What the label lists and what reports show
Drospirenone and estradiol side effects
Drospirenone and estradiol's FDA label: “The most common adverse reactions with Angeliq that occurred in at least 1% of users in clinical trials are: gastrointestinal and abdominal pain, female genital tract bleeding, breast pain and discomfort, and headache.” FAERS holds 538 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 headache (31 reports).
- No generic listed
- Boxed warning
Check it at the source: the drospirenone and estradiol FDA label on DailyMed (effective March 2, 2026, Bayer HealthCare Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What is the most important information I should know about Angeliq (a combination of estrogen and progestogen)?Do not use estrogens with or without progestogens to prevent heart disease, heart attacks, strokes, or dementia (declines of brain function). Using estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots. Using estrogens with progestogen may increase your chance of getting dementia, based on a study of women 65 years of age and older Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function). Using estrogen-alone may increase your chances of getting strokes or blood clots Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age and older Only one estrogen with progestogen product and dose have been shown to increase your chances of getting heart attacks, strokes, breast cancer, and dementia. Only one estrogen-alone product and dose have been shown to increase your chances of getting strokes, blood clots, and dementia. Because other products and doses have not been studied in the same way, it is not known how the use of Angeliq will affect your chances of these conditions. You and your healthcare provider should talk regularly about whether you still need treatment with Angeliq.
Source: FDA drug label, Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026 (SPL set 761834c2-6b61-4583-84c2-f1ca4a97c4f2), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions with Angeliq that occurred in at least 1% of users in clinical trials are: gastrointestinal and abdominal pain, female genital tract bleeding, breast pain and discomfort, and headache.
Table 1: Adverse Reactions that Occurred at a Frequency of ≥ 2% with Angeliq 0.25 mg DRSP/0.5 mg E2 and at a Higher Incidence than Placebo
| Adverse Reaction | Angeliq (0.25 mg DRSP/0.5 mg E2) N=183 (100%) n (%) | Placebo N=180 (100%) n (%) |
|---|---|---|
| Gastrointestinal and abdominal pains Gastrointestinal and abdominal pain includes:… | 11 (6.0) | 5 (2.8) |
| Headache | 11 (6.0) | 9 (5.0) |
| Vulvovaginal fungal infections | 10 (5.5) | 1 (0.6) |
| Breast pain Breast pain includes: breast pain, breast tenderness, nipple pain | 6 (3.3) | 1 (0.6) |
| Nausea | 6 (3.3) | 2 (1.1) |
| Diarrhea | 4 (2.2) | 1 (0.6) |
| Peripheral Edema | 4 (2.2) | 2 (1.1) |
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 are discussed elsewhere in the labeling: Cardiovascular Disorders [see Boxed Warning, Warnings and Precautions (5.1) ] Malignant Neoplasms [see Boxed Warning, Warnings and Precautions (5.3) ] The most common adverse reactions with Angeliq that occurred in at least 1% of users in clinical trials are: gastrointestinal and abdominal pain, female genital tract bleeding, breast pain and discomfort, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 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 practice. From clinical trials with different dose formulations of Angeliq containing E2 dose ranging from 0.5 mg to 1.0 mg combined with DRSP dose ranging from 0.25 mg to 3 mg: The most common adverse reactions were gastrointestinal and abdominal pain, female genital bleeding, breast pain and headache. The frequencies of common adverse reactions, in general, were higher for the Angeliq dose formulation containing E2 1 mg compared to Angeliq containing E2 0.5 mg. …
Source: FDA drug label, Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026 (SPL set 761834c2-6b61-4583-84c2-f1ca4a97c4f2), via openFDA; the full label on DailyMed
What do FAERS reports show?
538 reports list drospirenone and estradiol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 11 are coded as a death and 102 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 23 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?
- Drospirenone and 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