Cloxacillin Benzathine

Verify with FDA CVM →

133 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.
133
Total Reports
76
Deaths Reported
5710.0%
Death Rate

Active Ingredients

Cloxacillin Benzathine

Administration Routes

IntramammaryUnknown

Species Affected

Cattle 105
Unknown 28

Most Affected Breeds

Holstein-Friesian also known as Holstein 56
Unknown 28
Cattle (other) 26
Cattle (unknown) 18
Jersey 3
Crossbred Bovine/Cattle 1
Brown Swiss 1

Most Reported Reactions

Death 74
Lack of efficacy (bacteria) - NOS 36
Acute mastitis 21
Mastitis NOS 18
Residues in milk 16
Abortion 12
CULTURE/TITER DATA ABNORMAL 8
Malaise 6
Containers, Damaged 6
Necropsy performed 6
Recumbency 5
Underfilling, Package 4

Outcome Breakdown

Died
74 (56.9%)
Outcome Unknown
27 (20.8%)
Recovered/Normal
24 (18.5%)
Euthanized
4 (3.1%)
Ongoing
1 (0.8%)

Data Summary

Metric Value
Total adverse event reports 133
Reports involving death 76
Case-fatality rate (reported events) 5710.0%
Distinct species in reports 2
Distinct breeds in reports 7
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.

Cloxacillin Benzathine Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 133 adverse event reports referencing Cloxacillin Benzathine, including 76 reports in which the animal died — a 5710.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Cloxacillin Benzathine. Reported administration routes include Intramammary, 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 Cloxacillin Benzathine reports are Cattle (105 reports), Unknown (28 reports), with Cattle accounting for the largest share. Within those species, Holstein-Friesian also known as Holstein (56), Unknown (28), Cattle (other) (26) 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 Cloxacillin Benzathine are Death (74), Lack of efficacy (bacteria) - NOS (36), Acute mastitis (21), Mastitis NOS (18). Of the 130 reports with a coded outcome, Died is the leading category at 56.9%. 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 Cloxacillin Benzathine.

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