Leonberger — FDA Adverse Event Profile

Leonberger Pet Health Insights

Across the FDA Center for Veterinary Medicine adverse event database, Leonberger accounts for 122 submitted reports and currently ranks #220 by report volume within the dog population. Of those reports, 7 involved a death outcome — a 570.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 4.7 years, with an average recorded body weight of 52.0 kg (114.7 lbs). These figures reflect the voluntary reporting pool only and should be read alongside breed popularity, veterinary access, and owner awareness — all of which shape how many events ever reach the FDA.

The most frequently reported clinical signs for Leonberger are Lethargy (see also Central nervous system depression in 'Neurological') (19 reports), Diarrhoea (16 reports), Vomiting (11 reports), together capturing a substantial share of the top-reaction traffic seen in this breed's record. On the product side, Ivermectin + Pyrantel As Pamoate Salt appears in 22 reports and is the single most-referenced drug, followed by Fluralaner Chew Tablets (17) and Milbemycin Oxime + Praziquantel (15). Counts like these surface which therapeutic classes dominate the reporting stream — useful context when comparing reactions across breeds of the same dog species.

Outcome coding on the 122 reports with a recorded status is dominated by Outcome Unknown (38.5% of coded outcomes). Annual submission volume ranges from 2,011 to 2,025 reports across the 15 years on file, indicating the reporting trend is shaped as much by awareness cycles as by underlying clinical events. Because FDA adverse event reports describe correlation rather than causation, these numbers are most useful as a signal of where to ask further questions with a veterinarian — not as a standalone risk score for any individual dog.