Total Reports
5
FDA CVM filings
Dog /
2026 FDA CVM data 5 reports on file official source
American Bully — FDA Adverse Event Profile
Adverse-event records and label data for American Bully (Dog), sourced from the FDA Center for Veterinary Medicine. Refreshed as new reports are filed. Cite PlainBreed when reusing this analysis.
American Bully (Dog) has 5 FDA adverse event reports on record, with 0 deaths reported (0.0% death rate) — ranking #506 by report volume. The most frequently reported reaction is Lack of efficacy (ectoparasite) - flea (2 cases). The top associated drug is Nitenpyram. Average age at report: 3.0 years.
Deaths Reported
0
of 5 reports
Death Rate
0.0%
death-coded share
Avg Age at Report
3.0 yr
34.2 kg avg weight
Death-Coded Outcome Share
American Bully death-coded reports 0.0%
Database median
0.0% of 5 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: 34.2 kg (75.4 lbs)
Top Reported Reactions
Lack of efficacy (ectoparasite) - flea 2
Lack of efficacy (endoparasite) - hookworm 1
Diarrhoea 1
Vomiting 1
Lack of efficacy (bacteria) - Ehrlichia 1
Lack of efficacy (ectoparasite) - tick NOS 1
Scratching 1
General hair loss 1
Administration error NOS 1
Most Referenced Drugs
Nitenpyram 2
Ivermectin + Pyrantel As Pamoate Salt 1
Imidacloprid + Moxidectin 1
Afoxolaner 1
Outcome Breakdown
Outcome Unknown
4 (80.0%)
Recovered/Normal
1 (20.0%)
Gender Distribution
Male 3 (60.0%)
Female 2 (40.0%)
Reports by Year
| Year | Reports | Trend |
|---|---|---|
| 2025 | 5 | |
American Bully Pet Health Insights
Across the FDA Center for Veterinary Medicine adverse event database, American Bully accounts for 5 submitted reports and currently ranks #506 by report volume within the dog population. Of those reports, 0 involved a death outcome — a 0.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 3.0 years, with an average recorded body weight of 34.2 kg (75.4 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 American Bully are Lack of efficacy (ectoparasite) - flea (2 reports), Lack of efficacy (endoparasite) - hookworm (1 reports), Diarrhoea (1 reports), together capturing a substantial share of the top-reaction traffic seen in this breed's record. On the product side, Nitenpyram appears in 2 reports and is the single most-referenced drug, followed by Ivermectin + Pyrantel As Pamoate Salt (1) and Imidacloprid + Moxidectin (1). Counts like these surface which therapeutic classes dominate the reporting stream — useful context when comparing reactions across breeds of the same dog species.
Outcome coding on the 5 reports with a recorded status is dominated by Outcome Unknown (80.0% of coded outcomes). 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 dog.
Understanding American Bully Adverse Event Data
American Bully has 5 adverse event reports on file. Lower report volumes may reflect a less common breed, lower reporting rates, or genuinely fewer adverse events.
A 0.0% death rate is below average in the FDA adverse event database, suggesting reported events tend toward less severe outcomes.
The most frequently referenced drug in adverse reports is Nitenpyram, appearing in 2 reports. This may indicate widespread use of the medication rather than a specific safety concern for American Bully.
Other Dog Breeds
Retriever - Labrador
90,806 reports · 360.0% death rate
Crossbred Canine/dog
68,210 reports · 320.0% death rate
Dog (unknown)
47,381 reports · 870.0% death rate
Retriever - Golden
34,475 reports · 370.0% death rate
Shepherd Dog - German
31,142 reports · 430.0% death rate
Chihuahua
30,657 reports · 420.0% death rate
Frequently Asked Questions
How many FDA adverse event reports involve American Bully? ▼
There are 5 adverse event reports involving American Bully in the FDA database, with 0 reports involving death (0.0% death rate). American Bully ranks #506 by report volume.
What are the most common adverse reactions reported for American Bully? ▼
The most commonly reported adverse reactions for American Bully are Lack of efficacy (ectoparasite) - flea (2 reports), Lack of efficacy (endoparasite) - hookworm (1 reports), Diarrhoea (1 reports), Vomiting (1 reports), Lack of efficacy (bacteria) - Ehrlichia (1 reports).
What drugs are most frequently associated with American Bully adverse events? ▼
The drugs most frequently referenced in American Bully adverse event reports are Nitenpyram (2 reports), Ivermectin + Pyrantel As Pamoate Salt (1 reports), Imidacloprid + Moxidectin (1 reports), Afoxolaner (1 reports).
What is the average age of American Bully in adverse event reports? ▼
The average age of American Bully at the time of adverse event reports is 3.0 years, with an average weight of 34.2 kg (75.4 lbs).
Does a high number of adverse event reports mean American Bully 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 American Bully 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.
American Bully ranks #506 by total report volume. Death rate (0.0%) 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