Medication

Innofem

Generic name:

Pharmacist-reviewed drug information from the RxWiki encyclopedia.

Overview

Innofem is a prescription medication used to treat symptoms of menopause including hot flashes and vaginal dryness. 

Innofem consists of estradiol which is a form of the hormone estrogen. It replaces estrogen that is not naturally produced by the ovaries.

This medication comes is available as an an oral tablet. It is usually taken once a day, with food.

Common side effects include headache, breast pain, nausea, and bloating.

Warnings

WARNING: ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER.

CLOSE CLINICAL SURVEILLANCE OF ALL WOMEN TAKING ESTROGENS IS IMPORTANT. ADEQUATE DIAGNOSTIC MEASURES, INCLUDING ENDOMETRIAL SAMPLING WHEN INDICATED, SHOULD BE UNDERTAKEN TO RULE OUT MALIGNANCY IN ALL CASES OF UNDIAGNOSED PERSISTENT OR RECURRING ABNORMAL VAGINAL BLEEDING. THERE IS CURRENTLY NO EVIDENCE THAT THE USE OF “NATURAL” ESTROGENS RESULTS IN A DIFFERENT ENDOMETRIAL RISK PROFILE THAN SYNTHETIC ESTROGENS OF EQUIVALENT ESTROGEN DOSE.

CARDIOVASCULAR AND OTHER RISKS 

ESTROGENS WITH AND WITHOUT PROGESTINS SHOULD NOT BE USED FOR THE PREVENTION OF CARDIOVASCULAR DISEASE OR DEMENTIA.

THE WOMEN’S HEALTH INITIATIVE (WHI) STUDY REPORTED INCREASED RISKS OF MYOCARDIAL INFARCTION, STROKE, INVASIVE BREAST CANCER, PULMONARY EMBOLI, AND DEEP VEIN THROMBOSIS IN POSTMENOPAUSAL WOMEN (50 TO 79 YEARS OF AGE) DURING 5 YEARS OF TREATMENT WITH ORAL CONJUGATED ESTROGENS (CE 0.625 MG) COMBINED WITH MEDROXYPROGESTERONE ACETATE (MPA 2.5 MG) RELATIVE TO PLACEBO.

THE WOMEN’S HEALTH INITIATIVE MEMORY STUDY (WHIMS), A SUBSTUDY OF WHI, REPORTED INCREASED RISK OF DEVELOPING PROBABLE DEMENTIA IN POSTMENOPAUSAL WOMEN 65 YEARS OF AGE OR OLDER DURING 4 YEARS OF TREATMENT WITH ORAL CONJUGATED ESTROGENS PLUS MEDROXYPROGESTERONE ACETATE RELATIVE TO PLACEBO. IT IS UNKNOWN WHETHER THIS FINDING APPLIES TO YOUNGER POSTMENOPAUSAL WOMEN.

OTHER DOSES OF ORAL CONJUGATED ESTROGENS WITH MEDROXYPROGESTERONE ACETATE, AND OTHER COMBINATIONS AND DOSAGE FORMS OF ESTROGENS AND PROGESTINS WERE NOT STUDIED IN THE WHI CLINICAL TRIALS AND, IN THE ABSENCE OF COMPARABLE DATA, THESE RISKS SHOULD BE ASSUMED TO BE SIMILAR. BECAUSE OF THESE RISKS, ESTROGENS WITH OR WITHOUT PROGESTINS SHOULD BE PRESCRIBED AT THE LOWEST EFFECTIVE DOSES AND FOR THE SHORTEST DURATION CONSISTENT WITH TREATMENT GOALS AND RISKS FOR THE INDIVIDUAL WOMAN.

Quick facts

Estrogens increase the chance of getting cancer of the uterus.

Do not use estrogens to prevent heart disease, heart attacks, or strokes.

All information on this site is provided “as-is” for informational purposes only and is not a substitute for medical advice or treatment. You should consult with a medical professional if you have any questions about your health.