What the label lists and what reports show
Desogestrel and ethinyl estradiol side effects
Desogestrel and ethinyl estradiol's FDA label lists its adverse reactions in its own words. FAERS holds 4,024 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 pain (994 reports).
- Generic listed
- Boxed warning
Check it at the source: the desogestrel and ethinyl estradiol FDA label on DailyMed (effective December 12, 2025, Lupin Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsPost Marketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 2). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use. …
Source: FDA drug label, Lupin Pharmaceuticals, Inc., effective December 12, 2025 (SPL set 799fa1d8-4e7b-4b5e-844d-d638896a4b02), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,024 reports list desogestrel and ethinyl estradiol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 568 are coded as a death and 1,233 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 24 reactions below, 3 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.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Desogestrel and ethinyl estradiol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions