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Estradiol / norgestimate Side Effects

For the Consumer

Applies to estradiol / norgestimate: oral tablet

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of gallbladder problems like pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or very upset stomach or throwing up.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Very upset stomach or throwing up.
  • Very bad belly pain.
  • Change in eyesight.
  • Loss of eyesight.
  • Bulging eyes.
  • Change in how contact lenses feel in the eyes.
  • A lump in the breast, breast soreness, or nipple discharge.
  • Breast pain.
  • Vaginal itching or discharge.
  • Vaginal bleeding that is not normal.
  • Low mood (depression).
  • Memory problems or loss.
  • Swelling.
  • Feeling very tired or weak.
  • Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Back pain.
  • Feeling tired or weak.
  • Belly pain.
  • Gas.
  • Headache.
  • Dizziness.
  • Hair loss.
  • Upset stomach or throwing up.
  • Cramps.
  • Bloating.
  • Muscle or joint pain.
  • Tender breasts.
  • Enlarged breasts.
  • Vaginal bleeding or spotting.
  • Flu-like signs.
  • Signs of a common cold.
  • This drug may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to estradiol / norgestimate: oral tablet

Nervous system

Very common (10% or more): Headache (23%)
Common (1% to 10%): Dizziness[Ref]

Immunologic

Very common (10% or more): Upper respiratory tract infection (21%)
Common (1% to 10%): Sinusitis, pharyngitis, viral infection[Ref]

Genitourinary

Very common (10% or more): Breast pain (16%)
Common (1% to 10%): Vaginal bleeding (all), dysmenorrhea[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain (12%)
Common (1% to 10%): Nausea, flatulence, tooth disorder[Ref]

Musculoskeletal

Very common (10% or more): Back pain (12%)
Common (1% to 10%): Arthralgia, myalgia[Ref]

Other

Very common (10% or more): Influenza-like symptoms (11%)
Common (1% to 10%): Fatigue, pain[Ref]

Psychiatric

Common (1% to 10%): Depression[Ref]

Respiratory

Common (1% to 10%): Coughing[Ref]

References

1. "Product Information. Prefest (estradiol-norgestimate)." Barr Pharmaceuticals Inc, Pomona, NY.

2. Steiger MJ, Quinn NP "Hormone replacement therapy induced chorea." BMJ 302 (1991): 762

3. "Product Information. Ortho-Prefest (estradiol-norgestimate)" Ortho McNeil Pharmaceutical, Raritan, NJ.

4. Julian TM "Pseudoincontinence secondary to unopposed estrogen replacement in the surgically castrate premenopausal female." Obstet Gynecol 70 (1987): 382-3

5. Auerbach R, Mittal K, Schwartz PE "Estrogen and progestin receptors in an ovarian ependymoma." Obstet Gynecol 71 (1988): 1043-5

6. Boston Collaborative Drug Surveilance Program "Surgically confirmed gallbladder disease, venous thromboembolism, and breast tumors in relation to postmenopausal estrogen therapy." N Engl J Med 290 (1974): 15-9

7. "Hormone replacement therapy." Med Lett Drugs Ther 44 (2002): 78

8. "Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial." JAMA 288 (2002): 321-33

Further information

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.

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