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Zafemy Side Effects

Generic name: ethinyl estradiol / norelgestromin

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jun 15, 2024.

Note: This document contains side effect information about ethinyl estradiol / norelgestromin. Some dosage forms listed on this page may not apply to the brand name Zafemy.

Applies to ethinyl estradiol / norelgestromin: transdermal patch extended release.


Transdermal route (Patch, Extended Release)

Cardiovascular Risk Associated with Smoking, Risk of Venous Thromboembolism, and Pharmacokinetic Profile of Ethinyl EstradiolWomen over 35 years old who smoke should not use norelgestromin and ethinyl estradiol transdermal system.Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptives (CHC) use.There may be an increased risk of venous thromboembolism (VTE) among women who use the norelgestromin and ethinyl estradiol transdermal system compared to women who used certain oral contraceptives.The pharmacokinetic (PK) profile of ethinyl estradiol (EE) for the norelgestromin and ethinyl estradiol transdermal system is different from the PK profile for oral contraceptives in that it has a higher areas under the time-concentration curve, steady state concentrations and lower peak concentrations.

Serious side effects of Zafemy

Along with its needed effects, ethinyl estradiol / norelgestromin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ethinyl estradiol / norelgestromin:

More common

Incidence not known

Get emergency help immediately if any of the following symptoms of overdose occur while taking ethinyl estradiol / norelgestromin:

Symptoms of overdose

Other side effects of Zafemy

Some side effects of ethinyl estradiol / norelgestromin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Incidence not known

For Healthcare Professionals

Applies to ethinyl estradiol / norelgestromin: transdermal film extended release.


The most frequently reported side effects were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood affect and anxiety disorders.[Ref]


Very common (10% or more): Nausea (16.6%)

Common (1% to 10%): Abdominal pain, vomiting, diarrhea, abdominal distention

Postmarketing reports: Colitis[Ref]

Nervous system

Very common (10% or more): Headache (21%)

Common (1% to 10%): Dizziness, migraine

Rare (less than 0.1%): Cerebrovascular accident

Frequency not reported: Stroke

Postmarketing reports: Dysgeusia, migraine with aura, hemorrhage intracranial, cerebral hemorrhage, abnormal taste[Ref]


Rare (less than 0.1%): Pulmonary embolism

Postmarketing reports: Pulmonary artery thrombosis[Ref]


Very common (10% or more): Breast symptoms (22.4%), breast tenderness

Common (1% to 10%): Dysmenorrhea, vaginal bleeding/menstrual disorder, vaginal yeast infection/candidiasis, vulvovaginal infection, uterine spasm, vaginal discharge

Uncommon (0.1% to 1%): Galactorrhea, premenstrual syndrome, vulvovaginal dryness

Rare (less than 0.1%): Genital discharge

Frequency not reported: Uterine bleeding irregular

Postmarketing reports: Lactation suppressed, menstrual disorder[Ref]


Very common (10% or more): Application site disorder (17.1%)

Common (1% to 10%): Application site reaction

Rare (less than 0.1%): Application site pustule

Postmarketing reports: Erosion, abscess[Ref]


Uncommon (0.1% to 1%): Hypertension, blood pressure increased

Rare (less than 0.1%): Arterial thromboembolism

Postmarketing reports: Myocardial infarction, arterial thrombosis, cerebrovascular accident, deep vein thrombosis, hypertension, hypertensive crisis, thrombosis, venous thromboembolism[Ref]


Common (1% to 10%): Mood disorder, affect disorder, anxiety

Uncommon (0.1% to 1%): Insomnia, libido decreased

Rare (less than 0.1%): Libido increased

Postmarketing reports: Anger, emotional disorder, frustration, irritability[Ref]


Uncommon (0.1% to 1%): Hypercholesterolemia, fluid retention, appetite increase, lipid disorder

Postmarketing reports: Hyperglycemia, insulin resistance, blood glucose decreased, blood glucose increased, blood cholesterol abnormal, low density lipoprotein increased, blood glucose abnormal[Ref]


Common (1% to 10%): Acne, pruritus, rash, skin reaction, skin irritation

Uncommon (0.1% to 1%): Alopecia, allergic dermatitis, eczema, urticaria, photosensitivity, contact dermatitis, erythema

Frequency not reported: Chloasma

Postmarketing reports: Erythema multiforme, erythema nodosum, seborrheic dermatitis, pustular rash, angioedema, exfoliative rash[Ref]


Rare (less than 0.1%): Cholecystitis, cholelithiasis

Postmarketing reports: Cholestasis, hepatic lesion, cholestatic jaundice[Ref]


Common (1% to 10%): Fatigue, weight increased, malaise

Uncommon (0.1% to 1%): Edema, peripheral edema

Rare (less than 0.1%): Swelling

Postmarketing reports: Face edema, pitting edema, localized edema[Ref]


Common (1% to 10%): Muscle spasm[Ref]


Rare (less than 0.1%): Fibroadenoma of breast, uterine leiomyoma

Postmarketing reports: Breast cancer, cervix carcinoma, hepatic adenoma, hepatic neoplasm, breast mass, cervical dysplasia[Ref]


Postmarketing reports: Contact lens intolerance/complication[Ref]


Uncommon (0.1% to 1%): Hypersensitivity

Postmarketing reports: Allergic reaction[Ref]

More about Zafemy (ethinyl estradiol / norelgestromin)

Patient resources

Other brands

Xulane, Ortho Evra

Professional resources

Other brands

Xulane, Ortho Evra


1. (2001) "Product Information. Ortho Evra (ethinyl estradiol-norelgestromin)." Janssen Pharmaceuticals

2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.