Dog /

Breed profile · FDA CVM July 2026 extract

Leonberger adverse-event record

Adverse-event filings for Leonberger (Dog) in the FDA Center for Veterinary Medicine openFDA extract. Browse dog breeds, reactions, and outcomes below.

#221 of 510
by report volume (all breeds)
126
FDA CVM reports on file
5.6%
death-coded share of reports
#111 of 275
by death-coded share (≥50 reports)

How the 126 reports break down

By recorded gender -- every report on file for Leonberger, no filtering.

Annual report volume

Annual adverse-event report trend Yearly FDA CVM adverse-event report counts for this breed. 14 10.5 7 3.5 0 2018 2019 2020 2021 2022 2023 2024 2025 Reports filed Death-coded reports
Annual report volume for Leonberger drawn from FDA CVM filings.

Data updated September 2026

The verdict

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Leonberger ranks #221 of 510 by total reports (126) and #111 of 275 by death-coded share (5.6%). National dual: Retriever - Labrador is #1 of 510 by total adverse-event reports (93,675) at death-coded-share rank 195 of 275 breeds with at least 50 reports (3.7%); separately, Atlantic Salmon (Salmo salar) is #1 highest death-coded share at 99.0% (report rank #233).

93,675
Retriever - Labrador reports (#1)
99.0%
Atlantic Salmon (Salmo salar) death share (#1)
#221
This breed, reports of 510
#111
This breed, death share of 275

Report volume reflects how common a breed or drug is and how often owners and vets file — not actual risk. Death-coded share ranks are limited to entries with enough reports to be meaningful. The two maps do not agree at #1.

Release-over-release change

What changed in the latest FDA data snapshot

PlainBreed reconstructed the prior snapshot from dated openFDA partitions through 2025 Q4, then compared it with the 2026-07-27 openFDA export. Leonberger has 126 reports now versus 126 in that prior snapshot: 0 the same number of (0.0%).

Report change
+0
Death-coded reports
+0
Death-coded share
−0.0 pts

This compares reported-event counts in two source snapshots. It does not establish a change in real-world risk, product safety, or disease incidence.

Subscribe to Leonberger changes

Total Reports

126

Above-median volume

Deaths Reported

7

of 126 reports

Death-coded share of reports

5.6%

Above-median death-coded share

Avg Age at Report

4.7 yr

51.8 kg avg weight

Death-Coded Outcome Share

Leonberger death-coded reports 5.6%
Cross-breed median

5.6% of 126 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 (4.8%) among breeds with 50 or more reports; values above it suggest higher reporting bias toward severe outcomes, not necessarily higher true mortality.

Where Leonberger's death-coded share sits among indexed breeds

Death-coded share of FDA CVM reports, breeds with ≥50 reports (July 2026 extract)

6% 60th percentile Higher share than 60% of 275 indexed breeds

5%–10%: 1 indexed breeds (0%). This entry sits in this band. 20%–25%: 2 indexed breeds (1%). Above this entry. 25%–30%: 3 indexed breeds (1%). Above this entry. 30%–35%: 4 indexed breeds (1%). Above this entry. 35%–40%: 5 indexed breeds (2%). Above this entry. 40%–45%: 6 indexed breeds (2%). Above this entry. 45%–50%: 3 indexed breeds (1%). Above this entry. 50%–55%: 7 indexed breeds (3%). Above this entry. 55%–60%: 7 indexed breeds (3%). Above this entry. 60%–65%: 21 indexed breeds (8%). Above this entry. 65%–70%: 11 indexed breeds (4%). Above this entry. 70%–75%: 15 indexed breeds (5%). Above this entry. 75%–80%: 13 indexed breeds (5%). Above this entry. 80%–85%: 11 indexed breeds (4%). Above this entry. 85%–90%: 12 indexed breeds (4%). Above this entry. 90%–95%: 12 indexed breeds (4%). Above this entry. 95%–100%: 142 indexed breeds (52%). Above this entry. Leonberger 5% 100% every breed with ≥50 FDA reports, bucketed by value

Each bar is a band; taller bars hold more indexed breeds. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count, share, and where it sits relative to this entry.

Source FDA Center for Veterinary Medicine, openFDA adverse event extract (PlainBreed) · July 2026 extract

This histogram uses the same ≥50-report cohort as the highest death-coded share ranking. A higher share means more of this breed's reported events were death-coded, not a mortality rate for living animals.

Average weight at time of report: 51.8 kg (114.2 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
Lack of efficacy (ectoparasite) - tick NOS 5

Most Referenced Drugs

Ivermectin + Pyrantel As Pamoate Salt 23
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
49 (38.9%)
Recovered/Normal
36 (28.6%)
Ongoing
30 (23.8%)
Died
5 (4.0%)
Recovered with Sequela
4 (3.2%)
Euthanized
2 (1.6%)

Gender Distribution

Male 66 (52.4%)
Female 59 (46.8%)
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 9

Leonberger FDA adverse-event insights

Signature read: death-coded share at 5.6% is the standout outcome stamp on Leonberger's FDA row. According to FDA CVM filings indexed on PlainBreed as of July 2026 extract, Leonberger sits at #221 of 510 by report volume among all breeds and #165 of 298 among dog breeds, with 126 reports and 7 (5.6%) death-coded. On death-coded share among breeds with ≥50 reports, it ranks #111 of 275. Mean age at report: 4.7 years, average weight 51.8 kg (114.2 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 (23 reports), followed by Fluralaner Chew Tablets (17) and Milbemycin Oxime + Praziquantel (15).

Outcome coding on 126 status-recorded reports is dominated by Outcome Unknown (38.9%). Annual submissions ranged 1-2,025 across 15 years on file.

Dog Breeds With a Similar Report Volume

Showing 6 of 297 dog breeds in our dataset, ranked by closest report volume.

Nationwide breeds with similar profiles

Two openFDA-derived peer sets for Leonberger, both outside the Dog family so the neighborhoods are not species containment (the similar-volume list above stays within species).

Similar death-coded share

Nearest other-species breeds with ≥50 reports (5.6% death-coded here).

Similar average weight

Nearest other-species breeds by reported average weight (51.8 kg here).

What to do with this dog

A report does not prove a drug caused the reaction, and popular breeds simply generate more reports.

Frequently Asked Questions

How many FDA adverse event reports involve Leonberger?
There are 126 adverse event reports involving Leonberger in the FDA database, of which 7 were death-coded (5.6% of those reports). That is a share of REPORTED events, not a mortality rate for the breed: adverse events reach the FDA when something goes wrong, so the denominator is reports, never the population of animals. According to the same FDA CVM extract, Leonberger ranks #221 of 510 by report volume among all breeds PlainBreed indexes (#165 of 298 among dog breeds).
Where does Leonberger sit among other breeds in PlainBreed's corpus?
According to FDA CVM report volume, Leonberger is #221 of 510 breeds indexed on PlainBreed (same ordering as the most-reported-breeds ranking). Inside Dog, it is #165 of 298. Among breeds with at least 50 reports, its death-coded share ranks #111 of 275 (same cohort as highest-death-rate). These are placement ranks in the reporting corpus, not clinical risk scores.
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 (23 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 51.8 kg (114.2 lbs).

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

openFDA Animal & Veterinary Adverse Events (FDA CVM) for Leonberger (Dog), extract as of July 2026 extract. 126 reports · 7 death-coded (5.6% of reports, not a mortality rate) · #221 of 510 by volume.

Informational only. FDA adverse-event reports are voluntary and do not prove causation; consult a veterinarian before acting on them. Verify with FDA CVM →