Total Reports
122
FDA CVM filings
Dog /
FDA CVM · 2025 release 122 reports on file
Leonberger - FDA Adverse Event Profile
Adverse-event records for Leonberger (Dog) from the FDA Center for Veterinary Medicine.
Data updated June 2026
The record at a glance
Leonberger's FDA record: #220 most-reported dog breed, 122 total reports, 5.7% death-coded (7 reports).
- #220
- most-reported dog breed
- 5.7%
- death-coded report share
- 19
- Lethargy (see also Central nervous system depression in 'Neurological') - top reaction
- 4.7 yr
- average age at report
Read report counts next to breed popularity: a bigger number often just means more owners and more vet visits.
Deaths Reported
7
of 122 reports
Death Rate
5.7%
death-coded share
Avg Age at Report
4.7 yr
52.0 kg avg weight
Death-Coded Outcome Share
Leonberger death-coded reports 5.7%
Cross-breed median
5.7% of 122 leonberger reports involved a death outcome.
How to read this number
Read alongside breed popularity, veterinary access, and owner awareness, these shape how many events ever reach the FDA. The comparison line marks the cross-breed median death-coded share (about 4.8%) among breeds with 50 or more reports; values above it suggest higher reporting bias toward severe outcomes, not necessarily higher true mortality.
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
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
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 | |
Leonberger Pet Health Insights
Leonberger accounts for 122 FDA adverse event reports, ranking #220 by volume among dog breeds, with 7 reports (5.7%) coded as a death outcome. Mean age at report: 4.7 years, average weight 52.0 kg (114.7 lbs).
Top reported signs: Lethargy (see also Central nervous system depression in 'Neurological') (19), Diarrhoea (16), Vomiting (11). Most-referenced drug: Ivermectin + Pyrantel As Pamoate Salt (22 reports), followed by Fluralaner Chew Tablets (17) and Milbemycin Oxime + Praziquantel (15).
Outcome coding on 122 status-recorded reports is dominated by Outcome Unknown (38.5%). Annual submissions ranged 2,011-2,025 across 15 years on file.
Dog Breeds With a Similar Report Volume
Sheepdog - Old English (Bobtail)
122 reports · 9.0% death rate
Elkhound - Norwegian Black
121 reports · 1.7% death rate
Shepherd Dog - Belgian Tervueren
119 reports · 6.7% death rate
Hound - Afghan
126 reports · 8.7% death rate
Terrier - Toy Fox
126 reports · 4.0% death rate
Dogue de Bordeaux
141 reports · 6.4% death rate
Frequently Asked Questions
How many FDA adverse event reports involve Leonberger? ▼
There are 122 adverse event reports involving Leonberger in the FDA database, with 7 reports involving death (5.7% death rate). Leonberger ranks #220 by report volume.
What are the most common adverse reactions reported for Leonberger? ▼
The most commonly reported adverse reactions for Leonberger are Lethargy (see also Central nervous system depression in 'Neurological') (19 reports), Diarrhoea (16 reports), Vomiting (11 reports), Lack of efficacy (endoparasite) - whipworm (7 reports), Behavioural disorder NOS (6 reports).
What drugs are most frequently associated with Leonberger adverse events? ▼
The drugs most frequently referenced in Leonberger adverse event reports are Ivermectin + Pyrantel As Pamoate Salt (22 reports), Fluralaner Chew Tablets (17 reports), Milbemycin Oxime + Praziquantel (15 reports), Afoxolaner (11 reports), Lufenuron + Milbemycin Oxime (9 reports).
What is the average age of Leonberger in adverse event reports? ▼
The average age of Leonberger at the time of adverse event reports is 4.7 years, with an average weight of 52.0 kg (114.7 lbs).
Does a high number of adverse event reports mean Leonberger is unhealthy? ▼
No. FDA adverse event reports are voluntarily submitted and do not prove causation. Popular breeds with more veterinary visits tend to have more reports. The data reflects reporting patterns, not actual incidence rates. Always consult a veterinarian for health decisions.
Where does this Leonberger safety data come from? ▼
All data comes from the FDA Center for Veterinary Medicine's adverse event reporting system. Pet owners, veterinarians, and manufacturers voluntarily submit reports about adverse events potentially linked to animal drugs and other products.
Compare a breed's report volume against how common the breed is before drawing conclusions. See our methodology for how death rate and rankings are computed.
Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. Breed figures are computed directly from 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.