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What the label lists and what reports show

Drospirenone and ethinyl estradiol side effects

Drospirenone and ethinyl estradiol's FDA label: “The most common adverse reactions (≥ 2% of users) were: headache/migraine (6.7%), menstrual irregularities (including vaginal hemorrhage [primarily spotting] and metrorrhagia (4.7%), nausea/vomiting (4.2%), breast pain/tenderness (4%) and mood changes (mood …” FAERS holds 44,288 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 pain (12,879 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the drospirenone and ethinyl estradiol FDA label on DailyMed (effective May 29, 2025, Bayer HealthCare 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 changes This is not a complete list of possible side effects. Talk to your healthcare provider if you develop any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088. […]

Source: FDA drug label, Bayer HealthCare Pharmaceuticals Inc., effective May 29, 2025 (SPL set 065f33e4-b587-4e66-b896-ca9ab7b7c876), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

The most common adverse reactions (≥ 2% of users) were: headache/migraine (6.7%), menstrual irregularities (including vaginal hemorrhage [primarily spotting] and metrorrhagia (4.7%), nausea/vomiting (4.2%), breast pain/tenderness (4%) and mood changes (mood swings, depression, depressed mood and affect lability) (2.2%).

From the label: adverse reactions, continued

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: • Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ( 5.1 )] • Vascular events [see Warnings and Precautions ( 5.1 )] • Liver disease [see Warnings and Precautions ( 5.4 )] • The most frequent adverse reactions (≥ 2%) in contraception and acne clinical trials were: headache/migraine (6.7%), menstrual irregularities (4.7%), nausea/vomiting (4.2%), breast pain/tenderness (4.0%) and mood changes (2.2%). ( 6.1 ) • The most frequent adverse reactions (≥ 2%) in PMDD clinical trials were: menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%). ( 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. …

Source: FDA drug label, Bayer HealthCare Pharmaceuticals Inc., effective May 29, 2025 (SPL set 065f33e4-b587-4e66-b896-ca9ab7b7c876), via openFDA; the full label on DailyMed

What do FAERS reports show?

44,288 reports list drospirenone and ethinyl estradiol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 668 are coded as a death and 20,332 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, 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

  • Pain12,879
  • Injury10,714
  • Pulmonary Embolism (named in the label)9,180
  • Deep Vein Thrombosis (named in the label)8,263
  • Anxiety (a use or a product term, not a reaction)6,917
  • Emotional Distress6,365
  • Cholecystitis Chronic5,537
  • Cholelithiasis4,100
  • Gallbladder Disorder4,055
  • General Physical Health Deterioration3,267
  • Nausea (named in the label)2,940
  • Abdominal Pain2,783
  • Dyspnoea2,350
  • Anhedonia2,241
  • Thrombosis (named in the label)2,035
  • Vomiting (named in the label)2,027
  • Abdominal Pain Upper1,903
  • Chest Pain1,878
  • Depression1,840
  • Cholecystectomy1,782
  • Pain In Extremity1,764
  • Cerebrovascular Accident1,687
  • Headache (a use or a product term, not a reaction)1,653
  • Gallbladder Injury1,616
  • Cholecystitis1,489

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Drospirenone and ethinyl estradiol: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions