What the label lists and what reports show
Epinephrine side effects
Epinephrine's FDA label: “Most common adverse reactions to systemically administered epinephrine are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; peripheral coldness; nausea/vomiting; and/or respiratory difficulties.” FAERS holds 65,566 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is headache (4,408 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the epinephrine FDA label on DailyMed (effective July 13, 2026, A-S Medication Solutions); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of EpiPen or EpiPen Jr?EpiPen and EpiPen Jr may cause serious side effects. • EpiPen or EpiPen Jr should only be injected into the middle of your outer thigh (upper leg). Do not inject EpiPen or EpiPen Jr into your: o veins o buttocks o fingers, toes, hands or feet If you accidentally inject EpiPen or EpiPen Jr into any place other than the middle of your outer thigh, go to the nearest emergency room right away. Tell the healthcare provider where on your body you received the accidental injection. • Rarely, people who have used the EpiPen or EpiPen Jr auto-injector may get infections at the injection site within a few days of an injection. Some of these infections can be serious. […]
Source: FDA drug label (EPIPEN), Viatris Specialty LLC, effective February 15, 2023 (SPL set 7560c201-9246-487c-a13b-6295db04274a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions to systemically administered epinephrine are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; peripheral coldness; nausea/vomiting; and/or respiratory difficulties.
From the label: adverse reactions, continuedThe following adverse reactions are discussed elsewhere in labeling: • Hypertension [see Warnings and Precautions (5.1)] • Pulmonary Edema [see Warnings and Precautions (5.2)] • Cardiac Arrhythmias and Ischemia [see Warnings and Precautions (5.3)] • Extravassation and Tissue Necrosis with Intravenous Infusion [see Warnings and Precautions (5.4)] • Renal Impairment [see Warnings and Precautions (5.5)] • Allergic Reactions associated with Sulfite [see Warnings and Precautions (5.6)] The following adverse reactions associated with the infusion of epinephrine were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
Source: FDA drug label, A-S Medication Solutions, effective July 13, 2026 (SPL set 6e811e28-0199-4df7-a916-5940c632401d), via openFDA; the full label on DailyMed
What do FAERS reports show?
65,566 reports list epinephrine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4,097 are coded as a death and 17,922 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Epinephrine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions