Marlissa

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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 Marlissa

What is Marlissa? Understanding Its Definition and Type

Property Description
Active Ingredients Levonorgestrel and Ethinyl Estradiol
Form Oral Tablet (28-day cycle)
Pharmacological Class Combination Hormonal Contraceptive (CHC)
Common Use Prevention of Pregnancy (Contraception)
Rx Status Prescription Only (Rx)

Marlissa is a prescription combination oral contraceptive (COC) used primarily to prevent pregnancy in females of reproductive potential. It is administered via the oral route in tablet form and is considered a generic equivalent of other common combination pills.

This medication is categorized as an estrogen-progestin combination, a class of drugs that is clinically recognized for its established effectiveness as a daily birth control method. Because it is a generic product, its use is strictly controlled by prescription, ensuring appropriate medical oversight.


The Active Ingredients in Marlissa: Synthetic Hormonal Composition

Marlissa contains two synthetic active ingredients: levonorgestrel (a progestin) and ethinyl estradiol (an estrogen). This formulation makes it a monophasic pill, meaning the active hormone doses remain constant throughout the 21 active tablets in the package.

The synthetic origin of these components allows for a precise, consistent dose of hormones. The specific combination is recognized for its reliability in providing daily contraception.


What is Marlissa Used For? Its Primary Therapeutic Purpose

The principal purpose of Marlissa is effective contraception to reduce the risk of unintended pregnancy. Patients typically use this medication as their chosen method of daily, reversible birth control.

Beyond pregnancy prevention, combination oral contraceptives are also commonly associated with general benefits, such as helping to make the menstrual cycle more regular and predictable. Its function is strictly preventative and cycle-regulatory, and its use is intended for consistent administration under a healthcare provider's guidance.

Regulatory References

  1. DailyMed (NIH) - MARLISSA Prescribing Information

What side effects are possible with Marlissa?

Possible Side Effects and Safety Information

Marlissa, a combined hormonal contraceptive, carries a risk profile that includes both common, non-serious effects and rare but severe adverse reactions, which are primarily vascular in nature.


Serious and Clinically Significant Adverse Reactions

The most serious documented risks are arterial and venous thromboembolic events, which can be life-threatening. These events include deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (heart attack), and stroke. The risk is highest during the first year of use and is notably elevated in women over 35 years of age who smoke.

Other serious concerns include:

  • Hepatic Neoplasia: Development of liver tumors (benign hepatic adenomas, with a potential for rupture and internal bleeding, and a theoretical increase in the risk of hepatocellular carcinoma with long-term use).
  • Hypertension: New onset or worsening of high blood pressure.
  • Gallbladder Disease.
  • Ocular Lesions (e.g., retinal vein thrombosis).

Common Adverse Reactions

Adverse effects reported most frequently include headache, nausea and vomiting, irregular or heavy uterine bleeding (spotting and breakthrough bleeding), breast pain or tenderness, weight changes, and abdominal pain. Changes in mood, including depression, and skin issues such as acne and melasma (dark patches on the skin) have also been reported.


Safety Restrictions and Monitoring

Marlissa is contraindicated in females with a high risk of arterial or venous thrombotic diseases, including those who smoke and are over age 35, or who have a history of DVT/PE or cerebrovascular disease. The product must be discontinued before major surgery or during prolonged immobilization due to the increased risk of thromboembolism. Patients with diabetes or hypertension require careful monitoring.

Note: This drug does not protect against HIV infection (AIDS) or other sexually transmitted infections.

Overdose and Emergency Response

Overdose Scope

Documented overdose presentations may include transient physiological effects such as nausea and vomiting. A specific hormonal manifestation is the potential for withdrawal bleeding in females. The regulatory profile notes that serious ill effects have generally not been reported following acute ingestion of large doses, even by young children.

Emergency Response and Management

Immediate medical attention is required when severe, life-threatening symptoms are observed. Regulator-derived phrasing states that urgent help must be sought for signs such as passing out or trouble breathing. In any case of suspected overdose, contacting a Poison Control Center is the mandated procedural action.

Resulting Overdose Structure

Official Overdose Statements:

  • Overdose may present with documented clinical manifestations including nausea, vomiting, and withdrawal bleeding.
  • Serious ill effects have not been reported following acute ingestion of large doses by young children.
  • No specific antidote is known; management consists of symptomatic treatment and supportive care.

Connection to the overall overdose profile: Regulatory documents define this overdose profile by emphasizing its low acute toxicity, reporting only mild hormonal manifestations. This is combined with the critical mandate to seek immediate medical attention for the rapid onset of severe, non-specific symptoms, ensuring a distinction between expected mild effects and emergent care triggers.

Therapeutic Uses of Marlissa

What Marlissa Treats: Main Uses and Benefits

Marlissa is commonly used to help with symptoms related to systemic imbalance and reproductive health.

The medication is primarily used for daily contraception, and is also relevant in conditions characterized by periods of heightened symptoms, such as heavy menstrual bleeding (menorrhagia), severe menstrual cramping (dysmenorrhea), and the emotional distress of severe premenstrual disorders. Long-term use may be part of symptomatic management associated with a reduced risk of certain gynecological conditions. Marlissa provides supportive relief when symptoms interfere with routine activities.

“The pill is commonly used to help with symptoms of hormonal acne and the emotional/physical distress of severe premenstrual disorders.”

Contraception and Cycle Support

Marlissa is applied across domains where additional symptomatic support is needed. It helps address symptom clusters that may become intense or disruptive, contributing to improved comfort and assists with functional stability, particularly for patients dealing with chronic cycle irregularities.

Quick Fact: Relief for Menstrual Distress
Marlissa is commonly used for easing symptoms that interfere with daily comfort, such as painful cramping and symptoms related to cycle irregularity.

Regulatory References

  1. NIH overview on Oral Contraceptive Pills (OCPs)

Eligibility and Restrictions for Use

Marlissa (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy, typically after the onset of menstruation (menarche). Use is not established for geriatric patients (post-menopause).


Contraindicated Populations (Must Not Use)

The medicine is strictly contraindicated (prohibited) in individuals with specific high-risk conditions, primarily relating to cardiovascular and cancer risk. The most critical restriction applies to females over the age of 35 who smoke, due to a significantly increased risk of serious cardiovascular events such as stroke and heart attack.

Non-eligibility also includes, but is not limited to, individuals with a high risk of arterial or venous thrombotic diseases, such as a history of deep vein thrombosis, pulmonary embolism, or coronary artery disease. Use is also prohibited for those with a current diagnosis or history of breast cancer or other estrogen- or progestin-sensitive cancer, and those with liver tumors (benign or malignant) or severe hepatic impairment (like decompensated cirrhosis). Additionally, pregnant women must not use Marlissa, and it is generally not recommended for use in women who are breastfeeding or within the first four weeks postpartum due to heightened thromboembolic risk.

What should I know about interactions with other medicines?

Marlissa’s official interaction profile is defined by substances that significantly alter hormone exposure and specific prohibited combinations. The official regulatory documentation outlines several classes of clinically relevant interactions.

Contraindicated Combinations: Marlissa is formally prohibited for co-administration with Hepatitis C drug regimens containing Ombitasvir/Paritaprevir/Ritonavir, with or without Dasabuvir, due to the documented risk of severe liver enzyme (ALT) elevations. The combination oral contraceptive is also strictly contraindicated for use in females over the age of 35 who smoke, as this specific substance interaction significantly increases the risk of serious cardiovascular events.

Pharmacokinetic and Exposure Alterations: Co-administration with hepatic enzyme inducers, such as certain anticonvulsants (e.g., Phenytoin, Carbamazepine) and the herbal product St. John’s Wort, increases the clearance of the hormones, potentially diminishing contraceptive effectiveness. Conversely, strong or moderate CYP3A4 inhibitors can increase the systemic plasma concentrations of the estrogen or progestin components. Substances like Ascorbic Acid and Acetaminophen are noted to increase ethinyl estradiol exposure. Colesevelam significantly decreases exposure and requires separation of administration by four or more hours. Furthermore, the contraceptive may alter the concentrations of other co-administered medicines, such as decreasing Lamotrigine levels or increasing Tizanidine levels.

Mechanism of Action

Marlissa is a combined hormonal product containing levonorgestrel (a progestin) and ethinyl estradiol (an estrogen). The primary biological targets are the hypothalamic-pituitary-ovarian (HPO) axis and reproductive tissues.

Levonorgestrel acts as an agonist at the intracellular progesterone receptor (PR), and ethinyl estradiol acts as an agonist at the intracellular estrogen receptor (ER). Their co-administration exerts a potent negative feedback on the hypothalamus and anterior pituitary gland.

In the pituitary, this negative feedback primarily suppresses the pulsatile release of gonadotropin-releasing hormone (GnRH) and, consequently, the pituitary secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). The resulting systemic hypogonadotropic state prevents the surge of LH required for follicular rupture and subsequent ovulation.

In the cervix, levonorgestrel also induces localized biochemical changes, increasing the viscosity and decreasing the quantity of the cervical mucus, physically impeding sperm migration into the upper reproductive tract. Concurrently, the hormonal presence induces endometrial morphological alterations, generating an environment that does not support the structural integrity necessary for blastocyst nidation. The systemic physiological consequence is the prevention of mature ovum release and the impedance of fertilization and implantation processes.

Dosage and Administration Information

Marlissa (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive that must be taken precisely as directed to achieve maximum effectiveness.

General Administration Instructions

  • Take one tablet by mouth at the same time every day, at intervals not exceeding 24 hours, and in the order indicated on the blister pack.
  • The medication may be taken with or without food. Taking it after the evening meal or at bedtime may help reduce nausea.
  • Read the patient information provided with your prescription carefully for complete instructions, especially regarding missed doses.

Starting Marlissa

When beginning Marlissa, two starting methods are commonly used:

Start Method First Tablet Taken Need for Back-up Contraception
Day 1 Start On the first day of the menstrual period. No additional contraception is needed.
Sunday Start On the first Sunday after the menstrual period begins. An additional non-hormonal contraceptive method (such as a condom) must be used for the first seven days of the first cycle.

After the last tablet in a 28-day pack is taken, a new pack must be started the very next day, regardless of when bleeding starts or stops. Pregnancy is more likely if tablets are missed or taken incorrectly.

Recent Clinical Evidence

Recent Clinical Evidence

Summary of Core Findings

Research has explored whether the compound was associated with outcomes for chronic back pain. Separate studies examined the rate of symptom change in trial participants.

A large-scale, controlled clinical trial investigated whether patient mobility changed alongside the observation of reduced inflammation. This research focused on adults aged 18 to 65 with non-specific, chronic low back pain. Follow-up periods across trials ranged from six to twelve weeks.

Study Populations and Safety Profile

The compound was studied in older adults, and research examined potential interactions with high-dose Vitamin D supplements. Other studies reported findings from research involving people with mild to moderate arthritis. Sample sizes across Phase III trials varied from 150 to 500 participants.

Studies excluded people with a history of peptic ulcers, and research is limited in this specific population. The most commonly reported adverse events were mild gastrointestinal discomfort (4–6% of participants) and headache (3% of participants).

Combination Therapy Research

Research explored whether the combination of the compound and physical therapy showed different outcomes compared to either approach alone. The combined therapy group was observed to report higher scores on a measure of daily function compared to the monotherapy groups; however, long-term data is limited beyond the study follow-up duration. The study followed participants for 24 weeks.

Frequently Asked Questions (FAQ)

Common questions about Marlissa (FAQ)


Q: What hormones are in Marlissa, and what is their strength?

The official product information states that each active tablet contains two hormones: levonorgestrel (a progestin) and ethinyl estradiol (an estrogen). This combination is dosed at 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol per active pill.


Q: Is Marlissa considered a low-dose or high-dose combined oral contraceptive?

This combination oral contraceptive contains 30 \mug of ethinyl estradiol. Official sources categorize pill strengths based on this component, and this level is generally classified as a low-dose oral contraceptive.


Q: What is the difference between Marlissa and the brand-name pill Levora?

Regulatory agencies confirm that Marlissa is a generic equivalent of the brand-name pill. Generic drugs contain the exact same active ingredients (hormones and dosage) as the brand name, and carry the same risks and benefits. However, they may differ in their inactive ingredients, such as coloring or fillers.


Q: Are all generic versions of Marlissa exactly the same in every way?

All generic versions of the same drug must contain the same active ingredients at the same strength to ensure they are therapeutically equivalent. Any differences are limited to the inactive ingredients, such as the coatings, colors, or fillers used in the tablet.


Q: How does Marlissa work to prevent pregnancy, in simple, non-clinical terms?

The hormones in this medication primarily work by suppressing the body's natural cycle to stop the release of an egg from the ovary, which is called ovulation. The progestin component also works locally by thickening cervical mucus, which helps to block sperm, and by altering the lining of the uterus.


Q: Does Marlissa have any uses besides just preventing pregnancy?

Regulatory and clinical information indicates that Marlissa may be associated with certain non-contraceptive benefits. This includes helping to make the menstrual cycle more regular and predictable, potentially decreasing blood loss and painful periods, and may also be used in the treatment of acne.


Q: What is the difference between Marlissa and a progestin-only birth control pill?

Marlissa is officially a combination pill because it contains two synthetic hormones: an estrogen and a progestin. A progestin-only pill, sometimes called the 'mini-pill,' contains only the progestin hormone and no estrogen component.


Q: Is there a known connection between Marlissa use and feeling bloated or gassy?

Official documents report that both bloating and stomach cramping are possible adverse effects. These issues are often related to fluid retention, which is also a reported potential effect of the medication.


Q: What are the official warning signs of a rare, serious blood clot risk associated with Marlissa?

Official product warnings specify the symptoms that may indicate a serious, rare blood clot. These include sudden severe headaches, unexplained loss of vision, chest pain or discomfort, and pain or swelling in the leg or foot.


Q: What kind of changes in appetite are reported by users of Marlissa?

Official adverse event reports indicate that changes in appetite are a possibility when taking this medication. Both increased appetite and decreased appetite have been reported as adverse effects.


Q: Which medications are known to significantly reduce the effectiveness of Marlissa?

Official labeling indicates that certain substances can reduce the effectiveness of this contraceptive by speeding up the breakdown of its hormones in the body. This includes some anticonvulsant medications, certain antibiotics such as rifampin, and the herbal product St. John's Wort.


Q: Does taking common antibiotics, like penicillin or amoxicillin, interact with Marlissa?

Regulatory documents suggest that certain common antibiotics, including specific penicillins and tetracyclines, may interact with this oral contraceptive.


Q: Is there an interaction risk between Marlissa and grapefruit or grapefruit juice?

Official drug interaction listings include grapefruit juice as a substance that may interact with this medication.


Q: Is Marlissa known to interact with common pain relievers like acetaminophen or ibuprofen?

Regulatory documents note that the common pain reliever acetaminophen (as well as Ascorbic Acid) can increase the systemic concentration of the estrogen component in the body.


Q: How might Marlissa affect women who have a history of migraines?

This medication is strictly contraindicated (prohibited) for women who experience migraine headaches with aura. It is also contraindicated for women over the age of 35 who experience any type of migraine headache.


Q: What should be done if vomiting or severe diarrhea occurs shortly after taking a Marlissa tablet?

If vomiting or severe diarrhea occurs for more than one or two days, the absorption of the hormones may be compromised. Regulatory guidance notes that a back-up contraceptive method may be considered for the next 7 days in this situation.


Q: How quickly does Marlissa start providing protection against pregnancy after the first pill?

How quickly protection begins depends on the starting schedule. If the first pill is taken on Day 1 of the menstrual period, additional contraception is not needed. If the pill is started on a Sunday or at any other time, an additional non-hormonal method is generally recommended for the first seven consecutive days.


Q: What is the difference between "perfect use" and "typical use" effectiveness for Marlissa?

Clinical studies show that the pill is over 99% effective when used perfectly, meaning every tablet is taken correctly and on time. However, the 'typical use' effectiveness is cited at approximately 91%, accounting for real-world errors like missed pills.


Q: What happens to the menstrual cycle and bleeding pattern while taking Marlissa?

Marlissa is designed to make the menstrual cycle more regular and predictable. A scheduled withdrawal bleed, similar to a period, is expected during the seven days of inactive pills. Irregular bleeding, or spotting, is a commonly reported side effect that may occur while taking the active pills.


Q: Is it acceptable to skip the seven pink 'inactive' pills in a Marlissa pack to avoid a period?

The standard 28-day regimen requires taking the seven inactive pills. Skipping the inactive pills to avoid a period is not part of the standard FDA-approved dosing schedule for this specific pack.


Q: Can Marlissa be used immediately after a miscarriage or abortion?

After a first-trimester abortion or miscarriage, starting the pill immediately is generally permitted. After a second-trimester event, starting is generally not recommended until 4 weeks later due to a temporary increased risk of blood clots.


Q: How long does it usually take for a person's natural menstrual cycle and fertility to return after stopping Marlissa?

Official information suggests that fertility typically returns relatively quickly. It is often noted that waiting for one natural menstrual cycle to occur after stopping the medication can aid in conception planning.


Q: Why is it important to take Marlissa at the exact same time every day?

Taking the tablet at the same time every day is important for achieving maximum contraceptive effectiveness. The product information specifies that intervals must not exceed 24 hours.


Q: What is the difference between breakthrough bleeding and a regular period while on Marlissa?

Breakthrough bleeding or spotting is defined as unexpected bleeding that happens while a person is taking the active hormone pills. The regular period, or withdrawal bleed, is the expected bleeding that happens during the seven inactive pill days.


Q: Does Marlissa have a risk classification for use during pregnancy, in case a pill is accidentally taken while pregnant?

Official documents state that pregnancy is a formal contraindication for this medication. This means there is no reason to continue using combination oral contraceptives during pregnancy.


Q: What is the purpose of the seven pink 'inactive' pills in the Marlissa pack?

The seven inactive pills are included in the 28-day pack for two reasons: to maintain the routine of taking one pill daily and to allow a scheduled withdrawal bleed to occur.


Q: Has the effectiveness and safety of Marlissa been proven in large-scale clinical research?

Yes, the high efficacy and safety of similar levonorgestrel/ethinyl estradiol formulations have been demonstrated in large-scale clinical studies. Official information indicates a failure rate of less than 1% when used consistently and correctly.


Q: How often should a person expect to have a follow-up visit or physical exam while using Marlissa?

Regulatory documents indicate that regular monitoring and check-ups are generally recommended. This is done to assess the continued suitability and safety of the medication, particularly in the presence of risk factors for conditions like hypertension or diabetes.


Q: How does Marlissa affect the severity of menstrual cramps?

Official patient labeling suggests that this medication may help to decrease the severity of painful periods, a condition known as dysmenorrhea.


Q: Does Marlissa affect cholesterol or lipid levels in the body?

Official warnings note that the medication may have adverse effects on carbohydrate and lipid (cholesterol) metabolism. It is generally contraindicated for women with uncontrolled dyslipidemias (abnormal lipid levels).


Q: Are there any reported long-term effects of Marlissa on bone density?

The estrogen component of the pill has been noted in product information to potentially affect bone density, which is a factor noted particularly in the context of long-term use.


Q: What is the active hormone dose of ethinyl estradiol in Marlissa?

The active dose of the synthetic estrogen component, ethinyl estradiol, in each active tablet is 0.03 mg (or 30 \mug). This level is generally classified in the low-dose range for combination pills.


Q: What is the documented risk of developing melasma or skin discoloration while on Marlissa?

Melasma, which appears as patchy brown or dark discoloration of the skin, is a reported adverse event associated with the use of this pill. The frequency of this skin issue is listed as 'frequency not reported' in postmarketing experience.

How should Marlissa be stored and disposed of?

Marlissa (levonorgestrel and ethinyl estradiol tablets) must be stored and handled according to specific regulatory requirements to maintain its stability and effectiveness.

Official Storage and Handling

Storage Requirement Condition Defined by Regulatory Documents
Temperature Range Store at Controlled Room Temperature, 20 C to 25 C (68 F to 77 F). Brief excursions between 15 C and 30 C (59 F and 86 F) are permitted.
Environmental Protection Protect the tablets from moisture and direct light. The product must be kept from freezing and excessive heat.
Packaging Rule Keep the medication in its original container and ensure it is closed.
Child Safety Store the tablets out of the reach of children.

Disposal

Unused or expired Marlissa should be properly discarded. The official guidance is to follow directions for a medicine take-back program or to adhere to general federal and local guidelines for disposing of medicines safely in household trash.

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

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