Epipenepinephrine
According to the FDA label: EpiPen are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
60,536 adverse event reports submitted to the FDA (1999–2026)
Top Reported Adverse Events
The most frequently reported events in association with Epipen in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Drug Ineffective 5,496 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Headache 4,166 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Sinusitis 3,937 reports
Inflammation of the sinuses, the air-filled spaces around the nose, often causing congestion and pressure.
Full definition in the glossary →Fatigue 3,786 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 3,201 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Nausea 3,154 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Pain 3,152 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Product Dose Omission Issue 3,097 reports
A report that a dose of the medication was missed or skipped.
Full definition in the glossary →Off Label Use 2,679 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →COVID-19 2,585 reports
The illness caused by the SARS-CoV-2 coronavirus.
Full definition in the glossary →Pneumonia 2,544 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Cough 2,100 reports
A reflex that clears the throat or airways.
Full definition in the glossary → See all drugs reporting this event →Pyrexia 2,094 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Nasopharyngitis 2,092 reports
The medical term for the common cold, an infection of the nose and throat.
Full definition in the glossary →Rash 1,988 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 35,189 |
| Male | 17,310 |
| Unknown | 108 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 4,685 |
| 18-34 | 4,883 |
| 35-49 | 6,208 |
| 50-64 | 8,725 |
| 65-74 | 4,976 |
| 75+ | 2,656 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Epipen. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 25,564 |
| Other Serious | 24,251 |
| Hospitalization | 17,002 |
| Life-Threatening | 4,800 |
| Death | 3,917 |
| Disability | 641 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Epipen. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 1999 | 2 |
| 2002 | 1 |
| 2004 | 159 |
| 2005 | 144 |
| 2006 | 164 |
| 2007 | 230 |
| 2008 | 332 |
| 2009 | 359 |
| 2010 | 507 |
| 2011 | 981 |
| 2012 | 804 |
| 2013 | 702 |
| 2014 | 1,391 |
| 2015 | 2,473 |
| 2016 | 6,562 |
| 2017 | 3,443 |
| 2018 | 3,368 |
| 2019 | 4,153 |
| 2020 | 7,341 |
| 2021 | 4,863 |
| 2022 | 4,593 |
| 2023 | 4,835 |
| 2024 | 5,701 |
| 2025 | 5,998 |
| 2026 (partial) | 1,430 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Epipen
In FDA adverse event reports that mention Epipen, these medications appeared most often in the same report.
- Diphenhydramine (23,778 reports)
- Acetaminophen (18,398 reports)
- Lidocaine (12,906 reports)
- Albuterol (11,358 reports)
- Ergocalciferol (10,692 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026