Zafemy Side Effects

Generic name: ethinyl estradiol / norelgestromin

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jan 21, 2024.

Note: This document provides detailed information about Zafemy Side Effects associated with ethinyl estradiol / norelgestromin. Some dosage forms listed on this page may not apply specifically to the brand name Zafemy.

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

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often. Your doctor may also want to check your blood pressure while using this medicine.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you have had a baby within 4 weeks before you start using this medicine.

Tell the medical doctor or dentist in charge that you are using this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue using this medicine.

Norelgestromin and ethinyl estradiol transdermal may not work as well for you if you weigh more than 198 pounds (98 kilograms). Talk to your doctor about the kind of birth control that is best for you.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when light, or breakthrough bleeding when heavier. If this should occur:

• If this should occur, continue with your regular dosing schedule.
• The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
• If the bleeding continues after you have been using hormonal contraceptives on schedule and for more than 3 months, check with your doctor.

Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

This medicine will not protect you from getting HIV/AIDS, herpes, or other sexually transmitted diseases. Tell your doctor if you or your partner begin to have sexual intercourse with other people, or you or your partner tests positive for a sexually transmitted disease. If this is a concern for you, talk with your doctor.

Check with your doctor if you miss a menstrual period so that the cause may be determined. Missed periods may occur if you have not used the patch exactly as scheduled or the medicine is not the right strength or type for your needs. You might need a pregnancy test.

If you suspect that you may have become pregnant, stop using this medicine immediately and check with your doctor.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using this birth control, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about the type of diet and exercise to control your weight and blood cholesterol level.

You will be exposed to more estrogen if you use this medicine than if you use a typical birth control pill. Increased estrogen exposure may increase the risk of side effects. Talk to your doctor about this risk.

Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.

Check with your doctor immediately if you wear contact lenses or if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Using this medicine may increase your risk of breast cancer or cervical cancer. Talk with your doctor about this risk. Check with your doctor immediately if you experience abnormal vaginal bleeding.

Check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine or pale stools, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Using this medicine may increase your risk for gallbladder disease. Talk with your doctor about this risk.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Use with caution around small children. The contraceptive patch may be a choking hazard if swallowed by a child.

Make sure any doctor who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

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:

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

Symptoms of overdose

• unusual vaginal bleeding in women
• vomiting

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:

For healthcare professionals

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

General adverse events

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]

Gastrointestinal

• 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]

Respiratory

• Rare (less than 0.1%): Pulmonary embolism
• Postmarketing reports: Pulmonary artery thrombosis^[Ref]

Genitourinary

• 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]

Local

• 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]

Cardiovascular

• 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]

Psychiatric

• 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]

Metabolic

• 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]

Dermatologic

• 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]

Hepatic

• Rare (less than 0.1%): Cholecystitis, cholelithiasis
• Postmarketing reports: Cholestasis, hepatic lesion, cholestatic jaundice^[Ref]

Other

• 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]

Musculoskeletal

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

Oncologic

• 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]

Ocular

• Postmarketing reports: Contact lens intolerance/complication^[Ref]

Immunologic

• Uncommon (0.1% to 1%): Hypersensitivity
• Postmarketing reports: Allergic reaction^[Ref]

See also:

Further information

Zafemy side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer