65/100 · Elevated
Manufactured by Allergan, Inc.
Estradiol Adverse Events: Moderate Safety Concerns
159,657 FDA adverse event reports analyzed
Last updated: 2026-05-12
ESTRADIOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allergan, Inc.. Based on analysis of 159,657 FDA adverse event reports, ESTRADIOL has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for ESTRADIOL include DRUG INEFFECTIVE, OFF LABEL USE, PRODUCT ADHESION ISSUE, HEADACHE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ESTRADIOL.
Estradiol has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 159,657 adverse event reports for this medication, which is primarily manufactured by Allergan, Inc..
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Product Adhesion Issue. Of classified reports, 43.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Headache and nausea are the most common adverse events reported.
Serious adverse events account for 43.7% of all reports. The majority of reports are from female patients, with the highest number of reports from patients aged 56-60.
Patients taking Estradiol should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Estradiol can interact with other medications, and patients should be aware of potential drug interactions and follow the prescribed usage instructions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Estradiol received a safety concern score of 65/100 (elevated concern). This is based on a 43.7% serious event ratio across 83,666 classified reports. The score accounts for 159,657 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 76,888, Male: 1,037, Unknown: 164. The most frequently reported age groups are age 56 (1,586 reports), age 55 (1,582 reports), age 60 (1,569 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 83,666 classified reports for 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.
Estradiol can interact with other medications, and patients should be aware of potential drug interactions and follow the prescribed usage instructions.
If you are taking Estradiol, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, product adhesion issue, headache, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow the prescribed usage instructions carefully to minimize the risk of adverse events. Report any serious adverse events to your healthcare provider immediately. 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.
The FDA continues to monitor the safety of estradiol and may require additional studies or changes to labeling based on ongoing data.
The FDA has received approximately 159,657 adverse event reports associated with 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 Estradiol include Drug Ineffective, Off Label Use, Product Adhesion Issue, Headache, Nausea. By volume, the top reported reactions are: Drug Ineffective (7,618 reports), Off Label Use (5,559 reports), Product Adhesion Issue (5,172 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Estradiol.
Out of 83,666 classified reports, 36,561 (43.7%) were classified as serious and 47,105 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 Estradiol break down by patient sex as follows: Female: 76,888, Male: 1,037, Unknown: 164. 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 Estradiol adverse events are: age 56: 1,586 reports, age 55: 1,582 reports, age 60: 1,569 reports, age 58: 1,564 reports, age 57: 1,558 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 Estradiol adverse event reports is Allergan, 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 Estradiol include: Fatigue, Pain, Hot Flush, Diarrhoea, Dizziness. 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 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.
Estradiol has a safety concern score of 65 out of 100 (elevated 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. Headache and nausea are the most common adverse events reported.
Key safety signals identified in Estradiol's adverse event data include: Headache and nausea are the most frequently reported adverse events.. Serious adverse events, such as breast cancer and pneumonia, are reported but at lower frequencies.. A significant number of reports involve product quality and usage issues.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Estradiol can interact with other medications, and patients should be aware of potential drug interactions and follow the prescribed usage instructions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Estradiol.
Follow the prescribed usage instructions carefully to minimize the risk of adverse events. Report any serious adverse events to your healthcare provider immediately.
Estradiol has 159,657 adverse event reports on file with the FDA. Serious adverse events account for 43.7% of all reports. The volume of reports for Estradiol reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of estradiol and may require additional studies or changes to labeling based on ongoing data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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