82/100 · Critical
Manufactured by Bayer HealthCare Pharmaceuticals Inc.
High Safety Concerns with Drosperinone and Ethinyl Estradiol
140,358 FDA adverse event reports analyzed
Last updated: 2026-05-12
DROSPIRENONE AND ETHINYL ESTRADIOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bayer HealthCare Pharmaceuticals Inc.. Based on analysis of 140,358 FDA adverse event reports, DROSPIRENONE AND ETHINYL ESTRADIOL has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for DROSPIRENONE AND ETHINYL ESTRADIOL include PAIN, INJURY, PULMONARY EMBOLISM, DEEP VEIN THROMBOSIS, ANXIETY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DROSPIRENONE AND ETHINYL ESTRADIOL.
Drospirenone And Ethinyl Estradiol has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 140,358 adverse event reports for this medication, which is primarily manufactured by Bayer Healthcare Pharmaceuticals Inc..
The most commonly reported adverse events include Pain, Injury, Pulmonary Embolism. Of classified reports, 78.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Significant reports of serious cardiovascular events such as pulmonary embolism and deep vein thrombosis.
High incidence of gastrointestinal issues including nausea, abdominal pain, and diarrhea. Notable mental health concerns like anxiety, depression, and panic attacks.
Patients taking Drospirenone And Ethinyl Estradiol should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other drugs that increase the risk of thrombotic events are a concern, and patients should be warned about the potential for serious cardiovascular and gastrointestinal side effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Drospirenone And Ethinyl Estradiol received a safety concern score of 82/100 (high concern). This is based on a 78.0% serious event ratio across 44,740 classified reports. The score accounts for 140,358 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 44,213, Male: 97, Unknown: 27. The most frequently reported age groups are age 23 (1,261 reports), age 25 (1,257 reports), age 22 (1,246 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 44,740 classified reports for DROSPIRENONE AND ETHINYL ESTRADIOL:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Interactions with other drugs that increase the risk of thrombotic events are a concern, and patients should be warned about the potential for serious cardiovascular and gastrointestinal side effects.
If you are taking Drospirenone And Ethinyl Estradiol, here are important things to know. The most commonly reported side effects include pain, injury, pulmonary embolism, deep vein thrombosis, anxiety. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should be closely monitored for signs of thrombotic events, particularly pulmonary embolism and deep vein thrombosis. Discuss any history of cardiovascular or gastrointestinal issues with your healthcare provider before starting this medication. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is ongoing, with a focus on monitoring and managing the risks associated with this contraceptive regimen.
The FDA has received approximately 140,358 adverse event reports associated with Drospirenone And Ethinyl Estradiol. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Drospirenone And Ethinyl Estradiol include Pain, Injury, Pulmonary Embolism, Deep Vein Thrombosis, Anxiety. By volume, the top reported reactions are: Pain (13,035 reports), Injury (10,860 reports), Pulmonary Embolism (9,320 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Drospirenone And Ethinyl Estradiol.
Out of 44,740 classified reports, 34,898 (78.0%) were classified as serious and 9,842 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Drospirenone And Ethinyl Estradiol break down by patient sex as follows: Female: 44,213, Male: 97, Unknown: 27. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Drospirenone And Ethinyl Estradiol adverse events are: age 23: 1,261 reports, age 25: 1,257 reports, age 22: 1,246 reports, age 26: 1,234 reports, age 28: 1,234 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Drospirenone And Ethinyl Estradiol adverse event reports is Bayer Healthcare Pharmaceuticals Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Drospirenone And Ethinyl Estradiol include: Emotional Distress, Cholecystitis Chronic, Cholelithiasis, Gallbladder Disorder, General Physical Health Deterioration. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Drospirenone And Ethinyl Estradiol to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Drospirenone And Ethinyl Estradiol has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Significant reports of serious cardiovascular events such as pulmonary embolism and deep vein thrombosis.
Key safety signals identified in Drospirenone And Ethinyl Estradiol's adverse event data include: High number of reports for pulmonary embolism and deep vein thrombosis.. Multiple reports of gallbladder disorders, including cholecystitis and cholelithiasis.. Significant mental health issues reported, including anxiety, depression, and panic attacks.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other drugs that increase the risk of thrombotic events are a concern, and patients should be warned about the potential for serious cardiovascular and gastrointestinal side effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Drospirenone And Ethinyl Estradiol.
Patients should be closely monitored for signs of thrombotic events, particularly pulmonary embolism and deep vein thrombosis. Discuss any history of cardiovascular or gastrointestinal issues with your healthcare provider before starting this medication.
Drospirenone And Ethinyl Estradiol has 140,358 adverse event reports on file with the FDA. High incidence of gastrointestinal issues including nausea, abdominal pain, and diarrhea. The volume of reports for Drospirenone And Ethinyl Estradiol reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring and managing the risks associated with this contraceptive regimen. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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