Femodene ED

Quick links to important sections

Femodene ED

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 Femodene ED

Quick Facts

Property Description
Active ingredient Ethinyl Estradiol, Gestodene
Form Oral Tablet (Sugar-Coated)
Pharmacological class Combined Hormonal Contraceptive (COC)
Common use Prevention of Pregnancy
Origin Synthetic Hormones

What Type of Medicine is Femodene ED?

Femodene ED is a widely recognized prescription-only Combined Oral Contraceptive (COC), primarily utilized as a reversible method of contraception for the prevention of pregnancy in women. This medicinal entity belongs to the high-level pharmacological class of Sex Hormones and Modulators of the Genital System, specifically categorized as Progestogens and Oestrogens, Fixed Combinations. This specific fixed combination is indicated for oral contraception in women of childbearing age.

Active Ingredients and the 28-Day Tablet Form

The pharmaceutical identity of Femodene ED is defined by its two synthetic active ingredients: the oestrogen component Ethinyl Estradiol and the progestogen component Gestodene. The drug is designed for the oral route of administration in the dosage form of sugar-coated tablets. The designation ED (Every Day) appended to the name signifies its 28-day pack structure, a distinct feature that contrasts with 21-day regimens by incorporating seven hormonally inactive or placebo tablets intended to assist the user in maintaining a consistent daily intake routine. Gestodene is classified as a third-generation progestin, placing the preparation within a specific subtype of COCs.

What is the General Purpose of Femodene ED?

The general purpose of Femodene ED is to provide effective contraception through systemic hormonal influence. The fixed combination of Ethinyl Estradiol and Gestodene achieves this by initiating three primary physiological actions: the inhibition of ovulation, the thickening of cervical mucus, and the rendering of the endometrium unreceptive to implantation. This multi-modal approach facilitates the prevention of pregnancy by simultaneously interrupting the conditions necessary for conception to occur.

Regulatory References

  1. European Medicines Agency (EMA) website
  2. Public Assessment Report (PAR) for Ethinylestradiol/Gestodene
  3. National Library of Medicine (NLM) website
  4. Gestodene third-generation progestin review

What side effects are possible with Femodene ED?

Possible side effects and safety information

The safety profile of Femodene ED is structured around potential adverse reactions and specific risks documented by official government regulatory authorities. Adverse effects are classified by their frequency and organized by the physiological systems they affect, ensuring clarity regarding the range of possible experiences.

Adverse Reaction Classification

Side effects are classified using standard regulatory terminology. Common reactions (occurring in ge 1/100 users) typically involve the central nervous system, reproductive system, and gastrointestinal tract, including headache, depressed mood, nausea, abdominal pain, breast pain, breast tenderness, and weight increased. Uncommon reactions (ge 1/1,000 to <1/100) include vomiting, diarrhoea, fluid retention, migraine, and skin reactions like urticaria. Rare reactions (< 1/1,000) may include hypersensitivity and certain disturbances in liver function.

Serious Adverse Reactions and Safety Constraints

Official regulatory documents emphasize the potential for serious adverse reactions, primarily Venous Thromboembolism (VTE) and Arterial Thromboembolism (ATE), which are the formation of blood clots in the veins and arteries, respectively. The risk of VTE is noted to be greatest during the first year of initial treatment or when restarting treatment after a long break.

Regulatory safety constraints define the boundaries where use is contraindicated, such as in individuals with a history of blood clots, severe hepatic disease, liver tumours, or for smokers over 35 years of age due to significantly increased cardiovascular risk. Furthermore, unscheduled bleeding and spotting are frequently observed, particularly during the first three months of use, which often resolves spontaneously.

Overdose and Emergency Response

The official regulatory profile for Femodene ED overdose documents specific clinical manifestations and mandated emergency actions, providing a high-level assessment of the risk. Overdose from this combined hormonal product is generally not considered life-threatening, and no specific severe cardiovascular or neurological sequelae are explicitly listed as direct consequences in the product information.

Documented Clinical Manifestations

Suspected overdose may present with transient gastrointestinal and reproductive system effects. The officially documented overdose presentations include nausea and vomiting. A key physiological sign associated with high exposure is the occurrence of withdrawal bleeding (vaginal bleeding), which the official labeling notes may specifically occur in young girls following ingestion.

Required Emergency Actions and Management

In all cases of suspected overdose, immediate medical attention must be sought. This action is required by government health guidance, which mandates contacting a national poison control center or emergency services for immediate assessment. Management of Femodene ED overdose is primarily supportive. The regulatory profile explicitly states that no specific antidote is known for this combination product. Therefore, treatment should be symptomatic and supportive, addressing any observed clinical signs. Monitoring of vital signs may be required for clinical evaluation.

Therapeutic Uses of Femodene ED

What Femodene ED Treats: Main Uses and Benefits

The primary therapeutic purpose of Femodene ED is to provide an effective method of reversible pregnancy prevention for women of childbearing age seeking reproductive autonomy. This type of medication is commonly used across conditions characterized by periods of heightened symptoms, which extends its benefits beyond contraception.

Symptom Management and Cycle Support

The medication is considered relevant for easing symptoms that create noticeable physiological strain, applied in clinical settings where supportive symptom management is appropriate. It may offer supportive relief for women experiencing severe menstrual pain (dysmenorrhea) and excessive menstrual flow (menorrhagia), helping to improve day-to-day comfort. Furthermore, Femodene ED may assist with easing distressing manifestations of hormonal fluctuation, such as hormone-related acne and the distress associated with severe Premenstrual Syndrome (PMS), assisting with cycle regularity. Long-term use may also be associated with a potential reduction in the statistical risk of developing ovarian and endometrial cancers.

The brief listing of indications includes: reversible contraception, managing painful periods, support in managing heavy bleeding, supportive care for hormone-related acne, and assisting with cycle regularity.


“Long-term use may also be associated with a potential reduction in the statistical risk of developing ovarian and endometrial cancers.”


Quick Fact Description
Therapeutic Scope Used for managing symptoms related to heavy bleeding, painful periods, and hormone-related acne.
Primary Goal Effective and reversible pregnancy prevention for women of childbearing age.

Regulatory References

  1. NIH MedlinePlus Medical Encyclopedia overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Femodene ED?

Eligibility for Femodene ED, a combined oral contraceptive, is strictly defined by regulatory documents, focusing primarily on a patient's vascular health and hepatic status.

Contraindicated Populations

Use is absolutely prohibited (contraindicated) for individuals with a current or past history of arterial or venous thromboembolism (e.g., stroke, heart attack, deep vein thrombosis, pulmonary embolism) or a known inherited predisposition to clotting disorders. It is also contraindicated in women with severe uncontrolled hypertension, severe liver disease, liver tumours, or undiagnosed genital bleeding.

Restricted and Ineligible Groups

Population Group Eligibility Status
Pregnancy Contraindicated (Must not be used).
Lactation/Breastfeeding Not recommended (Use generally avoided).
Age and Smoking Contraindicated in women over 35 who smoke.
Age (Geriatric) Not indicated after menopause.

Eligibility is confined to women of childbearing age who are free of these specific conditions and risk factors, as documented by official regulatory authorities.

What should I know about interactions with other medicines?

Official Interaction Constraints

The co-administration of Femodene ED with certain medicinal products is formally restricted in regulatory labeling. This includes all fixed-dose combinations used for the treatment of Hepatitis C virus (HCV) that contain Ombitasvir, Paritaprevir, and Ritonavir, with or without Dasabuvir, or combinations such as Glecaprevir/Pibrentasvir. These combinations are officially contraindicated due to the documented risk of significant Liver Enzyme Elevation (ALT).

Separately, the herbal product St. John's Wort (Hypericum perforatum) is classified by regulators as a strong enzyme inducer and is contraindicated because it substantially reduces the plasma concentrations of the contraceptive hormones.

Pharmacokinetic and Efficacy Alterations

A primary class of interaction is driven by hepatic enzyme induction. Certain anticonvulsants (e.g., Phenytoin, Carbamazepine) and antibiotics (e.g., Rifampin) are documented to accelerate the clearance of Ethinyl Estradiol and Gestodene. This pharmacokinetic mechanism reduces the hormone plasma concentrations, which may lead to a reduction in contraceptive efficacy.

Conversely, co-administration with strong or moderate CYP3A4 inhibitors (such as specific azole antifungals) can increase the systemic exposure of the contraceptive hormones. The official labeling also notes that the protective effect may be compromised if the active tablet is not fully absorbed, such as in cases of vomiting or severe diarrhea occurring within four hours of administration.

Mechanism of Action

Femodene ED exerts its action through a layered pharmacological mechanism involving its synthetic hormones, ethinylestradiol and gestodene, which target three distinct physiological systems.

Central Suppression of the Ovulation Cascade

The hormones generate a negative feedback signal to the Hypothalamic-Pituitary-Ovarian (HPO) axis. This action suppresses the pulsatile release of GnRH and subsequently inhibits the pituitary secretion of FSH and LH. The resulting low gonadotropin levels interrupt the ovarian follicular development pathway, leading to the suppression of ovulation.

Modulation of Cervical Mucus Permeability

The progestin component, gestodene, acts on the cervical glands. It modifies the viscoelastic properties of the cervical mucus, increasing its viscosity and density. This creates a localized biological barrier that alters the conditions for sperm migration into the upper reproductive tract.

Alteration of Endometrial Receptivity

Both hormonal components induce changes in the endometrium (uterine lining). This leads to endometrial atrophy and premature secretory transformation, resulting in a uterine environment with altered conditions for cellular attachment and nidation.

Dosage and Administration Information

How to Use Femodene ED

The usage of Femodene ED is governed by a precise, continuous 28-day cyclic regimen, which is the sole approved administration pattern for this medication. The drug is administered via the oral route only, with the active component consisting of a fixed daily dose of Ethinyl Estradiol 0.03 mg and Gestodene 0.075 mg. The continuous cycle mandates taking one tablet daily for 28 consecutive days, followed immediately by a new pack, ensuring no break in daily intake.

Administration and Scheduling

The core usage protocol requires the tablet to be taken at approximately the same time each day to maintain consistent hormone levels. The medication is presented in a 28-day pack containing 21 active hormone-containing tablets followed by 7 hormone-free tablets. Tablets are swallowed whole with some liquid, without regard to meals.

Procedural Protocol

The regimen must be initiated on the first day (Day 1) of the natural menstrual period. If the start is delayed until Day 2–5, a non-hormonal back-up method must be used for the first seven consecutive days of active tablet-taking. The tablets must be consumed in the strict order indicated on the pack to adhere to the active/inactive sequence.

Specific, time-dependent procedural steps exist for managing a missed active tablet to ensure the usage pattern is maintained correctly. This fixed-dose regimen is intended for long-term use in women of childbearing age, and the usage instructions do not contain specific numerical dose adjustments for populations with organ impairment.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Femodene ED


Evidence for Primary Contraceptive Use

The evaluation of this combination of Ethinyl Estradiol and Gestodene was studied for its primary use in preventing pregnancy. The core evidence was evaluated in large-scale Randomized Controlled Trials (RCTs), where this medication was observed in comparison to other types of birth control pills. These trials focused on outcomes such as the statistical rate of pregnancy (often calculated as the Pearl Index) and patterns related to the occurrence and characteristics of the menstrual cycle. Research is ongoing to continuously monitor long-term effects and comparative data against the newest available hormonal methods.

Evidence for Supportive Use in Painful and Heavy Periods

Research has explored the use of this medication in populations with outcomes related to physical discomfort, specifically in women experiencing severe menstrual pain (dysmenorrhea) and excessive menstrual flow (menorrhagia**). Studies reported on how symptoms evolved in the observed populations, and findings describe patterns observed that were related to changes in symptom intensity. The majority of controlled trials assessing these outcomes related to physical discomfort only monitored short-term responses, typically over three to six menstrual cycles.

Evidence for Supportive Use in Hormone-Related Acne

The combination was evaluated in research exploring patterns related to conditions associated with acute or disruptive episodes in women with mild-to-moderate acne. Studies monitored specific outcomes linked to inflammatory or irritative states by counting the number of acne lesions. Research highlights outcomes measured during the study period, often spanning 6 to 12 months, which may contribute to understanding symptom patterns related to skin health. Comparative evidence against other hormonal options is lacking in some major systematic reviews.

Long-Term Studies and Follow-Up

Long-term outcomes have been evaluated in large-scale Observational Cohort Studies that tracked female populations over decades. The studies quantified the statistical incidence or relative risk ratio of developing ovarian and endometrial cancers in women who were compared based on prior or current use. Observational data consistently described the statistical incidence of ovarian and endometrial cancers in women who had used oral contraceptives. While these long-term data show patterns related to COCs generally, specific data for this exact ethinyl estradiol/gestodene combination, separate from the general findings, is not fully established in all major reviews.

What is Still Uncertain About Femodene ED Research

Comparative evidence is lacking for many secondary outcomes, such as symptoms of severe PMS, where evidence is limited to the general COC class rather than this specific pill. Furthermore, the true measured efficacy in the wider population is difficult to characterize fully, as measuring patient adherence in real-world settings is a major limiting factor for many studies, and follow-up durations were limited for many trials addressing short-term, supportive uses.

Key Studies & References Oral Contraceptive Pills (StatPearls): Review of Efficacy and Cancer Risks

Frequently Asked Questions (FAQ)

Common questions about Femodene ED (FAQ)

Q: How is Femodene ED different from a standard 21-day contraceptive pill?

A: Official documentation notes that the ED (Every Day) pack contains 21 active hormone tablets and 7 inactive (placebo) tablets, totaling 28 pills. This formulation is designed to ensure a consistent, continuous daily routine without a break. The inactive pills are taken during the week when the 21-day pill format would require a pill-free interval.


Q: How quickly does Femodene ED become effective at preventing pregnancy?

A: Contraceptive protection is considered established when administration is started on the first day of the natural menstrual period. If the start is delayed until Day 2–5, official guidelines state that a non-hormonal back-up method must be used for the first seven consecutive days of taking the active tablets.


Q: What is the typical effectiveness rate of Femodene ED when used as intended?

A: Studies evaluating the effectiveness of this medication often refer to the Pearl Index, a statistical measure. Evidence, often summarized using this index, describes that Femodene ED supports a high degree of efficacy when used as directed.


Q: Do the side effects of Femodene ED usually improve after the first few months of use?

A: Regulatory documents highlight that unscheduled bleeding or spotting is a frequently observed side effect, especially during the first three months of initial use. These specific symptoms are described as often showing spontaneous resolution as the body adjusts to the hormonal influence.


Q: Why does breakthrough bleeding (spotting) happen when first starting Femodene ED?

A: Breakthrough bleeding or spotting is related to the medication’s hormonal components altering the lining of the uterus (the endometrium). This change is part of the drug’s mechanism of action, and the body's initial adjustment to this process is associated with unscheduled bleeding.


Q: Can Femodene ED be used by women with certain existing health conditions, like migraines?

A: Official product information lists migraine as an uncommon adverse reaction. However, use is explicitly contraindicated if a woman experiences migraine with focal neurological symptoms (aura). Eligibility for use requires a full assessment of pre-existing conditions and risk factors.


Q: Is Femodene ED a monophasic or multiphasic type of pill?

A: Femodene ED is classified as a monophasic oral contraceptive. This means that every active tablet in the pack contains the same fixed daily dose of both estrogen and progestogen hormones.


Q: Does taking the inactive (dummy) pills reduce the level of contraceptive protection?

A: The inactive (dummy) tablets are hormone-free and are included solely to help maintain a continuous daily routine without a break in habit. Contraceptive protection is maintained during the inactive pill week, provided the preceding active tablets were taken correctly.


Q: Does Femodene ED commonly affect sexual desire or libido?

A: Official regulatory documents report changes to libido, specifically decreased or increased sexual desire, as common adverse reactions associated with the use of this medication.


Q: What skin changes, such as chloasma (dark patches), have been reported with Femodene ED?

A: The official warnings state that chloasma (dark patches, often on the face) may occur, particularly in women with a history of skin discoloration during pregnancy. The official documents note that women with a tendency toward chloasma should avoid exposure to the sun and ultraviolet radiation.


Q: What should be done if an expected withdrawal bleed does not occur during the inactive pill week?

A: Official guidance generally advises that a missed withdrawal bleed during the inactive pill week may indicate pregnancy. If this situation occurs, the decision to continue the pill requires medical guidance.


Q: Can women with diabetes or a family history of diabetes use Femodene ED?

A: Femodene ED may have an effect on peripheral insulin resistance and glucose tolerance. The regulatory documents establish that women with diabetes mellitus require careful observation while taking this medication.


Q: Does Femodene ED contain lactose or other ingredients that might be a concern for some users?

A: The tablets contain the excipients lactose and sucrose. Official documents define that individuals with known intolerances to these sugars, such as rare hereditary problems of fructose or galactose intolerance, are generally not indicated for this medicine.


Q: How long before a planned major surgery might a patient need to stop taking Femodene ED?

A: Due to the increased risk of blood clots (thromboembolism) associated with combined oral contraceptives, official labeling states the pill should be discontinued, if feasible, at least four weeks prior to major elective surgery and for two weeks following the procedure.


Q: How quickly does fertility typically return after a person stops taking Femodene ED?

A: Official information suggests that fertility is generally observed to return promptly after discontinuation of the pill. This occurs because the medication works by suppressing ovulation in a manner that is rapidly reversible once use is stopped.


Q: Does Femodene ED offer any protection against sexually transmitted infections (STIs)?

A: Regulatory documents state that this medication is indicated only for the prevention of pregnancy. It does not protect against sexually transmitted diseases or infections.


Q: Are there any specific concerns about taking Femodene ED for women who have varicose veins?

A: The medication is contraindicated in individuals with a history of venous thromboembolism (VTE), which involves blood clots in the veins. While varicose veins are not a direct contraindication, they are a known risk factor for VTE, and their presence is a factor considered during medical assessment.


Q: Is it possible to use Femodene ED continuously to skip periods?

A: The approved regimen is the 28-day continuous cycle, which includes the inactive pills that cause the withdrawal bleed. Skipping the inactive pills would delay the bleed, but the use of this medication outside the approved regimen should only be implemented following medical assessment.


Q: What is the recommended approach if the withdrawal bleed is unusually heavy or light?

A: While the official Summary of Product Characteristics (SmPC) primarily addresses unscheduled bleeding, it is noted that persistent abnormal or unacceptable bleeding patterns (heavy or light) are generally criteria for medical investigation.

How should Femodene ED be stored and disposed of?

Storage and Disposal Requirements

Femodene ED tablets must be stored according to regulatory specifications to ensure product stability and safety.

Labeled Storage Temperature Store at or below 30 C
Protection Requirements Protect from light and moisture; keep in the original package.
Child Safety Keep out of the sight and reach of children.
Prohibited Disposal Do not dispose of unused or expired product via wastewater or household waste.

Official documents require the tablets to be kept below 30 C and stored in the blister and carton to maintain protection from both light and moisture. The medicine must be kept safely away from children to prevent accidental access. Expired or no longer needed tablets should be returned to a pharmacist for appropriate disposal, adhering to environmental protection rules for pharmaceutical waste.

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

Available in countries:

Equivalent of Femodene ED found in:

A-Z Index: