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Ethinyl Estradiol / Norelgestromin Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 21, 2024.

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

Important warnings This medicine can cause some serious health issues

Transdermal route (patch, extended release)

Cardiovascular Risk Associated with Smoking, Risk of Venous Thromboembolism, and Pharmacokinetic Profile of Ethinyl Estradiol. Women 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

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 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
  • 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

Other side effects

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

  • 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
  • stomach cramps or bloating
  • 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.

General

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

Nervous system

Respiratory

Genitourinary

Local

Cardiovascular

Psychiatric

Metabolic

Dermatologic

Hepatic

Other

Musculoskeletal

Oncologic

Ocular

Immunologic

References

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

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

Further information

Ethinyl estradiol/norelgestromin 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.

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