Fenbendazol Oral Paste

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159 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.
159
Total Reports
17
Deaths Reported
1070.0%
Death Rate

Active Ingredients

Fenbendazol Oral Paste

Administration Routes

OralUnknown

Species Affected

Horse 68
Unknown 39
Dog 38
Cattle 4
Cat 3
Human 3
Pig 1
Turkey 1
Mule 1
Sheep 1

Most Affected Breeds

Unknown 43
Quarter Horse 21
Horse (unknown) 13
Crossbred Canine/dog 11
Thoroughbred 10
Paint 4
Mixed (Horse) 3
Dog (unknown) 3
Shepherd Dog - Australian 3
Terrier - Yorkshire 3

Most Reported Reactions

Lethargy (see also Central nervous system depression in 'Neurological') 19
INEFFECTIVE, STRONGYLES 14
Product problem 10
Uncoded sign 9
Underfilling, Container 9
Underfilling, Package 8
Ataxia 8
Drug administration error 8
Product Defect, General 8
Death 8
Weight loss 7
Diarrhoea 7

Outcome Breakdown

Ongoing
48 (38.4%)
Recovered/Normal
37 (29.6%)
Outcome Unknown
20 (16.0%)
Died
11 (8.8%)
Euthanized
6 (4.8%)
Recovered with Sequela
3 (2.4%)

Data Summary

Metric Value
Total adverse event reports 159
Reports involving death 17
Case-fatality rate (reported events) 1070.0%
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.

Fenbendazol Oral Paste Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 159 adverse event reports referencing Fenbendazol Oral Paste, including 17 reports in which the animal died — a 1070.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Fenbendazol Oral Paste. Reported administration routes include Oral, 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 Fenbendazol Oral Paste reports are Horse (68 reports), Unknown (39 reports), Dog (38 reports), with Horse accounting for the largest share. Within those species, Unknown (43), Quarter Horse (21), Horse (unknown) (13) 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 Fenbendazol Oral Paste are Lethargy (see also Central nervous system depression in 'Neurological') (19), INEFFECTIVE, STRONGYLES (14), Product problem (10), Uncoded sign (9). Of the 125 reports with a coded outcome, Ongoing is the leading category at 38.4%. 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 Fenbendazol Oral Paste.

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