Reaction profile

The FDA adverse-event record for product defect nos

131 FDA adverse-event reports reference product defect nos (VeDDRA 2283). See the species, breeds, and drugs most associated with it below.

131
reports citing this reaction
4.6%
death-coded share
Unknown
most-affected species
Metronidazole
most-associated drug
Verify with FDA CVM →
131
Total Reports
6
Deaths
4.6%
Death Rate

Species Most Affected

Unknown 82
Dog 20
Human 14
Cat 13
Other 1
Horse 1

Breeds Most Affected

Unknown 97
Cat (unknown) 6
Domestic Shorthair 5
Dog (unknown) 3
Chihuahua 3
Spitz - German Pomeranian 3
Retriever - Golden 3
Crossbred Canine/dog 2
Domestic Longhair 1
Russian 1

Associated Drugs

Metronidazole 16
Amoxicillin (As Trihydrate) + Clavulanic Acid (As Potassium Clavulanate) 16
Praziquantel 10
Oclacitinib Maleate 8
Fluralaner Spot-On Solution 5
Isoflurane 5
Milbemycin Oxime + Praziquantel 5
Lotilaner 5
Milbemycin Oxime + Spinosad 5
Fluralaner/Moxidectin Spot-On 4
Bexagliflozin 4
Moxidectin 4
Buprenorphine 4
Polysulfated Glycosaminoglycan 3
Imidacloprid 3
Imidacloprid + Moxidectin 3
Mirtazapine 3
Pyrantel Pamoate;Sarolaner 3
Lotilaner,Moxidectin,Praziquantel,Pyrantel Pamoate 3
Grapiprant 3

Product defect NOS Reaction Insights

131 reports name Product defect NOS; 6 recorded a death outcome (4.6% of reported events, not a population-level mortality rate). VeDDRA code: 2283.

By species: Unknown (82 reports), Dog (20 reports), Human (14 reports). By breed: Unknown (97), Cat (unknown) (6), Domestic Shorthair (5).

Most co-reported drugs: Metronidazole (16 reports), Amoxicillin (As Trihydrate) + Clavulanic Acid (As Potassium Clavulanate) (16 reports), Praziquantel (10 reports), Oclacitinib Maleate (8 reports).

Read these counts as reporting volume, not risk: per our methodology, co-reporting reflects temporal association captured in voluntary submissions, not proof that a drug caused this reaction. A widely-prescribed drug will rack up more raw co-reports at an identical true rate than a rarely-used one, so compare within similar-exposure products.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.