Formulary
Ethinylestradiol: Indications, Dosing, Side Effects and Interactions
Ethinylestradiol clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 4 min read
Ethinylestradiol: Indications, Dosing, Side Effects and Interactions
Ethinylestradiol clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Short-term treatment of symptoms of oestrogen deficiency,Osteoporosis prophylaxis if other drugs cannot be used**
- **Adult** (By Mouth): (female) 10-50 micrograms daily for 21 days, repeated after 7-day tablet-free period, to be given with progestogen for 12-14 days per cycle in women with intact uterus.
**Female hypogonadism**
- **Adult** (By Mouth): (female) 10-50 micrograms daily usually on cyclical basis, initial oestrogen therapy should be followed by combined oestrogen and progestogen therapy.
**Menstrual disorders**
- **Adult** (By Mouth): (female) 20-50 micrograms daily from day 5 to 25 of each cycle, to be given with progestogen, added either throughout the cycle or from day 15 to 25.
**Palliative treatment of prostate cancer**
- **Adult** (By Mouth): (male) 0.15-1.5 mg daily.
**Induction of sexual maturation in girls for ethinylestradiol**
- **Child (female)** (By mouth): Initially 2 micrograms daily for 6 months, then increased to 5 micrograms daily for 6 months, then increased to 10 micrograms daily for 6 months, then increased to 20 micrograms daily, after 12-18 months of treatment give progestogen for 7 days of each 28-day cycle.
**Maintenance of sexual maturation in girls for ethinylestradiol**
- **Child (female)** (By mouth): 20 micrograms daily, to be given with cyclical progestogen for 7 days of each 28-day cycle.
**Prevention of tall stature in girls for ethinylestradiol**
- **Child 2-11 years (female)** (By mouth): 20-50 micrograms daily.
Cautions
Cardiovascular disease (risk of fluid retention); diabetes (increased risk of heart disease); history of breast nodules or fibrocystic disease-closely monitor breast status (risk of breast cancer); history of endometrial hyperplasia; history of hypertriglyceridaemia (increased risk of pancreatitis); hypophyseal tumours; increased risk of gall-bladder disease; migraine (migraine-like headaches); presence of antiphospholipid antibodies (increased risk of thrombotic events); prolonged exposure to unopposed oestrogens may increase risk of developing endometrial cancer; risk factors for oestrogen-dependent tumours (e.g. breast cancer in first-degree relative); risk factors for venous thromboembolism; symptoms of endometriosis may be exacerbated; uterine fibroids may increase in size Cautions, further information Combined hormonal contraception For more information on cautions for ethinylestradiol in contraception see combined hormonal contraceptive preparations containing ethinylestradiol. Hormone replacement therapy For more information on cautions for hormone replacement therapy see Sex hormones
Contraindications
Active or recent arterial thromboembolic disease (e.g. angina or myocardial infarction); Acute porphyrias ; history of breast cancer; history of venous thromboembolism; liver disease (where liver function tests have failed to return to normal); oestrogen-dependent cancer; thrombophilic disorder; undiagnosed vaginal bleeding; untreated endometrial hyperplasia Contra-indications, further information Combined hormonal contraception For more information on contra-indications for ethinylestradiol in contraception see combined hormonal contraceptive preparations containing ethinylestradiol. Hormone replacement therapy For more information on contra-indications for hormone replacement therapy see Sex hormones
Side effects
Frequency not known Breast abnormalities; cervical mucus increased; cholelithiasis; contact lens intolerance; depression; electrolyte imbalance; embolism and thrombosis; erythema nodosum; feminisation; fluid retention; headaches; hypertension; jaundice cholestatic; metrorrhagia; mood altered; myocardial infarction; nausea; neoplasms; skin reactions; stroke; uterine disorders; vomiting; weight change Side-effects, further information Cyclical HRT (where a progestogen is taken for 12-14 days of each 28-day oestrogen treatment cycle) usually results in regular withdrawal bleeding towards the end of the progestogen. Continuous combined HRT commonly produces irregular breakthrough bleeding in the first 4-6 months of treatment. Bleeding beyond 6 months or after a spell of amenorrhoea requires further investigation to exclude serious gynaecological pathology.
Interactions
**Severe interactions:**
- Pharmacodynamic interactions During clinical trials with patients treated for hepatitis C virus infections (HCV) with the medicinal products containing ombitasvir / paritaprevir / ritonavir and...
**Other interactions (7):**
- The following have been shown to have clinically important interactions with COCs: Anticonvulsants: barbiturates (including phenobarbitone), primidone, phenytoin, carbamazepine, oxcarbazepine,...
- Antibiotics/antifungals: griseofulvin, rifampacin.
- Herbal remedies : St John's wort ( Hypericum perforatum ) Antiretroviral agents : ritonavir, nelfinavir, nevirapine.
- Substances decreasing the clearance of COCs (enzyme inhibitors) Strong and moderate CYP3A4 inhibitors such as azole antifungals (e.g.
- Etoricoxib doses of 60 to 120 mg/day have been shown to increase plasma concentrations of ethinylestradiol 1.4 to 1.6-fold, respectively when taken concomitantly with a combined hormonal...
- Accordingly, plasma and tissue concentrations may either increase (e.g.
Pregnancy
Not known to be harmful.
Breast feeding
Avoid until weaning or for 6 months after birth (adverse effects on lactation).
Hepatic impairment
Manufacturer advises caution; avoid in acute or active disease.
Medicinal forms
Tablet
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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