Total Reports
44
FDA CVM filings
Horse /
FDA CVM · 2025 release 44 reports on file
Holsteiner - FDA Adverse Event Profile
Adverse-event records for Holsteiner (Horse) from the FDA Center for Veterinary Medicine.
Data updated June 2026
The record at a glance
With 44 reports on file, Holsteiner sits at #277 among horse breeds by volume; death-coded share is 4.5% (2 reports).
- #277
- most-reported horse breed
- 4.5%
- death-coded report share
- 9
- Lack of efficacy - NOS - top reaction
- 13.6 yr
- average age at report
Higher volume usually means a more popular breed, not a riskier one, compare against how common the breed is.
Deaths Reported
2
of 44 reports
Death Rate
4.5%
death-coded share
Avg Age at Report
13.6 yr
483.8 kg avg weight
Death-Coded Outcome Share
Holsteiner death-coded reports 4.5%
Cross-breed median
4.5% of 44 holsteiner reports involved a death outcome.
How to read this number
Read alongside breed popularity, veterinary access, and owner awareness, these shape how many events ever reach the FDA. The comparison line marks the cross-breed median death-coded share (about 4.8%) among breeds with 50 or more reports; values above it suggest higher reporting bias toward severe outcomes, not necessarily higher true mortality.
Average weight at time of report: 483.8 kg (1066.8 lbs)
Top Reported Reactions
Lack of efficacy - NOS 9
INEFFECTIVE, GASTRIC ULCER(S) 7
Fever 7
Anorexia 5
Injection site pain 5
Most Referenced Drugs
Omeprazole 12
Pergolide Mesylate 8
Ceftiofur Crystalline Free Acid 6
Omeprazole 37% Oral Paste 3
Flunixin 3
Outcome Breakdown
Recovered/Normal
17 (39.5%)
Outcome Unknown
14 (32.6%)
Ongoing
10 (23.3%)
Died
1 (2.3%)
Euthanized
1 (2.3%)
Gender Distribution
Male 21 (47.7%)
Female 20 (45.5%)
Unknown 3 (6.8%)
Reports by Year
| Year | Reports | Trend |
|---|---|---|
| 2010 | 1 | |
| 2012 | 1 | |
| 2013 | 1 | |
| 2014 | 1 | |
| 2015 | 4 | |
| 2016 | 1 | |
| 2017 | 4 | |
| 2018 | 3 | |
| 2019 | 1 | |
| 2020 | 6 | |
| 2021 | 5 | |
| 2022 | 3 | |
| 2023 | 1 | |
| 2024 | 7 | |
| 2025 | 5 | |
Holsteiner Pet Health Insights
Holsteiner accounts for 44 FDA adverse event reports, ranking #277 by volume among horse breeds, with 2 reports (4.5%) coded as a death outcome. Mean age at report: 13.6 years, average weight 483.8 kg (1066.8 lbs).
Top reported signs: Lack of efficacy - NOS (9), INEFFECTIVE, GASTRIC ULCER(S) (7), Fever (7). Most-referenced drug: Omeprazole (12 reports), followed by Pergolide Mesylate (8) and Ceftiofur Crystalline Free Acid (6).
Outcome coding on 43 status-recorded reports is dominated by Recovered/Normal (39.5%). Annual submissions ranged 2,010-2,025 across 15 years on file.
Horse Breeds With a Similar Report Volume
Frequently Asked Questions
How many FDA adverse event reports involve Holsteiner? ▼
There are 44 adverse event reports involving Holsteiner in the FDA database, with 2 reports involving death (4.5% death rate). Holsteiner ranks #277 by report volume.
What are the most common adverse reactions reported for Holsteiner? ▼
The most commonly reported adverse reactions for Holsteiner are Lack of efficacy - NOS (9 reports), INEFFECTIVE, GASTRIC ULCER(S) (7 reports), Fever (7 reports), Anorexia (5 reports), Injection site pain (5 reports).
What drugs are most frequently associated with Holsteiner adverse events? ▼
The drugs most frequently referenced in Holsteiner adverse event reports are Omeprazole (12 reports), Pergolide Mesylate (8 reports), Ceftiofur Crystalline Free Acid (6 reports), Omeprazole 37% Oral Paste (3 reports), Flunixin (3 reports).
What is the average age of Holsteiner in adverse event reports? ▼
The average age of Holsteiner at the time of adverse event reports is 13.6 years, with an average weight of 483.8 kg (1066.8 lbs).
Does a high number of adverse event reports mean Holsteiner 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 Holsteiner 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.
Compare a breed's report volume against how common the breed is before drawing conclusions. See our methodology for how death rate and rankings are computed.
Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. Breed figures are computed directly from FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.