What the label lists and what reports show
Ethinyl estradiol and levonorgestrel side effects
Ethinyl estradiol and levonorgestrel's FDA label lists its adverse reactions in its own words. FAERS holds 3,159 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 nausea (259 reports).
- Generic listed
- Boxed warning
Check it at the source: the ethinyl estradiol and levonorgestrel FDA label on DailyMed (effective August 27, 2026, Exeltis USA, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of TYBLUME?TYBLUME may cause serious side effects, including: blood clots in your lungs, heart attack, or a stroke that may lead to death. Some other examples of serious blood clots include blood clots in the legs or eyes. Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. Serious blood clots are more likely to happen when you: first start taking birth control pills. restart the same or different birth control pills after not using them for a month or more. Call your healthcare provider or go to the nearest emergency room right away if you have: leg pain that will not go away. sudden severe shortness of breath. sudden change in vision or blindness. chest pain. a sudden, severe headache unlike our usual headaches. weakness or numbness in your arm or leg. trouble speaking. Other serious side effects include: liver problems, including: jaundice. […]
Source: FDA drug label, Exeltis USA, Inc., effective August 27, 2026 (SPL set b2482d51-d606-4aaa-8af4-19e4fe2f8872), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following serious adverse reactions with the use of CHCs are discussed elsewhere in labeling: Serious cardiovascular events [see Boxed Warning and Warnings and Precautions (5.1 and 5.4) ] Vascular events [see Warnings and Precautions (5.1) ] Liver disease [see Warnings and Precautions (5.2) ] Hypertension [see Warnings and Precautions (5.3) ] Gallbladder disease [see Warnings and Precautions (5.5) ] Adverse carbohydrate and lipid metabolic effects [see Warnings and Precautions (5.6) ] Headache [see Warnings and Precautions (5.7) ] Bleeding irregularities and amenorrhea [see Warnings and Precautions (5.8) ] Depression [see Warnings and Precautions (5.9) ] Cervical cancer [see Warnings and Precautions (5.10) ] Effect on binding globulins [see Warnings and Precautions (5.11) ] Hereditary angioedema [see Warnings and Precautions (5.12) ] Chloasma [see Warnings and Precautions (5.13) ] …
Table 3: Adverse Drug Reactions Reported by 2% of TWIRLA-Treated Women in One Phase 3 Clinical Trial
This table is printed in the Twirla label published by Agile Therapeutics, Inc. of June 30, 2026; the label quoted above does not print one.
| Adverse reaction | TWIRLA (n=2,031) |
|---|---|
| General disorders and administration site conditions Application site disorder | 6.2% |
| Gastrointestinal disorders Nausea | 4.1% |
| Nervous system disorders Headache | 3.6% |
| Reproductive system and breast disorder Dysmenorrhoea | 2.3% |
| Investigations Weight increased | 2.0% |
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, Exeltis USA, Inc., effective August 27, 2026 (SPL set b2482d51-d606-4aaa-8af4-19e4fe2f8872), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,159 reports list ethinyl estradiol and levonorgestrel among the medicines taken, each a report of something that happened, not proof the medicine caused it; 40 are coded as a death and 557 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, 5 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 levonorgestrel: 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