Breed · Horse
American Saddlebred: adverse event reports
FDA breed label "Saddlebred - American" · single-breed animals only
166 adverse event reports received by FDA describe an animal recorded as American Saddlebred (FDA breed label "Saddlebred - American"). That is 0.9% of all reports about horses. Crossbred animals are not counted here, only reports that give this single breed.
3 reports arrived in the 12 months to March 2026, down 50% from 6 in the 12 months before. A breed's count mostly mirrors how common the breed is; registration and ownership figures by breed are not public data, so no per-animal rate can be given.
By active ingredient, the drugs named most often are ivermectin + praziquantel, detomidine hydrochloride and moxidectin. Ivermectin + Praziquantel is named in 20.5% of this breed's reports, a larger share than in reports about all horses (14.4%).
The terms listed most often are death by euthanasia (7.8%), lip oedema (7.8%) and abdominal pain (6.6%). Death by euthanasia appears in 7.8% of reports, a larger share than in all horse reports (4.2%). 46.8% of reports stating seriousness were classed as serious, against 44.1% for horses overall.
Drugs named most often, by active ingredient
| Active ingredients recorded for the drug | Reports | Share of American Saddlebred reports | Share of all horse reports |
|---|---|---|---|
| Ivermectin + Praziquantel | 34 | 20.5% | 14.4% |
| Detomidine Hydrochloride | 15 | 9% | 5.6% |
| Moxidectin | 14 | 8.4% | 7.4% |
| Ceftiofur Crystalline Free Acid | 13 | 7.8% | 4.8% |
| Pergolide mesylate | 13 | 7.8% | 6.5% |
| Omeprazole | 12 | 7.2% | 9.9% |
| Butorphanol Tartrate | 6 | 3.6% | 1.6% |
| Firocoxib | 6 | 3.6% | 2.6% |
| Pyrantel Tartrate | 6 | 3.6% | 4% |
| Moxidectin + Praziquantel | 5 | 3% | 2% |
| Xylazine | 5 | 3% | 2.4% |
| Clodronate | 4 | 2.4% | 1.7% |
| Flunixin Meglumine | 4 | 2.4% | 3.5% |
| Hyaluronate Sodium | 4 | 2.4% | 2.9% |
| Ivermectin | 4 | 2.4% | 4.6% |
| Ketamine Hydrochloride | 3 | 1.8% | 3.3% |
| Diclofenac sodium | 2 | 1.2% | 0.2% |
| Ketoprofen | 2 | 1.2% | 0.1% |
| Penicillin G Procaine | 2 | 1.2% | 0.5% |
| Ponazuril | 2 | 1.2% | 1.1% |
Ordered by report count. Differences from the species column often come from body size (which drugs a breed is prescribed) and from how common the breed was in the years a drug sold most. FDA states that these data cannot be used to estimate risk or to compare one product with another. Brand and manufacturer names are masked by FDA in these records.
Signs listed in reports
share of American Saddlebred reports listing the termall horse reports
- Death by euthanasia[the animal was euthanized]7.8%13
- Lip oedema7.8%13
- Abdominal pain6.6%11
- Fever6.6%11
- Colic6%10
- Lack of efficacy - NOS[the product did not have the expected effect]6%10
- Death5.4%9
- Application site swelling[swelling where the product was applied]4.8%8
- Ataxia[unsteady, uncoordinated movement]4.8%8
- Diarrhoea[diarrhea]4.8%8
- Hypersalivation[drooling]4.8%8
- Recumbency[lying down and unable or unwilling to rise]4.8%8
- Tachypnoea[fast breathing]4.8%8
- Anaphylaxis[sudden severe allergic-type reaction]4.2%7
- Hyperhidrosis4.2%7
- Ineffective, sedation[legacy FDA term: the product did not have the expected effect (sedation)]4.2%7
- Anorexia[not eating]3.6%6
- Injection site swelling[swelling where the injection was given]3.6%6
- Behavioural disorder NOS[behaviour change, type not specified]3%5
- Stomatitis3%5
- Facial oedema[swollen face]2.4%4
- Injection site pain[pain where the injection was given]2.4%4
- Laminitis2.4%4
- Lethargy[unusually tired or inactive]2.4%4
- Malaise[generally unwell]2.4%4
Age and weight
Age of the animal
Weight of the animal
Coloured bar: American Saddlebred reports. Grey bar: all horse reports.
Trend and outcomes
Reports by month FDA received them. The newest months are incomplete because FDA posts reports with a delay of three to six months.
Outcome recorded in the report
Beside all horses
| Measure | American Saddlebred | All horses |
|---|---|---|
| Reports | 166 | 18,382 |
| Latest 12 months | 3 | 898 |
| Classed serious, of reports stating it | 46.8% | 44.1% |
| Death or euthanasia recorded, per 1,000 reports | 144.6 | 136 |
Questions about American Saddlebred reports
How many FDA adverse event reports involve American Saddlebreds?
166 reports through March 2026, 0.9% of reports about horses; 3 in the latest 12 months.
Which drugs are named most often in American Saddlebred reports?
By active ingredient: ivermectin + praziquantel (34), detomidine hydrochloride (15), moxidectin (14), ceftiofur crystalline free acid (13) and pergolide mesylate (13). Brands are masked in the public data.
What signs are reported most for this breed?
death by euthanasia (7.8%), lip oedema (7.8%), abdominal pain (6.6%), fever (6.6%) and colic (6%).
Is the American Saddlebred more sensitive to certain drugs?
Report counts cannot answer that. They show what was reported, not what a drug did, and they are not adjusted for how many American Saddlebred animals exist or were treated. Breed-related drug sensitivities that are established are described on FDA-approved labels; a veterinarian is the person to ask about an individual animal.
Why are crossbreds not included?
FDA records crossbred animals with one or more component breeds. Counting them under each component would double count, so breed pages use single-breed reports only. Crossbreds remain in the species totals.
How do I report a problem?
Call the drug company using the number on the label, or send Form FDA 1932a to FDA. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Animal & Veterinary adverse event bulk files released 28 Sep 2026, which hold reports FDA's Center for Veterinary Medicine received through 31 Mar 2026. openFDA masks brand and manufacturer names in these files, so drugs are counted by the active ingredients each record discloses and no figure is attributed to a brand, application or company. Ingredient names, and the separate reference lists of approved products, follow the FDA Green Book as of 1 Oct 2026. Breed names are FDA's labels rearranged into everyday order ("Saddlebred - American" becomes "American Saddlebred"). No report text, lot numbers or reporter details are published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.