Reaction profile

The FDA adverse-event record for product defect, product difficult to use/handle (see also 'drug device difficult to use/handle')

1,283 FDA adverse-event reports reference product defect, product difficult to use/handle (see also 'drug device difficult to use/handle') (VeDDRA 99955). See the species, breeds, and drugs most associated with it below.

1,283
reports citing this reaction
0.3%
death-coded share
Unknown
most-affected species
Pyrantel Pamoate;Sarolaner
most-associated drug
Verify with FDA CVM →
1,283
Total Reports
4
Deaths
0.3%
Death Rate

Species Most Affected

Unknown 1,110
Cat 72
Dog 69
Human 29
Horse 1
Donkey 1
Llama 1

Breeds Most Affected

Unknown 1,141
Domestic Shorthair 41
Dog (unknown) 16
Cat (unknown) 12
Domestic Longhair 6
Retriever - Labrador 5
Boxer (German Boxer) 5
Chihuahua 4
Siamese 3
Maine Coon 3

Associated Drugs

Pyrantel Pamoate;Sarolaner 163
Cyclosporine 130
Mirtazapine 117
Fluralaner Spot-On Solution 76
Metronidazole 69
Gentamicin Sulfate + Hydrocortisone Aceponate + Miconazole Nitrate 45
Velagliflozin Proline Monohydrate 42
Moxidectin 40
Lotilaner,Moxidectin,Praziquantel,Pyrantel Pamoate 36
Deslorelin Acetate 34
Praziquantel 32
Lotilaner 32
Bexagliflozin 31
Fluralaner/Moxidectin Spot-On 24
Ciclesonide 24
Milbemycin Oxime + Praziquantel 20
Meloxicam 20
Selamectin;Sarolaner 19
Oclacitinib Maleate 18
Milbemycin Oxime + Spinosad 17

Product defect, product difficult to use/handle (see also 'Drug device difficult to use/handle') Reaction Insights

1,283 reports name Product defect, product difficult to use/handle (see also 'Drug device difficult to use/handle'); 4 recorded a death outcome (0.3% of reported events, not a population-level mortality rate). VeDDRA code: 99955.

By species: Unknown (1,110 reports), Cat (72 reports), Dog (69 reports). By breed: Unknown (1,141), Domestic Shorthair (41), Dog (unknown) (16).

Most co-reported drugs: Pyrantel Pamoate;Sarolaner (163 reports), Cyclosporine (130 reports), Mirtazapine (117 reports), Fluralaner Spot-On Solution (76 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.