What the label lists and what reports show
Ethinyl estradiol and norethindrone side effects
Ethinyl estradiol and norethindrone's FDA label lists its adverse reactions in its own words. FAERS holds 3,631 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 (299 reports).
- Generic listed
- Boxed warning
Check it at the source: the ethinyl estradiol and norethindrone FDA label on DailyMed (effective November 18, 2025, Lupin Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the common side effects of birth control pills?The most common side effects of birth control pills are: • spotting or bleeding between menstrual periods • nausea • breast tenderness • headache These side effects are usually mild and usually disappear with time. Less common side effects are: • acne • less sexual desire • bloating or fluid retention • blotchy darkening of the skin, especially on the face • high blood sugar, especially in women who already have diabetes • high fat (cholesterol, triglyceride) levels in the blood • depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself • problems tolerating contact lenses • weight gain These are not all the possible side effects of FEMLYV. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. […]
Source: FDA drug label (FEMLYV), Millicent US, Inc., effective September 3, 2025 (SPL set a3c99fc1-9b05-4f0a-ad00-5e3e206302c9), via openFDA; the full label on DailyMed
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. …
Table 1. Associated Adverse Reactions Reported by ≥5 Percent of Women by Body System*
This table is printed in the Fyavolv label published by Lupin Pharmaceuticals, Inc. of January 6, 2026; the label quoted above does not print one.
| Reaction | Placebo N = 247 | Number (Percent) of Subjects Norethindrone Acetate and Ethinyl Estradiol 0.5/2.5 N = 244 | Norethindrone Acetate and Ethinyl Estradiol 1/5 N = 258 |
|---|---|---|---|
| BODY AS A WHOLE | 23 (12.8) | 30 (16.9) | 30 (15.7) |
| Edema – Generalized | 10 (4.0) | 12 (4.9) | 11 (4.3) |
| Headache | 12 (4.9) | 14 (5.7) | 16 (6.2) |
| DIGESTIVE SYSTEM | 8 (4.4) | 17 (9.6) | 25 (13.1) |
| Abdominal Pain | 3 (1.2) | 13 (5.3) | 14 (6.8) |
| UROGENITAL SYSTEM | 20 (11.1) | 34 (19.2) | 45 (23.6) |
| Breast Pain | 9 (3.6) | 22 (9.0) | 20 (7.8) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Lupin Pharmaceuticals, Inc., effective November 18, 2025 (SPL set ddbb5d60-cacf-4672-935d-86d668287992), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,631 reports list ethinyl estradiol and norethindrone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 36 are coded as a death and 526 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 22 reactions below, 8 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 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