Ortho Evra® Patient Information Sheet

 

More FDA Resources

Ortho Evra® is a birth control patch used to prevent pregnancy. It is called a combination hormonal contraceptive as it contains 2 hormones, estrogen and progestin.

Who should not take Ortho Evra®?

Women who smoke cigarettes increase their risk of serious adverse effects on the heart and blood vessels from the use of the patch. This risk only gets worse with age and heavy smoking. Any women using hormonal birth control methods, including Ortho Evra®, should not smoke.

Ortho Evra® should not be used by women who have a history of:

  • Chest pain
  • Blood clots in the legs, lungs, or eyes
  • Heart attack
  • Stroke
  • Breast cancer
  • Cancer of the uterus, cervix or vagina
  • High blood pressure
  • Diabetes
  • Allergies to Ortho Evra® or to its ingredients
  • Jaundice during pregnancy or during past use of hormonal contraceptives
  • Liver tumor
  • Unexplained vaginal bleeding.

The majority of women can use the Ortho Evra® patch safely, but some women are at high risk of developing certain diseases that can cause permanent disabilities or even death.

What should I tell my doctor?

Tell your doctor about:

  • Your medical history and all medical conditions
  • Smoking habits, if any
  • All medications and supplements that you take.

What are the possible side effects of Ortho Evra®?

Some common side effects from using Ortho Evra® include, but are not limited to:

  • Nausea
  • Headache
  • Breast tenderness and enlargement
  • Vaginal discharge
  • Menstrual changes
  • Abdominal cramps
  • Bloating

Reference:

"Patient Information Sheet - Norlegstromin/Ethinyl Estradiol (Marketed as Ortho Evra)," FDA, November 2002.

 

Contact a lawyer if you have a legal question or for a FREE case review:

Your Name:

Your E-Mail:

Your Phone Number:

Describe Your Case: