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What the label lists and what reports show

Ethinyl estradiol and ethynodiol side effects

Ethinyl estradiol and ethynodiol's FDA label lists its adverse reactions in its own words. FAERS holds 159 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is headache (12 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the ethinyl estradiol and ethynodiol FDA label on DailyMed (effective February 5, 2025, Xiromed LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS ): Thrombophlebitis and thrombosis Arterial thromboembolism Pulmonary embolism Myocardial infarction and coronary thrombosis Cerebral hemorrhage Cerebral thrombosis Hypertension Gallbladder disease Benign and malignant liver tumors, and other hepatic lesions There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed: Mesenteric thrombosis Neuro-ocular lesions (e.g., retinal thrombosis and optic neuritis) The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: Nausea Vomiting Gastrointestinal symptoms (such as abdominal cramps and bloating) Breakthrough bleeding Spotting Change in menstrual …

Source: FDA drug label, Xiromed LLC, effective February 5, 2025 (SPL set 1aff28b0-93eb-5e44-9164-d76ffd08cd59), via openFDA; the full label on DailyMed

What do FAERS reports show?

159 reports list ethinyl estradiol and ethynodiol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 14 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Headache (named in the label)12
  • Nausea (named in the label)11
  • Anxiety9
  • Dizziness (named in the label)8
  • Fatigue (named in the label)7
  • Vomiting (named in the label)7
  • Condition Aggravated (a use or a product term, not a reaction)6
  • Diarrhoea6
  • Muscle Spasms6
  • Product Dose Omission Issue (a use or a product term, not a reaction)6
  • Product Substitution Issue6
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)6
  • Rash (named in the label)6
  • Visual Impairment6
  • Depression5
  • Erythema5
  • Off Label Use (a use or a product term, not a reaction)5
  • Somnolence5
  • Urticaria5
  • Alopecia4
  • Coeliac Disease4
  • Dermatitis Atopic4
  • Drug Ineffective (a use or a product term, not a reaction)4
  • Dry Mouth4
  • Feeling Abnormal4

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Ethinyl estradiol and ethynodiol: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions