Ethinyl Estradiol: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Ethinyl Estradiol. Educational only — not medical advice.

Reported adverse reactions

ReactionHighest frequency reported*
Urogenital system40.8%
Body as a whole40.1%
Respiratory system37.2%
Digestive system33%
Musculoskeletal system21.7%
Headache18.2%
Rhinitis15.4%
Psychobiologic function14.1%
Abdominal pain10.2%
Sinusitis9.7%
Breast pain9%
Viral infection8.6%
Myalgia8.6%
Nausea and/or vomiting7.4%
Arthralgia6.9%
Urinary tract infection6.2%
Depression5.8%
Diarrhea5.7%
Nervousness5.4%
Vaginitis5.4%

*Highest percentage across placebo-controlled trial tables summarized in current labeling.

Labeled uses

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…

Source: FDA labeling via NIH DailyMed (set 434511bb…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.