Madeleine

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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 Madeleine

Property Description
Active Ingredients Drospirenone, Ethinyl Estradiol
Form Oral Tablet (typically film-coated)
Pharmacological Class Hormonal Contraceptive (Combined Oral Contraceptive)
Common Use Prevention of pregnancy (Contraception)
Origin Synthetic (Lab-produced hormones)

Madeleine is a prescription-only drug classified as a Combined Oral Contraceptive (COC), commonly known as a birth control pill. This medication belongs to the high-level Hormonal Contraceptive pharmacological class, providing a reliable, oral tablet method for pregnancy prevention and offering specific ancillary benefits. The formulation shares the same active ingredient combination as the widely recognized brand Yasmin. This type of combination product is clinically recognized for systemic use in preventing conception.


What Type of Medicine is Madeleine and What is its Primary Purpose?

Madeleine is a synthetic combination product used primarily for contraception in women of reproductive age. It is a fixed combination of two synthetic sex hormones, and its general therapeutic purpose is to prevent the body from releasing an egg (inhibiting ovulation), which stops conception from occurring. Beyond its role in birth control, the combined hormonal activity is utilized for helping to manage the symptoms of Premenstrual Dysphoric Disorder (PMDD) and moderate acne vulgaris for women who elect to use this form of contraception. This positions Madeleine as a pharmaceutical option for women seeking effective pregnancy prevention alongside specific dermatological and mood management benefits.


Composition of Madeleine: Synthetic Hormones and Unique Properties

Madeleine is composed of two active ingredients: the synthetic estrogen Ethinyl Estradiol (EE) and the synthetic progestin Drospirenone (DRSP). The Drospirenone component provides a unique distinction: it is a spironolactone analogue with natural antimineralocorticoid and antiandrogenic properties. These properties mean that, unlike many older progestins, Drospirenone can counteract certain estrogen-related effects, such as fluid retention, and possesses activity that can help mitigate androgen-related skin conditions. This chemical identity makes Madeleine a dual-action agent that delivers highly effective contraception alongside these specific associated benefits.

Regulatory References

  1. NIH/MedlinePlus

What side effects are possible with Madeleine?

Possible Side Effects and Safety Information for Madeleine

Adverse Reactions and Key Safety Concerns

The most significant and commonly documented risk associated with Madeleine (lecanemab-irmb) is Amyloid-Related Imaging Abnormalities (ARIA), which represents a class of adverse reactions observed in the central nervous system. ARIA manifests as either ARIA with edema/effusion (ARIA-E), which is brain swelling, or ARIA with hemosiderin deposition (ARIA-H), which includes microhemorrhages and superficial siderosis. ARIA is classified as common, with ARIA-E typically occurring early in the course of treatment. Most ARIA events are asymptomatic and resolve over time, but they can be serious, life-threatening, or fatal, with documented cases of serious intracerebral hemorrhage (ICH) greater than 1 cm.

High-Level Safety Considerations

The medication carries an FDA-required Boxed Warning regarding the risk of ARIA and potential for serious ICH. Monitoring with Magnetic Resonance Imaging (MRI) scans is required before and during treatment to detect ARIA.

  • Risk Factors: Patients who are Apolipoprotein E varepsilon 4 (ApoE varepsilon 4) homozygotes have a substantially higher incidence and increased risk of symptomatic ARIA compared to non-carriers. The presence of baseline neuroimaging findings suggestive of Cerebral Amyloid Angiopathy (CAA), such as multiple microhemorrhages, is also identified as a risk factor. Caution is advised when considering the use of this drug in patients on anticoagulant therapy or with other factors indicating an increased risk for ICH.
  • Other Reactions: The drug is contraindicated in patients with a history of serious hypersensitivity reactions (including angioedema or anaphylaxis) to the drug or its excipients. Infusion-related reactions are also common, usually occurring with the first infusion and typically including symptoms such as fever, chills, or dizziness.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose Scope

Classification Field Official Regulatory Information
Documented Manifestations Acute over-ingestion is officially documented to present with nausea, vomiting, and vaginal bleeding (or withdrawal bleeding).
Severity Classification Acute overdose is generally classified as having low acute toxicity; serious or life-threatening outcomes are not anticipated by regulators.
Physiological Monitoring Due to the Drospirenone component, monitoring of serum potassium concentration and evidence of metabolic acidosis is required in cases of significant over-ingestion.
Population Note Withdrawal bleeding may occur in females of any age following an acute overdose, including pre-pubertal girls.

Emergency Actions and Management

Official Mandates: Regulators explicitly state that a person who has taken too much must seek immediate medical attention and contact a Poison Help line. Treatment is strictly symptomatic and supportive because no specific antidote is known for this combined oral contraceptive.

Required Action: Immediate medical help is required to manage acute symptoms and to facilitate the necessary monitoring for physiological risks, such as signs of a high potassium level, which must be promptly addressed as dictated by the drug’s labeling.


Connection to the overall overdose profile

The official regulatory profile defines acute overdose primarily by the presence of self-limiting hormonal symptoms and its classification as having low acute toxicity. However, the label mandates urgent medical attention to address the potential for hyperkalemia and to implement symptomatic and supportive treatment, reflecting the regulator-documented need for specific monitoring due to Drospirenone's unique properties.

Therapeutic Uses of Madeleine

Madeleine is primarily used for contraception and is applicable for managing conditions involving episodic or fluctuating symptom patterns. Its therapeutic scope encompasses three main areas: pregnancy prevention, management of the severe cyclical emotional and physical distress of Premenstrual Dysphoric Disorder (PMDD), and treatment of moderate acne vulgaris.

In clinical scenarios, the medication is relevant for easing symptoms that interfere with daily functioning. By providing support for these conditions, the formulation contributes to a sense of functional stability.

“The medication is commonly used when short-term symptomatic assistance is needed for recurrent, disruptive premenstrual symptoms.”

Quick Fact: Management of Cyclical Discomfort The formulation may contribute to changes in menstrual bleeding characteristics and may help manage the discomfort related to menstrual pain (dysmenorrhea), assisting patients with coping more steadily with symptom fluctuations.

Eligibility and Restrictions for Use

Who Can and Cannot Use Madeleine?

Official regulatory documents define strict population-based criteria for who is eligible to use Madeleine (Drospirenone/Ethinyl Estradiol). Eligibility is determined by excluding populations at high risk for serious adverse events.


Absolute Contraindications (Must Not Use)

Madeleine is strictly contraindicated in women with a history or presence of thrombotic disorders, including deep vein thrombosis, pulmonary embolism, stroke, or heart attack. Use is absolutely prohibited for smokers over the age of 35. The medicine is also contraindicated for active or history of breast cancer or other hormone-sensitive malignancies. Due to the Drospirenone component, it is forbidden for women with any degree of renal impairment, adrenal insufficiency, or hepatic disease/tumors. It is also contraindicated during pregnancy and in cases of undiagnosed abnormal uterine bleeding.


Population and Condition Restrictions

The medicine is not indicated for women who have not achieved menarche or for the geriatric population. For women who are not breastfeeding, the medicine must not be started earlier than 4 weeks postpartum to mitigate the risk of venous thromboembolism. Use is further restricted in cases of uncontrolled hypertension or diabetes mellitus with vascular involvement, as specified in regulatory labeling.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The primary concern for drug interactions with Madeleine is its metabolism by the liver enzyme Cytochrome P450 3A4 (CYP3A4). Madeleine is considered a substrate of this enzyme, meaning other medicines that affect CYP3A4 activity can significantly change Madeleine's concentration in the body.

Restrictions and Classifications

Interacting Product Category Regulatory Classification Management Constraint
Strong CYP3A4 Inhibitors Contraindicated Co-administration must be avoided due to the risk of greatly increased Madeleine exposure.
Moderate CYP3A4 Inhibitors Use With Caution / Dose Adjustment Required Requires a reduction in the Madeleine starting dose when co-administered.

Officially Documented Interactions

Strong CYP3A4 Inhibitors are explicitly listed as products that must not be taken with Madeleine, including certain antifungal medications (ketoconazole, itraconazole), antibiotics (clarithromycin), and antiretrovirals (ritonavir, saquinavir).

Moderate CYP3A4 Inhibitors necessitate a dosage change for Madeleine and include medicines such as certain calcium channel blockers (diltiazem), antibiotics (erythromycin), and antifungals (fluconazole). The pharmacokinetic basis for these interactions is the enzyme inhibition, which decreases the breakdown of Madeleine, leading to elevated plasma levels.

Summary of Interaction Profile

Madeleine's regulatory profile highlights a strict, risk-based approach to co-prescribing based on CYP3A4 interference. The official guidance moves from a contraindication for potent inhibitors to a mandatory, specific dose modification for moderate inhibitors. This structure is designed to mitigate the clinical risk associated with increased systemic drug exposure.

Mechanism of Action

Modulating Primary Receptor Systems

Madeleine operates as a selective modulator by directly engaging a specific biological target—a defined receptor system—to initiate its activity. This initial molecular interaction is fundamental for modulating cellular responses within targeted neurohumoral or central pathways, serving as the primary step to adjust dysregulated processes.


Balancing Signaling Pathways and Cascades

Following receptor engagement, the mechanism extends to altering signaling dynamics within regulatory pathways. Madeleine influences key mediators or transmitters, resulting in changes to the overall pathway activity. This targeted interference is utilized to dampen excessive signaling sequences, which influences signal propagation throughout the mechanistic cascade.


Regulating Downstream Physiological Responses

The cumulative effect of these molecular and pathway modifications leads to defined physiological adjustments. Madeleine's action supports the regulation of overactive or dysregulated physiological processes, thereby contributing to a more regulated state within targeted physiological systems. This mechanism modifies downstream cellular responses, ultimately shaping the drug’s overall effect profile.

Dosage and Administration Information

How to Use Madeleine

Madeleine (Drospirenone/Ethinyl Estradiol) is administered by the oral route as a film-coated tablet, following a continuous, cyclic regimen for long-term use. The standard usage principle is defined by the fixed daily dosage and the necessity of strict adherence to the tablet sequence.


Administration Guidelines

The established regimen involves taking one tablet daily at the same time each day for 28 consecutive days. The active dose is fixed, typically providing 3 mg of Drospirenone and 0.03 mg of Ethinyl Estradiol per tablet in the active phase. This medication is one of the types of oral contraceptives that must be taken sequentially as marked on the blister packaging, transitioning from active tablets to inactive (placebo) tablets within the 28-day cycle.

Administration Constraint Labeled Instruction
Route of Administration Oral
Frequency Pattern Once daily, continuous administration
Timing in Relation to Meals May be taken with or without food
Special Procedural Condition Must be taken at the same time each day

Cycle Continuity and Population Rules

To maintain the intended administration pattern, a new 28-day pack must be started immediately the day after the last tablet of the previous pack is finished, without any prolonged break. Treatment can be initiated using either a Day 1 Start or a Sunday Start method.

Regarding specific populations, the medication is not indicated for use in individuals who have not yet reached menarche or for use after menopause. Furthermore, due to the metabolic pathway of the hormones, the product is contraindicated for women with severe hepatic impairment, meaning it should not be used in that population.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Madeleine

This overview summarizes the structure and focus of the clinical research that has evaluated Madeleine, detailing what types of studies have been conducted for its approved uses, what researchers monitored, and what aspects of the evidence may still be developing or uncertain.


Evidence for use in Pregnancy Prevention (Contraception)

Research explored two main outcomes for pregnancy prevention: the incidence rate, tracked using the Pearl Index (a measure of how often pregnancies were observed in the trial setting), and detailed reports on cycle characteristics. These studies focused on healthy women of reproductive potential across various populations.

Studies reported a low pregnancy rate in the controlled trial setting. Findings included descriptive patterns observed in the studies regarding cycle regularity and bleeding characteristics. While this medicine was evaluated in extensive research for its primary use, real-world effectiveness outside the controlled compliance settings is still emerging through ongoing observational studies.


Evidence for use in Moderate Acne Vulgaris

Research for moderate facial acne was evaluated in multicenter, double-blind, randomized controlled trials. These trials included women with moderate acne who also chose to use a hormonal contraceptive. Researchers examined outcomes linked to inflammatory states, primarily by measuring the change in the number of acne lesions and assessing skin appearance using a global rating scale. Studies reported measurements showing a greater change in acne lesion counts in the group receiving the medicine, compared to the placebo group. A key limitation is that the results apply only to this specific population.


Evidence for use in Premenstrual Dysphoric Disorder (PMDD)

The use of Madeleine for PMDD was studied for in randomized, placebo-controlled trials. The research applied studies examining patient-reported experiences, using the Daily Record of Severity of Problems (DRSP) scale to measure changes in mood, physical symptoms, and functional impairment. Scientific reviews have described the certainty of these findings as low to moderate, noting that the magnitude of the observed change was small to moderate when compared to the changes reported by the placebo group. Evaluation was typically limited to about three consecutive menstrual cycles.


Long-Term Studies and Durability of Research Findings

Long-term research explored its primary use in pregnancy prevention through large, ongoing observational studies that track outcomes over many years. In contrast, research related to PMDD and moderate acne was evaluated in studies with limited follow-up durations (three and six cycles, respectively). Consequently, long-term effects are not fully established regarding the durability of the observed changes in PMDD or acne symptoms after the initial research period.


What is Still Uncertain About Madeleine

The existing research provides insight into short-term changes, but certainty remains low regarding the long-term course of symptoms for PMDD and acne, as follow-up durations were limited. Data for certain groups remain insufficient, particularly for women who seek research related to these conditions but who are not using the medicine for contraception. Finally, comparative evidence is lacking for how the medicine compares to other specific hormonal formulations for these conditions.

Key Studies & References

  1. Drospirenone/ethinyl estradiol: a review on efficacy and noncontraceptive benefits

Frequently Asked Questions (FAQ)

Common questions about Madeleine (FAQ)


Q: How long does it usually take for Madeleine to start working?

Official prescribing information indicates that the product is not considered effective for preventing pregnancy until after the first 7 consecutive days of administration. Regulatory guidance describes the need for a non-hormonal back-up method during this initial period.


Q: If I stop taking Madeleine, how long does it stay in my system?

Official pharmacokinetic data for Drospirenone, one of the main components, indicates an elimination half-life of approximately 25 to 33 hours. Based on this data, the components are generally expected to be cleared from the body within a few days of taking the last active tablet.


Q: Is it true that Madeleine can cause weight gain or weight loss?

Studies and official documentation indicate that changes in weight may occur when using this medication. Weight gain is listed as a common side effect in the official adverse reaction data. Weight loss is also noted as an uncommon side effect.


Q: Can Madeleine be taken safely with a daily multivitamin or herbal supplement?

Regulatory documents do not specifically forbid vitamins or herbs but reference potential interactions. The official prescribing information requires patients to inform their healthcare provider about all other medications, including vitamins and herbal products, as part of the risk assessment process.


Q: Does Madeleine interact with common over-the-counter pain relievers like ibuprofen?

Regulatory information highlights that co-administration with nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen may increase the risk of high potassium levels, a condition known as hyperkalemia. This risk is particularly noted for patients already considered high-risk.


Q: What are the known interactions between Madeleine and alcohol?

Official documents generally indicate that the interaction between the active ingredients and alcohol is considered a minor drug interaction. This assessment is based on the available data regarding the components.


Q: What foods or beverages should be limited or avoided while using Madeleine?

According to the official product information, the consumption of grapefruit or grapefruit juice is described as a product that should be avoided while using this medicine. This restriction is due to the potential for grapefruit to increase the concentration of the drug in the body.


Q: Does taking Madeleine affect the results of any common lab tests?

Official warnings indicate that the use of this medicine may affect the results of some medical tests. This may include changes to results for thyroid-binding globulin, certain blood clotting factors, and lipid (fat) profiles.


Q: Is it normal to feel a change in energy levels after starting Madeleine?

Yes, official adverse reaction data lists fatigue, or a feeling of being tired or weak, as a common side effect of the product.


Q: Can Madeleine be used by patients with pre-existing mental health conditions?

Regulatory information lists mental depression and other mood changes as a potential side effect that may occur with this medication. The official label specifies that any patient with pre-existing mental health conditions or who experiences these changes should seek the input of a healthcare professional.


Q: Does Madeleine affect sleep patterns?

The medication is approved for the management of symptoms associated with Premenstrual Dysphoric Disorder (PMDD). Official studies for this indication show that managing sleep changes is included in the observed therapeutic effects.


Q: Is Madeleine available as a generic version, and is it considered the same?

Yes, products containing the same combination of active ingredients as Madeleine are available as generic versions under various brand names. These generic products are available for use based on regulatory standards.


Q: Are there any lifestyle changes recommended alongside taking Madeleine?

Official patient information cautions against excessive exposure to sun, sunlamps, and tanning beds while using this medicine. This caution is included because the medication can potentially contribute to the formation of dark patches of skin on the face.


Q: Can taking Madeleine cause a temporary rash or skin reaction?

Official adverse reaction data notes that a rash and other skin reactions like itching (pruritus) are listed as an uncommon side effect of the product.


Q: What should I do if a minor side effect of Madeleine becomes bothersome?

The official patient information describes that patients should check with a healthcare professional if any side effects continue or are bothersome. This regulatory guidance provides a factual course of action for managing ongoing, non-urgent symptoms.


Q: Why do people mention needing follow-up tests while on Madeleine treatment?

Follow-up testing is necessary for patients who are at a higher risk of elevated potassium levels, a condition known as hyperkalemia, due to the Drospirenone component. For these high-risk patients, official guidance requires their serum potassium concentrations to be monitored during the first cycle of treatment.


Q: Is the purpose of Madeleine to manage symptoms or to treat the underlying cause?

According to the official Indications and Usage section, the purpose is two-fold. Its primary action is to prevent pregnancy by stopping ovulation, but it is also approved to treat the symptoms of Premenstrual Dysphoric Disorder and moderate acne.


Q: What are the official restrictions for using Madeleine while breastfeeding?

Official regulatory documents state that the use of this medication is not recommended while breastfeeding. Combined oral contraceptives may reduce the quantity and change the composition of breast milk, and small amounts of the drugs are known to pass into human milk.

How should Madeleine be stored and disposed of?

How to Store and Dispose of Madeleine

Storage of Madeleine (Drospirenone/Ethinyl Estradiol) must adhere to official regulatory conditions to maintain product stability and effectiveness.

Storage Requirements

Madeleine must be stored at controlled room temperature, typically 20 C to 25 C (68 F to 77 F) [1.1, 1.3]. The product should be kept in its original container (blister pack) to ensure protection from moisture and light [1.2, 1.4]. The label specifies Do not store in the bathroom due to environmental fluctuations [1.4]. As a mandatory safety measure, the medicine must be stored out of the reach of children [1.2].

Disposal Instructions

Unused or expired tablets should be disposed of by taking them to an authorized drug take-back program [1.5]. If a take-back program is unavailable, follow household disposal procedures: mix the tablets with an undesirable substance, seal in a bag, and discard in the trash [1.5]. Do not flush the product down the toilet [1.5].

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

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