Serum

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11 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.
11
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

Serum

Administration Routes

UnknownOphthalmicOther

Species Affected

Dog 10
Horse 1

Most Affected Breeds

Terrier - Rat 4
Chihuahua 2
Thoroughbred 1
Dachshund - Miniature 1
Retriever - Golden 1
Pinscher - Miniature 1
Retriever - Labrador 1

Most Reported Reactions

Corneal ulcer 8
Keratoconjunctivitis sicca 7
Dry nose 7
Squinting 6
Blepharospasm 6
Ear discharge 4
Lethargy (see also Central nervous system depression in 'Neurological') 4
Vomiting 4
Eye haemorrhage 4
Otitis externa 4
Otitis media 4
Eye disorder NOS (for photophobia see 'neurological') 4

Outcome Breakdown

Outcome Unknown
5 (45.5%)
Recovered/Normal
4 (36.4%)
Recovered with Sequela
1 (9.1%)
Ongoing
1 (9.1%)

Data Summary

Metric Value
Total adverse event reports 11
Reports involving death 0
Case-fatality rate (reported events) 0.0%
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.

Serum Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 11 adverse event reports referencing Serum, including 0 reports in which the animal died — a 0.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Serum. Reported administration routes include Unknown, Ophthalmic, Other. 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 Serum reports are Dog (10 reports), Horse (1 reports), with Dog accounting for the largest share. Within those species, Terrier - Rat (4), Chihuahua (2), Thoroughbred (1) 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 Serum are Corneal ulcer (8), Keratoconjunctivitis sicca (7), Dry nose (7), Squinting (6). Of the 11 reports with a coded outcome, Outcome Unknown is the leading category at 45.5%. 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 Serum.

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