45/100 · Moderate
Manufactured by ANI Pharmaceuticals, Inc.
Low to Moderate Safety Profile for Estradiol Gel 0.1% with Common Adverse Events
79,046 FDA adverse event reports analyzed
Last updated: 2026-05-12
ESTRADIOL GEL 0.1% is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. Based on analysis of 79,046 FDA adverse event reports, ESTRADIOL GEL 0.1% has a safety score of 45 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 GEL 0.1% include DRUG INEFFECTIVE, NAUSEA, FATIGUE, HEADACHE, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ESTRADIOL GEL 0.1%.
Estradiol Gel 0.1% has a safety concern score of 45 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 79,046 adverse event reports for this medication, which is primarily manufactured by Ani Pharmaceuticals, Inc..
The most commonly reported adverse events include Drug Ineffective, Nausea, Fatigue. Of classified reports, 49.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions include nausea, fatigue, and headache, indicating a mild to moderate safety profile.
Serious adverse events account for 49.8% of reports, with conditions like breast cancer and dizziness being notable. The majority of reports are non-serious, with gastrointestinal and dermatological issues being frequent. The drug is primarily used by females, with the majority of reports coming from middle-aged adults.
Patients taking Estradiol Gel 0.1% should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions and misuse are reported, including issues with incorrect dose administration and inappropriate schedule of product administration. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Estradiol Gel 0.1% received a safety concern score of 45/100 (moderate concern). This is based on a 49.8% serious event ratio across 41,489 classified reports. The score accounts for 79,046 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 38,034, Male: 724, Unknown: 84. The most frequently reported age groups are age 60 (829 reports), age 55 (825 reports), age 53 (806 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 41,489 classified reports for ESTRADIOL GEL 0.1%:
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.
Drug interactions and misuse are reported, including issues with incorrect dose administration and inappropriate schedule of product administration.
If you are taking Estradiol Gel 0.1%, here are important things to know. The most commonly reported side effects include drug ineffective, nausea, fatigue, headache, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed usage instructions carefully to avoid adverse events. Report any serious or unusual symptoms 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 Gel 0.1% and advises healthcare providers to report any adverse events.
The FDA has received approximately 79,046 adverse event reports associated with Estradiol Gel 0.1%. 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 Gel 0.1% include Drug Ineffective, Nausea, Fatigue, Headache, Off Label Use. By volume, the top reported reactions are: Drug Ineffective (3,428 reports), Nausea (2,575 reports), Fatigue (2,570 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 Gel 0.1%.
Out of 41,489 classified reports, 20,655 (49.8%) were classified as serious and 20,834 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 Gel 0.1% break down by patient sex as follows: Female: 38,034, Male: 724, Unknown: 84. 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 Gel 0.1% adverse events are: age 60: 829 reports, age 55: 825 reports, age 53: 806 reports, age 54: 779 reports, age 56: 759 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 Gel 0.1% adverse event reports is Ani 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 Estradiol Gel 0.1% include: Pain, Diarrhoea, Breast Cancer Female, Dizziness, Arthralgia. 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 Gel 0.1% 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 Gel 0.1% has a safety concern score of 45 out of 100 (moderate 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. The most common reactions include nausea, fatigue, and headache, indicating a mild to moderate safety profile.
Key safety signals identified in Estradiol Gel 0.1%'s adverse event data include: Breast cancer and female-specific conditions are reported, suggesting potential risks for certain populations.. Serious adverse events include respiratory and cardiovascular issues, indicating a need for careful monitoring.. Drug interactions and misuse are reported, highlighting the importance of proper usage instructions.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions and misuse are reported, including issues with incorrect dose administration and inappropriate schedule of product administration. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Estradiol Gel 0.1%.
Follow prescribed usage instructions carefully to avoid adverse events. Report any serious or unusual symptoms to your healthcare provider immediately.
Estradiol Gel 0.1% has 79,046 adverse event reports on file with the FDA. Serious adverse events account for 49.8% of reports, with conditions like breast cancer and dizziness being notable. The volume of reports for Estradiol Gel 0.1% reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Estradiol Gel 0.1% and advises healthcare providers to report any adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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