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 patch extended release

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
  • Body aches or pain
  • chills
  • cough
  • difficulty with breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
Incidence not known
  • Anxiety
  • changes in skin color
  • chest pain or discomfort
  • confusion
  • dark urine
  • diarrhea
  • dizziness
  • eye pain
  • fainting
  • inability to speak
  • itching
  • lack or loss of appetite
  • light-colored stools
  • lightheadedness
  • nausea
  • numbness in the hands
  • pain in the abdomen or stomach
  • pain in the chest, groin, or legs, especially the calves
  • pain or discomfort in the arms, jaw, back, or neck
  • pain, tenderness, or swelling of the foot or leg
  • pounding in the ears
  • rash
  • seizures
  • slow or fast heartbeat
  • slurred speech
  • sudden headache
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg on one side of the body
  • sudden, unexplained shortness of breath
  • sweating
  • swelling, pain, or tenderness in the upper abdominal or stomach area
  • temporary blindness
  • unpleasant breath odor
  • vision changes
  • vomiting of blood
  • yellow eyes or skin

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

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
  • Burning, itching, or redness of the skin
  • menstrual cramps
  • pain, soreness, swelling, or discharge from the breast or breasts
  • swelling or soreness at the patch site
Incidence not known
  • Abdominal or stomach cramps or bloating
  • absent, missed, or irregular menstrual periods
  • bloody vaginal discharge
  • brown, blotchy spots on exposed skin
  • change in amount of vaginal discharge
  • change in menstrual flow
  • decreased amount of breast milk
  • discouragement
  • dry mouth
  • feeling sad or empty
  • increase or decrease in weight
  • increased hunger or thirst
  • increased urination
  • irritability
  • itching of the vagina or outside of the genitals
  • light vaginal bleeding between periods and after sexual intercourse
  • loss of interest or pleasure
  • pain during sexual intercourse
  • stopping of menstrual bleeding
  • swelling
  • thick, white curd-like vaginal discharge without odor or with mild odor
  • trouble concentrating
  • trouble sleeping

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).

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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