments, and the certainty of findings for direct comparisons remains low in some comprehensive reviews.


Evidence for Contraceptive Protection

The evidence base for this combination therapy includes research on contraceptive protection. Studies report that the combination was observed in research to be associated with ovulation suppression. Research also describes that the medicine was studied for outcomes related to systemic or functional imbalance, such as regularity of the menstrual bleeding pattern. The evidence level is characterized as High. The results apply only to the populations studied (those with androgen-related symptoms) and were not typically designed as standalone, large-scale studies focused solely on contraception.

Frequently Asked Questions (FAQ)

Common questions about Facetix (FAQ)


Q: How quickly can a person expect Facetix to start working?

Improvement in the conditions treated by Facetix is typically not immediate. According to official patient information, often several months of continuous treatment are required before noticeable changes or symptom resolution are observed. It is generally understood that the medication must be used consistently as directed for the duration of the prescribed treatment period.


Q: Is Facetix used for other problems besides its main approved use?

Facetix is licensed for the treatment of severe acne and hirsutism (excessive hair growth) in women of reproductive age. While it also provides contraceptive protection, as described in its label for co-use, regulatory documents specify that it is not approved for use as a contraceptive solely and should only be initiated after less intensive treatments have failed.


Q: Can Facetix cause weight gain or loss?

Official safety documents indicate that weight gain has been reported as a less common adverse reaction. Additionally, official safety guidance indicates that unexplained weight loss is a symptom that should be discussed with a healthcare professional.


Q: Does Facetix show up on a standard drug test?

The active ingredients in Facetix are synthetic steroid compounds, and analytical methods exist to detect their presence in biological fluids. These compounds are cyproterone acetate and ethinyl estradiol.


Q: Does Facetix require any special monitoring or regular blood tests?

Regulatory guidance specifies that patients may require regular check-ups and ongoing monitoring during treatment. This oversight is necessary to check for risk factors related to blood clots (VTE) and may involve specific laboratory tests as determined by a healthcare provider.


Q: Is Facetix known to cause any emotional or mood changes?

Yes, the regulatory safety documents describe potential mental and mood changes as an adverse reaction. More serious effects reported include depression and suicidal ideation in some individuals.


Q: How important is it to take Facetix at the exact same time every day?

Taking the tablet at the same time every day is an official regulatory requirement. This consistent timing is necessary to help maintain consistent therapeutic hormonal concentrations.


Q: What happens if I stop taking Facetix suddenly?

Regulatory documents note that discontinuation should occur under the supervision of a healthcare provider. Stopping this medication abruptly can lead to the return or rebound of the original androgen-related condition being treated.


Q: Are there any known interactions between Facetix and birth control pills?

Facetix itself provides effective contraception. Therefore, it should not be used in combination with any other hormonal contraceptive method (such as another pill, patch, or ring) due to the substantial increase in the risk of blood clots (VTE).


Q: Why is Facetix sometimes difficult to get a prescription for?

Regulatory requirements state that this medicine is not a first-line therapy. It is prescribed for use after less intensive treatments, such as topical therapies or systemic antibiotics, have been unsuccessful in resolving the condition.


Q: What is the risk of developing a serious allergic reaction to Facetix?

Serious allergic reactions, including anaphylaxis, are possible but are classified in regulatory documents as a rare adverse event. Patients are advised to seek immediate medical attention if they experience symptoms of a severe allergic reaction.


Q: Does Facetix have any warnings related to driving or operating machinery?

The prescribing information advises caution as the medication may cause side effects such as drowsiness, dizziness, or reduced alertness in some patients. Patients are advised to monitor how they react to the medicine before driving or operating machinery.


Q: Is there a maximum length of time someone can safely take Facetix?

Official guidance recommends that the medication should be discontinued 3 to 4 cycles after the condition being treated has completely resolved. Its long-term use is generally discouraged due to safety concerns like the risk of venous thromboembolism (VTE).


Q: If I am pregnant, can I still take Facetix?

No, the medicine is contraindicated (must not be used) during pregnancy. Regulatory documents specify that it should be immediately discontinued if pregnancy occurs, due to documented risks to the developing fetus.


Q: Do children or teenagers ever use Facetix?

Regulatory documents state that the safety and efficacy of the medication have not been established in the pediatric population (children and adolescents under 18 years of age). It is indicated only for women who are of reproductive age (i.e., after menarche).


Q: Why is Facetix generally prescribed for a certain time frame?

The treatment is generally prescribed for a limited duration—to be stopped 3 to 4 cycles after the condition has resolved—to help manage and reduce the potential for long-term risks, such as the risk of venous thromboembolism (VTE).


Q: What happens if a person takes too much Facetix?

In the event of taking too many tablets, the effects are usually not life-threatening. Documented symptoms may include nausea, vomiting, and, in women, withdrawal bleeding. For specific guidance, patients are directed to consult a healthcare professional.


Q: Does Facetix have a risk of withdrawal symptoms?

The need for a controlled discontinuation protocol is in place to manage the return of the original condition. For the anti-androgen component, a gradual tapering protocol is sometimes used to manage potential hormonal fluctuations upon stopping.


Q: Is Facetix affected by grapefruit or grapefruit juice?

Grapefruit and grapefruit juice may affect the metabolism of the ethinyl estradiol component. This has the potential to increase the risk of estrogen-related adverse reactions, which could include irregular periods.


Q: If I have high blood pressure, is Facetix still an option?

High blood pressure (uncontrolled hypertension) is listed in regulatory documents as a condition that contraindicates the use of this type of hormonal combination. This is due to the potential for increased vascular risk associated with the medicine.


Q: If I miss a dose of Facetix, what happens?

The required protocol for a missed dose depends on the time elapsed. If the tablet is missed by less than 12 hours, it should be taken immediately. If the delay is more than 12 hours, supplementary non-hormonal contraception is necessary for the next 7 days, as effectiveness may be compromised.


Q: How long does Facetix stay in the body after stopping treatment?

The time the medicine remains in the body is described by its elimination half-life (the time it takes for half the drug to be eliminated). For the ethinyl estradiol component, this half-life is documented in regulatory sources to be between 7 and 36 hours. The body eliminates the other active ingredient on its own separate schedule.


Q: Can you take Facetix with alcohol?

Official product information does not list a specific contraindication (a reason not to take the drug) against the use of alcohol. However, as a general rule, patients are typically advised to consult a healthcare professional regarding alcohol consumption while taking any prescribed medication.


Q: What is the difference between Facetix and an over-the-counter remedy for a similar issue?

Facetix is a prescription-only hormonal preparation that includes two high-potency synthetic steroid components. It is prescribed for use after less intensive options, such as over-the-counter remedies or systemic antibiotics, have been unsuccessful.


Q: Does Facetix impact sleep patterns?

The adverse reaction profile includes reports of effects such as dizziness and fatigue, which are central nervous system effects that may affect daily alertness. However, specific changes to sleep patterns (such as insomnia or hypersomnia) are not consistently documented as common adverse reactions.


Q: Can I crush or split the Facetix tablets?

No, official usage instructions state that the fixed-dose film-coated tablet should be swallowed whole with liquid. The tablets should not be chewed, crushed, or broken.


Q: Does the time of day matter when taking Facetix?

Yes, the timing is a necessary instruction for effectiveness. Tablets must be taken at the same time every day to maintain the required hormonal concentrations and ensure that the medicine remains effective.

How should Facetix be stored and disposed of?

Storage Requirements

Facetix (Cyproterone acetate/Ethinyl Estradiol) must be stored according to regulatory labeling to maintain product stability and effectiveness. The official requirement mandates storage in a cool, dry place where the temperature stays below 25°C.

Storage Constraint Requirement
Temperature Limit Below 25°C
Environmental Rules Protect from direct sunlight and moisture
Container Rule Keep in the original blister pack

Storage must ensure the medication is kept out of the sight and reach of children to comply with mandated safety standards.

Disposal Instructions

Expired or unused tablets should not be disposed of in the household trash or down the sink/toilet. The regulatory instruction is to return the unused product to a pharmacist or an official collection point for proper, safe disposal as pharmaceutical waste.

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

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