Drug Safety Information for EPIPEN (Epinephrine)

Safety-related Labeling Changes for EPIPEN (EPINEPHRINE) Rx Drug: FDA Link

Safety-related Labeling Changes for ADRENACLICK (EPINEPHRINE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for XYLOCAINE DENTAL WITH EPINEPHRINE (EPINEPHRINE; LIDOCAINE HYDROCHLORIDE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for CITANEST FORTE DENTAL (EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for AUVI-Q (EPINEPHRINE) Rx Drug: FDA Link

Safety-related Labeling Changes for ADRENALIN (EPINEPHRINE) Rx Drug: FDA Link

Safety-related Labeling Changes for SYMJEPI (EPINEPHRINE) Rx Drug: FDA Link

Adverse Drug Reactions for EPIPEN* (Epinephrine)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with EPIPEN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain829
2Renal failure702
3Anxiety646
4Drug ineffective599
5Injury592
6Hypotension573
7Dyspnoea566
8Unevaluable event521
9Multi-organ failure511
10Fear434
11Death428
12Emotional distress427
13Product quality issue417
14Accidental exposure401
15Cardiac arrest383
16Renal impairment373
17Nausea373
18Renal injury370
19Stress342
20Headache337

* This side effect also appears in "Top 10 Side Effects of EPIPEN " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking EPIPEN
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication5598
2Anaphylactic reaction1847
3Hypersensitivity1685
4Hypotension802
5Asthma450
6Arthropod sting432
7Allergy to arthropod sting414
8Food allergy396
9Dyspnoea204
10Cardiac arrest181

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for EPIPEN

Total Reports Filed with FDA: 52413


Number of FDA Adverse Event Reports by Patient Age for EPIPEN

Total Reports Filed with FDA: 52413*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Epinephrine (Arterenol, Epipen e z pen, Epi e z pen jr, Glaucon, Bronkaid mist, Twinject 0.15, Dopamina, Adrenaclick, Primatene mist, Twinject 0.3, Ephinephrine, Adrenalinum, Auvi-q, Asthmahaler, Racemic epinephrine, Noradrenalin, Epipen jr, Levarterenol, Twinject, Noradrenalina, Vaponefrin, Noradrenaline, Dopamine, Epifrin, Micronefrin, Epipen jr., Adrenalin, Epipen, Epinephrine)

Charts are based on 52413 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and EPIPEN Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.