Florfenicol

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303 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.
303
Total Reports
135
Deaths Reported
4460.0%
Death Rate

Active Ingredients

Florfenicol

Administration Routes

UnknownSubcutaneousOralIntramuscularTopicalParenteralOphthalmicNasalOtherIntraocular

Species Affected

Cattle 130
Unknown 72
Fish 34
Human 32
Goat 10
Dog 7
Pig 6
Sheep 6
Cat 4
Alpaca 1

Most Affected Breeds

Unknown 120
Crossbred Bovine/Cattle 39
Cattle (unknown) 25
Holstein-Friesian also known as Holstein 22
Fish (unknown) 16
Aberdeen Angus 14
Cattle (other) 14
Mixed (Cattle) 11
Goat (unknown) 5
Sheep (unknown) 4

Most Reported Reactions

Death 101
Lack of efficacy (bacteria) - NOS 62
Unclassifiable adverse event 42
Accidental exposure 25
Lack of efficacy - NOS 18
Vials, Leaking 15
Respiratory tract disorder NOS 14
Injection site pain 13
Death by euthanasia 13
Skin lesion NOS 12
Injection site swelling 11
Necropsy performed 11

Outcome Breakdown

Died
126 (59.4%)
Recovered/Normal
31 (14.6%)
Outcome Unknown
30 (14.2%)
Euthanized
13 (6.1%)
Ongoing
11 (5.2%)
Recovered with Sequela
1 (0.5%)

Data Summary

Metric Value
Total adverse event reports 303
Reports involving death 135
Case-fatality rate (reported events) 4460.0%
Distinct species in reports 10
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.

Florfenicol Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 303 adverse event reports referencing Florfenicol, including 135 reports in which the animal died — a 4460.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Florfenicol. Reported administration routes include Unknown, Subcutaneous, Oral, Intramuscular. 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 Florfenicol reports are Cattle (130 reports), Unknown (72 reports), Fish (34 reports), with Cattle accounting for the largest share. Within those species, Unknown (120), Crossbred Bovine/Cattle (39), Cattle (unknown) (25) 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 Florfenicol are Death (101), Lack of efficacy (bacteria) - NOS (62), Unclassifiable adverse event (42), Accidental exposure (25). Of the 212 reports with a coded outcome, Died is the leading category at 59.4%. 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 Florfenicol.

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