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2026 FDA CVM data 138 reports on file official source

Standardbred (unspecified) — FDA Adverse Event Profile

Adverse-event records and label data for Standardbred (unspecified) (Horse), 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. 11 8.25 5.5 2.75 0 2018 2019 2020 2021 2022 2023 2024 2025 Reports filed Death-coded reports
Annual report volume for Standardbred (unspecified) drawn from FDA CVM filings.

Standardbred (unspecified) (Horse) has 138 FDA adverse event reports on record, with 19 deaths reported (1380.0% death rate) — ranking #214 by report volume. The most frequently reported reaction is INEFFECTIVE, GASTRIC ULCER(S) (17 cases). The top associated drug is Ceftiofur Crystalline Free Acid. Average age at report: 8.9 years.

Total Reports

138

FDA CVM filings

Deaths Reported

19

of 138 reports

Death Rate

1380.0%

death-coded share

Avg Age at Report

8.9 yr

415.8 kg avg weight

Death-Coded Outcome Share

Standardbred (unspecified) death-coded reports 100.0%
Database median

1380.0% of 138 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: 415.8 kg (916.8 lbs)

Top Reported Reactions

INEFFECTIVE, GASTRIC ULCER(S) 17
Injection site swelling 16
Death 11
Injection site pain 10
Recumbency 10
Fever 10
Lack of efficacy - NOS 9
Application site swelling 8
Other abnormal test result NOS 8
Collapse (see also 'Cardio-vascular' and 'Systemic disorders') 6
Seizure NOS 6
Death by euthanasia 6
Anorexia 5
Anaphylaxis 5
Diarrhoea 5

Most Referenced Drugs

Ceftiofur Crystalline Free Acid 25
Omeprazole 18
Ivermectin + Praziquantel 7
Ceftiofur 6
Omeprazole 37% Oral Paste 6
Pergolide Mesylate 6
Ketamine Hydrochloride 5
Hyaluronate Sodium 5
Pyrantel Tartrate 3
Detomidine 3
Ivermectin, Praziquantel 3
Moxidectin 3
Oxytetracycline 3
Flunixin Meglumine 3
Ivermectin(1.55%)/Praziquantel(7.75%) Paste 3

Outcome Breakdown

Outcome Unknown
37 (33.9%)
Recovered/Normal
31 (28.4%)
Ongoing
21 (19.3%)
Died
13 (11.9%)
Euthanized
6 (5.5%)
Recovered with Sequela
1 (0.9%)

Gender Distribution

Male 77 (55.8%)
Female 51 (37.0%)
Unknown 6 (4.3%)
Mixed 4 (2.9%)

Reports by Year

Year Reports Trend
2010 15
2011 15
2012 13
2013 11
2014 6
2015 11
2016 3
2017 11
2018 4
2019 10
2020 6
2021 11
2022 8
2023 7
2024 2
2025 5
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 Standardbred (unspecified) sits in the registered size-class taxonomy. Average reported weight: 415.8 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.

Standardbred (unspecified) Pet Health Insights

Across the FDA Center for Veterinary Medicine adverse event database, Standardbred (unspecified) accounts for 138 submitted reports and currently ranks #214 by report volume within the horse population. Of those reports, 19 involved a death outcome — a 1380.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 8.9 years, with an average recorded body weight of 415.8 kg (916.8 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 Standardbred (unspecified) are INEFFECTIVE, GASTRIC ULCER(S) (17 reports), Injection site swelling (16 reports), Death (11 reports), together capturing a substantial share of the top-reaction traffic seen in this breed's record. On the product side, Ceftiofur Crystalline Free Acid appears in 25 reports and is the single most-referenced drug, followed by Omeprazole (18) and Ivermectin + Praziquantel (7). Counts like these surface which therapeutic classes dominate the reporting stream — useful context when comparing reactions across breeds of the same horse species.

Outcome coding on the 109 reports with a recorded status is dominated by Outcome Unknown (33.9% 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 horse.

Understanding Standardbred (unspecified) Adverse Event Data

Standardbred (unspecified) has 138 adverse event reports on file. Lower report volumes may reflect a less common breed, lower reporting rates, or genuinely fewer adverse events.

The 1380.0% 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 Ceftiofur Crystalline Free Acid, appearing in 25 reports. This may indicate widespread use of the medication rather than a specific safety concern for Standardbred (unspecified).

Other Horse Breeds

Frequently Asked Questions

How many FDA adverse event reports involve Standardbred (unspecified)?
There are 138 adverse event reports involving Standardbred (unspecified) in the FDA database, with 19 reports involving death (1380.0% death rate). Standardbred (unspecified) ranks #214 by report volume.
What are the most common adverse reactions reported for Standardbred (unspecified)?
The most commonly reported adverse reactions for Standardbred (unspecified) are INEFFECTIVE, GASTRIC ULCER(S) (17 reports), Injection site swelling (16 reports), Death (11 reports), Injection site pain (10 reports), Recumbency (10 reports).
What drugs are most frequently associated with Standardbred (unspecified) adverse events?
The drugs most frequently referenced in Standardbred (unspecified) adverse event reports are Ceftiofur Crystalline Free Acid (25 reports), Omeprazole (18 reports), Ivermectin + Praziquantel (7 reports), Ceftiofur (6 reports), Omeprazole 37% Oral Paste (6 reports).
What is the average age of Standardbred (unspecified) in adverse event reports?
The average age of Standardbred (unspecified) at the time of adverse event reports is 8.9 years, with an average weight of 415.8 kg (916.8 lbs).
Does a high number of adverse event reports mean Standardbred (unspecified) 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 Standardbred (unspecified) 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.

Standardbred (unspecified) ranks #214 by total report volume. Death rate (1380.0%) 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