Bismuth Subnitrate 60% Intramammary

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37 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.
37
Total Reports
29
Deaths Reported
7840.0%
Death Rate

Active Ingredients

Bismuth Subnitrate 60% Intramammary

Administration Routes

IntramammaryUnknownOral

Species Affected

Cattle 37

Most Affected Breeds

Holstein-Friesian also known as Holstein 18
Cattle (other) 12
Cattle (unknown) 5
Unknown 1
Jersey 1

Most Reported Reactions

Death 27
Lack of efficacy (bacteria) - NOS 17
Acute mastitis 8
CULTURE/TITER DATA ABNORMAL 5
Mastitis NOS 5
NT - Abnormal necropsy finding NOS 4
Necropsy performed 4
Lack of efficacy (bacteria) - E.coli 3
INEFFECTIVE, ANTIBIOTIC 2
Septicaemia 2
Diarrhoea 2
Fever 2

Outcome Breakdown

Died
27 (50.9%)
Outcome Unknown
12 (22.6%)
Recovered/Normal
11 (20.8%)
Euthanized
2 (3.8%)
Ongoing
1 (1.9%)

Data Summary

Metric Value
Total adverse event reports 37
Reports involving death 29
Case-fatality rate (reported events) 7840.0%
Distinct species in reports 1
Distinct breeds in reports 5
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.

Bismuth Subnitrate 60% Intramammary Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 37 adverse event reports referencing Bismuth Subnitrate 60% Intramammary, including 29 reports in which the animal died — a 7840.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Bismuth Subnitrate 60% Intramammary. Reported administration routes include Intramammary, Unknown, Oral. 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 Bismuth Subnitrate 60% Intramammary reports are Cattle (37 reports), with Cattle accounting for the largest share. Within those species, Holstein-Friesian also known as Holstein (18), Cattle (other) (12), Cattle (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 Bismuth Subnitrate 60% Intramammary are Death (27), Lack of efficacy (bacteria) - NOS (17), Acute mastitis (8), CULTURE/TITER DATA ABNORMAL (5). Of the 53 reports with a coded outcome, Died is the leading category at 50.9%. 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 Bismuth Subnitrate 60% Intramammary.

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