Total Reports
44
FDA CVM filings
Horse /
2026 FDA CVM data 44 reports on file official source
Holsteiner — FDA Adverse Event Profile
Adverse-event records and label data for Holsteiner (Horse), sourced from the FDA Center for Veterinary Medicine. Refreshed as new reports are filed. Cite PlainBreed when reusing this analysis.
Holsteiner (Horse) has 44 FDA adverse event reports on record, with 2 deaths reported (450.0% death rate) — ranking #277 by report volume. The most frequently reported reaction is Lack of efficacy - NOS (9 cases). The top associated drug is Omeprazole. Average age at report: 13.6 years.
Deaths Reported
2
of 44 reports
Death Rate
450.0%
death-coded share
Avg Age at Report
13.6 yr
483.8 kg avg weight
Death-Coded Outcome Share
Holsteiner death-coded reports 100.0%
Database median
450.0% of 44 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: 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
Injection site swelling 4
Behavioural disorder NOS 3
Other abnormal test result NOS 3
Lethargy (see also Central nervous system depression in 'Neurological') 3
Partial lack of efficacy 3
Gastric ulcer 2
Lameness 2
Decreased appetite 2
Injection site abscess 2
Abnormal ultrasound finding 2
Most Referenced Drugs
Omeprazole 12
Pergolide Mesylate 8
Ceftiofur Crystalline Free Acid 6
Omeprazole 37% Oral Paste 3
Flunixin 3
Oxybendazole 2
Triamcinolone Acetonide 2
Flunixin Meglumine Injectable 2
Dexamethasone 2
Ceftiofur 1
Ponazuril 1
Chloramphenicol 1
Atropine 1
Oxytetracycline 1
Minocycline 1
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
Across the FDA Center for Veterinary Medicine adverse event database, Holsteiner accounts for 44 submitted reports and currently ranks #277 by report volume within the horse population. Of those reports, 2 involved a death outcome — a 450.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 13.6 years, with an average recorded body weight of 483.8 kg (1066.8 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 Holsteiner are Lack of efficacy - NOS (9 reports), INEFFECTIVE, GASTRIC ULCER(S) (7 reports), Fever (7 reports), together capturing a substantial share of the top-reaction traffic seen in this breed's record. On the product side, Omeprazole appears in 12 reports and is the single most-referenced drug, followed by Pergolide Mesylate (8) and Ceftiofur Crystalline Free Acid (6). 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 43 reports with a recorded status is dominated by Recovered/Normal (39.5% 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 Holsteiner Adverse Event Data
Holsteiner has 44 adverse event reports on file. Lower report volumes may reflect a less common breed, lower reporting rates, or genuinely fewer adverse events.
The 450.0% 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 Omeprazole, appearing in 12 reports. This may indicate widespread use of the medication rather than a specific safety concern for Holsteiner.
Other Horse Breeds
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 (450.0% 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.
Guides & Resources
Understanding Adverse Events
What FDA reports are and how they are collected
Breed-Specific Risks
Why some breeds appear in more adverse event reports
Pet Medication Safety
Evaluating medication risks using FDA data
Most Reported Medications
Drugs that appear most in adverse event reports
How FDA CVM Tracks Events
The reporting process and database limitations
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.
Holsteiner ranks #277 by total report volume. Death rate (450.0%) 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.
Read our methodology — how this data is sourced, computed, and verified.
Related
Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial