What the label lists and what reports show
Ethinyl estradiol and norelgestromin side effects
Ethinyl estradiol and norelgestromin's FDA label: “The most common adverse reactions (≥ 5%) reported during clinical trials were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders.” FAERS holds 1,837 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 product adhesion issue (691 reports).
- Generic listed
- Boxed warning
Check it at the source: the ethinyl estradiol and norelgestromin FDA label on DailyMed (effective April 16, 2026, Zydus Pharmaceuticals USA Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 5%) reported during clinical trials were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| System/Organ Class * Adverse reaction | Norelgestromin and Ethinyl Estradiol Transdermal System (n = 3322) Reproductive system and breast disorders |
|---|---|
| Breast symptoms | 22.4% |
| Dysmenorrhea | 7.8% |
| Vaginal bleeding and menstrual disorders | 6.4% |
| Nausea | 16.6% |
| Abdominal pain | 8.1% |
| Vomiting | 5.1% |
| Diarrhea | 4.2% |
| Headache | 21.0% |
| Dizziness | 3.3% |
| Migraine | 2.7% |
| Application site disorder | 17.1% |
| Fatigue | 2.6% |
| Mood, affect and anxiety disorders | 6.3% |
| Acne | 2.9% |
| Pruritus | 2.5% |
| Vaginal yeast infection | 3.9% |
| Weight increased | 2.7% |
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.
From the label: adverse reactions, continuedThe following serious adverse reactions with the use of combination hormonal contraceptives, including norelgestromin and ethinyl estradiol transdermal system, are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ( 5.1 )] Vascular events, including venous and arterial thromboembolic events [see Warnings and Precautions ( 5.1 )] Liver disease [see Warnings and Precautions ( 5.3 )] Adverse reactions commonly reported by users of combination hormonal contraceptives are: Irregular uterine bleeding Nausea Breast tenderness Headache The most frequent adverse reactions reported during clinical trials (≥ 5%) were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. …
Source: FDA drug label, Zydus Pharmaceuticals USA Inc., effective April 16, 2026 (SPL set 10fa1458-c8ed-4197-922a-1ba7271d2b02), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,837 reports list ethinyl estradiol and norelgestromin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5 are coded as a death and 66 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 18 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.
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 norelgestromin: 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