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Estradiol / norgestimate Side Effects

Applies to estradiol / norgestimate: oral tablet.


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:

Common side effects may include:

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]


Very common (10% or more): Upper respiratory tract infection (21%)

Common (1% to 10%): Sinusitis, pharyngitis, viral infection[Ref]


Very common (10% or more): Breast pain (16%)

Common (1% to 10%): Vaginal bleeding (all), dysmenorrhea[Ref]


Very common (10% or more): Abdominal pain (12%)

Common (1% to 10%): Nausea, flatulence, tooth disorder[Ref]


Very common (10% or more): Back pain (12%)

Common (1% to 10%): Arthralgia, myalgia[Ref]


Very common (10% or more): Influenza-like symptoms (11%)

Common (1% to 10%): Fatigue, pain[Ref]


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


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


1. Steiger MJ, Quinn NP. Hormone replacement therapy induced chorea. BMJ. 1991;302:762.

2. Product Information. Ortho-Prefest (estradiol-norgestimate). Ortho McNeil Pharmaceutical. 2001;PROD.

3. Product Information. Prefest (estradiol-norgestimate). Barr Pharmaceuticals Inc. 2017.

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

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

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. 1974;290:15-9.

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

8. Hormone replacement therapy. Med Lett Drugs Ther. 2002;44:78.

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.