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Ortho-Prefest Side Effects

Generic name: estradiol / norgestimate

Note: This document contains side effect information about estradiol / norgestimate. Some of the dosage forms listed on this page may not apply to the brand name Ortho-Prefest.

For the Consumer

Applies to estradiol / norgestimate: oral tablet

Warning

You should not use this medicine if you have had a hysterectomy, or if you have: undiagnosed vaginal bleeding, liver disease, a bleeding disorder, if you will have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Do not use if you are pregnant.

Estradiol and norgestimate may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.

Using this medicine can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries. Estradiol and norgestimate should not be used to prevent heart disease, stroke, or dementia.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;

  • swelling or tenderness in your stomach;

  • jaundice (yellowing of the skin or eyes);

  • memory problems, confusion, unusual behavior;

  • unusual vaginal bleeding, pelvic pain;

  • a lump in your breast; or

  • high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

  • nausea, vomiting, bloating, stomach cramps;

  • fluid retention (swelling, rapid weight gain);

  • headache;

  • breast pain;

  • thinning scalp hair; or

  • vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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

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

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. "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

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

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.