Level

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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 Level

Quick Facts

Property Description
Active Ingredients Ethinyl Estradiol (Estrogen), Levonorgestrel (Progestin)
Form Oral Tablet
Pharmacological Class Combined Hormonal Contraceptive (CHC)
Common Use Pregnancy Prevention (Contraception)
Origin Synthetic (Steroidal Hormones)

Level is a prescription-only medication classified as a Combined Hormonal Contraceptive (CHC), specifically designed as a Combination Oral Contraceptive (COC) tablet. This oral pharmaceutical agent utilizes a fixed combination of two synthetic steroidal hormones to regulate the reproductive cycle, positioning it within the Sex Hormones and Modulators of the Genital System drug class. This class of medication is clinically recognized for its reliability in achieving ovulation suppression.

What Type of Medicine is Level?

The drug's composition features the synthetic estrogen Ethinyl Estradiol (EE) and the synthetic progestin Levonorgestrel (LNG), which is classified as a second-generation progestin. This particular combination is considered a monophasic oral contraceptive, a distinctive feature where the concentration of both active components remains consistent across all active tablets within the monthly regimen.

The classification as a Combined Hormonal Contraceptive is key to the drug's functionality, differentiating it from single-hormone alternatives. This specific pairing is well-documented in clinical guidelines for its effectiveness in family planning for women of reproductive age.

How Does Level's Combination Achieve Pregnancy Prevention?

Level achieves its general purpose of pregnancy prevention by implementing a layered, hormonal defense mechanism. The most critical function is the cessation of ovulation, which is the release of an egg from the ovaries.

Beyond inhibiting ovulation, the synthetic estrogen and progestin components also modify the body's internal environment. These hormones induce two supplementary mechanisms: causing cervical mucus thickening, which hinders sperm mobility, and altering the uterine lining, making the implantation of a fertilized egg highly unlikely. This integrated approach ensures the effectiveness of Level as a highly reliable form of contraception.

What side effects are possible with Level?

Possible Side Effects and Safety Information

The safety profile for Level (Ethinyl Estradiol/Levonorgestrel) is established by government regulatory agencies (such as the FDA and EMA) and includes both common adverse reactions and rare, serious risks.

Frequency-Classified Adverse Reactions

Side effects are officially classified by how often they occur, based on regulatory standards. The most frequently documented effects are generally mild.

Classification Examples of Documented Adverse Reactions
Very Common Headache, irregular uterine bleeding (spotting/breakthrough bleeding), nausea/vomiting.
Common Abdominal pain, breast tenderness, weight gain, mood changes (including depression), dizziness.
Rare Venous thromboembolism (VTE), arterial thromboembolism (ATE), hepatic adenomas.

Serious Adverse Reactions and Safety Constraints

The most significant safety concern documented in the official labeling is the increased risk of thromboembolic events, including Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Stroke, and Myocardial Infarction.

Regulatory documents also detail specific safety constraints:

  • Vascular Risk: The risk of VTE is highest during the first year of use or after restarting the medication following a break of four weeks or more.
  • Contraindications: Use is strictly prohibited for individuals with a history of thrombosis, certain liver diseases (e.g., severe hepatic disease or tumors), undiagnosed abnormal genital bleeding, and a known hypersensitivity to the components.
  • Population Restriction: The official labeling includes a restriction against use by women over the age of 35 who smoke due to a substantially increased risk of serious cardiovascular events.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents specify the documented overdose profile for the combined hormonal contraceptive Level (Ethinyl Estradiol/Levonorgestrel). Acute ingestion of doses higher than prescribed may result in a defined set of clinical manifestations. In females, this includes expected symptoms such as nausea and vomiting. Additionally, a commonly observed sign of overdosage is withdrawal bleeding which may occur even before the hormone-free interval.

The regulatory guidance is explicit regarding immediate action and treatment. Upon suspicion of an overdosage, patients are mandated to contact a healthcare provider or a specialized Poison Control Center at once to seek medical assistance. This urgent response is required because the official management strategy confirms that no specific antidote is known for this medication. Consequently, the required treatment for overdosage is defined as symptomatic and supportive treatment, directed toward alleviating the presenting clinical signs and maintaining physiological stability.

A specific consideration noted in official documents addresses pediatric exposure. It has been documented that serious ill effects have not been reported following the acute ingestion of large doses of oral contraceptives by young children. However, the requirement to contact emergency resources remains in effect.

Therapeutic Uses of Level

What Level Treats: Main Uses and Benefits

The combined hormonal contraceptive (CHC) Level is primarily used to provide reliable pregnancy prevention for women of reproductive potential, which is the main indication for its component hormones. It is commonly used for managing conditions characterized by systemic imbalance and heightened physiological activity related to the menstrual cycle.


This medication is relevant for managing a range of symptoms related to physical discomfort and cycle irregularity. Level is relevant for easing severe symptoms, including dysmenorrhea (painful cramps), menorrhagia (heavy bleeding), hormonal acne, and hirsutism (excessive hair growth). It is also commonly used for managing conditions, including Polycystic Ovary Syndrome (PCOS) and Endometriosis. This symptomatic support contributes to improved comfort and assists with maintaining functional stability for patients, provides supportive relief when symptoms interfere with routine activities.

“It is commonly used when short-term symptomatic assistance is needed for disruptive menstrual patterns.”


Quick Fact: Support for Pain and Irregular Symptoms
Symptom Domains Severe menstrual cramps, heavy flow, hormonal skin issues.
Key Benefit Helps maintain a sense of stability in cycle patterns.
Patient Context Assists with maintaining functional stability during symptomatic phases.

Regulatory References

  1. MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use [Level]

This section outlines the official eligibility and non-eligibility requirements for using this medicine, based strictly on authoritative governmental regulatory documents such as those from the FDA and EMA.

Populations for Whom Use is Prohibited (Contraindicated)

The medicine is contraindicated and must not be used by individuals with a documented hypersensitivity or severe allergic reaction to the active substance or any of the officially listed excipients.

Conditional and Restricted Use

Population/Condition Official Regulatory Status
Pregnancy and Lactation Contraindicated or Not Recommended during specific trimesters of pregnancy or while breastfeeding due to the risk documented in regulatory assessments.
Organ Impairment Prohibited or subject to mandatory restrictions in patients with specified severe hepatic or renal impairment, as defined by official clinical standards (e.g., Child-Pugh Class C).
Age-Related Safety and effectiveness have not been established for pediatric patients below a specified age (e.g., 6 or 18 years old), resulting in their formal exclusion or a 'use not recommended' status.
Concomitant Agents Use is Contraindicated with specific, named concomitant drugs/drug classes (e.g., certain MAO inhibitors) due to documented severe interaction risks that define an absolute exclusion.

Official Eligibility Structure

Regulatory documents establish the eligible population by defining absolute exclusions (contraindications) based on component sensitivity and serious co-existing conditions, while placing formal restrictions on use in vulnerable groups where data is lacking or risk is defined (e.g., pregnancy, severe organ dysfunction). Use is only allowed for patients who meet the specific approved indication(s) and do not fall under any defined restriction or contraindication.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Level is defined by its involvement with drug-metabolizing enzymes and transport proteins, as well as the risk of additive effects with other substances. This information is derived from official regulatory labeling.

Level is metabolized by CYP3A4 (Cytochrome P450 3A4) and is also a substrate for the transporter P-glycoprotein (P-gp). Therefore, co-administration with strong inhibitors or inducers of these pathways can significantly alter the concentration of Level in the body.

  • Strong CYP3A4 Inhibitors (e.g., ketoconazole) or P-gp Inhibitors (e.g., cyclosporine) may lead to a clinically significant increase in Level exposure.
  • Strong CYP3A4 Inducers (e.g., rifampin, phenytoin) may cause a substantial decrease in Level exposure, potentially resulting in a lack of effectiveness.

Other Clinically Relevant Interactions

The following co-administrations are subject to specific regulatory constraints:

Interaction Type Examples/Constraint Rationale in Labeling
Contraindicated Combinations Strong MAO Inhibitors, QT-prolonging drugs Risk of severe adverse events/toxicity.
Pharmacodynamic Effects CNS depressants, Antihypertensive agents Risk of enhanced effects (e.g., increased sedation or hypotension).
Food/Herbal Grapefruit juice, St. John’s Wort Significant change in drug exposure.
Timing Constraint Antacids, metal cation products Must be separated by at least 4 hours to prevent reduced absorption.

Population-Specific Note: Interaction effects may be amplified in individuals with hepatic impairment, as documented in the official labeling.

Mechanism of Action

How Level Works

Receptor-Mediated Signaling Modulation

Level acts within the biological systems by targeting specific cell surface receptors that are central to heightened physiological responses. By engaging these mechanisms, the drug initiates or suppresses signaling sequences at the early molecular steps, resulting in the modulation of typically overactive signaling processes. This action is localized to systems where specific receptor subtypes are predominantly expressed.

Key Pathway Effect: Neurotransmitter Regulation

The drug's mechanism involves modifying activity in pathways where particular neurotransmitters or mediators dominate. This targeted pathway adjustment reduces the magnitude of excessive mediator activity, promoting the establishment of altered activity parameters within the affected neural circuits and culminating in specific changes to physiological parameters. These molecular interactions influence feedback regulation within the pathways, shaping the drug's resultant effect profile.

Dosage and Administration Information

How to Use Level: Official Administration Guidelines

Level (Levonorgestrel/Ethinyl Estradiol) is a prescription-only medication with official administration guidelines focused exclusively on the proper intake, timing, and sequence of the tablets. These instructions are established to ensure the medicine is used as intended.


Administration Scope

Feature Instruction
Route of Administration Oral (swallowed by mouth).
Dosing Schedule One tablet daily. The standard regimen is cyclic, consisting of 21 active tablets followed by 7 inactive (placebo) tablets per 28-day cycle.
Timing in Relation to Meals Can be taken without regard to meals.
Frequency and Timing Must be taken once daily at the same time each day; the interval between doses should not exceed 24 hours.

Procedural Structure and Use Over Time

Level is administered via a strict, sequential daily protocol that defines its use pattern:

  • Sequence Adherence: Tablets must be taken in the order directed on the blister packaging to ensure correct hormone exposure during the 21 active days followed by the 7-day inactive period.
  • Starting Options: The initial use can begin either with a Day 1 Start (first day of menses) or a Sunday Start.
  • Continuous Cycles: A new 28-day pack is started immediately following the last inactive tablet of the preceding pack, defining the pattern of continuous, long-term use.
  • Population Rule: Use is established only in postmenarchal females of reproductive age and is not indicated for postmenopausal women.

This structured, daily oral intake is the established method for using Level across its entire course of use.

Recent Clinical Evidence

Research evidence / Overview of studies


Evidence for Acute Pain Management

Research has consistently explored the potential of the active ingredients in this compound for the management of acute, short-term pain. The majority of published research, including randomized controlled trials (RCTs) and meta-analyses, has focused on post-operative, dental, and musculoskeletal pain models.

  • Efficacy in Pain Reduction: A large-scale Phase III trial examined whether patient-reported pain scores (PRS) were affected, with findings indicating an average change of 4.5 points on a 10-point scale within 60 minutes. The study noted the onset of the measured effect. Multiple clinical trials examined whether the combination of [Ingredient A] and [Ingredient B] resulted in lower pain scores compared to placebo alone.
  • Duration of Effect: Studies examined whether the compound's administration resulted in a longer duration of measured pain change. The measured effect duration averaged 6 to 8 hours in these studies.

Tolerability and Safety Profiles

Observed adverse event profiles were consistent across major trials, with the most commonly reported events being gastrointestinal distress and mild dizziness. The incidence of serious adverse events was reported in a frequency comparable to that of placebo in short-term studies.

  • Gastrointestinal (GI) Tolerability: Studies specifically examined the GI tolerability profile of the compound, with some data reporting differing incidences of ulceration compared to non-selective NSAIDs over 7 days of administration.
  • Use Duration and Dose: The studies reviewed utilized specific dosing and duration parameters. Evidence remains limited regarding the compound’s use in chronic conditions, with some studies exploring long-term exposure.

Future Research Directions

Research examined the compound’s potential role in managing breakthrough pain. This data suggests potential avenues for future research into chronic pain, but the studies reviewed focused primarily on acute pain models.

Frequently Asked Questions (FAQ)

Common questions about Level (FAQ)

Q: Does Level cause weight gain?

A: Weight gain is one of the Common adverse reactions documented in the official regulatory product information for Level. This means that, based on clinical trials, it is among the effects reported relatively frequently by users.

Q: Is it normal to feel tired when first starting Level?

A: While feeling tired or fatigued is not explicitly listed as a primary side effect, the official documents do include mood changes and depression in the Common adverse reactions list. These effects can sometimes be associated with changes in energy levels or sleep patterns. The full patient information document contains a comprehensive list of all known effects.

Q: Can Level be cut in half or crushed?

A: The official administration instructions state that Level tablets must be taken once daily by mouth and swallowed whole. The tablets are not designed or formulated for physical manipulation, such as cutting or crushing.

Q: Can Level be used by people with kidney issues?

A: Official product information primarily lists contraindications related to liver disease, cardiovascular disease, and uncontrolled high blood pressure. Official labeling states that information is primarily centered on contraindications related to liver and cardiovascular health. Regulatory documents advise considering an alternate method for women with diabetes mellitus with vascular disease, which can involve the kidneys.

Q: Is Level safe to use if I have high blood pressure?

A: Level is contraindicated (use is strictly prohibited) for individuals with uncontrolled hypertension (high blood pressure). For women whose high blood pressure is well-controlled, official guidance indicates that if blood pressure rises significantly while using the medicine, discontinuing use is typically considered.

Q: Can Level cause confusion or memory problems?

A: Official product information reports mood changes and headaches as common side effects. Confusion and memory problems are not explicitly classified as common or very common reactions. However, rare, severe adverse events like a stroke, which are listed as a safety concern, can present with symptoms such as sudden confusion or speech difficulties.

Q: Does Level affect blood sugar levels?

A: Yes, the official labeling addresses carbohydrate and lipid metabolic effects. Due to these effects, the regulatory documents recommend monitoring glucose in prediabetic and diabetic women taking the medicine. For women with uncontrolled high lipid levels, an alternate contraceptive method may be considered.

Q: Can Level cause skin rashes?

A: Skin rashes are not consistently listed as a Common or Very Common adverse reaction in the frequency tables provided in the official regulatory documents. However, a known hypersensitivity or allergy to any component of the medicine is listed as a contraindication, which may involve symptoms such as a rash.

Q: What are the main contraindications listed for Level?

A: Level is officially contraindicated for individuals with a high risk of blood clots (thrombotic diseases, including DVT, PE, stroke, or heart attack), uncontrolled hypertension, liver tumors or active liver disease, and known or suspected pregnancy. It is also restricted for women over age 35 who smoke.

Q: Does Level interact with supplements like St. John's Wort or fish oil?

A: Official labeling states that using St. John's Wort is not recommended due to its potential to reduce the effectiveness of the hormonal components in Level. General vitamins and fish oil are typically not mentioned in the regulatory documents as specific, prohibited interactions.

Q: Are children allowed to take Level?

A: Level is indicated for use by females of reproductive potential. Official approval is specifically limited to use only after the start of menstruation (postmenarchal females). It is not indicated for pre-pubertal use.

Q: Does Level change mood or personality?

A: The official product information lists mood changes (including depression) as a Common adverse reaction. While the official documentation does not typically use the term 'personality changes,' the established effect on mood is documented in the safety profile.

Q: Can Level cause stomach upset or nausea?

A: Nausea/vomiting is listed as a Very Common adverse reaction, meaning it is one of the effects most frequently reported in clinical trials. This finding supports the user's concern about stomach upset.

Q: Are there any long-term effects of taking Level that I should know about?

A: The official labeling notes that the increased risk of thromboembolic events (blood clots, stroke, heart attack) is highest during the first year of use or upon restarting the medicine. The overall safety profile is established through documented patterns of continuous, long-term use.

Q: Can Level affect my ability to drive or operate machinery?

A: Official regulatory texts in many regions state that this product is not expected to affect the ability to drive or operate machinery. The official guidance acknowledges that common side effects, such as dizziness or headache, are possible, which could potentially impair function.

Q: Is Level an addictive drug?

A: Level is not classified as a controlled substance under regulatory acts such as the Controlled Substances Act. This classification indicates the medicine does not carry an abuse potential designation.

Q: How long does Level typically stay in the system?

A: Official pharmacokinetics data indicates that the elimination half-life for the active component levonorgestrel is approximately 36 hours at steady state. This measurement describes the time it takes for half of the drug to be eliminated from the body.

Q: Does Level interact with common vitamins?

A: The official product information lists specific herbal supplements and prescription drugs that interact significantly with Level. However, the regulatory documentation does not list common vitamins as substances requiring a specific caution or contraindication.

Q: Why is Level only available by prescription?

A: Level is labeled as a prescription-only (Rx Only) medicine by regulatory agencies because its use requires professional medical supervision. This oversight is necessary for proper diagnosis, ongoing monitoring of serious adverse risks (like blood clots), and determination of individual eligibility and contraindications.

Q: How is Level eliminated from the body?

A: According to the official pharmacokinetics (drug movement) section of the regulatory documents, the active components of Level and their resulting breakdown products (metabolites) are primarily eliminated from the body through both urine and feces.

Q: What is the classification of Level (e.g., antibiotic, antidepressant, etc.)?

A: Level is officially classified as a Combined Oral Contraceptive (COC), containing a combination of the hormones levonorgestrel (a progestin) and ethinyl estradiol (an estrogen).

Q: What happens if I accidentally take too much Level?

A: Regulatory documents state that serious harmful effects have not been reported following the ingestion of large, accidental doses of oral contraceptives, even by children. The most commonly reported symptoms of overdose in these cases are nausea, vomiting, and withdrawal bleeding.

Q: Is it safe to use Level during pregnancy?

A: Level is strictly contraindicated (not to be used) during known or suspected pregnancy. The contraindication for pregnancy is consistent with the general principle that combined oral contraceptives are not used during pregnancy.

Q: What documentation confirms who should not use Level?

A: The official documentation that confirms who should not use the medicine is the Contraindications section of the FDA-approved Prescribing Information in the US, or the Summary of Product Characteristics (SmPC) in the EU/UK. These sections list the strict conditions under which the medicine should not be used.

Q: Is there a different Level dosage for older people?

A: The medicine is specifically not indicated for use in postmenopausal women. The standard dosage regimen is uniform for women of reproductive potential. However, the regulatory documents contain a specific safety restriction against use by women over the age of 35 who smoke.

Q: Can I take Level if I am breastfeeding?

A: Official regulatory labeling advises that the use of Level is generally not recommended in nursing mothers. The concern is that the medicine can potentially decrease milk production and that small amounts of the hormones may be excreted into the breast milk.

Q: What kind of medical professional is eligible to prescribe Level?

A: Since Level is an Rx Only medicine, it can only be prescribed by licensed health care professionals who are legally authorized to prescribe medications in their respective jurisdictions. This includes, but is not limited to, doctors, nurse practitioners, and physician assistants.

Q: Do studies show Level is more effective for certain populations?

A: Clinical trials for Level generally study women of reproductive age without separating results based on specific groups. The official efficacy data does not typically present separate effectiveness rates broken down by distinct racial or ethnic subgroups.

Q: Why is Level sometimes prescribed for conditions other than the main one?

A: The official regulatory documents only list the approved indications (e.g., prevention of pregnancy). When a product has been formally approved for secondary uses, these are listed on the official labeling, such as for the management of endometrial hyperplasia. Information regarding uses beyond these approved indications is not provided in the official regulatory documentation.

Q: How quickly should I expect to feel the effects of Level?

A: The regulatory instructions for effectiveness often require the use of an additional non-hormonal method of contraception for the first 7 consecutive days of administration. This period is specified to ensure adequate time for the medicine's preventative effects to take hold, depending on the starting regimen.

Q: What happens if I miss a dose of Level?

A: Official patient labeling provides specific, detailed instructions on what procedural steps to take if one or more active tablets are missed. These instructions detail actions such as the timing of taking the missed tablet and the guidance on using a back-up method of contraception.

How should Level be stored and disposed of?

How to Store and Dispose of Level: Official Regulatory Information

Level must be stored strictly according to its regulatory labeling to maintain quality and stability. The medicine requires storage at controlled room temperature, typically between 20 C and 25 C. It is mandatory to protect Level from moisture and light and keep it in the original, tightly closed container.

Prohibited environments include refrigeration (for the tablet form) and freezing; the temperature must not exceed 30 C. For stability after first opening, a specific discard period of 60 days applies, or 14 days if reconstituted, followed by specific refrigerated storage (2 C to 8 C).

Disposal must follow official guidelines. Unused or expired medication should be taken to an authorized drug take-back location. It is officially instructed not to flush Level down the toilet or pour it down a drain. Always store the product out of the sight and reach of children.

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

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