OC-35

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Medically reviewed

Rosario Oropesa

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 OC-35

Property Description
Active ingredient Cyproterone Acetate, Ethinyl Estradiol
Form Oral Tablet
Pharmacological class Combination Antiandrogen-Estrogen
Common use Management of male hormone-dependent conditions
Origin Synthetic Steroid Combination

What Type of Medicine is OC-35?

OC-35 is a prescription-only hormonal combination medicine administered via the oral route as a standardized tablet. The drug is classified as a Combination Antiandrogen-Estrogen and utilizes two powerful synthetic steroid active ingredients, Cyproterone Acetate (CPA) and Ethinyl Estradiol (EE).

Its dual classification is essential to its identity: the medicine provides both a progestogen with potent antiandrogenic activity and an estrogen component. This unique structural composition distinguishes it from standard oral contraceptives that lack significant androgen blockade, establishing its specialized role in treating symptoms where androgen excess is the root cause.

Composition and The Antiandrogenic Principle

The active components in OC-35 are Cyproterone Acetate and Ethinyl Estradiol. This combination product is engineered such that the CPA component serves as the primary functional agent in neutralizing male hormones, with its chemical properties categorized as a steroidal antiandrogen.

The underlying antiandrogenic principle relies on Cyproterone Acetate acting by blocking the androgen receptors in target tissues. The complementary Ethinyl Estradiol component reinforces this effect by increasing plasma levels of Sex Hormone-Binding Globulin (SHBG), consequently reducing the quantity of free, biologically active androgens circulating in the bloodstream. This comprehensive hormonal regulation is observed in clinical practice.

General Purpose of this Combination Product

The general purpose of this medicine is the active and comprehensive management of conditions related to excessive male hormone (androgen) activity. This formulation is typically utilized when dermatological concerns require hormonal intervention, positioning it uniquely among hormonal therapies. By simultaneously suppressing hormone production and neutralizing the effects of existing androgens at the cellular level, the drug achieves its core function of profound hormonal adjustment, providing the foundational rationale for its use.

Regulatory References

  1. EMA Public health recommendation on cyproterone acetate/ethinylestradiol

What side effects are possible with OC-35?

Possible side effects and safety information

The official safety profile for the combination medicine OC-35 (Cyproterone Acetate/Ethinyl Estradiol) is structured around both common, expected adverse reactions and rare, serious systemic events, as documented in regulatory materials.


Serious Safety Concerns

The most significant, although rare (occurring in ge 1/10,000 to < 1/1,000 users), safety concerns involve thromboembolic events. These include Venous Thromboembolism (VTE), such as Deep Vein Thrombosis and Pulmonary Embolism, and Arterial Thromboembolism (ATE), which may manifest as Myocardial Infarction or Stroke. Other serious reactions documented in official labels include Hepatic Tumours (benign and malignant) and a noted association with Breast Cancer risk.


Common Adverse Reactions

The majority of side effects are classified as common (occurring in ge 1/100 to < 1/10 users) and affect several system-organ classes. Reactions commonly listed in regulatory documents include headache, nausea, abdominal pain, weight gain, and depressive mood. Changes affecting the reproductive system often involve breast tenderness/pain and breakthrough bleeding or spotting.


Safety Restrictions and Context

Official labeling specifies clear limitations for use. The risk of VTE is noted as being highest during the first year of use or upon re-initiation. The medicine is contraindicated in individuals with a current or history of VTE/ATE and those with severe hepatic impairment. Furthermore, the label notes a significantly increased cardiovascular risk for women who smoke, especially those over 35 years of age. Treatment duration for specific indications is often restricted in regulatory texts to minimize overall hormonal exposure.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documentation defines the overdose profile for OC-35 (Cyproterone Acetate/Ethinyl Estradiol) based strictly on documented clinical experience and mandated emergency actions.

Documented Overdose Manifestations

The prescribing information indicates that overdosage is generally associated with mild, non-life-threatening symptoms. There have been no reports of serious deleterious effects documented following accidental or intentional overdose.

The most commonly recorded manifestations are:

  • Nausea
  • Vomiting
  • Slight vaginal bleeding (specifically noted in young girls)

Emergency Actions and Required Management

Regulators emphasize that no specific antidote is known or available to counteract the effects of an OC-35 overdose.

Category Regulatory Statement
Severity Classification No reports of serious deleterious effects documented.
Immediate Action Mandate Further treatment should be symptomatic and supportive.

Urgent professional medical attention is required for the application of symptomatic and supportive treatment to address the presenting clinical signs (nausea, vomiting, or bleeding). This guidance reflects the need for professional care to manage the documented manifestations, despite the absence of known serious toxicity.

Therapeutic Uses of OC-35

Therapeutic Focus: What OC-35 Manages

The primary role of OC-35 is to provide therapeutic support for chronic conditions where symptoms are primarily driven by excess male hormone activity (hyperandrogenism) in women. The medicine is commonly used in the therapeutic domain of moderate to severe acne, seborrhea (oily skin), and hirsutism (excessive hair growth), particularly when these symptoms are linked to androgen sensitivity.

This combination of uses is relevant in clinical settings marked by heightened systemic burden, such as those presenting with symptoms of Polycystic Ovary Syndrome (PCOS). The treatment may assist with managing the visible, distressing skin and hair manifestations, while also playing a supportive role in managing symptoms related to menstrual cycle irregularity, which contributes to easing systemic imbalance.

“The treatment may assist with managing the symptom cluster of excessive hair growth, which supports the management of this chronic, distressing manifestation.”

Quick Fact: Supportive Management for Androgen-Driven Symptoms

This medication is applied across domains where additional symptomatic support is needed, typically when pronounced skin and hair symptoms have not adequately responded to standard, non-hormonal treatments. Its use contributes to maintaining comfort and may assist with functional stability during symptomatic periods.

Regulatory References

  1. European Medicines Agency (EMA) therapeutic review

Eligibility and Restrictions for Use

OC-35 is restricted to women of reproductive age (post-menarche) for androgen-dependent conditions, such as severe acne or hirsutism. Official regulatory labeling strictly mandates that the medicine must not be prescribed solely for the purpose of contraception and should only be initiated after other systemic treatments have failed.

Absolute Contraindications prohibit use in specific populations due to severe risk. These include any current or history of venous or arterial thromboembolism (blood clots, stroke, myocardial infarction), known thrombogenic mutations, and severe diabetes mellitus with vascular changes or uncontrolled hypertension. The medicine is also contraindicated in patients with a history of meningioma, liver tumours, active severe hepatic disease, or hormone-sensitive malignancies like breast cancer.

Furthermore, the drug is contraindicated during known or suspected pregnancy and breast-feeding. Age eligibility is clearly defined: use is not indicated after menopause, and women over 35 years of age who smoke face a significantly elevated risk of vascular events, placing them in a highly restricted category. Use in patients with renal impairment is currently classified as not established due to insufficient data.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the officially documented interaction patterns for the combination medicine Cyproterone Acetate/Ethinyl Estradiol (OC-35), based strictly on regulatory prescribing information.


Formal Contraindicated Combinations

Co-administration is strictly prohibited with certain medicinal products as stated in regulatory documents:

  • Other Hormonal Contraceptives: Use with other estrogen or progestogen-containing products is contraindicated to avoid additive hormonal exposure and increased thromboembolic risk.
  • Hepatitis C Combinations: Combination regimens for Hepatitis C containing specific antivirals (e.g., ombitasvir/paritaprevir/ritonavir pm dasabuvir) are contraindicated due to the risk of significant elevation in liver enzyme levels (ALT).

Pharmacokinetic Interaction Patterns

The most frequent and clinically significant interactions are pharmacokinetic, affecting the clearance of the active ingredients:

  • Enzyme Inducers: Medicines that induce hepatic enzymes, such as certain anticonvulsants (e.g., phenytoin, carbamazepine) and the anti-infective rifampicin, officially cause an increased clearance of Cyproterone Acetate and Ethinyl Estradiol. This results in reduced systemic exposure of the hormonal components.
  • Herbal Products: The herbal product St. John’s Wort is also documented as an enzyme inducer that should not be co-administered.
  • Enzyme Inhibitors: Strong hepatic enzyme inhibitors (e.g., azole antifungals) may conversely increase the plasma concentrations of Ethinyl Estradiol or Cyproterone Acetate.
  • Effect on Other Medicines: Ethinyl Estradiol may inhibit the metabolism of other co-administered drugs (e.g., substrates of CYP1A2 like theophylline), potentially leading to increased plasma levels of those medicines.

Mechanism of Action

OC-35 is a combination pharmacological agent containing ethinylestradiol (EE) and cyproterone acetate (CPA).

Ethinylestradiol is an agonist of the nuclear estrogen receptor (ER). Activation of the ER signaling pathway in the liver elevates the synthesis of Sex Hormone-Binding Globulin (SHBG). The increased circulating SHBG subsequently binds to circulating androgens, decreasing the free (biologically active) fraction of androgens in the plasma. This estrogenic component also contributes to antigonadotropic activity via negative feedback on the hypothalamic-pituitary-ovarian (HPO) axis.

Cyproterone acetate exerts a dual mechanism. Primarily, it functions as a competitive antagonist at the androgen receptor (AR), blocking the nuclear translocation and transcriptional effects of endogenous androgens. Secondarily, CPA is an agonist of the progesterone receptor (PR), contributing to antigonadotropic effects by inhibiting the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) from the pituitary gland. The combined antigonadotropic action of both components suppresses ovarian androgen synthesis.

The overall system-level consequence is a dual-action peripheral blockade of androgen binding at target tissues, coupled with the central inhibition of ovarian androgen secretion.

Dosage and Administration Information

How to Use OC-35: Official Administration Guidelines

OC-35, a combination of Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.035 mg, is administered exclusively via the oral route as a standardized coated tablet. The core principle of its use is a 28-day cyclic regimen that structures the entire course of treatment.


Administration Protocol

Treatment begins with the first tablet taken on the first day of the menstrual period. The tablets must be taken once daily for 21 consecutive days, followed by a mandatory 7-day tablet-free interval.

To ensure proper administration, the medicine must be taken at approximately the same time every day, and the tablets must be consumed in the sequential order indicated on the blister packaging. The tablet may be swallowed whole with a little liquid.


Dosing and Course Duration

Property Administration Constraint
Dosing Frequency One tablet daily (Active dose: 2 mg CPA / 0.035 mg EE).
Tablet-Free Rule The tablet-free interval must never exceed 7 days to maintain the integrity of the regimen.
Concomitant Use Must not be used concurrently with any other hormonal contraceptive methods.
Age Constraint Indicated only for use in women after menarche and not after menopause.

Treatment should be discontinued 3 to 4 cycles after the clinical signs of the treated hyperandrogenism condition, such as acne or hirsutism, have completely resolved. Treatment may be reinitiated if the condition recurs.

Recent Clinical Evidence

Research Evidence / Overview of Studies for OC-35

Evidence Base for Hirsutism (Excessive Hair Growth)

The core research includes studies that explored outcomes related to excessive hair growth (hirsutism), involving Randomized Controlled Trials (RCTs) and comprehensive Systematic Reviews. Studies monitored objective ways to measure hair growth, such as changes recorded on the Ferriman-Gallwey score, and also considered patient-reported outcomes describing perceived discomfort. Research describes that studies often monitored outcomes over observation periods of six months or longer.

Findings describe patterns observed in the studies related to concurrent changes in hormone levels, including a documented rise in Sex Hormone-Binding Globulin (SHBG) and a measured shift in circulating androgen levels.

Evidence Base for Moderate to Severe Acne and Seborrhea

Studies examined this medicine for specific types of androgen-sensitive acne and skin oiliness (seborrhea), including populations where participants had previously used standard topical or systemic treatments. Research explored outcomes linked to inflammatory or irritative states using objective measures, such as monitoring the reduction in total acne lesion counts and tracking changes in severity grade.

Research describes patterns observed in the studies related to change in both acne severity and seborrhea, with assessments typically conducted over periods ranging from three to twelve months. These findings contribute to understanding how symptoms evolved in the observed populations under the specific conditions of the clinical research.

Research Context in Polycystic Ovary Syndrome (PCOS) Symptoms

This section outlines the studies that monitored patterns related to conditions characterized by fluctuating or episodic manifestations, such as Polycystic Ovary Syndrome (PCOS). Research focused on outcomes related to systemic or functional imbalance, such as monitoring changes in androgen-driven symptoms and tracking shifts toward menstrual cycle regularity in women experiencing irregular cycles.

Areas of Ongoing Research and Uncertainty

Evidence highlights where data are still emerging and where certainty remains low. Due to the wide variability (heterogeneity) of underlying conditions like PCOS, subgroup findings are uncertain, and results apply only to the specific populations studied. Research consistently notes that there is limited information for long-term outcomes regarding the durability of symptom control and the impact on certain metabolic and cardiovascular markers.

Frequently Asked Questions (FAQ)

Common questions about OC-35 (FAQ)

Q: How does OC-35 compare generally to other medicines for the same condition?

Official safety data indicates that the risk of venous thromboembolism (VTE), which involves the formation of blood clots, appears to be higher for this medicine compared to certain other combined oral contraceptive products.

Specifically, regulatory documents often note a higher comparative risk versus products containing levonorgestrel. This factual comparison is used to describe the specialized safety profile of OC-35.


Q: Is it normal to feel a bit nauseous when first starting OC-35?

Nausea, abdominal pain, and headache are among the commonly reported side effects when beginning treatment with this medicine.

Regulatory-derived patient information indicates that most of these common side effects usually resolve gradually over the first few months of use.


Q: How quickly does OC-35 typically start working and what is the expected timeline for seeing the full effect?

Official documentation states that the time needed to observe a documented relief of symptoms is typically at least three months.

Since the drug works by altering hormone levels over a cycle, the full effect may take several cycles to become apparent. Treatment continuation is subject to periodic evaluation by the prescribing physician.


Q: Does taking OC-35 for a long time change how it works?

Pharmacokinetic studies describe that repeated daily dosing leads to a higher accumulation of the active component, Cyproterone Acetate, which results in a longer terminal half-life.

Official guidance restricts the overall treatment duration for specific conditions to minimize long-term hormonal exposure and any potential associated risks.


Q: Why do some people stop taking OC-35?

Regulatory guidelines describe two main categories for discontinuing treatment. The first is the resolution of the condition being treated, typically 3 to 4 cycles after clinical signs have fully cleared.

The second is the occurrence of specific, serious side effects or complications listed in the warnings, such as blood clots, jaundice, or severe high blood pressure.


Q: Do I need a special test before starting OC-35?

Official patient information notes that a pregnancy test is typically performed before treatment initiation, as the medicine is contraindicated during pregnancy.

Furthermore, regulatory documentation emphasizes the recommendation for a medical evaluation and regular check-ups during the course of therapy.


Q: What happens if I forget to take a dose of OC-35?

The official drug labeling provides detailed, step-by-step guidance for managing missed tablets.

This guidance is complex and varies depending on the number of tablets missed and the specific week in the 21-day treatment cycle. This information is critical for maintaining the intended regimen.


Q: What should I do if a side effect of OC-35 feels severe?

Official patient information strongly advises that in the presence of possible signs of a severe side effect, such as symptoms indicative of a blood clot or severe headache, the recommendation is to seek immediate medical attention.

This is noted in official warnings as an essential step when severe reactions are suspected.


Q: Is OC-35 known to be addictive?

Regulatory-derived patient information generally classifies this medicine as not habit-forming.

It is a hormonal combination product, not a controlled substance, and is not associated with substance abuse patterns.


Q: Where can I find the official prescribing information for OC-35?

Official prescribing information can be found on the websites of national regulatory agencies (such as the FDA in the US, EMA in Europe, or Health Canada).

Key documents include the Summary of Product Characteristics (SmPC) or the Patient Information Leaflet (PIL) available through these authorities.


Q: Does alcohol consumption affect the safety or effectiveness of OC-35?

While a formal drug interaction with alcohol is not typically listed in the core interaction tables, regulatory-derived patient information often includes a recommendation to limit or avoid alcohol consumption during treatment.

This is noted as a general precautionary measure to help reduce the risk of certain side effects.


Q: Is it okay to take OC-35 with vitamins?

The ethinyl estradiol component of OC-35 may interact with certain high-dose vitamins, such as ascorbic acid (Vitamin C), by competing for metabolic pathways.

Regulatory guidance emphasizes the importance of informing a healthcare professional about all co-administered products, including vitamins and herbal supplements, before starting treatment.


Q: How long does OC-35 stay in the system after the last dose?

Regulatory pharmacokinetic data describes the terminal half-life of the primary active ingredient, Cyproterone Acetate, at steady-state to be approximately 78.6 hours (around 3.3 days).

This is the time it takes for the concentration of the substance in the body to be reduced by half.


Q: Can OC-35 make me feel dizzy?

Dizziness has been reported as an adverse reaction in clinical studies, though it is listed as one of the less common effects in regulatory documents.

If dizziness is experienced, caution is generally recommended.


Q: Are there any restrictions on driving or operating machinery while taking OC-35?

Regulatory guidance suggests that this medicine is generally unlikely to affect the ability to drive or operate machinery.

However, official information indicates that caution or avoidance of activities requiring high concentration is recommended if side effects such as dizziness or fatigue are experienced.


Q: Does OC-35 need to be taken with food?

Regulatory-derived patient information generally indicates that the tablet may be taken after meals or with food.

This recommendation is intended to help reduce the potential risk of stomach discomfort or nausea.


Q: Is it possible to be allergic to OC-35?

Like all medicines, an allergic reaction or hypersensitivity to the active ingredients (Cyproterone Acetate or Ethinyl Estradiol) or other components of the tablet is possible.

A known history of hypersensitivity is considered an absolute contraindication to its use, according to official labeling.


Q: Are there any known issues with sun exposure while taking OC-35?

Official patient information notes that this medicine may increase the risk of developing chloasma, which appears as dark patches on the skin.

Regulatory guidance includes a recommendation to limit sun exposure, including sunlamps and tanning beds, and to utilize sun protection measures while taking this medication.

How should OC-35 be stored and disposed of?

How to Store and Dispose of OC-35

The storage of OC-35 (Cyproterone Acetate/Ethinyl Estradiol) must adhere strictly to the conditions specified in official regulatory labeling to ensure product stability and efficacy.


Required Storage Conditions

Constraint Requirement
Temperature Store at Room Temperature, defined as below 25 C to 30 C.
Protection Keep away from direct sunlight, excessive heat, and moisture.
Container Must be kept in the original package (blister/carton) until use.
Prohibited Must not be stored in the bathroom or frozen.

Handling and Disposal

The product must be kept out of the sight and reach of children at all times. The medicine must not be used after the expiry date printed on the packaging.

Disposal of unused or expired OC-35 should follow official pharmaceutical waste protocol. The product should be returned to a pharmacist for disposal or handled according to local regulations; it should not be discarded in household trash or flushed down the toilet.

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

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