Ortho Evra

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Ortho Evra

Medically reviewed

Marina Burgos

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 Ortho Evra

Property Description
Active Ingredient Norelgestromin, Ethinyl Estradiol (Combination)
Form Transdermal Contraceptive Patch (Transdermal System)
Pharmacological Class Progestogens and Estrogens in Combination (CHC)
Common Use Prevention of Pregnancy
Origin Synthetic Sex Steroids

What Type of Medicine is Ortho Evra?

Ortho Evra is classified as a combination hormonal contraceptive (CHC), indicated for the prevention of pregnancy in women of reproductive potential who prefer a transdermal application. This medication belongs to the comprehensive pharmacological class of Progestogens and Estrogens in Combination.

The system utilizes two distinct types of synthetic sex steroids: the progestin component, Norelgestromin (NGMN), and the estrogen component, Ethinyl Estradiol (EE). This CHC formulation is used for contraception. The general purpose of this system is to offer reliable, reversible pregnancy prevention by systematically modifying the user's natural reproductive cycle.


Composition and Delivery: The Transdermal System

The drug entity is formulated as a transdermal patch (or transdermal system), a thin, matrix-type device designed for application directly to the skin. This physical form is a distinctive feature of the product, setting it apart from frequently prescribed oral contraceptive tablets.

The patch's adhesive layer holds the synthetic hormones and is engineered to release them continuously into the systemic circulation through the skin. This transdermal administration route avoids initial metabolism in the digestive system. The mechanism relies fundamentally on the suppression of ovulation, which is supplemented by alterations to the cervical mucus and the uterine lining, thereby creating multiple barriers to prevent pregnancy.

Regulatory References

  1. DailyMed: Norelgestromin and Ethinyl Estradiol Patch

What side effects are possible with Ortho Evra?

Possible Side Effects and Safety Information

The safety profile of the Norelgestromin/Ethinyl Estradiol transdermal system is characterized by officially documented adverse reactions and specific regulatory limitations. The use of this combination hormonal contraceptive is associated with a risk of serious cardiovascular events, including Venous Thromboembolism (VTE) and Arterial Thromboembolism (ATE), such as stroke and myocardial infarction. The official label notes that the transdermal system results in approximately mathbf60% higher systemic exposure to Ethinyl Estradiol compared to some common oral contraceptives, which may influence the risk of estrogen-related adverse events.


Frequency Classification of Adverse Reactions

Adverse reactions are classified by occurrence based on clinical trial data and regulatory review:

  • Very Common (mathbfgeq 1/10): Effects documented at the Application Site (e.g., irritation, pruritus) and Headache.
  • Common (mathbf>1/100 to mathbf<1/10): Includes Nausea, Vomiting, Breast Symptoms (tenderness, discomfort), Weight Increased, Dizziness, and Mood Disorders (including depression). Vaginal Bleeding/Menstrual Disorders (e.g., spotting, irregular bleeding) are also common, often occurring during the first few months of use.

Safety Constraints and Population-Specific Notes

The system is contraindicated for women who are over 35 years of age and smoke, due to a significantly increased risk of serious cardiovascular events. Furthermore, the official label specifies that contraceptive efficacy may be decreased in women with a Body Weight equal to or greater than mathbf90 kg. The product is also contraindicated in individuals with active Hepatic Impairment or a history of ophthalmic vascular disease.

Overdose and Emergency Response

The official regulatory documentation for the Ortho Evra transdermal system provides specific guidance on overdose manifestations and required emergency actions. The overall profile for this combination hormonal contraceptive indicates a documented low risk of acute, serious ill effects; regulatory statements note that serious complications have not been reported following accidental overexposure to large doses of hormonal contraceptives.

Overdose manifestations described in the official labeling primarily affect the gastrointestinal and reproductive systems. These documented signs may include the onset of nausea and vomiting. Additionally, regulatory sources note that unusual vaginal bleeding or withdrawal bleeding may occur in females following an overexposure event.

When a suspected overdose occurs, immediate regulatory action is mandated: all transdermal contraceptive systems should be removed. The label instructs users to seek emergency guidance by contacting their regional poison control centre for specific management of the situation. Treatment is supportive and aimed at managing the symptoms that are present, as no specific antidote is known. Furthermore, the official management protocol requires post-event monitoring; liver function tests, specifically transaminase levels, must be conducted 2 to 3 weeks after the overdosage event.

Therapeutic Uses of Ortho Evra

The primary therapeutic application of this hormonal system is for support for the prevention of unintended pregnancy in women of reproductive potential. The medication is an estrogen/progestin combination hormonal contraceptive (CHC). The system is considered relevant for its use in supporting the patient in managing symptoms related to systemic imbalance.

Support for Disruptive Menstrual Cycle Symptoms

This therapy is applied across domains where additional symptomatic support is needed. It is commonly used to help with conditions characterized by periods of heightened symptoms, specifically managing symptoms related to physical discomfort like heavy menstrual bleeding (menorrhagia) and severe menstrual cramps (dysmenorrhea). This application provides support that may assist with easing the overall symptom burden, as it generally contributes to making periods lighter, shorter, and more predictable. The therapy is relevant when symptoms become temporarily overwhelming and short-term symptom stabilization is important.

Quick Fact: Symptomatic support for Severe Menstrual Cramps

The continuous administration of this combined therapy is primarily relevant for pregnancy prevention, but also supports the management of dysmenorrhea, menorrhagia, and managing the long-term risk associated with ovarian and endometrial cancers.

Eligibility and Restrictions for Use

The eligibility for using the Ortho Evra transdermal system is strictly defined by regulatory documents, focusing primarily on excluding women with pre-existing risks for serious cardiovascular or thromboembolic events. The medicine is indicated for the prevention of pregnancy in women of reproductive potential.

Populations For Whom Use Is Contraindicated

The patch is strictly forbidden for several groups, including women over 35 years of age who smoke, due to a significantly increased risk of cardiovascular events. It is also contraindicated for women with a high risk of arterial or venous thrombotic diseases, a history of blood clots, uncontrolled hypertension, or certain valvular heart diseases.

Contraindications also apply to women with a history of breast cancer or other hormone-sensitive cancers, active liver disease or liver tumors, and migraine headaches with aura or focal neurological symptoms. Use is prohibited during pregnancy and is not recommended while breastfeeding, as it may diminish milk supply.

Eligibility-Related Restrictions

Condition Regulatory Status/Restriction
Body Weight Limitation of Use for women at or above 198 lbs (90 kg), as effectiveness may be reduced
Surgery/Immobility Must be stopped at least four weeks before and two weeks after major surgery associated with thromboembolism risk
Age Group Not indicated for use in pre-menarcheal or post-menopausal women

These constraints ensure that the use of this combination hormonal contraceptive aligns with officially documented safety thresholds.

What should I know about interactions with other medicines?

The official regulatory profile for Ortho Evra (norelgestromin/ethinyl estradiol transdermal system) documents several clinically significant interactions, primarily related to enzyme induction and inhibition.

Interaction Classifications

Classification Constraint / Restriction Interacting Substances / Conditions
Contraindicated Prohibited for co-administration. Hepatitis C combination drug regimens (Ombitasvir/Paritaprevir/Ritonavir and/or Dasabuvir); Smoking in women over 35 years of age.
Clinically Significant Potential for diminished efficacy or increased exposure. Hepatic enzyme inducers/inhibitors; Specific analgesics/vitamins.

Official Interaction Statements

  • Enzyme Inducers: Medicines or herbal products that induce hepatic microsomal enzymes (e.g., CYP3A4), such as Rifampicin, Carbamazepine, Phenytoin, and St. John’s Wort, are documented to increase the clearance of the hormones, potentially diminishing the contraceptive effectiveness.
  • Exposure Modifiers: Substances including Etoricoxib, Ascorbic Acid, and certain CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole) may increase the systemic plasma concentrations of Ethinyl Estradiol.
  • Hepatitis C Regimens: Following discontinuation of the contraindicated Hepatitis C combination regimen, Ortho Evra can be restarted two weeks after treatment completion.
  • Population Note: Caution is noted for use in patients with renal impairment, as the unbound fraction of ethinyl estradiol is suggested to be higher in this population.

The regulatory structure emphasizes the critical pharmacokinetic risks: reduced hormone exposure from enzyme inducers and increased exposure from certain inhibitors or supplements. The profile strictly prohibits co-administration with specific antiviral regimens and mandates a constraint on use based on smoking status and age.

Mechanism of Action

The mechanism of action involves the systemic delivery of norelgestromin and ethinyl estradiol, which are transdermally absorbed into the systemic circulation. Norelgestromin acts as an agonist for the intracellular progesterone receptor (PGR), while ethinyl estradiol is an agonist for the estrogen receptors (ER/ESR1 and ESR2). The combination exerts a coordinated negative feedback on the hypothalamic-pituitary-ovarian (HPO) axis.

This hormonal input suppresses the secretion of gonadotropin-releasing hormone (GnRH) from the hypothalamus, which, in turn, blunts the pulsatile release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) from the anterior pituitary gland. The systemic physiological consequence is the prevention of the preovulatory LH surge, which is necessary for follicular rupture. Simultaneously, the hormones modify local reproductive tract tissues. Norelgestromin induces alterations in cervical mucus, increasing its viscosity to impede gamete transit. Furthermore, the compounds induce changes in the endometrium, diminishing its proliferative state.

Dosage and Administration Information

Administration Instructions (Transdermal)

The Ortho Evra transdermal patch is to be used on a 28-day (four-week) cycle. A new patch is applied once weekly for three consecutive weeks (21 total days), followed by one patch-free week. The new cycle begins on the day after the patch-free week ends, regardless of whether withdrawal bleeding has occurred.

Dosing Schedule and Application Site

  • Dosing: One patch is worn at a time. The patch must not be cut, damaged, or altered in size.
  • Frequency: Patches must be changed on the same designated day each week (the “Patch Change Day”) for Weeks 1, 2, and 3. The patch is not worn during Week 4.
  • Route: The patch must be applied to clean, dry, intact skin on the upper outer arm, abdomen, buttock, or back. It must not be placed on the breasts, on irritated skin, or in a location where tight clothing could rub it. Users should also ensure that no make-up, creams, lotions, or powders are applied to the patch site.

Missed Dose Guidelines

Patch Detachment/Missed Change Required Action
Off for LESS than 24 hours (Week 1, 2, or 3) Reapply or apply a new patch immediately. The original Patch Change Day remains the same. No back-up contraception is needed.
Off for MORE than 24 hours (Week 1, 2, or 3) Stop the current cycle, apply a new patch immediately, and begin a new 4-week cycle with a new Patch Change Day. Non-hormonal back-up contraception must be used for the first 7 days of the new cycle.
Patch-free interval extended beyond 7 days Start a new 4-week cycle immediately and use non-hormonal back-up contraception for the first 7 days of the new cycle. If intercourse occurred during the extended patch-free interval, the possibility of pregnancy should be considered.

The maximum recommended patch-free interval is seven days; under no circumstances should it be exceeded.

Recent Clinical Evidence

Research Evidence: Overview of Studies


Evidence for use in Type 2 Diabetes Mellitus

Research has evaluated this agent in adults diagnosed with Type 2 Diabetes Mellitus, including those with elevated cardiovascular risk. Research was primarily conducted using Randomized Controlled Trials (RCTs). Research examined changes in the measurement of glycated hemoglobin (HbA1c), shifts in body weight, and blood pressure. Findings describe patterns observed in the studies where lower measured values of HbA1c were reported in the studied group compared to control groups. Cardiovascular Outcome Trials (CVOTs) were conducted over several years. These studies evaluated whether there were observed differences in the frequency of serious heart-related events (like heart attack or stroke) in high-risk populations. Long-term effects are not fully established beyond the duration of the primary trials.


Evidence for use in Weight Management

This agent was studied for weight management in adults classified as obese or overweight who also had at least one weight-related health issue. Studies examined outcomes such as the measurement of body weight change over an intermediate period. Research describes changes measured during the study period, with findings indicating measured reductions in average body weight for the study group compared to the control group. Evidence is limited regarding the long-term sustainment of these measurements once the treatment is stopped. Sample sizes were modest or non-existent for certain populations, meaning the results apply only to the populations studied.


What is Still Uncertain About the Research

Data are still emerging from various ongoing trials, and the full picture of the agent in the broader evidence landscape is still being constructed. The subgroup findings are uncertain for many groups not specifically targeted by the primary trials. Findings were mixed or inconsistent across studies when looking at fine details. Research provides context but not individual predictions. Comparative evidence remains limited for certain very frail patient subgroups. This means data are still emerging regarding how patients' physiological markers may change over many years of continuous use.

Key Studies & References

  1. Glucagon-Like Peptide-1 Receptor Agonists - StatPearls - NCBI Bookshelf (General Efficacy, Safety, and Metabolism Overview)
  2. Role of GLP-1 Agonists in Obesity: A Comprehensive Review (Focus on Liraglutide/Semaglutide Weight Management Trials)
  3. Guidance for Prescribing Glucagon-like peptide 1 (GLP 1) agonists for adults with Type 2 Diabetes (T2DM) - NICE Aligned Clinical Guideline

Frequently Asked Questions (FAQ)

Common questions about Ortho Evra (FAQ)


Q: What is the main difference between the Ortho Evra patch and birth control pills?

A: One key difference, as described in official documentation, is the delivery method. The patch delivers the hormones through the skin, avoiding the initial metabolism in the digestive system that occurs with oral pills. This transdermal system results in approximately 60% higher total systemic exposure to the estrogen component (Ethinyl Estradiol) compared to some commonly prescribed oral contraceptives.


Q: How quickly does Ortho Evra start working after the first application?

A: The timing of expected protection depends on when the first patch is applied. If the patch is started on the first day of a menstrual period, official product information indicates that contraceptive protection is expected to begin immediately. If the patch is started on the first Sunday after the period begins, non-hormonal back-up contraception is recommended for the first seven days of the first cycle.


Q: Can the Ortho Evra patch fall off during swimming or showering?

A: The patch is designed to stick securely to the skin and is generally not expected to interfere with routine activities such as showering, swimming, or exercising. Official usage instructions advise that users check the patch daily to ensure it remains fully in place.


Q: Is it normal to have some spotting or bleeding when starting Ortho Evra?

A: Yes, irregular bleeding, which includes spotting (light bleeding), or other menstrual disorders are documented as common side effects. This is especially true during the first few months of use as the body adjusts to the hormones, and this bleeding may continue for two or three cycles.


Q: What should be done if the patch is forgotten for a day?

A: If the patch change is forgotten or the patch has been off for less than 24 hours during Weeks 1, 2, or 3, official instructions state to reapply or apply a new patch immediately and keep the original weekly change day. If it has been off for more than 24 hours, the current cycle is considered stopped, and a new cycle is advised to begin immediately with a new weekly change day. Official instructions note that non-hormonal back-up contraception is used for the first seven days of the new cycle.


Q: Is it okay to use a heating pad on the patch area?

A: Regulatory documents prohibit applying the patch to irritated, cut, or damaged skin. Applying heat to the patch site may affect the patch's performance, but this is not explicitly addressed in all regulatory warnings. General guidance is to avoid placing the patch where clothing might cause rubbing.


Q: Are there any common skin reactions where the patch is placed?

A: Yes, skin reactions at the application site are documented as Very Common side effects, meaning they are reported in 1 out of 10 or more users. These reactions can include local irritation, redness, itching (pruritus), or a rash.


Q: Does Ortho Evra protect against sexually transmitted infections (STIs)?

A: No. The patch is a hormonal contraceptive solely indicated for the prevention of pregnancy. Official warnings clearly state that the patch does not protect users against HIV infection (the cause of AIDS) or any other sexually transmitted infections.


Q: Is there a maximum time someone can stay on Ortho Evra?

A: The official product information describes use as a continuous 28-day cycle repeated for as long as contraception is desired. There is no specific maximum duration of use stated, but official documentation notes that cardiovascular risk factors are generally monitored during the course of continuous use.


Q: Can I exercise intensely while wearing the patch?

A: The patch is engineered for secure adhesion and is not expected to be affected by intense physical activities, including exercising or playing sports. Official usage instructions advise that users check the patch daily to ensure it remains fully in place.


Q: What should be the next step if I experience severe headaches while on the patch?

A: Official warnings describe severe or sudden headaches, particularly those accompanied by neurological symptoms, as potential signs of a serious vascular event, such as a stroke. Such symptoms are listed as a reason to seek immediate medical attention.


Q: Does using the patch affect the timing of one's menstrual cycle?

A: The patch establishes a planned 28-day cycle with a hormone-free week, during which a withdrawal bleed is expected. However, irregular bleeding, spotting, or a missed period are documented as common side effects, especially during the first few months of use.


Q: What are the main benefits of using a patch instead of a daily pill?

A: Official clinical reviews suggest the main practical benefit relates to the administration schedule, which is once weekly instead of daily, which, in studies, resulted in reported higher adherence rates. The transdermal route also provides a steady hormone release, avoiding the peaks and troughs seen with daily oral dosing.


Q: Can you feel the patch working, or is it unnoticeable?

A: The hormonal effect of the drug is internal and unnoticeable to the user. However, application site reactions, such as irritation or itching, are common side effects and represent local physical sensations that the user may experience.


Q: Can Ortho Evra cause changes in vision?

A: Yes, sudden or partial loss of vision is listed in official documents as a serious adverse reaction that requires immediate medical attention. Furthermore, use is strictly contraindicated for women with a history of ophthalmic vascular disease.


Q: What kind of routine checks are recommended while on Ortho Evra?

A: Official safety information notes that general practices for combined hormonal contraceptive users include the monitoring of blood pressure, and in accordance with standard medical care, breast and pelvic examinations, and screening for cervical cancer.


Q: What are the official guidelines for starting Ortho Evra for the first time?

A: Official guidelines outline two starting methods: the 'Day 1 Start' or the 'Sunday Start.' The Day 1 method involves starting the patch within 24 hours of the start of a menstrual period. For the Sunday start method, official instructions note that non-hormonal back-up contraception is generally used for the first seven days.


Q: Is Ortho Evra still available, or has it been replaced by other patches?

A: The original brand product, Ortho Evra, was discontinued. However, official drug information indicates that therapeutically equivalent generic versions of the norelgestromin and ethinyl estradiol transdermal system, such as Xulane, are available on the market and contain the same active ingredients.


Q: If I switch from the pill to the patch, will my side effects be the same?

A: The adverse effects reported with the patch are generally similar to those reported with combined oral contraceptives, as noted in regulatory reviews. However, the patch is associated with slightly higher reported rates of breast symptoms and application-site reactions compared to some oral formulations.


Q: How is Ortho Evra different from the NuvaRing or other hormonal rings?

A: Both the patch and the hormonal ring are combination hormonal contraceptive methods. They differ primarily in their administration route (transdermal versus vaginal). Comparative studies show differences in hormone exposure, with the patch noted to have a higher total estrogen exposure (Area Under the Curve) and a steadier concentration level than some vaginal rings.


Q: What happens to the old patch when a new one is applied?

A: The official disposal instructions state that after removal, the used patch must be immediately folded in half so the sticky sides are together. The folded patch must then be discarded in a location that is inaccessible to children and pets. Official disposal instructions state that used patches must not be flushed down the toilet.


Q: Does Ortho Evra help with acne?

A: The patch is officially indicated only for the prevention of pregnancy. While other combined hormonal contraceptives are approved for the treatment of moderate acne, this specific transdermal patch does not carry the acne treatment indication in its official label.


Q: Is it safe to drink alcohol while using Ortho Evra?

A: Official interaction data note an interaction between the estrogen component and ethanol (alcohol). Patients with high blood pressure are advised to be cautious, as both alcohol consumption and combined hormonal contraceptives may be associated with elevated blood pressure.


Q: Is Ortho Evra a suitable option for teenagers?

A: The patch is indicated for the prevention of pregnancy in women of reproductive potential. Official documents note it is not indicated for use in pre-menarcheal women (before the start of menstruation). The regulatory classification for this patch is based on use in women of reproductive potential.


Q: Does Ortho Evra affect mood or cause emotional changes?

A: Yes, official safety information documents mood disorders, including depression, as 'Common' side effects. This means they are reported in more than 1 in 100 but less than 1 in 10 users.


Q: Does Ortho Evra affect future fertility after stopping its use?

A: Official regulatory documents describe the contraceptive efficacy as fully reversible. The majority of women can expect their normal menstrual cycle patterns to return within a few months after discontinuation.


Q: Does Ortho Evra cause weight gain or changes in appetite?

A: Increased weight is documented in official safety information as a 'Common' side effect, reported in more than 1 in 100 but less than 1 in 10 users. Lack or loss of appetite has also been reported in studies, though the frequency of this specific side effect is classified as unknown.


Q: Is the hormone dose in the patch higher or lower than in common pills?

A: Official studies indicate that the transdermal system results in approximately 60% higher total systemic exposure to Ethinyl Estradiol (the estrogen component) over the course of a cycle compared to some commonly used oral contraceptives.


Q: Is it possible to become pregnant during the patch-free week?

A: Contraceptive protection continues during the patch-free week only if the patch-free interval is strictly limited to 7 days. Official warnings state that if the patch-free interval is extended beyond 7 days, the risk of pregnancy increases, and official instructions state that non-hormonal back-up contraception is used.


Q: Can Ortho Evra be used to delay or skip a period?

A: Official instructions specify the 28-day cycle, which includes a 7-day patch-free interval when withdrawal bleeding is expected. The prescribing information does not describe or instruct on how to use the patch to delay or skip a period.


Q: Are there any specific concerns for women over 35 using the patch?

A: Yes. While use is strictly forbidden for women over 35 who smoke, women over 35 who do not smoke also have concerns. Age is considered an independent risk factor for serious cardiovascular events, and official guidelines note the importance of assessment for these risk factors in this population.

How should Ortho Evra be stored and disposed of?

Storage and Disposal of Ortho Evra

Storage Requirements

The Ortho Evra transdermal system must be stored at controlled room temperature, specifically 25 C (77 F), with permitted excursions between 15 C and 30 C (59 F and 86 F). The product must not be refrigerated or frozen. Patches should be kept in their original sealed foil pouch until use and stored away from moisture, heat, and direct light.

All patches, both used and unused, must be kept out of the reach of children and pets.

Disposal Instructions

Used patches still contain residual medication. After removal, the patch must be immediately folded in half with the sticky sides together. The folded patch must then be discarded in a location inaccessible to children and pets. Do not flush used patches down the toilet. For disposal of unused or expired patches, regulatory guidelines recommend utilizing a drug take-back program.

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

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