65/100 · Elevated
Manufactured by Viatris Specialty LLC
Epinephrine Adverse Events: Moderate Safety Concerns
135,553 FDA adverse event reports analyzed
Last updated: 2026-05-12
EPINEPHRINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Viatris Specialty LLC. Based on analysis of 135,553 FDA adverse event reports, EPINEPHRINE 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 EPINEPHRINE include DRUG INEFFECTIVE, HEADACHE, SINUSITIS, FATIGUE, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for EPINEPHRINE.
Epinephrine 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 135,553 adverse event reports for this medication, which is primarily manufactured by Viatris Specialty Llc.
The most commonly reported adverse events include Drug Ineffective, Headache, Sinusitis. Of classified reports, 57.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Headache and fatigue are the most common non-serious adverse events.
Serious adverse events, such as anaphylactic reactions and cardiac arrest, are notable. Drug ineffectiveness and off-label use are frequent issues reported.
Patients taking Epinephrine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Epinephrine can cause serious adverse events such as anaphylactic reactions and cardiac arrest, and should be used with caution, especially in patients with known allergies or cardiovascular conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Epinephrine received a safety concern score of 65/100 (elevated concern). This is based on a 57.1% serious event ratio across 61,486 classified reports. The score accounts for 135,553 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: 35,456, Male: 17,777, Unknown: 127. The most frequently reported age groups are age 52 (650 reports), age 60 (630 reports), age 58 (609 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 61,486 classified reports for EPINEPHRINE:
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.
Epinephrine can cause serious adverse events such as anaphylactic reactions and cardiac arrest, and should be used with caution, especially in patients with known allergies or cardiovascular conditions.
If you are taking Epinephrine, here are important things to know. The most commonly reported side effects include drug ineffective, headache, sinusitis, fatigue, dyspnoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always use epinephrine as prescribed and for the intended purpose. Be aware of potential serious adverse events and seek immediate medical attention if they occur. 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 closely monitors epinephrine safety and regularly updates guidelines based on adverse event reports. Healthcare providers should follow these guidelines to ensure patient safety.
The FDA has received approximately 135,553 adverse event reports associated with Epinephrine. 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 Epinephrine include Drug Ineffective, Headache, Sinusitis, Fatigue, Dyspnoea. By volume, the top reported reactions are: Drug Ineffective (5,555 reports), Headache (4,161 reports), Sinusitis (3,917 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Epinephrine.
Out of 61,486 classified reports, 35,114 (57.1%) were classified as serious and 26,372 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 Epinephrine break down by patient sex as follows: Female: 35,456, Male: 17,777, Unknown: 127. 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 Epinephrine adverse events are: age 52: 650 reports, age 60: 630 reports, age 58: 609 reports, age 64: 605 reports, age 57: 595 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 Epinephrine adverse event reports is Viatris Specialty Llc. 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 Epinephrine include: Pain, Nausea, Product Dose Omission Issue, Off Label Use, Covid-19. 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 Epinephrine 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.
Epinephrine 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 fatigue are the most common non-serious adverse events.
Key safety signals identified in Epinephrine's adverse event data include: Anaphylactic reactions and cardiac arrest are key safety signals.. Off-label use and drug ineffectiveness are significant safety signals.. Serious adverse events like pneumonia and sepsis are also important signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Epinephrine can cause serious adverse events such as anaphylactic reactions and cardiac arrest, and should be used with caution, especially in patients with known allergies or cardiovascular conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Epinephrine.
Always use epinephrine as prescribed and for the intended purpose. Be aware of potential serious adverse events and seek immediate medical attention if they occur.
Epinephrine has 135,553 adverse event reports on file with the FDA. Serious adverse events, such as anaphylactic reactions and cardiac arrest, are notable. The volume of reports for Epinephrine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors epinephrine safety and regularly updates guidelines based on adverse event reports. Healthcare providers should follow these guidelines to ensure patient safety. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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