Ethinyl Estradiol: Side Effects, Uses & Monitoring
femhrt is indicated in women with an intact uterus for the: Treatment of moderate to severe vasomotor symptoms associated with the menopause.
- Data source
- FDA labeling via NIH DailyMed (label 434511bb…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Urogenital system | 40.8% |
| Body as a whole | 40.1% |
| Respiratory system | 37.2% |
| Digestive system | 33% |
| Musculoskeletal system | 21.7% |
| Headache | 18.2% |
| Rhinitis | 15.4% |
| Psychobiologic function | 14.1% |
| Abdominal pain | 10.2% |
| Sinusitis | 9.7% |
| Breast pain | 9% |
| Viral infection | 8.6% |
| Myalgia | 8.6% |
| Nausea and/or vomiting | 7.4% |
| Arthralgia | 6.9% |
| Urinary tract infection | 6.2% |
| Depression | 5.8% |
| Diarrhea | 5.7% |
| Nervousness | 5.4% |
| Vaginitis | 5.4% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
femhrt is indicated in women with an intact uterus for the: Treatment of moderate to severe vasomotor symptoms associated with the menopause. Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis. Non-estrogen medications should be carefully considered. The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women. Risk factors for osteoporosis include low bone mineral density, low estrogen levels, family history of osteoporosis, previous fracture, small frame (low BMI), light skin color, smoking, and alcohol intake. Response to therapy can be predicted by pre-treatment serum estradiol, and can be assessed during t…
Conditions associated with Ethinyl Estradiol in labeling
Frequently Asked Questions
What is Ethinyl Estradiol used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Ethinyl Estradiol?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Ethinyl Estradiol. Individual risk varies.
Does Ethinyl Estradiol require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Ethinyl Estradiol.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.