Dog /

Setter - Irish Red

640 adverse event reports submitted to the FDA

Important: Adverse event reports are voluntarily submitted and do not prove causation. Consult your veterinarian for medical decisions about your dog.
640
Total Reports
25
Deaths Reported
390.0%
Death Rate
5.2 yr
Avg Age at Report
Average weight at time of report: 27.8 kg (61.3 lbs)

Top Reported Reactions

Vomiting 134
Diarrhoea 44
Lethargy (see also Central nervous system depression in 'Neurological') 41
Lack of efficacy (endoparasite) - hookworm 38
Lack of efficacy - NOS 34
Seizure NOS 34
Lack of efficacy (ectoparasite) - tick NOS 29
Emesis 27
INEFFECTIVE, HEARTWORM LARVAE 26
Digestive tract disorder NOS 26
Anorexia 25
Lack of efficacy (endoparasite) - roundworm NOS 25
Not eating 23
Lack of efficacy (endoparasite) - heartworm 23
Lack of efficacy (bacteria) - Borrelia 22

Most Referenced Drugs

Ivermectin + Pyrantel As Pamoate Salt 80
Milbemycin Oxime + Spinosad 75
Afoxolaner 66
Pyrantel Pamoate;Sarolaner 57
Fluralaner Chew Tablets 40
Moxidectin 31
Milbemycin Oxime + Praziquantel 29
Carprofen 26
Fluralaner 13.64% 12-Week Chew 21
Bedinvetmab 21
Spinosad 17
Oclacitinib Maleate 17
Selamectin 15
Milbemycin 14
Firocoxib 12

Outcome Breakdown

Outcome Unknown
201 (34.1%)
Ongoing
172 (29.2%)
Recovered/Normal
165 (28.0%)
Recovered with Sequela
27 (4.6%)
Euthanized
13 (2.2%)
Died
12 (2.0%)

Gender Distribution

Male 332 (51.9%)
Female 296 (46.3%)
Unknown 11 (1.7%)
Mixed 1 (0.2%)

Reports by Year

Year Reports Trend
2010 26
2011 23
2012 30
2013 29
2014 34
2015 37
2016 43
2017 50
2018 51
2019 43
2020 52
2021 42
2022 49
2023 37
2024 61
2025 33

Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Rank #125 by report volume. Data reflects voluntary submissions and may not represent actual incidence rates.