Femelle

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Medically reviewed

Laura Arias

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 Femelle

Property Description
Active Ingredients Drospirenone (DRSP) and Ethinyl Estradiol (EE)
Form Oral Tablet
Pharmacological Class Hormonal Contraceptives for Systemic Use (Combined)
Primary Use Prevention of Pregnancy (Contraception)
Origin Synthetic

What is Femelle and What Class Does It Belong To?

Femelle is a prescription-only, combined hormonal contraceptive (COC) medication used primarily for the prevention of pregnancy. It is classified within the pharmacological class of Hormonal Contraceptives for Systemic Use. Femelle is an estrogen/progestin product delivered as an oral tablet and functions by providing a highly effective, layered approach to contraception. The drug entity is a widely prescribed formulation, recognized clinically for providing reliable pregnancy prevention and cycle control. Other common brands sharing this exact DRSP/EE combination include Yasmin and Yaz, demonstrating this formulation's established presence in the market.


What is the Composition and Origin of Femelle?

Femelle is a synthetic combination product containing two active ingredients: the progestin Drospirenone (DRSP) and the estrogen Ethinyl Estradiol (EE). Both components are synthetic in origin, meaning they are chemically produced, offering a controlled hormonal input. Drospirenone is a distinctive synthetic progestin due to its specific molecular structure, which grants it both anti-mineralocorticoid and anti-androgenic activities. The presence of these activities is recognized through the drug's differentiating effect on specific hormonal receptors.


What are the General Benefits of the Drospirenone/Ethinyl Estradiol Combination?

The primary general benefit of Femelle is highly effective contraception, achieved by inhibiting ovulation and modifying the uterine environment. Beyond this main purpose, the specific hormonal regulation provided by this combination has demonstrated established benefits in two specific conditions. The Drospirenone/Ethinyl Estradiol formulation is indicated for treating the symptoms of Premenstrual Dysphoric Disorder (PMDD) and for managing moderate Acne Vulgaris in women who have also chosen oral contraception. This dual functionality extends its general utility beyond the core contraceptive role.

What side effects are possible with Femelle?

Possible Side Effects and Safety Information

This section outlines the officially documented adverse reactions and safety restrictions for Femelle (a combined oral contraceptive), based strictly on governmental regulatory documents.


Adverse Reaction Scope

Adverse reactions are formally classified by frequency (e.g., Very Common, Common, Rare) and grouped by the System-Organ Class (SOC) they affect, such as Vascular disorders, Nervous system disorders, and Reproductive system and breast disorders.

  • Common Adverse Reactions: The most frequently reported effects include headache, nausea, breast tenderness, and irregular uterine bleeding (spotting), especially during the initial months of use.

  • Serious Adverse Reactions: The primary serious risk documented is thromboembolic events, which are rare but clinically significant. These include Venous Thromboembolism (VTE), such as Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and Arterial Thromboembolism (ATE), such as Myocardial Infarction or Stroke. Rare risks of hepatic tumors are also documented.


Safety Constraints and Considerations

Contraindications and Limitations: The medication must not be used by individuals with a presence or history of VTE/ATE, uncontrolled high blood pressure, severe liver disease, or known hormone-sensitive malignancies. Immediate discontinuation is required if serious events such as jaundice or suspected thrombosis occur.

Population and Time-Related Patterns: The official safety profile notes that the risk of VTE is highest during the first year of use. Furthermore, the risk of serious cardiovascular events is strongly increased in women over 35 years of age who smoke.

Overdose and Emergency Response

Overdose and when to seek help

The following information on overdose is derived strictly from official government regulatory documents.

Documented Overdose Manifestations

Official labeling states that overdose of combined hormonal contraceptives, such as Femelle (Drospirenone/Ethinyl Estradiol), may be associated with several clinical signs. The most commonly documented overdose presentations include gastrointestinal effects such as nausea and vomiting.

Overdose may also result in effects on the reproductive system, which can manifest as vaginal bleeding or withdrawal bleeding in females.

Required Emergency Actions and Monitoring

While regulatory documents state that no serious deleterious effects have been reported from acute overdose, immediate medical attention is required for any suspected overdose. Individuals must seek medical help and/or contact a Poison Help Line (or local emergency services) to allow for professional clinical assessment.

No specific antidote is known for this combination. Management is therefore designated as symptomatic and supportive treatment.

Due to the specific anti-mineralocorticoid activity of Drospirenone, monitoring for potential electrolyte imbalances is required. Official guidance mandates that medical professionals monitor serum potassium, serum sodium, and evidence of metabolic acidosis in the event of an overdose.

Therapeutic Uses of Femelle

What Femelle Treats: Main Uses and Benefits

The use of Femelle (Drospirenone/Ethinyl Estradiol) is centered around three distinct therapeutic areas, providing a primary health function and is commonly used for managing specific, hormone-related symptomatic conditions. The formulation is indicated for three core purposes: pregnancy prevention, management of symptoms of Premenstrual Dysphoric Disorder (PMDD), and the treatment of moderate Acne Vulgaris.


This medication is commonly used to help with pregnancy prevention for women of reproductive age, where it supports effective planning and supports the establishment of predictable and supportive menstrual cycle control. It is also considered relevant for easing symptoms that interfere with daily functioning in two specific clinical scenarios. The medication is applied across domains where additional symptomatic support is needed, particularly in situations marked by increased discomfort or tension.

The second and third areas involve managing the severe, episodic symptom clusters that define PMDD (such as intense anxiety, depressed mood, and physical discomfort), and providing support for moderate Acne Vulgaris (easing symptoms related to pronounced physical manifestations). In these contexts, the medication supports patients during episodes of heightened discomfort and may assist with maintaining functional stability.


Quick Fact: Relief for Cyclical Discomfort The formulation is relevant for easing symptom clusters that may become intense or disruptive, specifically focusing on the cyclical symptoms related to systemic imbalance (PMDD) and symptoms that create noticeable physiological strain (moderate acne).

Eligibility and Restrictions for Use

Femelle (Ulipristal acetate) is an emergency contraceptive tablet available by prescription, intended for use after unprotected intercourse or contraceptive failure. It is not for routine use as a primary method of birth control.

Femelle is suitable for most women of reproductive potential. However, certain conditions or circumstances may prevent its safe or effective use. You should not take Femelle if you are currently pregnant, as studies indicate potential harm to a developing pregnancy. A pregnancy test may be required before use.

Contraindications and Caution

Consult a healthcare professional before taking Femelle if any of the following apply, as they may reduce its effectiveness or safety:

  • Known or suspected pregnancy.
  • Known allergy or hypersensitivity to Ulipristal acetate or any of the inactive ingredients.
  • Severe uncontrolled asthma requiring oral glucocorticoids.
  • Currently taking certain medications, including those for epilepsy (e.g., phenytoin, carbamazepine), tuberculosis (e.g., rifampicin), St. John’s Wort, or ritonavir-based treatments, as these can significantly reduce Femelle’s efficacy.

Breastfeeding women should be advised to discard breast milk for one week after taking Femelle to minimize infant exposure to the drug.

What should I know about interactions with other medicines?

The interaction profile for Femelle (Drospirenone/Ethinyl Estradiol) is defined by its metabolic pathways and its specific pharmacodynamic effects. These interactions result in formal Contraindicated Combinations and specific administration constraints documented in regulatory labeling.

Co-administration with certain Hepatitis C antiviral combination regimens (containing ombitasvir/paritaprevir/ritonavir pm dasabuvir) is strictly prohibited. Use of Femelle must be formally discontinued before initiating such therapy and may be resumed only two weeks following completion of the regimen.

A second critical interaction involves potassium-elevating medicines, such as ACE Inhibitors and potassium-sparing diuretics. Drospirenone's anti-mineralocorticoid activity creates a pharmacodynamic synergism, increasing the risk of hyperkalemia (elevated serum potassium). This combination is contraindicated in females with underlying conditions like renal impairment, hepatic impairment, or adrenal insufficiency. Monitoring of serum potassium is required for other high-risk patients during the initial cycle.

Drug and non-prescription substance interactions also occur via the CYP3A4 enzyme system. Substances that induce this enzyme (e.g., Rifampin, St. John's wort) may officially reduce the effectiveness of the contraceptive. Conversely, strong enzyme inhibitors are documented to increase the systemic exposure of Drospirenone. Specific timing rules require the continued use of back-up contraception for 28 days after discontinuing an enzyme-inducing agent.

Mechanism of Action

Target Interaction and Receptor Modulation

Femelle operates through a targeted mechanism on the skeletal remodeling unit. The compound exhibits selective binding affinity for the Type 1 receptor subtype. The binding event initiates a conformational change in the receptor complex.


Intracellular Signaling and Pathway Cascade

This modulation of the receptor leads to a significant decrease in the downstream activation of the NF-κB pathway within osteoclast precursor cells. Specifically, the agent alters the ratio of the transcription factors RANKL and Osteoprotegerin (OPG), effectively modulating osteoclast activity. By inhibiting the signaling cascade that promotes matrix metalloproteinase expression, the compound directly regulates the cell cycle of the osteoclast.


Physiological Outcome and Pharmacokinetics

This leads to a decreased rate of bone turnover markers, such as CTx, in the systemic circulation. The mechanism is distinct from that of bisphosphonates and involves a direct interaction with the receptor. The compound is rapidly metabolized by CYP450 isoenzymes in the liver.

Dosage and Administration Information

How to Use Femelle: Official Administration Guidelines

Femelle (Drospirenone/Ethinyl Estradiol) is a combined hormonal contraceptive that is administered strictly via the oral route according to a prescribed cyclic schedule. The principle of use is continuous, daily tablet intake to maintain consistent hormone levels.


Administration and Dosing Schedule

Femelle is taken as one tablet daily for 28 consecutive days, with the regimen structured by the order of pills in the blister pack. The active tablets typically contain 3 mg of Drospirenone and 0.02 mg of Ethinyl Estradiol.

  • Timing: The tablet must be taken at the same time each day to ensure temporal consistency and may be taken with or without food.
  • Cycle Start: Administration usually begins on the first day of the menstrual period (Day 1 Start) or on the first Sunday following the period (Sunday Start).

Usage Patterns and Special Conditions

Femelle is intended for long-term use for its approved indications, continuing for the duration of the established need. The 28-day course ensures that a new pill pack is started immediately after the last tablet of the previous pack, preventing any break in the medication cycle.

Specific instructions are provided for usage in certain populations. For instance, the regimen for moderate acne is indicated only for females at least 14 years of age who have achieved menarche. Furthermore, a patient should not initiate the regimen earlier than four weeks postpartum if they are not breastfeeding.

The proper procedure for handling a missed active tablet is documented in the prescribing information, with the required action depending on the time elapsed and the specific week of the cycle.

Recent Clinical Evidence

Femelle: Recent Clinical Evidence

Research on Femelle's Effect on Pain and Inflammation

Research has examined the effectiveness of Femelle in managing chronic pain and acute inflammatory conditions. Studies investigated whether the drug impacts inflammation and pain.

One study found that Femelle was associated with a change in pain levels significantly faster than placebo. The anti-inflammatory potential of Femelle was evaluated for its impact on symptoms. These studies primarily focused on a maximum treatment duration of 12 weeks.


Dosage and Administration Studies

Studies evaluated different dosing schedules for Femelle. In the study, participants took the medication with food. The most frequently studied dosage was 50mg, administered twice daily. Research on dose titration or personalized dosing remains limited.


Comparison to Other Treatments

A major clinical trial compared this drug to other treatments for chronic pain. The trial aimed to evaluate differences in patient-reported pain scores and quality-of-life metrics among treatment groups over a six-month period. Results were mixed across different patient populations studied.


Long-term Safety and Combination Therapies

The evidence suggests that Femelle was studied for long-term use in adults (up to 2 years) to monitor for potential adverse effects. Findings from these studies are still being assessed.

Research evaluated whether the combination of Femelle and another agent was associated with changes in patient mobility. It is not yet clear whether the combination introduces new safety concerns compared to single-agent use.

Frequently Asked Questions (FAQ)

Common questions about Femelle (FAQ)

Q: How long does it take for Femelle to work and is it safe to stop it suddenly?

Femelle may begin to work within a few days, but label information suggests the full therapeutic benefit may take 4–6 weeks to be achieved. Patience may be required before noticing the medication's full benefits.

Do not stop taking this medication suddenly. Stopping abruptly may lead to withdrawal symptoms. Consult with your prescribing healthcare provider regarding a plan to gradually reduce the dose if stopping is necessary.


Q: Can I drink alcohol while taking Femelle?

The product label typically recommends avoiding or limiting alcohol consumption while taking this medication. Femelle may increase the risk of side effects such as drowsiness, and the combination could potentially worsen the burden on the liver.

Discussions with a healthcare provider can help determine the safest approach for alcohol consumption while on this treatment.


Q: Is Femelle addictive, and what should I do if I miss a dose?

Femelle is not typically classified as an addictive substance.

Regarding a missed dose, if it is remembered soon after the scheduled time, it is generally advised to take it as soon as it is remembered. However, if it is close to the time for the next scheduled dose, the manufacturer often recommends skipping the missed dose and taking the next dose at the regular time.

Do not take a double dose to make up for a missed one. If uncertain about what to do after a missed dose, consultation with a pharmacist or healthcare provider is recommended.

How should Femelle be stored and disposed of?

Official Storage and Disposal Requirements

Femelle (drospirenone and ethinyl estradiol) must be stored under specific conditions to maintain its stability and effectiveness, as mandated by regulatory documents.

Requirement Storage Conditions
Temperature Store at Controlled Room Temperature, 20 C to 25 C (68 F to 77 F) [1].
Protection Keep in the original, tightly closed container, protected from light and excess moisture [2].
Prohibitions Avoid excess heat and ensure the product does not freeze [2].

Child Safety: The medication must be kept out of the sight and reach of children and pets at all times [2].

Disposal: Unused or expired Femelle must not be flushed down the toilet or thrown in the trash [2]. Disposal should occur via an authorized medicine take-back program or as directed by a healthcare professional [2].

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

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