What the label lists and what reports show
Bupivacaine side effects
Bupivacaine's FDA label: “Most common adverse reactions are related to the central nervous system and the cardiovascular system.” FAERS holds 16,179 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 pain (1,083 reports).
- Generic listed
- In shortage
- Boxed warning
Check it at the source: the bupivacaine FDA label on DailyMed (effective April 14, 2026, 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.
Table 1: Treatment-Emergent Adverse Reactions with an Incidence Greater than or Equal to 2%: Local Infiltration Placebo-Controlled Studies in Adults (Studies 1 and 2)
This table is printed in the EXPAREL label published by Pacira Pharmaceuticals, Inc. of December 12, 2025; the label quoted above does not print one.
| Reaction | EXPAREL 106 mg (N=97) n (%) | Placebo (N=96) n (%) | EXPAREL 266 mg (N=95) n (%) | Placebo (N=94) n (%) |
|---|---|---|---|---|
| Any TEAE | 53 (54.6) | 59 (61.5) | 10 (10.5) | 17 (18.1) |
| Gastrointestinal Disorders | 41 (42.3) | 38 (39.6) | 7 (7.4) | 13 (13.8) |
| Nausea | 39 (40.2) | 36 (37.5) | 2 (2.1) | 1 (1.1) |
| Vomiting | 27 (27.8) | 17 (17.7) | 2 (2.1) | 4 (4.3) |
| Constipation | 2 (2.1) | 1 (1.0) | 2 (2.1) | 2 (2.1) |
| Anal Hemorrhage | 0 (0.0) | 0 (0.0) | 3 (3.2) | 4 (4.3) |
| Painful Defecation | 0 (0.0) | 0 (0.0) | 2 (2.1) | 5 (5.3) |
| Rectal Discharge | 0 (0.0) | 0 (0.0) | 1 (1.1) | 3 (3.2) |
| Nervous System Disorders | 20 (20.6) | 30 (31.3) | 0 (0.0) | 0 (0.0) |
| Dizziness | 11 (11.3) | 25 (26.0) | 0 (0.0) | 0 (0.0) |
| Headache | 5 (5.2) | 8 (8.3) | 0 (0.0) | 0 (0.0) |
| Somnolence | 5 (5.2) | 1 (1.0) | 0 (0.0) | 0 (0.0) |
| Syncope | 2 (2.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Skin And Subcutaneous Tissue Disorders | 8 (8.2) | 7 (7.3) | 0 (0.0) | 0 (0.0) |
| Generalized Pruritus | 5 (5.2) | 6 (6.3) | 0 (0.0) | 0 (0.0) |
| Pruritus | 3 (3.1) | 1 (1.0) | 0 (0.0) | 0 (0.0) |
| Investigations | 5 (5.2) | 3 (3.1) | 4 (4.2) | 3 (3.2) |
| Increased Alanine Aminotransferase | 3 (3.1) | 3 (3.1) | 1 (1.1) | 0 (0.0) |
| Increased Aspartate Aminotransferase | 3 (3.1) | 2 (2.1) | 0 (0.0) | 0 (0.0) |
| Increased Blood Creatinine | 2 (2.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Increased Body Temperature | 0 (0.0) | 0 (0.0) | 3 (3.2) | 3 (3.2) |
| General Disorders And Administration Site Conditions | 4 (4.1) | 0 (0.0) | 1 (1.1) | 1 (1.1) |
| Feeling Hot | 2 (2.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Pyrexia | 2 (2.1) | 0 (0.0) | 1 (1.1) | 1 (1.1) |
| Infections And Infestations | 2 (2.1) | 1 (1.0) | 0 (0.0) | 0 (0.0) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
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 April 14, 2026 (SPL set bb44c7e1-d911-4788-908f-09b7b271969b), via openFDA; the full label on DailyMed
What do FAERS reports show?
16,179 reports list bupivacaine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 974 are coded as a death and 4,086 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 18 reactions below, 10 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: 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