Ortho Evra Side Effects

Please note - some side effects for 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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Ortho Evra - for the Consumer

Ortho Evra Patch

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ortho Evra Patch:

Breast tenderness or enlargement; headache; menstrual cramps; nausea; stomach pain, cramps, or bloating; vaginal spotting or breakthrough bleeding; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; breast pain; calf pain, swelling, or tenderness; changes in vision or speech (eg, loss of vision); chest pain; coughing of blood; fainting; mental/mood changes (eg, depression, memory loss); pain, swelling, or tenderness in the stomach; severe headache or vomiting; severe or persistent vaginal bleeding; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, itching, or odor; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

Side Effects by Body System

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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