What the label lists and what reports show
Ethinyl estradiol and ferrous fumarate and norethindrone side effects
Ethinyl estradiol and ferrous fumarate and norethindrone's FDA label lists its adverse reactions in its own words. FAERS holds 6,411 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 nausea (460 reports).
- Generic listed
- Boxed warning
Check it at the source: the ethinyl estradiol and ferrous fumarate and norethindrone FDA label on DailyMed (effective May 21, 2026, PD-Rx Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsAn increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section): Thrombophlebitis Arterial thromboembolism Pulmonary embolism Myocardial infarction Cerebral hemorrhage Cerebral thrombosis Hypertension Gallbladder disease Hepatic adenomas or benign liver tumors Post 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 1) (70-74). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1) (70, 73, 75). One of these studies reported no association between breast cancer risk and COC use. …
Source: FDA drug label, ANDA076081 (Barr), as published by PD-Rx Pharmaceuticals, Inc., effective May 21, 2026 (SPL set 93a2f8c9-3550-42ec-8f76-3ac9badf4bb2), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,411 reports list ethinyl estradiol and ferrous fumarate and norethindrone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 26 are coded as a death and 679 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 21 reactions below, 7 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?
- Ethinyl estradiol and ferrous fumarate and norethindrone: 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