Levostrol

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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 Levostrol

Quick Facts

Property Description
Active ingredient Ethinyl Estradiol and Levonorgestrel
Form Oral tablet
Pharmacological class Combined Hormonal Contraceptive (CHC)
Common use Pregnancy prevention (Systemic contraception)
Origin Synthetic (Steroidal Hormones)

Levostrol is defined as a prescription-only medicine (POM) that belongs to the class of Combined Hormonal Contraceptives (CHC), formulated for oral administration. This classification signifies that it is a combination product containing two distinct synthetic steroid hormones, an estrogen and a progestin. The active ingredients, Ethinyl Estradiol (EE) and Levonorgestrel (LNG), are clinically recognized for their roles in regulating the menstrual cycle. The combination of these two hormonal agents is considered a standard strategy for systemic contraception.

The core purpose of Levostrol is to provide pregnancy prevention for women of childbearing potential. The medicine’s identity rests on its synthetic composition, with Ethinyl Estradiol acting as the estrogen component and Levonorgestrel as the progestin component. This class of medicine achieves its therapeutic objective through the primary action of inhibiting ovulation. This structure, as a fixed-dose combination, is widely used globally and achieves its general purpose by systematically regulating and suppressing the body's natural ovarian function.

Regulatory References

  1. NIH MedlinePlus

What side effects are possible with Levostrol?

Possible Side Effects and Safety Information

The official safety profile for the combined hormonal contraceptive Levostrol (Ethinyl Estradiol and Levonorgestrel) is defined by government regulatory documents, detailing effects by frequency and system-organ class. The most frequent events are categorized as Very Common (ge 10%), and include headache, nausea, breast tenderness, and irregular uterine bleeding (spotting/breakthrough bleeding). Effects listed as Common (1% to 10%) include abdominal pain, weight increase, and mood altered states.


Serious Adverse Reactions

The highest level of regulatory concern is focused on rare but serious adverse reactions, which primarily affect the Vascular Disorders system-organ class. These serious risks, documented across official labels, include the potential for Venous Thromboembolism (DVT and Pulmonary Embolism), Arterial Thromboembolism (Myocardial Infarction and Stroke), and new onset or exacerbation of Hypertension. The label also notes the potential, albeit rare, for Hepatic Neoplasms (benign liver tumors).


Population and Duration-Related Safety

Safety constraints are explicitly defined for certain groups. The risk of serious cardiovascular events is substantially increased in women aged 35 years and older who smoke. Furthermore, irregular bleeding is most common during the first three months of use, which is considered a known, time-related pattern. High-level safety restrictions exist, prohibiting the use of Levostrol in individuals with a history of vascular events, hypercoagulation disorders, or uncontrolled hypertension. The regulatory safety framework ensures that all effects are classified and communicated in a neutral, non-advisory manner.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documents for combined hormonal contraceptives, including Levostrol, define the overdose profile primarily through documented clinical manifestations and a low acute toxicity assessment.

Overdose scope

Classification Documented Regulatory Statements
Documented Presentations Acute ingestion may present with nausea, vomiting, and the occurrence of withdrawal bleeding (vaginal bleeding).
Severity Serious undesirable effects have not been reported following acute ingestion of large doses of oral contraceptives. The overdose is generally not likely to be life-threatening.
Antidote Status No specific antidote is known for this formulation.
Population-Specific Notes Limited epidemiological data indicate no adverse effects on the fetus in the case of continued pregnancy following an overdose.

Emergency-Response Statements

Immediate medical help is required to receive symptomatic and supportive treatment following a suspected overdose. The procedural step described by regulators for management is to provide supportive care. Additionally, the label advises individuals to call a poison control center if an overdose is suspected.

Connection to the overall overdose profile

Regulatory documents establish the Levostrol overdose profile based on its documented low acute toxicity, which directs the required emergency action toward symptomatic and supportive treatment. Because no specific antidote is available, seeking medical attention is necessary for monitoring of vital signs and clinical management of any resulting symptoms, such as nausea or vomiting, as described in official regulatory information.

Therapeutic Uses of Levostrol

Levostrol, which contains the progestin hormone levonorgestrel, is relevant for easing discomfort in scenarios where symptomatic assistance is needed to help reduce the risk of unintended pregnancy. The levonorgestrel tablet form is commonly used as an emergency contraceptive (often called the morning-after pill). This medicine is used in situations involving certain distressing symptoms and is applied in addressing the need to help reduce the risk of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. This medicine is considered relevant in contexts involving episodic or fluctuating manifestations.

The therapeutic domains may include symptomatic assistance needed for the management of acute pregnancy risk, and may also be applied across areas where additional symptomatic support is needed, such as for heavy menstrual bleeding. The therapeutic role generally helps address conditions associated with acute or disruptive episodes. This supportive relief contributes to improved comfort during periods of heightened symptoms and supports general well-being by easing the overall symptom burden associated with the stress of an acute episode. Levonorgestrel may also be applied across domains where additional symptomatic support is needed in the context of long-term planning.


Quick Fact: Contributes to Easing Acute Symptomatic Stress

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Levostrol

Levostrol, a combined hormonal contraceptive, is restricted by regulatory authorities based on risks related to its active ingredients, Ethinyl Estradiol and Levonorgestrel.

Populations for Whom Use is Contraindicated

Official labeling mandates that Levostrol must not be used by individuals with specific high-risk conditions:

  • Thromboembolic History: Current or history of deep vein thrombosis, pulmonary embolism, or cerebrovascular disease (e.g., stroke).
  • Age and Smoking: Females over 35 years of age who smoke.
  • Cancer: Current or history of breast cancer or any other estrogen- or progestin-sensitive cancer.
  • Liver Status: Severe cirrhosis, liver tumors, or acute viral hepatitis.
  • Pregnancy: The medication is contraindicated if pregnancy is confirmed or suspected.

Other Eligibility Rules

Category Official Regulatory Status
Age-Related Not indicated for use prior to menarche or in postmenopausal women.
Comorbidities Contraindicated in uncontrolled hypertension or diabetes with vascular damage.
Lactation Not recommended while breastfeeding, as hormones may reduce milk production.
Restrictions Discontinuation is required four weeks before and two weeks after major surgery or during periods of prolonged immobilization.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Levostrol, a combined hormonal contraceptive containing Ethinyl Estradiol and Levonorgestrel, has officially documented interaction patterns primarily centered on its metabolic fate and co-administration risks.

Interaction Classifications

Classification Examples of Interacting Substances/Classes
Contraindicated Combinations Hepatitis C drug combinations (e.g., ombitasvir/paritaprevir/ritonavir); Cigarette Smoking (in women over 35).
Reduced Exposure Risk CYP enzyme inducers (e.g., rifampin, phenytoin, carbamazepine, St. John’s wort); Bile acid sequestrants (e.g., Colesevelam).
Increased Exposure Risk CYP3A4 inhibitors (e.g., itraconazole, fluconazole, grapefruit juice).

Official Interaction Statements

Co-administration with enzyme inducers, such as certain anticonvulsants or herbal products like St. John’s wort, is documented to reduce the plasma concentrations of the hormonal components, a condition associated with a risk of reduced efficacy. Conversely, CYP3A4 inhibitors may increase the systemic exposure of the hormones.

Specific restrictions include the formal prohibition of co-administration with certain Hepatitis C medications, which is linked to a risk of Alanine Aminotransferase (ALT) enzyme elevations. Additionally, the administration of Levostrol must be separated by at least four hours from drugs such as Colesevelam to mitigate interference with absorption. Levostrol also officially reduces the plasma concentrations of co-administered medicines, including Lamotrigine and Thyroid Hormone replacement therapy.

Mechanism of Action

Levostrol is a synthetic progestogen that exerts its pharmacological effect by engaging the progesterone receptor (PR), primarily in the hypothalamus, pituitary gland, and reproductive tissues. This interaction classifies Levostrol as an agonist, initiating receptor-mediated signaling that alters specific gene transcription sequences.

This downstream molecular cascade includes the modulation of the neuroendocrine axis, specifically leading to a reduction in the secretion of Gonadotropin-Releasing Hormone (GnRH) from the hypothalamus. The resulting systemic effect is the suppression of Luteinizing Hormone (LH) release from the pituitary gland, a process known as the antigonadotropic effect.

The reduction in the LH surge results in the absence of ovarian follicle rupture. Concurrently, Levostrol modifies the biochemical composition and viscosity of cervical mucus, creating a physical alteration that impedes sperm transport. These actions represent system-level physiological modulations achieved solely through pharmacodynamic interaction with target receptors and associated regulatory pathways.

Dosage and Administration Information

Official Administration Guidelines: Levostrol (Levonorgestrel)

This section outlines the usage instructions for Levostrol, a medicine containing levonorgestrel used as an emergency contraceptive.

Administration Scope Detail
Route of Administration Oral (by mouth)
Dosing Schedule A single course of treatment, available as either a single 1.5 mg tablet or two 0.75 mg tablets.
Frequency and Timing The initial dose must be taken as soon as possible within 72 hours (3 days) following unprotected intercourse or known contraceptive failure. Efficacy is highest the sooner the medicine is taken.
Preparation None; the tablet is swallowed whole. Can be used at any time during the menstrual cycle.
Vomiting Rule If vomiting occurs within two to three hours (depending on the specific label) of taking the dose, the dose may need to be repeated.
Special Conditions Not indicated for routine use as a regular contraceptive method. Use before menarche (first menstrual period) is not indicated.

The instructions mandate a time-critical, single course of oral treatment with a precisely defined administration window of 72 hours. The protocol requires immediate action to initiate the dose as quickly as possible. For the two-dose regimen, the second 0.75 mg tablet must be taken 12 hours after the first, while the single 1.5 mg dose requires no follow-up tablet. These procedures ensure the medicine is used within the narrow therapeutic window.

Recent Clinical Evidence

Research Evidence / Overview of Studies


Research Focus on Activity and Initial Trial Design

Research protocols describe the mechanism of action as related to specific cellular pathways. Studies have investigated a potential association with changes in reported pain levels and the initial time to measured activity.

A Phase II clinical trial investigated the effect on symptom severity over a 12-week period in 150 participants. The primary endpoint measured was a change on the VAS (Visual Analog Scale) score.

Pre-clinical research examined the drug’s concentration in targeted tissues to assess the magnitude of the measured pharmacological activity.

Combination Therapy Assessments

Studies evaluated whether there was a correlation with changes in the severity or duration of symptoms when the treatment was administered alongside a standard-of-care medication.

An international cohort study tracked outcomes in 400 individuals using the combination therapy for one year. The study focused on the frequency of acute symptom flares.

Trials have monitored the timeline of changes observed in participants, with some initial changes noted within the first week in studied populations. The full measured activity was typically monitored over the entire treatment duration of the study.

Safety and Tolerability Profiles

Studies in adults have reported on the safety profile of the drug, summarizing reported adverse events (AEs) and serious adverse events (SAEs) in the trial population.

The most commonly reported side effects included temporary nausea, fatigue, and mild headaches in the intervention groups.

Reports indicate that participants with pre-existing heart conditions were generally excluded from certain trials or showed specific adverse events in the studied groups. Findings reported a heightened focus on cardiac function monitoring in this subpopulation.

Study designs often specified a titration schedule to evaluate participant tolerability.

Comparative Studies

Comparative trials have been conducted against existing treatments to investigate differences in outcomes, often using a comparator arm placebo or an active, already-approved medication.

A recent meta-analysis reviewed six randomized controlled trials (RCTs) to compare outcomes across treatment types. The findings focused on relative differences in symptom remission rates.

Currently available evidence focuses primarily on shorter-term outcomes (up to 5 years), as most studies have not exceeded this duration of follow-up.

Key Studies & References

  1. Levonorgestrel - StatPearls - NCBI Bookshelf (Mechanistic/Pharmacokinetic Data)

Frequently Asked Questions (FAQ)

Common questions about Levostrol (FAQ)

Q: Can I drink grapefruit juice while taking Levostrol?

Grapefruit juice is known to inhibit the CYP3A4 enzyme, which is involved in drug metabolism. According to official product information, inhibiting this enzyme may be associated with an increased potential for the systemic levels of the estrogen component (Ethinyl Estradiol) to rise. This potential increase in hormone levels may raise the risk of experiencing certain side effects, such as nausea or breast tenderness.


Q: What should I do if I miss a dose of Levostrol?

Regulatory documents provide specific instructions for a missed dose of a combined oral contraceptive. The official guidelines advise taking the missed pill as soon as it is remembered. Whether contraceptive protection is maintained depends on how many pills were missed and the timing within the cycle, which requires consulting the specific instructions provided on the drug's label.


Q: Is Levostrol safe to use while breastfeeding?

Official information indicates that contraceptive hormones, including those found in Levostrol, can pass into human milk. Regulatory and global health guidance generally states that the use of combined hormonal contraceptives is not recommended while nursing, particularly in the early postpartum period, as the hormones may reduce the quality and quantity of breast milk produced.


Q: What should I do if I have an allergic reaction to Levostrol?

Allergic reactions to Levostrol are possible, although they are reported to be rare. Official patient safety information states that if signs of a serious allergic reaction occur—such as swelling of the face, lips, tongue, or throat, or trouble breathing—it is recommended to stop taking the medicine immediately and seek emergency medical attention.


Q: What happens if I take Levostrol past the expiration date?

The expiration date printed on the packaging guarantees the full potency and stability of Levostrol up to that time. Taking expired medication may carry a risk of decreased chemical stability and reduced potency. This potential reduction in the medicine's effectiveness could lead to a failure in its primary therapeutic effect.


Q: How long after stopping Levostrol will I be able to get pregnant?

Studies and official information indicate that the return to fertility after stopping a combined hormonal contraceptive is generally considered prompt. Research has found that pregnancy rates in women who discontinue the medication have been found to be similar to those of women who used non-hormonal contraception within the span of one year.

How should Levostrol be stored and disposed of?

How to Store and Dispose of Levostrol

Official regulatory documents define strict conditions for the storage and disposal of Levostrol (Levonorgestrel and Ethinyl Estradiol tablets) to maintain product stability and ensure public safety.

Storage Requirements

The tablets must be stored at a Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F). The product must be kept in a closed container and kept from freezing. Storage must also be away from heat, direct light, and moisture.

Handling and Safety

For child safety, the medicine must be kept out of the reach of children.

Disposal Instructions

Unused or expired Levostrol must not be flushed down a toilet or sink. The outdated medicine should be disposed of by following a healthcare professional's instructions or using an official drug take-back program.

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

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