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2026 FDA CVM data 2,952 reports on file official source

Mastiff — FDA Adverse Event Profile

Adverse-event records and label data for Mastiff (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. 245 183.75 122.5 61.25 0 2016 2017 2018 2019 2020 2021 2022 2023 Reports filed Death-coded reports
Annual report volume for Mastiff drawn from FDA CVM filings.

Mastiff (Dog) has 2,952 FDA adverse event reports on record, with 182 deaths reported (620.0% death rate) — ranking #63 by report volume. The most frequently reported reaction is Vomiting (604 cases). The top associated drug is Milbemycin Oxime + Spinosad. Average age at report: 3.4 years.

Total Reports

2,952

FDA CVM filings

Deaths Reported

182

of 2,952 reports

Death Rate

620.0%

death-coded share

Avg Age at Report

3.4 yr

49.7 kg avg weight

Death-Coded Outcome Share

Mastiff death-coded reports 100.0%
Database median

620.0% of 2,952 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: 49.7 kg (109.6 lbs)

Top Reported Reactions

Vomiting 604
Emesis 395
Lethargy (see also Central nervous system depression in 'Neurological') 243
Diarrhoea 206
Lack of efficacy (endoparasite) - heartworm 203
INEFFECTIVE, HEARTWORM LARVAE 174
Lack of efficacy - NOS 163
Lack of efficacy (ectoparasite) - flea 149
Lack of efficacy (endoparasite) - hookworm 110
Seizure NOS 99
Anorexia 97
Death 96
Underdose 85
Other abnormal test result NOS 80
Death by euthanasia 75

Most Referenced Drugs

Milbemycin Oxime + Spinosad 777
Ivermectin + Pyrantel As Pamoate Salt 346
Spinosad 278
Moxidectin 210
Afoxolaner 173
Pyrantel Pamoate;Sarolaner 156
Fluralaner Chew Tablets 129
Carprofen 115
Oclacitinib Maleate 109
Milbemycin Oxime + Praziquantel 106
Sarolaner 75
Melarsomine Dihydrochloride 59
Lufenuron + Milbemycin Oxime 46
Fluralaner 13.64% 12-Week Chew 44
Ivermectin, Pyrantel 43

Outcome Breakdown

Recovered/Normal
956 (36.0%)
Outcome Unknown
758 (28.5%)
Ongoing
658 (24.7%)
Died
113 (4.2%)
Recovered with Sequela
105 (3.9%)
Euthanized
69 (2.6%)

Gender Distribution

Male 1,711 (58.0%)
Female 1,169 (39.6%)
Unknown 60 (2.0%)
Mixed 12 (0.4%)

Reports by Year

Year Reports Trend
2010 127
2011 246
2012 280
2013 230
2014 212
2015 219
2016 245
2017 236
2018 208
2019 201
2020 224
2021 195
2022 166
2023 163
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 Mastiff sits in the registered size-class taxonomy. Average reported weight: 49.7 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.

Mastiff Pet Health Insights

Across the FDA Center for Veterinary Medicine adverse event database, Mastiff accounts for 2,952 submitted reports and currently ranks #63 by report volume within the dog population. Of those reports, 182 involved a death outcome — a 620.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 3.4 years, with an average recorded body weight of 49.7 kg (109.6 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 Mastiff are Vomiting (604 reports), Emesis (395 reports), Lethargy (see also Central nervous system depression in 'Neurological') (243 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 777 reports and is the single most-referenced drug, followed by Ivermectin + Pyrantel As Pamoate Salt (346) and Spinosad (278). 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 2,659 reports with a recorded status is dominated by Recovered/Normal (36.0% of coded outcomes). Annual submission volume ranges from 2,010 to 2,023 reports across the 14 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 Mastiff Adverse Event Data

Mastiff has a moderate volume of adverse event reports (2,952). Report counts are influenced by breed popularity, owner awareness, and veterinary reporting practices.

The 620.0% 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 777 reports. This may indicate widespread use of the medication rather than a specific safety concern for Mastiff.

Other Dog Breeds

Frequently Asked Questions

How many FDA adverse event reports involve Mastiff?
There are 2,952 adverse event reports involving Mastiff in the FDA database, with 182 reports involving death (620.0% death rate). Mastiff ranks #63 by report volume.
What are the most common adverse reactions reported for Mastiff?
The most commonly reported adverse reactions for Mastiff are Vomiting (604 reports), Emesis (395 reports), Lethargy (see also Central nervous system depression in 'Neurological') (243 reports), Diarrhoea (206 reports), Lack of efficacy (endoparasite) - heartworm (203 reports).
What drugs are most frequently associated with Mastiff adverse events?
The drugs most frequently referenced in Mastiff adverse event reports are Milbemycin Oxime + Spinosad (777 reports), Ivermectin + Pyrantel As Pamoate Salt (346 reports), Spinosad (278 reports), Moxidectin (210 reports), Afoxolaner (173 reports).
What is the average age of Mastiff in adverse event reports?
The average age of Mastiff at the time of adverse event reports is 3.4 years, with an average weight of 49.7 kg (109.6 lbs).
Does a high number of adverse event reports mean Mastiff 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 Mastiff 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.

Mastiff ranks #63 by total report volume. Death rate (620.0%) 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