Disorder of gastrointestinal flora

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VeDDRA Code: 2563

195 adverse event reports referencing this reaction

195
Total Reports
32
Deaths
1640.0%
Death Rate

Species Most Affected

Dog 171
Cat 19
Cattle 1
Rabbit 1
Pig 1
Human 1
Fish 1

Breeds Most Affected

Retriever - Labrador 17
Domestic Shorthair 14
Dog (unknown) 13
Chihuahua 11
Retriever - Golden 10
Crossbred Canine/dog 8
Boxer (German Boxer) 7
Shepherd Dog - German 6
Shih Tzu 5
Terrier - Yorkshire 5

Associated Drugs

Fluralaner Chew Tablets 27
Oclacitinib Maleate 22
Milbemycin Oxime + Praziquantel 18
Moxidectin 17
Maropitant Citrate 16
Carprofen 14
Pyrantel Pamoate;Sarolaner 14
Prednisone 11
Sarolaner 9
Trilostane 8
Insulin Injectable Vial 7
Grapiprant 7
Gabapentin 6
Milbemycin Oxime + Spinosad 6
Fluralaner 13.64% 12-Week Chew 6
Anti-Il31 Mab Mcs Lot #1283563 5
Fluralaner Spot-On Solution 5
Metronidazole 4
Maropitant 4
Buprenorphine 4

Data Summary

Metric Value
Total reports referencing reaction 195
Reports with fatal outcome 32
Case-fatality rate (reported events) 1640.0%
Species observed 7
Breeds observed 20
Drugs associated with reaction 20

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER); reaction term coded under VeDDRA 2563.

Disorder of gastrointestinal flora Reaction Insights

The FDA Center for Veterinary Medicine database currently lists 195 adverse event reports that reference Disorder of gastrointestinal flora as a reaction term, including 32 reports with a death outcome — a 1640.0% case-fatality figure calculated across only those events where this reaction was coded. The reaction is indexed in the openFDA system under VeDDRA code 2563, the standardized veterinary dictionary used to normalize clinical signs across submitters. Because reports are voluntary and often describe multiple concurrent signs per animal, the volume here reflects reporting intensity rather than true incidence in the broader pet population.

Disorder of gastrointestinal flora appears most frequently in reports for Dog (171 reports), Cat (19 reports), Cattle (1 reports) — with Dog dominating at 171 entries. Within those species, the breeds most often named alongside this reaction are Retriever - Labrador (17), Domestic Shorthair (14), Dog (unknown) (13). These distributions are influenced both by underlying breed popularity and by how veterinarians and owners code a given clinical sign, so they should be interpreted as a reporting fingerprint rather than a pure susceptibility ranking.

The drugs most commonly co-reported with Disorder of gastrointestinal flora are Fluralaner Chew Tablets (27 reports), Oclacitinib Maleate (22 reports), Milbemycin Oxime + Praziquantel (18 reports), Moxidectin (17 reports), with Fluralaner Chew Tablets appearing alongside this reaction in 27 submissions. Co-reporting does not establish that any specific product caused the reaction — FDA CVM data captures temporal association only. The value of these aggregates is in flagging which therapeutic classes appear repeatedly alongside a given clinical sign, so owners and veterinarians can ask targeted questions about medications currently in use.

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