Last reviewed 2026-04-20 · How we verify

Ortho Evra (NORELGESTROMIN)

Ortho Evra works by binding to the progesterone receptor in the body, mimicking the effects of the natural hormone progesterone.

Ortho Evra, also known as Norlegestromin, is a small molecule progestin that targets the progesterone receptor. It was originally developed and is currently owned by a pharmaceutical company. Ortho Evra is used for contraception and was FDA approved in 2001. The commercial status of Ortho Evra is not specified, but it is a patented product. Key safety considerations include its use as a transdermal patch, which may increase the risk of blood clots and other cardiovascular events.

At a glance

Mechanism of action

NGMN is the active progestin largely responsible for the progestational activity that occurs in women following application of norelgestromin and ethinyl estradiol transdermal system. NGMN is also the primary active metabolite produced following oral administration of NGM, the progestin component of some oral contraceptive products.Combination hormonal contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).

Approved indications

• Contraception

Boxed warnings

• WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI |GTE 30 kg/m2 • Cigarette Smoking and Serious Cardiovascular Events Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including norelgestromin and ethinyl estradiol transdermal system, are contraindicated in women who are over 35 years of age and smoke [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. • Contraindicated in Women with a BMI ≥ 30 kg/m 2 Norelgestromin and ethinyl estradiol transdermal system is contraindicated in women with a BMI ≥ 30 kg/m 2 . The risk of VTE may be greater with norelgestromin and ethinyl estradiol transdermal in women with a BMI ≥ 30 kg/m 2 compared to women with a lower BMI [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 kg/m 2 See full prescribing information for complete boxed warning. ● Norelgestromin and ethinyl estradiol transdermal is contraindicated in women over 35 years old who smoke. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. ( 4 , 5.1 ) ● Norelgestromin and ethinyl estradiol transdermal is contraindicated for use in women with a BMI ≥ 30 kg/m 2 . Women with a BMI ≥ 30 kg/m 2 who use norelgestromin and ethinyl estradiol transdermal may have a higher risk of venous thromboembolic events compared with women with a lower BMI. ( 4 , 5.1 , 8.8 )

Common side effects

• Breast symptoms
• Headache
• Nausea
• Application site disorder
• Vaginal bleeding and menstrual disorders
• Dysmenorrhea
• Abdominal pain
• Mood, affect and anxiety disorders
• Vomiting
• Diarrhea
• Dizziness
• Fatigue

Drug interactions

• benzylpenicillin
• oxcarbazepine
• phenobarbital
• phenylbutazone
• phenytoin
• primidone
• rifabutin
• rifampicin
• secobarbital
• topiramate

Key clinical trials

• Investigating Ovulation Inhibition for Use as a Contraceptive (PHASE2)
• Transdermal Ethinyl Estradiol and Norelgestromin for Irregular Bleeding in Contraceptive Implant Users (PHASE2)
• Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles (PHASE3)
• Dose-finding Study of MR-130A-01 Contraceptive Transdermal Patch (PHASE2)
• Inpatient Adolescent Contraception (EARLY_PHASE1)
• A Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30) (Study 34237 (P06650)) (COMPLETED) (PHASE4)
• Effects of Oral vs. Non-oral Contraceptives on the GH/IGF-1 Axis (PHASE4)
• A Postmarketing Study of the Risk of Venous Thromboembolism (Blood Clots), Myocardial Infarction (Heart Attacks), and Stroke Among Women Using ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared With Women Who Take Oral Contraceptives for Birth Control

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Ortho Evra CI brief — competitive landscape report
• Ortho Evra updates RSS · CI watch RSS