Total Reports
93
FDA CVM filings
Horse /
2026 FDA CVM data 93 reports on file official source
Saddlebred - American — FDA Adverse Event Profile
Adverse-event records and label data for Saddlebred - American (Horse), sourced from the FDA Center for Veterinary Medicine. Refreshed as new reports are filed. Cite PlainBreed when reusing this analysis.
Saddlebred - American (Horse) has 93 FDA adverse event reports on record, with 15 deaths reported (1610.0% death rate) — ranking #235 by report volume. The most frequently reported reaction is Lack of efficacy - NOS (11 cases). The top associated drug is Pergolide Mesylate. Average age at report: 14.7 years.
Deaths Reported
15
of 93 reports
Death Rate
1610.0%
death-coded share
Avg Age at Report
14.7 yr
432.3 kg avg weight
Death-Coded Outcome Share
Saddlebred - American death-coded reports 100.0%
Database median
1610.0% of 93 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: 432.3 kg (953.2 lbs)
Top Reported Reactions
Lack of efficacy - NOS 11
Death by euthanasia 10
Colic 10
Other abnormal test result NOS 6
Fever 6
Abdominal pain 5
Anorexia 5
Diarrhoea 5
Tachypnoea 5
Seizure NOS 4
Injection site swelling 4
Swollen lip (see also 'Skin') 4
Lethargy (see also Central nervous system depression in 'Neurological') 4
Death 3
Lip oedema (see also 'Skin') 3
Most Referenced Drugs
Pergolide Mesylate 13
Ceftiofur Crystalline Free Acid 12
Detomidine Hydrochloride 9
Omeprazole 9
Ivermectin + Praziquantel 8
Ivermectin(1.55%)/Praziquantel(7.75%) Paste 6
Firocoxib 5
Butorphanol Tartrate 5
Clodronate Disodium 4
Ivermectin, Praziquantel 3
N-Butylscopolaminium Bromide 3
Pyrantel Tartrate 2
Ivermectin 2
Omeprazole 37% Oral Paste 2
Moxidectin 2
Outcome Breakdown
Recovered/Normal
36 (41.9%)
Outcome Unknown
24 (27.9%)
Ongoing
10 (11.6%)
Euthanized
9 (10.5%)
Died
6 (7.0%)
Recovered with Sequela
1 (1.2%)
Gender Distribution
Female 40 (43.0%)
Male 40 (43.0%)
Unknown 7 (7.5%)
Mixed 6 (6.5%)
Reports by Year
| Year | Reports | Trend |
|---|---|---|
| 2010 | 2 | |
| 2011 | 7 | |
| 2012 | 8 | |
| 2013 | 1 | |
| 2014 | 2 | |
| 2015 | 3 | |
| 2016 | 9 | |
| 2017 | 7 | |
| 2018 | 11 | |
| 2019 | 7 | |
| 2020 | 10 | |
| 2021 | 4 | |
| 2022 | 4 | |
| 2023 | 7 | |
| 2024 | 7 | |
| 2025 | 4 | |
Saddlebred - American Pet Health Insights
Across the FDA Center for Veterinary Medicine adverse event database, Saddlebred - American accounts for 93 submitted reports and currently ranks #235 by report volume within the horse population. Of those reports, 15 involved a death outcome — a 1610.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 14.7 years, with an average recorded body weight of 432.3 kg (953.2 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 Saddlebred - American are Lack of efficacy - NOS (11 reports), Death by euthanasia (10 reports), Colic (10 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 13 reports and is the single most-referenced drug, followed by Ceftiofur Crystalline Free Acid (12) and Detomidine Hydrochloride (9). 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 86 reports with a recorded status is dominated by Recovered/Normal (41.9% 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 Saddlebred - American Adverse Event Data
Saddlebred - American has 93 adverse event reports on file. Lower report volumes may reflect a less common breed, lower reporting rates, or genuinely fewer adverse events.
The 1610.0% 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 13 reports. This may indicate widespread use of the medication rather than a specific safety concern for Saddlebred - American.
Other Horse Breeds
Frequently Asked Questions
How many FDA adverse event reports involve Saddlebred - American? ▼
There are 93 adverse event reports involving Saddlebred - American in the FDA database, with 15 reports involving death (1610.0% death rate). Saddlebred - American ranks #235 by report volume.
What are the most common adverse reactions reported for Saddlebred - American? ▼
The most commonly reported adverse reactions for Saddlebred - American are Lack of efficacy - NOS (11 reports), Death by euthanasia (10 reports), Colic (10 reports), Other abnormal test result NOS (6 reports), Fever (6 reports).
What drugs are most frequently associated with Saddlebred - American adverse events? ▼
The drugs most frequently referenced in Saddlebred - American adverse event reports are Pergolide Mesylate (13 reports), Ceftiofur Crystalline Free Acid (12 reports), Detomidine Hydrochloride (9 reports), Omeprazole (9 reports), Ivermectin + Praziquantel (8 reports).
What is the average age of Saddlebred - American in adverse event reports? ▼
The average age of Saddlebred - American at the time of adverse event reports is 14.7 years, with an average weight of 432.3 kg (953.2 lbs).
Does a high number of adverse event reports mean Saddlebred - American 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 Saddlebred - American 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.
Saddlebred - American ranks #235 by total report volume. Death rate (1610.0%) 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