What the label lists and what reports show
Bupivacaine and epinephrine side effects
Bupivacaine and epinephrine's FDA label: “Most common adverse reactions are related to the central nervous system and the cardiovascular system.” FAERS holds 3,123 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 musculoskeletal pain (207 reports).
- Generic listed
- Boxed warning
Check it at the source: the bupivacaine and epinephrine FDA label on DailyMed (effective February 2, 2024, Hospira, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions are related to the central nervous system and the cardiovascular system.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions have been reported and described in the Warnings and Precautions section of the labeling: • Cardiac Arrest in Obstetrical Anesthesia [see Warnings and Precautions (5.1) ] • Dose-Related Toxicity [see Warnings and Precautions (5.2) ] • Methemoglobinemia [see Warnings and Precautions (5.3) ] • Chondrolysis with Intra-Articular Infusion [see Warnings and Precautions (5.5) ] • Severe, Persistent Hypertension, Cerebrovascular Accidents, and Bradycardia Due to Drug Interactions [see Warnings and Precautions (5.6) ] • Cardiac Arrest with Intravenous Regional Anesthesia Use [see Contraindications (4), Warnings and Precautions (5.7) ] • Allergic-Type Reactions [see Warnings and Precautions (5.8) ] • Systemic Toxicities with Unintended Intravascular or Intrathecal Injection [see Warnings and Precautions (5.9) ] • Respiratory Arrest Following Retrobulbar Block [see Warnings and Precautions (5.15) ] The following adverse reactions from voluntary reports or clinical studies have been reported with bupivacaine or bupivacaine and epinephrine. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. …
Source: FDA drug label, Hospira, Inc., effective February 2, 2024 (SPL set 93cf0914-de08-4ec6-8f8c-d663243b9958), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,123 reports list bupivacaine and epinephrine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 100 are coded as a death and 543 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 22 reactions below, 7 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?
- Bupivacaine and 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