Drug label confusion

Verify with FDA CVM →

VeDDRA Code: 99826

230 adverse event reports referencing this reaction

230
Total Reports
3
Deaths
130.0%
Death Rate

Species Most Affected

Unknown 164
Dog 54
Cat 10
Human 1
Cattle 1

Breeds Most Affected

Unknown 165
Chihuahua 9
Crossbred Canine/dog 7
Dog (unknown) 7
Domestic Shorthair 6
Pit Bull 4
Spitz - German Pomeranian 3
Terrier - Jack Russell 2
American Pit Bull Terrier 2
Retriever - Labrador 2

Associated Drugs

Nitenpyram 149
Milbemycin Oxime + Praziquantel 9
Milbemycin Oxime + Spinosad 8
Spinosad 8
Ivermectin 7
Imidacloprid 7
Robenacoxib 4
Heartworm Prevention (Unknown) 4
Betamethasone + Florfenicol + Terbinafine 4
Flea Collar 3
Grapiprant 3
Levothyroxine Sodium 3
Lotilaner 3
Praziquantel 3
Flea Product (Unknown) 2
Flea Shampoo 2
Milbemycin Oxime 2
Ivermectin + Pyrantel As Pamoate Salt 2
Febantel + Praziquantel + Pyrantel Pamoate 2
Cloprostenol Sodium 1

Data Summary

Metric Value
Total reports referencing reaction 230
Reports with fatal outcome 3
Case-fatality rate (reported events) 130.0%
Species observed 5
Breeds observed 20
Drugs associated with reaction 20

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER); reaction term coded under VeDDRA 99826.

Drug label confusion Reaction Insights

The FDA Center for Veterinary Medicine database currently lists 230 adverse event reports that reference Drug label confusion as a reaction term, including 3 reports with a death outcome — a 130.0% case-fatality figure calculated across only those events where this reaction was coded. The reaction is indexed in the openFDA system under VeDDRA code 99826, 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.

Drug label confusion appears most frequently in reports for Unknown (164 reports), Dog (54 reports), Cat (10 reports) — with Unknown dominating at 164 entries. Within those species, the breeds most often named alongside this reaction are Unknown (165), Chihuahua (9), Crossbred Canine/dog (7). 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 Drug label confusion are Nitenpyram (149 reports), Milbemycin Oxime + Praziquantel (9 reports), Milbemycin Oxime + Spinosad (8 reports), Spinosad (8 reports), with Nitenpyram appearing alongside this reaction in 149 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