Bupivacaine Lipsome Injectable Suspension

Verify with FDA CVM →

153 adverse event reports submitted to the FDA

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
153
Total Reports
10
Deaths Reported
650.0%
Death Rate

Active Ingredients

Bupivacaine Lipsome Injectable Suspension

Administration Routes

IntralesionalUnknownOphthalmicSubcutaneousIntraspinalIntra-gingivalOral

Species Affected

Dog 90
Unknown 46
Human 8
Cat 6
Horse 2
Chinchilla 1

Most Affected Breeds

Unknown 55
Dog (unknown) 29
Retriever - Labrador 8
Crossbred Canine/dog 7
Pit Bull 6
Shepherd Dog - German 4
Boxer (German Boxer) 4
Mixed (Dog) 4
Cat (unknown) 3
Mastiff 2

Most Reported Reactions

Product problem 37
Vials, Damaged 22
Injection site swelling 13
Injection site infection 13
Injection site seroma 12
Application site serosanguinous discharge 9
Other abnormal test result NOS 9
Injection site serosanguinous discharge 9
Death 8
Injection site bruising 7
Stopper, abnormal 7
Injection site serous discharge 5

Outcome Breakdown

Outcome Unknown
49 (45.8%)
Recovered/Normal
48 (44.9%)
Died
8 (7.5%)
Euthanized
2 (1.9%)

Data Summary

Metric Value
Total adverse event reports 153
Reports involving death 10
Case-fatality rate (reported events) 650.0%
Distinct species in reports 6
Distinct breeds in reports 20
Distinct reactions reported 20
Active ingredients on file 1

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Bupivacaine Lipsome Injectable Suspension Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 153 adverse event reports referencing Bupivacaine Lipsome Injectable Suspension, including 10 reports in which the animal died — a 650.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Bupivacaine Lipsome Injectable Suspension. Reported administration routes include Intralesional, Unknown, Ophthalmic, Subcutaneous. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in Bupivacaine Lipsome Injectable Suspension reports are Dog (90 reports), Unknown (46 reports), Human (8 reports), with Dog accounting for the largest share. Within those species, Unknown (55), Dog (unknown) (29), Retriever - Labrador (8) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with Bupivacaine Lipsome Injectable Suspension are Product problem (37), Vials, Damaged (22), Injection site swelling (13), Injection site infection (13). Of the 107 reports with a coded outcome, Outcome Unknown is the leading category at 45.8%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Bupivacaine Lipsome Injectable Suspension.

Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial