Sucralfate

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1,220 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.
1,220
Total Reports
307
Deaths Reported
2520.0%
Death Rate

Active Ingredients

Sucralfate

Administration Routes

UnknownOralIntravenousRectalSubcutaneousOphthalmicTopical

Species Affected

Dog 898
Horse 247
Cat 70
Parrot 2
Human 1
Ferret 1
Mule 1

Most Affected Breeds

Retriever - Labrador 180
Quarter Horse 59
Domestic Shorthair 48
Retriever - Golden 47
Thoroughbred 43
Horse (unknown) 38
Warmblood (unspecified) 36
Terrier - Yorkshire 35
Chihuahua 31
Terrier - Bull - American Pit 25

Most Reported Reactions

Vomiting 349
Lethargy (see also Central nervous system depression in 'Neurological') 248
Anorexia 226
Lack of efficacy - NOS 218
Diarrhoea 194
Death by euthanasia 185
Other abnormal test result NOS 178
Elevated alanine aminotransferase (ALT) 161
Elevated serum alkaline phosphatase (SAP) 141
Leucocytosis NOS 137
Anaemia NOS 128
Weight loss 116

Outcome Breakdown

Ongoing
462 (37.8%)
Outcome Unknown
243 (19.9%)
Recovered/Normal
206 (16.9%)
Euthanized
187 (15.3%)
Died
121 (9.9%)
Recovered with Sequela
2 (0.2%)

Data Summary

Metric Value
Total adverse event reports 1,220
Reports involving death 307
Case-fatality rate (reported events) 2520.0%
Distinct species in reports 7
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.

Sucralfate Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 1,220 adverse event reports referencing Sucralfate, including 307 reports in which the animal died — a 2520.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Sucralfate. Reported administration routes include Unknown, Oral, Intravenous, Rectal. 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 Sucralfate reports are Dog (898 reports), Horse (247 reports), Cat (70 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (180), Quarter Horse (59), Domestic Shorthair (48) 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 Sucralfate are Vomiting (349), Lethargy (see also Central nervous system depression in 'Neurological') (248), Anorexia (226), Lack of efficacy - NOS (218). Of the 1,221 reports with a coded outcome, Ongoing is the leading category at 37.8%. 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 Sucralfate.

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