Generic name
Epinephrine: adverse event reports filed with FDA
10,460 reports list it as a suspect or interacting product, 2004–2026. Class: Catecholamine. Also reported as Epinephrine Injection Usp, Epinephrine /00003902/, Epinephrine Inj.
- 10,460
- reports as suspect product
- 0.1% of all reports · about 465 a year
- 877
- reports, 12 months to June 2026
- 1,065 in the 12 months before
- 76%
- marked serious by the reporter
- 75.4% across the class
- 12.2%
- record death among outcomes, as reported
- 1,271 reports · not verified by FDA
10,460 adverse event reports received by FDA list epinephrine, a generic name as a suspect or interacting product, from January 2004 to June 2026. A further 31,072 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 877 reports listed it, down 18% from 1,065 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 465 reports a year and 0.1% of the 20,646,523 reports in the database, and 46.1% of the reports for the catecholamine class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are drug ineffective (27.9%), drug hypersensitivity (7.9%) and off label use (6.8%). A report can list several reactions, so shares add to more than 100%; 1,211 different terms appear across these reports. Drug ineffective is recorded in 27.9% of these reports, a larger share than in the median catecholamine drug (22.2%).
76% of the reports are marked serious by the reporter (75.4% across the class); 12.2% record death among the outcomes and 39.6% record hospitalisation, as reported. 43.3% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (21.2%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Epinephrine reports recording the termmedian drug in catecholamine
- Drug ineffectivethe medicine did not work as expected27.9%2,915
- Drug hypersensitivityan allergic-type reaction to a medicine7.9%828
- Off label useused for a purpose or in a way not on the label6.8%707
- Product quality issuea problem with the product itself6.3%657
- Hypotensionlow blood pressure6.3%656
- Cardiac arrestthe heart stopped4.4%463
- Toxicity to various agentspoisoning or toxic effect of one or more substances3.8%401
- Dyspnoeashortness of breath3.7%389
- Condition aggravatedthe condition being treated got worse3.5%365
- Stress cardiomyopathy3.2%331
- Bradycardiaslow heart rate3%316
- Device failurethe device failed3%311
- Tachycardiafast heart rate2.9%306
- Anaphylactic reactiona severe, sudden allergic reaction2.9%302
- Hypertensionhigh blood pressure2.7%283
- Overdosea dose above the recommended amount2.6%270
- Headachehead pain2.5%264
- Cardiogenic shockshock from the heart failing to pump2.2%230
- Palpitationsawareness of the heartbeat2.1%221
- Product use in unapproved indicationused for a purpose not on the label2.1%216
- Hypersensitivityan allergic-type reaction2%214
- Maternal exposure during pregnancythe mother took the medicine during pregnancy2%206
- Metabolic acidosistoo much acid in the body fluids1.9%203
- Acute kidney injurysudden loss of kidney function1.8%186
- Angioedemadeep swelling of skin or mucous membranes1.7%181
- Ventricular tachycardiaa fast rhythm from the lower heart chambers1.7%180
- Rashskin rash1.7%178
Top 30 of 1,211 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 7 drugs in the catecholamine class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 22,692 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 65.6% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Anaphylactic reaction | 973 | 9.3% |
| Hypotension | 461 | 4.4% |
| Hypersensitivity | 353 | 3.4% |
| Cardiac arrest | 214 | 2% |
| Angioedema | 196 | 1.9% |
| Local anaesthesia | 173 | 1.7% |
The indication field is filled in by the reporter and is often blank; shares are of all 10,460 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Epinephrine reports |
|---|---|---|
| Norepinephrine | 1,382 | 13.2% |
| Vasopressin | 960 | 9.2% |
| Lidocaine | 894 | 8.5% |
| Fentanyl | 681 | 6.5% |
| Propofol | 586 | 5.6% |
| Hydrocortisone | 500 | 4.8% |
| Methylprednisolone | 486 | 4.6% |
| Phenylephrine | 484 | 4.6% |
| Sodium bicarbonate | 431 | 4.1% |
| Diphenhydramine | 402 | 3.8% |
Other products listed in reports where Epinephrine is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Epinephrine | Catecholamine | All reports |
|---|---|---|---|
| Reports as suspect product | 10,460 | 22,692 | 20,646,523 |
| Share of that pool | — | 46.1% | 0.1% |
| Reports, latest 12 months | 877 | — | 1,332,454 |
| Marked serious | 76% | 75.4% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 122 | 169 | 91 |
| Hospitalisation recorded, per 1,000 reports | 396 | 381 | 213 |
| Consumer-filed share | 23.4% | 25.3% | 45.8% |
| Top term, share of reports | Drug ineffective 27.9% | median 22.2% | 6.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the catecholamine class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Norepinephrine | generic | 4,736 | 372 | 98% |
| Epipen | brand | 3,696 | 201 | 50.1% |
| Norepinephrine bitartrate | generic | 1,545 | 361 | 92.4% |
| Dopamine | generic | 947 | 71 | 95.9% |
| Epipen Jr | brand | 664 | 18 | 36.3% |
| Auvi-q | generic | 644 | 13 | 16.1% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Epinephrine reports
How many adverse event reports has FDA received for Epinephrine?
10,460 reports list Epinephrine as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 877 of them arrived in the latest 12 months. Another 31,072 list it only as a concomitant medication.
What reactions are recorded in Epinephrine reports?
drug ineffective (27.9%), drug hypersensitivity (7.9%), off label use (6.8%), product quality issue (6.3%) and hypotension (6.3%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Epinephrine was responsible.
How serious are the reports?
76% are marked serious by the reporter. Among the outcomes recorded, 12.2% of reports include death and 39.6% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (43.3%), physician (24.4%) and consumer or non-health professional (23.4%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Epinephrine rising?
877 reports in the 12 months to June 2026, down 18% from 1,065 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Epinephrine was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Epinephrine?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Epinephrine as a suspect or interacting product; reports listing it only as a concomitant medication (31,072) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.