Bacitracin Methylene Disalicylate

Verify with FDA CVM →

51 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.
51
Total Reports
25
Deaths Reported
4900.0%
Death Rate

Active Ingredients

Bacitracin Methylene Disalicylate

Administration Routes

OralUnknownRespiratory (Inhalation)Topical

Species Affected

Chicken 19
Unknown 13
Turkey 5
Pig 4
Human 4
Partridge 1
Ostrich 1
Cattle 1
Other Birds 1
Quail 1

Most Affected Breeds

Unknown 19
Chicken (unknown) 9
Turkey (unknown) 5
Chicken (other) 5
Crossbred Porcine/Pig 4
Chicken (unspecified) 3
Partridge 2
Mixed (Chicken) 1
Cattle (other) 1
Other Birds (other) 1

Most Reported Reactions

Death 20
Lack of efficacy - NOS 6
Lack of efficacy (protozoa) - Coccidia 6
Increased mortality rate 5
INEFFECTIVE, COCCIDIA 5
Accidental exposure 4
Uncoded sign 4
Enteritis 4
Recumbency 3
Unclassifiable adverse event 3
Product Defect, General 3
NT - Abnormal necropsy finding NOS 3

Outcome Breakdown

Died
25 (62.5%)
Outcome Unknown
13 (32.5%)
Recovered/Normal
2 (5.0%)

Data Summary

Metric Value
Total adverse event reports 51
Reports involving death 25
Case-fatality rate (reported events) 4900.0%
Distinct species in reports 10
Distinct breeds in reports 11
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.

Bacitracin Methylene Disalicylate Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 51 adverse event reports referencing Bacitracin Methylene Disalicylate, including 25 reports in which the animal died — a 4900.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Bacitracin Methylene Disalicylate. Reported administration routes include Oral, Unknown, Respiratory (Inhalation), Topical. 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 Bacitracin Methylene Disalicylate reports are Chicken (19 reports), Unknown (13 reports), Turkey (5 reports), with Chicken accounting for the largest share. Within those species, Unknown (19), Chicken (unknown) (9), Turkey (unknown) (5) 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 Bacitracin Methylene Disalicylate are Death (20), Lack of efficacy - NOS (6), Lack of efficacy (protozoa) - Coccidia (6), Increased mortality rate (5). Of the 40 reports with a coded outcome, Died is the leading category at 62.5%. 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 Bacitracin Methylene Disalicylate.

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