Dog /

Setter (unspecified)

161 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.
161
Total Reports
7
Deaths Reported
430.0%
Death Rate
5.9 yr
Avg Age at Report
Average weight at time of report: 25.8 kg (56.9 lbs)

Top Reported Reactions

Vomiting 23
Emesis 16
Lethargy (see also Central nervous system depression in 'Neurological') 16
Lack of efficacy - NOS 15
Diarrhoea 13
Lack of efficacy (endoparasite) - heartworm 10
INEFFECTIVE, HEARTWORM LARVAE 8
Behavioural disorder NOS 8
Other abnormal test result NOS 8
Lack of efficacy (ectoparasite) - flea 7
Seizure NOS 7
Lack of efficacy (endoparasite) - hookworm 7
Panting 7
Lack of efficacy (ectoparasite) - tick NOS 6
Death by euthanasia 5

Most Referenced Drugs

Milbemycin Oxime + Spinosad 23
Milbemycin Oxime + Praziquantel 21
Moxidectin 13
Lotilaner 13
Spinosad 10
Milbemycin Oxime 9
Lufenuron + Milbemycin Oxime 8
Fluralaner 13.64% 12-Week Chew 8
Imidacloprid + Moxidectin 7
Febantel + Praziquantel + Pyrantel Pamoate 5
Milbemycin Oxime, Lufenuron 5
Florfenicol + Mometasone Furoate + Terbinafine Hydrochloride 5
Pyrantel Pamoate;Sarolaner 5
Carprofen 4
Nitenpyram 4

Outcome Breakdown

Outcome Unknown
55 (34.2%)
Recovered/Normal
52 (32.3%)
Ongoing
44 (27.3%)
Euthanized
5 (3.1%)
Recovered with Sequela
3 (1.9%)
Died
2 (1.2%)

Gender Distribution

Female 86 (53.4%)
Male 70 (43.5%)
Unknown 4 (2.5%)
Mixed 1 (0.6%)

Reports by Year

Year Reports Trend
2010 1
2011 4
2012 16
2013 16
2014 21
2015 7
2016 6
2017 8
2018 4
2019 10
2020 7
2021 6
2022 10
2023 15
2024 23
2025 7

Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Rank #196 by report volume. Data reflects voluntary submissions and may not represent actual incidence rates.