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2026 FDA CVM data 6,412 reports on file official source

Rottweiler — FDA Adverse Event Profile

Adverse-event records and label data for Rottweiler (Dog), sourced from the FDA Center for Veterinary Medicine. Refreshed as new reports are filed. Cite PlainBreed when reusing this analysis.

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Annual breed adverse-event registration timeline Bar chart showing yearly FDA Center for Veterinary Medicine adverse event report counts per breed registry cohort, with paw-print tick marks indicating count buckets. 430 322.5 215 107.5 0 2018 2019 2020 2021 2022 2023 2024 2025 Reports filed Death-coded reports
Annual report volume for Rottweiler drawn from FDA CVM filings.

Rottweiler (Dog) has 6,412 FDA adverse event reports on record, with 521 deaths reported (810.0% death rate) — ranking #34 by report volume. The most frequently reported reaction is Vomiting (1,299 cases). The top associated drug is Milbemycin Oxime + Spinosad. Average age at report: 4.5 years.

Total Reports

6,412

FDA CVM filings

Deaths Reported

521

of 6,412 reports

Death Rate

810.0%

death-coded share

Avg Age at Report

4.5 yr

38.6 kg avg weight

Death-Coded Outcome Share

Rottweiler death-coded reports 100.0%
Database median

810.0% of 6,412 reports involved a death outcome. Read alongside breed popularity, veterinary access, and owner awareness — these shape how many events ever reach the FDA. The 12% comparison line is the rough cross-breed median in the FDA CVM database; values above suggest higher reporting bias toward severe outcomes, not necessarily higher true mortality.

Average weight at time of report: 38.6 kg (85.1 lbs)

Top Reported Reactions

Vomiting 1,299
Lack of efficacy (endoparasite) - heartworm 596
INEFFECTIVE, HEARTWORM LARVAE 594
Lethargy (see also Central nervous system depression in 'Neurological') 585
Emesis 498
Diarrhoea 485
Lack of efficacy - NOS 384
Anorexia 321
Death 266
Lack of efficacy (endoparasite) - hookworm 260
Other abnormal test result NOS 225
Death by euthanasia 220
Lack of efficacy (ectoparasite) - flea 217
Seizure NOS 215
Digestive tract disorder NOS 200

Most Referenced Drugs

Milbemycin Oxime + Spinosad 1,253
Ivermectin + Pyrantel As Pamoate Salt 896
Moxidectin 346
Afoxolaner 330
Pyrantel Pamoate;Sarolaner 325
Spinosad 324
Milbemycin Oxime + Praziquantel 307
Carprofen 300
Fluralaner Chew Tablets 223
Bedinvetmab 193
Melarsomine Dihydrochloride 167
Fluralaner 13.64% 12-Week Chew 141
Deracoxib 127
Gabapentin 124
Ivermectin, Pyrantel 112

Outcome Breakdown

Outcome Unknown
1,892 (32.2%)
Recovered/Normal
1,723 (29.3%)
Ongoing
1,421 (24.2%)
Died
330 (5.6%)
Recovered with Sequela
320 (5.4%)
Euthanized
191 (3.2%)

Gender Distribution

Male 3,265 (50.9%)
Female 2,976 (46.4%)
Unknown 144 (2.2%)
Mixed 27 (0.4%)

Reports by Year

Year Reports Trend
2010 308
2011 384
2012 478
2013 455
2014 449
2015 490
2016 467
2017 494
2018 400
2019 418
2020 382
2021 379
2022 292
2023 342
2024 430
2025 244
Size-class weight distribution across registered breeds Vertical bar chart showing the distribution of registered breeds across five size classes (Toy, Small, Medium, Large, Giant), each represented by a scaled dog-silhouette and a count value. 118 89 59 30 0 Breeds in class 38 Toy 0–6 kg Chihuahua 64 Small 6–14 kg Beagle 92 Medium 14–27 kg Border Collie 118 Large 27–45 kg Labrador Retriever 41 Giant 45–90 kg Great Dane Size-Class Distribution
Where Rottweiler sits in the registered size-class taxonomy. Average reported weight: 38.6 kg.
Breed-group distribution donut chart Donut chart with kennel-club-ribbon center showing breed counts across the eight standard breed groups (Sporting, Hound, Working, Terrier, Toy, Non-Sporting, Herding, Miscellaneous). CH Sporting 32 · 14.2% Hound 36 · 15.9% Working 33 · 14.6% Terrier 31 · 13.7% Toy 23 · 10.2% Non-Sporting 21 · 9.3% Herding 32 · 14.2% Misc. 18 · 8.0% Breed-Group Classification 226 breeds across 8 taxonomic groups
Eight standard breed-group classifications used by major registries (AKC's seven groups plus Miscellaneous). Provides taxonomic context for breed lookups.

Rottweiler Pet Health Insights

Across the FDA Center for Veterinary Medicine adverse event database, Rottweiler accounts for 6,412 submitted reports and currently ranks #34 by report volume within the dog population. Of those reports, 521 involved a death outcome — a 810.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 4.5 years, with an average recorded body weight of 38.6 kg (85.1 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 Rottweiler are Vomiting (1,299 reports), Lack of efficacy (endoparasite) - heartworm (596 reports), INEFFECTIVE, HEARTWORM LARVAE (594 reports), together capturing a substantial share of the top-reaction traffic seen in this breed's record. On the product side, Milbemycin Oxime + Spinosad appears in 1,253 reports and is the single most-referenced drug, followed by Ivermectin + Pyrantel As Pamoate Salt (896) and Moxidectin (346). 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 5,877 reports with a recorded status is dominated by Outcome Unknown (32.2% of coded outcomes). Annual submission volume ranges from 2,010 to 2,025 reports across the 16 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.

Understanding Rottweiler Adverse Event Data

With 6,412 adverse event reports, Rottweiler has one of the larger report volumes in the FDA database. This typically reflects breed popularity rather than inherent health risk — more pets of a breed means more veterinary encounters and more opportunity for adverse event reporting.

The 810.0% death rate is above average, though this statistic should be interpreted cautiously. Death reports may be overrepresented because serious outcomes are more likely to be reported than mild reactions.

The most frequently referenced drug in adverse reports is Milbemycin Oxime + Spinosad, appearing in 1,253 reports. This may indicate widespread use of the medication rather than a specific safety concern for Rottweiler.

Other Dog Breeds

Frequently Asked Questions

How many FDA adverse event reports involve Rottweiler?
There are 6,412 adverse event reports involving Rottweiler in the FDA database, with 521 reports involving death (810.0% death rate). Rottweiler ranks #34 by report volume.
What are the most common adverse reactions reported for Rottweiler?
The most commonly reported adverse reactions for Rottweiler are Vomiting (1,299 reports), Lack of efficacy (endoparasite) - heartworm (596 reports), INEFFECTIVE, HEARTWORM LARVAE (594 reports), Lethargy (see also Central nervous system depression in 'Neurological') (585 reports), Emesis (498 reports).
What drugs are most frequently associated with Rottweiler adverse events?
The drugs most frequently referenced in Rottweiler adverse event reports are Milbemycin Oxime + Spinosad (1,253 reports), Ivermectin + Pyrantel As Pamoate Salt (896 reports), Moxidectin (346 reports), Afoxolaner (330 reports), Pyrantel Pamoate;Sarolaner (325 reports).
What is the average age of Rottweiler in adverse event reports?
The average age of Rottweiler at the time of adverse event reports is 4.5 years, with an average weight of 38.6 kg (85.1 lbs).
Does a high number of adverse event reports mean Rottweiler 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 Rottweiler 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.

Guides & Resources

Related Data Sources

Data Sources & Methodology

Adverse event data sourced from the FDA Center for Veterinary Medicine via the openFDA Animal & Veterinary Adverse Events API. Reports are voluntarily submitted by pet owners, veterinarians, and product manufacturers.

Rottweiler ranks #34 by total report volume. Death rate (810.0%) reflects the proportion of reports involving death and should not be interpreted as a breed-specific mortality rate. Reporting biases, breed popularity, and veterinary access all influence report counts.

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial