Ortho Evra Side Effects

Generic name: ethinyl estradiol / norelgestromin

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

Some side effects of Ortho Evra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ethinyl estradiol / norelgestromin: transdermal film extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking ethinyl estradiol / norelgestromin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using the patches and call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, especially on one side of the body;

• sudden and severe headache, confusion, problems with vision, speech, or balance;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden cough, wheezing, rapid breathing, coughing up blood;

• pain, swelling, warmth, or redness in one or both legs;

• a change in the pattern or severity of migraine headaches;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• swelling in your hands, ankles, or feet;

• a breast lump; or

• symptoms of depression (sleep problems, weakness, tired feeling, mood changes).

Less serious side effects of ethinyl estradiol / norelgestromin may include:

• mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps;

• breast tenderness or swelling, nipple discharge;

• freckles or darkening of facial skin, increased hair growth, loss of scalp hair;

• changes in weight or appetite;

• problems with contact lenses;

• vaginal itching or discharge; or

• changes in your menstrual periods, decreased sex drive.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ethinyl estradiol / norelgestromin: transdermal film extended release

Gastrointestinal

Gastrointestinal side effects reported by 9% to 22% of women in clinical trials (n=3330) have included nausea, and abdominal pain. Nausea and vomiting led to therapy discontinuation in 1% to 2.4% of women. Side effects reported in connection with the use of combination hormonal contraceptives in general have included gastrointestinal cramps and bloating, nausea, and vomiting.

Respiratory

Respiratory side effects reported by 9% to 22% of women in clinical trials (n=3330) have included upper respiratory infection.

Local

Local side effects reported by 9% to 22% of women in clinical trials (n=3330) have included application site reaction. This side effect led to therapy discontinuation in 1% to 2.4% of women.

Nervous system

Nervous system side effects reported by 9% to 22% of women in clinical trials (n=3330) have included headache. Emotional lability and headache led to therapy discontinuation in 1% to 2.4% of women. Side effects reported in connection with the use of combination hormonal contraceptives in general have included migraine headaches.

Psychiatric

Psychiatric side effects reported in connection with the use of combination hormonal contraceptives in general have included mental depression.

Genitourinary

Genitourinary side effects reported by 9% to 22% of women in clinical trials (n=3330) have included menstrual cramps. Side effects reported in connection with the use of combination hormonal contraceptives in general have included change in menstrual flow, spotting, breakthrough bleeding, amenorrhea, temporary infertility after discontinuation of treatment, change in cervical erosion and secretion, and vaginal candidiasis.

General

General side effects reported by 9% to 22% of women in clinical trials (n=3330) have included breast symptoms. Breast symptoms led to therapy discontinuation in 1% to 2.4% of women. Side effects reported in connection with the use of combination hormonal contraceptives in general have included diminution in lactation when given immediately postpartum, and breast changes, such as tenderness, enlargement, and secretion.

Metabolic

Metabolic side effects reported in connection with the use of combination hormonal contraceptives in general have included edema, changes in weight, and reduced tolerance to carbohydrates.

Dermatologic

Dermatologic side effects reported in connection with the use of combination hormonal contraceptives in general have included persistent melasma.

Ocular

Ocular side effects reported in connection with the use of combination hormonal contraceptives in general have included intolerance to contact lenses and changes in corneal curvature.

Hepatic

Hepatic side effects reported in connection with the use of combination hormonal contraceptives in general have included cholestatic jaundice.

Hypersensitivity

Hypersensitivity side effects reported in connection with the use of combination hormonal contraceptives in general have included rash (allergic).

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