Breed · Dog
Leonberger: adverse event reports
FDA breed label "Leonberger" · single-breed animals only
FDA's database holds 119 reports where the animal's breed is given as "Leonberger", shown here as Leonberger: 0% of reports about dogs. Reports on crossbred animals are left out of breed pages.
6 reports arrived in the 12 months to March 2026, down 45% from 11 in the 12 months before. A breed's count mostly mirrors how common the breed is; registration and ownership figures by breed are not public data, so no per-animal rate can be given.
By active ingredient, the drugs named most often are fluralaner, ivermectin + pyrantel pamoate and afoxolaner. Fluralaner is named in 15.1% of this breed's reports, a larger share than in reports about all dogs (6.7%).
The terms listed most often are lethargy (16.8%), diarrhoea (13.4%) and vomiting (9.2%). Lethargy appears in 16.8% of reports, a larger share than in all dog reports (7.9%). 45.7% of reports stating seriousness were classed as serious, against 38.3% for dogs overall.
Drugs named most often, by active ingredient
| Active ingredients recorded for the drug | Reports | Share of Leonberger reports | Share of all dog reports |
|---|---|---|---|
| Fluralaner | 18 | 15.1% | 6.7% |
| Ivermectin + Pyrantel Pamoate | 14 | 11.8% | 14.9% |
| Afoxolaner | 10 | 8.4% | 5.7% |
| Lufenuron + Milbemycin Oxime | 10 | 8.4% | 2.7% |
| Milbemycin Oxime + Praziquantel | 9 | 7.6% | 3.1% |
| Firocoxib | 7 | 5.9% | 0.8% |
| Pyrantel Pamoate + Sarolaner | 6 | 5% | 5.1% |
| Milbemycin Oxime + Spinosad | 5 | 4.2% | 13.1% |
| Moxidectin | 5 | 4.2% | 5% |
| Bedinvetmab | 4 | 3.4% | 1.9% |
| Grapiprant | 4 | 3.4% | 0.8% |
| Acepromazine Maleate | 3 | 2.5% | 0.2% |
| Atropine | 3 | 2.5% | 0.1% |
| Carprofen | 3 | 2.5% | 4.8% |
| Famotidine | 3 | 2.5% | 0.3% |
| Milbemycin Oxime | 3 | 2.5% | 3% |
| Oclacitinib | 3 | 2.5% | 2.9% |
| Propofol | 3 | 2.5% | 0.3% |
| Sevoflurane | 3 | 2.5% | 0.1% |
| Afoxolaner + Moxidectin + Pyrantel Pamoate | 2 | 1.7% | 0.8% |
Ordered by report count. Differences from the species column often come from body size (which drugs a breed is prescribed) and from how common the breed was in the years a drug sold most. FDA states that these data cannot be used to estimate risk or to compare one product with another. Brand and manufacturer names are masked by FDA in these records.
Signs listed in reports
share of Leonberger reports listing the termall dog reports
- Lethargy[unusually tired or inactive]16.8%20
- Diarrhoea[diarrhea]13.4%16
- Vomiting9.2%11
- Lack of efficacy (endoparasite) - whipworm[the product did not have the expected effect: whipworms]5.9%7
- Behavioural disorder NOS[behaviour change, type not specified]5%6
- Anorexia[not eating]4.2%5
- Decreased appetite4.2%5
- Emesis (multiple)[vomiting more than once]4.2%5
- Glazed eye4.2%5
- Ineffective, hooks[legacy FDA term: the product did not have the expected effect (hooks)]4.2%5
- Lack of efficacy (ectoparasite) - flea[the product did not have the expected effect: fleas]4.2%5
- Lack of efficacy (ectoparasite) - tick NOS[the product did not have the expected effect: ticks]4.2%5
- Lack of efficacy (endoparasite) - hookworm[the product did not have the expected effect: hookworms]4.2%5
- Lack of efficacy - NOS[the product did not have the expected effect]4.2%5
- Abnormal breathing3.4%4
- Ataxia[unsteady, uncoordinated movement]3.4%4
- Death3.4%4
- Digestive tract disorder NOS[digestive problem, type not specified]3.4%4
- Ineffective, whips[legacy FDA term: the product did not have the expected effect (whips)]3.4%4
- Lack of efficacy (endoparasite) - roundworm NOS[the product did not have the expected effect: roundworms]3.4%4
- Other abnormal test result NOS[abnormal laboratory result, type not specified]3.4%4
- Panting3.4%4
- Disorientation2.5%3
- Emesis[vomiting]2.5%3
- Ineffective, heartworm larvae[legacy FDA term: the product did not have the expected effect (heartworm larvae)]2.5%3
Age and weight
Age of the animal
Weight of the animal
Coloured bar: Leonberger reports. Grey bar: all dog reports.
Trend and outcomes
Reports by month FDA received them. The newest months are incomplete because FDA posts reports with a delay of three to six months.
Outcome recorded in the report
Beside all dogs
| Measure | Leonberger | All dogs |
|---|---|---|
| Reports | 119 | 985,675 |
| Latest 12 months | 6 | 53,292 |
| Classed serious, of reports stating it | 45.7% | 38.3% |
| Death or euthanasia recorded, per 1,000 reports | 58.8 | 55 |
Questions about Leonberger reports
How many FDA adverse event reports involve Leonbergers?
119 reports through March 2026, 0% of reports about dogs; 6 in the latest 12 months.
Which drugs are named most often in Leonberger reports?
By active ingredient: fluralaner (18), ivermectin + pyrantel pamoate (14), afoxolaner (10), lufenuron + milbemycin oxime (10) and milbemycin oxime + praziquantel (9). Brands are masked in the public data.
What signs are reported most for this breed?
lethargy (16.8%), diarrhoea (13.4%), vomiting (9.2%), lack of efficacy (endoparasite) - whipworm (5.9%) and behavioural disorder NOS (5%).
Is the Leonberger more sensitive to certain drugs?
Report counts cannot answer that. They show what was reported, not what a drug did, and they are not adjusted for how many Leonberger animals exist or were treated. Breed-related drug sensitivities that are established are described on FDA-approved labels; a veterinarian is the person to ask about an individual animal.
Why are crossbreds not included?
FDA records crossbred animals with one or more component breeds. Counting them under each component would double count, so breed pages use single-breed reports only. Crossbreds remain in the species totals.
How do I report a problem?
Call the drug company using the number on the label, or send Form FDA 1932a to FDA. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Animal & Veterinary adverse event bulk files released 28 Sep 2026, which hold reports FDA's Center for Veterinary Medicine received through 31 Mar 2026. openFDA masks brand and manufacturer names in these files, so drugs are counted by the active ingredients each record discloses and no figure is attributed to a brand, application or company. Ingredient names, and the separate reference lists of approved products, follow the FDA Green Book as of 1 Oct 2026. Breed names are FDA's labels rearranged into everyday order ("Leonberger" becomes "Leonberger"). No report text, lot numbers or reporter details are published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.