Dog /

Leonberger

122 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.
122
Total Reports
7
Deaths Reported
570.0%
Death Rate
4.7 yr
Avg Age at Report
Average weight at time of report: 52.0 kg (114.7 lbs)

Top Reported Reactions

Lethargy (see also Central nervous system depression in 'Neurological') 19
Diarrhoea 16
Vomiting 11
Lack of efficacy (endoparasite) - whipworm 7
Behavioural disorder NOS 6
Lack of efficacy - NOS 5
Lack of efficacy (ectoparasite) - flea 5
Decreased appetite 5
Other abnormal test result NOS 5
Anorexia 5
Emesis (multiple) 5
INEFFECTIVE, HOOKS 5
Glazed eye 5
Emesis 4
Lack of efficacy (ectoparasite) - tick NOS 4

Most Referenced Drugs

Ivermectin + Pyrantel As Pamoate Salt 22
Fluralaner Chew Tablets 17
Milbemycin Oxime + Praziquantel 15
Afoxolaner 11
Lufenuron + Milbemycin Oxime 9
Firocoxib 7
Milbemycin Oxime + Spinosad 6
Milbemycin Oxime 6
Moxidectin 5
Fluralaner 13.64% 12-Week Chew 5
Pyrantel Pamoate;Sarolaner 5
Bedinvetmab 5
Grapiprant 4
Carprofen 3
Famotidine 3

Outcome Breakdown

Outcome Unknown
47 (38.5%)
Recovered/Normal
36 (29.5%)
Ongoing
28 (23.0%)
Died
5 (4.1%)
Recovered with Sequela
4 (3.3%)
Euthanized
2 (1.6%)

Gender Distribution

Male 65 (53.3%)
Female 56 (45.9%)
Unknown 1 (0.8%)

Reports by Year

Year Reports Trend
2011 1
2012 8
2013 10
2014 4
2015 5
2016 9
2017 16
2018 14
2019 13
2020 9
2021 5
2022 9
2023 2
2024 12
2025 5

Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Rank #220 by report volume. Data reflects voluntary submissions and may not represent actual incidence rates.