Bovine Respiratory Syncytial Virus, 597-10 10Th Psg Strain 375; Bovine Viral Dia

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231 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.
231
Total Reports
202
Deaths Reported
8740.0%
Death Rate

Active Ingredients

Bovine Respiratory Syncytial Virus, 597-10 10Th Psg Strain 375; Bovine Viral Dia

Administration Routes

SubcutaneousIntramuscularUnknown

Species Affected

Cattle 226
Unknown 5

Most Affected Breeds

Cattle (other) 121
Mixed (Cattle) 69
Holstein-Friesian also known as Holstein 17
Aberdeen Angus 11
Unknown 5
Crossbred Bovine/Cattle 5
Cattle (unknown) 1
Texas Longhorn 1
Hereford cattle 1

Most Reported Reactions

Lack of efficacy (bacteria) - NOS 139
Death 116
Lack of efficacy - NOS 52
Abnormal test result 48
CULTURE/TITER DATA ABNORMAL 35
Increased mortality rate 31
Abnormal necropsy finding 31
Other abnormal test result NOS 27
NT - Abnormal necropsy finding NOS 26
Unrelated death 25
Pulmonary disorder NOS 19
NT - fibrinous (broncho) pneumonia/fibrinous pleuropneumonia 15

Outcome Breakdown

Died
199 (50.4%)
Outcome Unknown
167 (42.3%)
Recovered/Normal
12 (3.0%)
Ongoing
9 (2.3%)
Euthanized
6 (1.5%)
Recovered with Sequela
2 (0.5%)

Data Summary

Metric Value
Total adverse event reports 231
Reports involving death 202
Case-fatality rate (reported events) 8740.0%
Distinct species in reports 2
Distinct breeds in reports 9
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.

Bovine Respiratory Syncytial Virus, 597-10 10Th Psg Strain 375; Bovine Viral Dia Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 231 adverse event reports referencing Bovine Respiratory Syncytial Virus, 597-10 10Th Psg Strain 375; Bovine Viral Dia, including 202 reports in which the animal died — a 8740.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Bovine Respiratory Syncytial Virus, 597-10 10Th Psg Strain 375; Bovine Viral Dia. Reported administration routes include Subcutaneous, Intramuscular, Unknown. 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 Bovine Respiratory Syncytial Virus, 597-10 10Th Psg Strain 375; Bovine Viral Dia reports are Cattle (226 reports), Unknown (5 reports), with Cattle accounting for the largest share. Within those species, Cattle (other) (121), Mixed (Cattle) (69), Holstein-Friesian also known as Holstein (17) 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 Bovine Respiratory Syncytial Virus, 597-10 10Th Psg Strain 375; Bovine Viral Dia are Lack of efficacy (bacteria) - NOS (139), Death (116), Lack of efficacy - NOS (52), Abnormal test result (48). Of the 395 reports with a coded outcome, Died is the leading category at 50.4%. 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 Bovine Respiratory Syncytial Virus, 597-10 10Th Psg Strain 375; Bovine Viral Dia.

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