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2026 FDA CVM data 42 reports on file official source

Trakehner — FDA Adverse Event Profile

Adverse-event records and label data for Trakehner (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. 4 3 2 1 0 2017 2019 2020 2021 2022 2023 2024 2025 Reports filed Death-coded reports
Annual report volume for Trakehner drawn from FDA CVM filings.

Trakehner (Horse) has 42 FDA adverse event reports on record, with 3 deaths reported (710.0% death rate) — ranking #283 by report volume. The most frequently reported reaction is Colic (7 cases). The top associated drug is Pergolide Mesylate. Average age at report: 15.6 years.

Total Reports

42

FDA CVM filings

Deaths Reported

3

of 42 reports

Death Rate

710.0%

death-coded share

Avg Age at Report

15.6 yr

469.5 kg avg weight

Death-Coded Outcome Share

Trakehner death-coded reports 100.0%
Database median

710.0% of 42 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: 469.5 kg (1035.2 lbs)

Top Reported Reactions

Colic 7
INEFFECTIVE, GASTRIC ULCER(S) 5
Swollen lip (see also 'Skin') 4
Depression 4
Anorexia 4
Drooling 3
Application site swelling 3
Injection site swelling 3
Lameness 3
Digestive tract disorder NOS 2
Lethargy (see also Central nervous system depression in 'Neurological') 2
Aggression 2
Facial swelling (see also 'Skin') 2
Anaphylactoid reaction 2
Ataxia 2

Most Referenced Drugs

Pergolide Mesylate 8
Omeprazole 6
Ivermectin(1.55%)/Praziquantel(7.75%) Paste 4
Detomidine Hydrochloride 4
Flunixin Meglumine 3
Ceftiofur Crystalline Free Acid 3
Omeprazole 37% Oral Paste 3
Amikacin 3
Polysulfated Glycosaminoglycan 2
Flunixin Meglumine Injectable 2
Pentosan Polysulfate Sodium 2
Sterile Saline 2
Gentamicin 2
Lactated Ringer&Apos;S Solution 2
Vitamin Iron Mineral Supplement 2

Outcome Breakdown

Recovered/Normal
14 (35.9%)
Outcome Unknown
11 (28.2%)
Ongoing
11 (28.2%)
Euthanized
2 (5.1%)
Died
1 (2.6%)

Gender Distribution

Male 21 (50.0%)
Female 20 (47.6%)
Unknown 1 (2.4%)

Reports by Year

Year Reports Trend
2010 1
2011 2
2012 4
2013 4
2014 3
2015 4
2016 2
2017 1
2019 2
2020 4
2021 1
2022 2
2023 4
2024 4
2025 4
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 Trakehner sits in the registered size-class taxonomy. Average reported weight: 469.5 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.

Trakehner Pet Health Insights

Across the FDA Center for Veterinary Medicine adverse event database, Trakehner accounts for 42 submitted reports and currently ranks #283 by report volume within the horse population. Of those reports, 3 involved a death outcome — a 710.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 15.6 years, with an average recorded body weight of 469.5 kg (1035.2 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 Trakehner are Colic (7 reports), INEFFECTIVE, GASTRIC ULCER(S) (5 reports), Swollen lip (see also 'Skin') (4 reports), together capturing a substantial share of the top-reaction traffic seen in this breed's record. On the product side, Pergolide Mesylate appears in 8 reports and is the single most-referenced drug, followed by Omeprazole (6) and Ivermectin(1.55%)/Praziquantel(7.75%) Paste (4). 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 39 reports with a recorded status is dominated by Recovered/Normal (35.9% of coded outcomes). Annual submission volume ranges from 2,010 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 horse.

Understanding Trakehner Adverse Event Data

Trakehner has 42 adverse event reports on file. Lower report volumes may reflect a less common breed, lower reporting rates, or genuinely fewer adverse events.

The 710.0% 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 Pergolide Mesylate, appearing in 8 reports. This may indicate widespread use of the medication rather than a specific safety concern for Trakehner.

Other Horse Breeds

Frequently Asked Questions

How many FDA adverse event reports involve Trakehner?
There are 42 adverse event reports involving Trakehner in the FDA database, with 3 reports involving death (710.0% death rate). Trakehner ranks #283 by report volume.
What are the most common adverse reactions reported for Trakehner?
The most commonly reported adverse reactions for Trakehner are Colic (7 reports), INEFFECTIVE, GASTRIC ULCER(S) (5 reports), Swollen lip (see also 'Skin') (4 reports), Depression (4 reports), Anorexia (4 reports).
What drugs are most frequently associated with Trakehner adverse events?
The drugs most frequently referenced in Trakehner adverse event reports are Pergolide Mesylate (8 reports), Omeprazole (6 reports), Ivermectin(1.55%)/Praziquantel(7.75%) Paste (4 reports), Detomidine Hydrochloride (4 reports), Flunixin Meglumine (3 reports).
What is the average age of Trakehner in adverse event reports?
The average age of Trakehner at the time of adverse event reports is 15.6 years, with an average weight of 469.5 kg (1035.2 lbs).
Does a high number of adverse event reports mean Trakehner 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 Trakehner 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.

Trakehner ranks #283 by total report volume. Death rate (710.0%) 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