Alesse

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Alesse

Quick Facts

Property Description
Active ingredient Ethinyl Estradiol and Levonorgestrel
Form Oral Contraceptive Tablet
Pharmacological class Combined Oral Contraceptive (COC)
Common use Pregnancy prevention
Origin Synthetic hormones

Defining Alesse: Identity and Pharmacological Class

Alesse is a prescription medicine manufactured by Pfizer (or its predecessor Wyeth) and classified as a Combined Oral Contraceptive (COC), which is a widely utilized form of Hormonal Contraceptive. As a combination product, it is provided in the Oral Contraceptive Tablet form and is typically administered via a Monophasic regimen, meaning the hormone concentration in the active tablets remains uniform. This specific combination is often identified as a low-dose formulation, distinguishing it within the COC class, though generic equivalents also share this characteristic composition.

Composition and Synthetic Origin

Alesse contains two distinct Active ingredients: the Estrogen component, Ethinyl Estradiol, and the Progestin component, Levonorgestrel. These hormones are classified as synthetic hormones, meaning they are chemically manufactured to function similarly to endogenous female sex hormones. The combination of this specific Progestin with the Ultrapotent estrogenic component is clinically recognized for the suppression of the reproductive cycle.

Primary Function: Pregnancy Prevention

The overarching purpose of Alesse is Contraception, which is the General indication for the prevention of pregnancy in Women of reproductive potential. The combined hormones work primarily through the Inhibition of ovulation, preventing the monthly release of an egg. Additionally, the Physiological actions include promoting Cervical mucus thickening and Endometrial alteration, which contribute to the drug's fundamental function as a method for Pregnancy prevention.

Regulatory References

  1. Contraception - World Health Organization (WHO)

What side effects are possible with Alesse?

The safety profile for Alesse (Levonorgestrel and Ethinyl Estradiol) is characterized by an established classification of common adverse reactions and serious vascular and systemic risks, as documented in official prescribing information.

Adverse Reaction Categories

Classification Examples of Reactions System-Organ Class (SOC)
Very Common Nausea/Vomiting, Headache Gastrointestinal, Nervous System
Common Irregular or heavy vaginal bleeding (metrorrhagia), Acne, Breast tenderness, Weight increase, Mood changes Reproductive System, Skin, Metabolic
Uncommon Rash, Urticaria (hives), Chloasma (skin discoloration) Skin and Subcutaneous Tissue
Rare Venous Thromboembolism (VTE), Arterial Thrombotic Events, Liver Tumors Vascular, Hepatobiliary

Serious Safety Considerations

The most serious documented safety concerns are the risks of Thromboembolic Events, which include Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Myocardial Infarction, and Stroke. These are rare but clinically significant. The label also notes risks of Hepatic Neoplasia (benign or malignant liver tumors) and a potential for developing or worsening Severe Hypertension.

Population and Time-Related Safety

Use is contraindicated in specific high-risk groups, most notably in females over 35 years of age who smoke, due to a substantially increased risk of serious cardiovascular events. Safety restrictions also apply to those with specific conditions such as uncontrolled high blood pressure or certain types of migraines with aura.

Regarding exposure, the risk of thromboembolic events is officially documented as highest during the first year of use and when treatment is restarted after a break of four weeks or longer. Irregular bleeding or spotting is typically more common during the first three months of use.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation classifies an acute overdose of Alesse (ethinyl estradiol and levonorgestrel) as not likely to be life-threatening, with severe outcomes officially documented as very unlikely. However, immediate medical attention must be sought for any suspected overdose event, regardless of symptom severity.

Documented Manifestations

Overdose presentations primarily involve clinical manifestations consistent with excess hormonal exposure. These documented symptoms typically include nausea, vomiting, abdominal pain, breast tenderness, drowsiness, fatigue, headache, and rash. In females, vaginal bleeding (withdrawal bleeding) is a specific population-related manifestation that may occur two to seven days after the acute event.

Mandated Emergency Actions and Management

The official guidance requires that individuals seek medical help right away and contact the Poison Help hotline. Urgent attention from emergency services is necessary if the affected person collapses, experiences a seizure, or has trouble breathing. Treatment is limited to symptomatic and supportive management, as no specific antidote is known for this overdose. Clinical protocols mandate that providers measure and monitor vital signs during observation.

Therapeutic Uses of Alesse

Alesse (ethinyl estradiol and levonorgestrel) is commonly used to help with conception control and supports pregnancy prevention for women of reproductive potential. The medication may also be relevant for easing symptoms associated with certain gynecological and skin conditions.

The medication is commonly used across conditions presenting with symptoms related to physical discomfort, such as dysmenorrhea, and symptoms that create noticeable physiological strain, such as heavy or erratic periods. Alesse is relevant in contexts where additional symptomatic support is needed for symptoms related to systemic imbalance, including those manifesting externally.

“This medication is applied in clinical settings where patients require supportive management for symptoms that interfere with daily comfort, providing assistance with maintaining functional stability.”

Quick Fact: Relief for Menstrual Discomfort

Alesse is commonly used to help with conditions characterized by periods of heightened symptoms, which can include menstrual pain, cycle irregularity, and hormonally-driven acne. It contributes to improved comfort during symptomatic periods, which helps ease the overall symptom load. The medication may assist with functional stability related to menstrual patterns, thus providing supportive relief when symptoms interfere with routine activities.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Alesse is indicated exclusively for females of reproductive potential after the onset of menstruation (post-menarchal). The eligibility profile is strictly defined by regulatory authorities to ensure patient safety, primarily focusing on managing cardiovascular and hormone-sensitive risks. Use is formally not indicated for pre-menarchal children or for postmenopausal women.

Official Regulatory Limitations

Classification Restricted Population/Condition
Absolute Contraindication Females over 35 years of age who smoke; history of or current thromboembolic disorders (DVT, PE, stroke); known or suspected breast cancer; active or severe liver disease; uncontrolled hypertension; known or suspected pregnancy.
Conditional Use/Not Recommended Lactating women (use may decrease milk production); prolonged immobilization or major surgery (medicine must be discontinued for a specified period); use in females with a BMI > 35 kg/m^2 (efficacy not adequately evaluated).

The regulatory documents formally establish that all individuals with a history of high-risk vascular or hormone-sensitive conditions must be excluded from use. Furthermore, temporary discontinuation is mandated prior to major surgery due to the increased acute risk of thromboembolism.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory documentation identifies specific medicinal products and substances that formally interact with Alesse (ethinyl estradiol and levonorgestrel).

Contraindicated Combinations and Substances

Co-administration is formally contraindicated with certain medications and substances due to documented interaction risks. These include the Hepatitis C Virus (HCV) regimen containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, because of the potential for significant ALT enzyme elevations. Additionally, the drug is contraindicated for co-administration with oral tranexamic acid due to a documented pharmacodynamic interaction that increases the risk of thromboembolic events. Cigarette smoking is also a formal contraindication for females over 35 years of age due to a substantially increased risk of serious cardiovascular events.

Interactions Affecting Drug Effectiveness

Several drug classes are documented to cause decreased effectiveness by altering metabolic clearance. Substances categorized as enzyme inducers, such as certain anticonvulsants and the herbal product St. John's Wort, can lower the plasma concentrations of the contraceptive components. Conversely, the ethinyl estradiol component can raise serum concentrations of binding globulins, an effect that may necessitate an increase in the dosage of co-administered replacement thyroid hormone or cortisol therapy.

Administration Timing Restrictions

A mandatory timing rule requires the drug to be discontinued at least four weeks prior to and through two weeks after major surgery or during and following prolonged immobilization. This is an interaction-related restriction applied under specific conditions.

Mechanism of Action

Alesse is a combined hormonal therapy whose mechanism of action is mediated by the synthetic hormones ethinyl estradiol and levonorgestrel. The ethinyl estradiol component acts as an agonist at the estrogen receptors, while the levonorgestrel component acts as an agonist at the progesterone receptors. The primary effect is the suppression of the hypothalamic-pituitary-ovarian (HPO) axis, achieved through negative feedback on the hypothalamus and pituitary gland. This feedback mechanism reduces the pulsatile release of GnRH and inhibits the secretion of pituitary gonadotropins (LH and FSH), ultimately leading to the inhibition of ovulation.

Simultaneously, the progestin component induces peripheral changes, specifically increasing the viscosity of the cervical mucus, which physically impedes sperm migration. It also modifies the morphology of the endometrium, affecting its receptivity. These three actions—HPO axis suppression, increased cervical mucus viscosity, and endometrial modification—combine to modulate the physiological reproductive function.

Dosage and Administration Information

How Alesse is Used: Official Administration Guidelines

Alesse (levonorgestrel and ethinyl estradiol) is administered exclusively via the oral route as a tablet, adhering to a standardized monophasic, 28-day cyclic regimen.


Standard Dosing and Schedule

The fundamental pattern requires taking one tablet daily, ensuring the intervals between each dose do not exceed 24 hours to maintain consistent hormone exposure.

Each cycle involves two distinct phases:

  • Active Dosing Phase: One active tablet, containing the low-dose formulation of 100 mcg levonorgestrel and 20 mcg ethinyl estradiol, is taken for 21 consecutive days.
  • Hormone-Free Phase: This is followed immediately by 7 consecutive days of taking an inert (placebo) tablet.

Following the 28-day course, a new pack is started immediately, without pause, regardless of whether withdrawal bleeding has occurred or ceased.


Administration Context and Principles

For adherence, it is standard practice to take the tablet at approximately the same time each day, often suggested to be after the evening meal or at bedtime.

Initiation of the first cycle is procedural, commonly beginning either on Day 1 of the menstrual period or on the first Sunday after the period begins. If the cycle is not initiated on Day 1, a nonhormonal back-up method is typically utilized for the first seven consecutive days of active tablet intake.

Usage is typically long-term, continuing in the repeating 28-day cyclic pattern. The medication is not intended for use in postmenopausal women or before menarche.

Recent Clinical Evidence

Research evidence / Overview of Studies for Alesse

This section provides an overview of the research evidence and clinical evaluation studies conducted for Alesse (ethinyl estradiol and levonorgestrel), focusing on what the research explored and what remains uncertain, based on official regulatory and scientific sources.


Evidence for Use in Pregnancy Prevention

Research into preventing pregnancy has been conducted primarily through large, intermediate-term Phase 3 Clinical Trials and long-term Observational Studies. These studies focus on healthy women of reproductive potential who are seeking contraception. Researchers monitored whether pregnancy occurred in the study participants over a defined period, usually measured across 13 menstrual cycles (one year).

Studies for this medication and the overall class of combined oral contraceptives (COCs) have reported standardized measurements of pregnancy incidence, often using the Pearl Index (PI). Findings describe patterns related to low pregnancy incidence, with differences noted between rates reported by participants who used the medication perfectly (strict adherence) versus those who followed a typical use pattern (real-world use). This evidence describes a pattern that is consistent across the Combined Oral Contraceptive (COC) drug class.

Evidence for Non-Contraceptive Indications Studied

Research has also explored the use of combined oral contraceptives, including formulations like Alesse, by studying outcomes related to conditions influenced by the menstrual cycle.

Research on Dysmenorrhea (Menstrual Pain/Cramps)

Alesse was studied for outcomes related to physical discomfort in women experiencing menstrual pain. These studies examined patient-reported outcomes describing perceived discomfort, functional capacity, and measured changes in the use of other pain medications over observation periods typically lasting three to six cycles. Findings describe patterns related to changes in the measured pain intensity scores.

Research on Acne Vulgaris

The specific combination of hormones in Alesse was evaluated in women with moderate acne vulgaris who also desire contraception. Trials focused on objective measures, such as monitoring the measured counts of both inflammatory and non-inflammatory skin lesions during the study period. Findings describe patterns related to measured changes in lesion counts over the observation period.

Research Gaps and What Remains Uncertain About Alesse

Key limitations include the fact that results apply only to the populations studied and that data for certain groups remain insufficient, particularly in the high-BMI category. Furthermore, while the primary contraceptive research describes consistent patterns, the long-term patterns of this specific low-dose combination on non-contraceptive outcomes like dysmenorrhea and acne are not fully established, as follow-up durations were limited in many of those specific trials.

Frequently Asked Questions (FAQ)

Common questions about Alesse (FAQ)


Q: Does Alesse have any potential benefits beyond preventing pregnancy, such as for acne or painful periods?

Official regulatory documents state that Alesse is approved only for the prevention of pregnancy. While studies have explored non-contraceptive effects, acne itself is listed as a potential adverse reaction in the drug's safety profile.

Q: How long does it typically take for the body to adjust to starting a new course of Alesse?

The time it takes for a person's body to adjust varies, but regulatory information indicates that irregular bleeding or spotting is commonly reported during the first few months of use. This is often the period when the body is adapting to the medication.

Q: What is the stated effectiveness rate of Alesse for preventing pregnancy when used as directed?

According to the clinical trial summaries, the overall pregnancy rate reported for Alesse was 0.84 per 100 women over one year of use. This figure is based on participants in trials and includes those who did not take the medication perfectly according to the strict regimen.

Q: Are changes in body weight or bloating common effects reported by new users of Alesse?

The official product information lists both weight gain and gastrointestinal symptoms, such as abdominal bloating, as reported adverse reactions. These are among the common physical changes that users may experience.

Q: What mood-related changes, such as anxiety or depression, have been reported in users of Alesse?

Mood changes, including depression, are reported adverse reactions of this medication. Official safety information notes the importance of observation for women who have a history of depression.

Q: Is a change in sex drive or libido a reported side effect of using Alesse?

Yes, a change in libido, or sex drive, is specifically listed as a reported adverse reaction in the official drug documents.

Q: Does Alesse typically improve existing acne, or is worsening of skin condition sometimes reported?

According to regulatory documents, acne is listed among the most common adverse reactions reported in clinical trials. This classification means that skin changes, including acne, are a recognized effect.

Q: Is nausea a common side effect experienced only during the initial month of taking Alesse?

Nausea is classified as a very common adverse reaction. Official information does not restrict this symptom only to the initial month of use and notes that if nausea persists or intensifies, consulting a healthcare professional is appropriate.

Q: What are the recognized symptoms of a serious, but rare, side effect like a blood clot?

The patient information leaflet describes potential signs of a blood clot, which is a rare but serious risk. These signs include sudden, severe pain or swelling in a leg, or sudden, severe chest pain and breathlessness. Unusual, severe, or long-lasting headaches are also mentioned.

Q: Can Alesse use affect vision or cause issues for contact lens wearers?

Official documents report that the use of Alesse may cause adverse reactions such as intolerance to contact lenses. It may also cause a change, described as the steepening, in the curvature of the cornea.

Q: Are there any warnings or precautions about sun exposure while taking Alesse?

The official labeling states that avoiding exposure to the sun or ultraviolet (UV) radiation is recommended for women with a history of chloasma (skin discoloration).

Q: Do common classes of antibiotics interact with and potentially reduce the effectiveness of Alesse?

Regulatory guidance indicates that certain enzyme-inducing antibiotics, such as rifampin, can reduce the effectiveness of hormonal contraceptives. This is a known interaction risk with this class of medication.

Q: How is a menstrual period expected to change in terms of flow or duration while taking Alesse?

A change in menstrual flow is listed as a reported adverse reaction in the official product documents.

Q: Is it common for a person to experience a lighter-than-usual or missed period while on the inactive pills of Alesse?

Experiencing a lighter-than-usual period (oligomenorrhea) or a missed period (amenorrhea) is a possible occurrence while on Alesse. Official information states that this is more common during the first few months of use or if the conditions were pre-existent.

Q: Is there official information describing the practice of using Alesse to skip or delay a period?

While official documents do not use the term 'skipping a period,' the recommended 28-day regimen requires starting a new pill pack immediately after the 7 inactive tablets, without any pause between packs.

Q: Does Alesse offer any protection against sexually transmitted diseases (STDs)?

Official patient counseling information clearly states that oral contraceptives, including Alesse, do not offer any protection against HIV infection (AIDS) or other sexually transmitted diseases (STDs).

Q: Can Alesse potentially interfere with the results of certain laboratory tests?

The estrogen component of Alesse is documented to potentially raise the serum concentrations of certain binding globulins. This effect may interfere with the accuracy of some related laboratory tests.

Q: Are there any official public advisories regarding the physical appearance or condition of the Alesse tablets?

Based on public safety advisories, users have been officially advised to visually examine the tablets before administration. The advisory recommends looking for any unusual appearance, such as discoloration, jagged edges, or breakage.

Q: What is the general timeline for a person's menstrual cycle to return to its previous pattern after stopping Alesse?

After stopping the use of Alesse, amenorrhea or oligomenorrhea (missed or lighter periods) may occur. Regulatory documents only note this potential effect, especially if these conditions were already present before starting the medication.

How should Alesse be stored and disposed of?

How to Store and Dispose of Alesse

Alesse (levonorgestrel and ethinyl estradiol tablets) must be stored under specific, controlled conditions to maintain product stability, as required by official regulatory labeling.


Storage Requirements

Condition Requirement
Temperature Store at controlled room temperature, 20 C to 25 C (68 F to 77 F). Excursions up to 30 C (86 F) are permitted.
Protection Keep away from excessive heat, moisture, and direct light. The product must be kept from freezing.
Container Store in a closed container to maintain integrity.
Child Safety Keep the medication out of the reach of children.

Disposal

Disposal of unused or expired Alesse tablets must adhere to official pharmaceutical waste guidelines. The medication should be returned to a pharmacy-sponsored drug take-back program or disposed of according to local environmental regulations. Official guidance directs that the tablets should not be flushed down the toilet.

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

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