Veterinary NSAID Adverse Events: What 104,441 FDA Reports Reveal
Analysis of 104,441 NSAID-related adverse-event reports in the FDA CVM database: carprofen, meloxicam, deracoxib, grapiprant, firocoxib, and robenacoxib — species, reactions, and fatal outcomes.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most frequently prescribed medication classes in veterinary medicine. Carprofen alone has been the backbone of canine pain management for over two decades. But what does the FDA's own adverse-event database show when you examine every NSAID report together?
This article analyzes 104,441 adverse-event reports linked to veterinary NSAID active ingredients in the FDA Center for Veterinary Medicine (CVM) animal drug adverse-event database — spanning 1987 through early 2026 and covering carprofen, meloxicam, deracoxib, firocoxib, grapiprant, robenacoxib, flunixin, tepoxalin, ketoprofen, phenylbutazone, and acetaminophen exposure in animals. Every number below comes from a direct computation of the FDA CVM adverse-event reports (analysis run date: 2026-06-09).
Three things these numbers do not mean
Before the data, three caveats that apply to every pharmacovigilance analysis:
- Reports are not causal proof. The FDA states explicitly that reports in this database have not been verified for causality. A report linking carprofen to elevated liver enzymes does not mean carprofen caused the elevation.
- Volume reflects usage. Carprofen has been the most widely prescribed veterinary NSAID for over 20 years. It will accumulate more reports than a newer drug like grapiprant simply because more dogs have taken it.
- Under-reporting is substantial. The FDA acknowledges that only a fraction of adverse events are ever reported. The gap between actual events and reported events is unknown and varies by product.
The NSAID ingredients by report count
The database contains 104,441 reports naming at least one veterinary NSAID active ingredient. The breakdown by ingredient:
| Rank | Active ingredient | Reports | Share of NSAID total | Combined Died + Euthanized |
|---|---|---|---|---|
| 1 | Carprofen | 50,978 | 48.8% | 8,676 (17.0%) |
| 2 | Meloxicam | 16,916 | 16.2% | 2,156 (12.7%) |
| 3 | Deracoxib | 11,930 | 11.4% | 2,296 (19.2%) |
| 4 | Grapiprant | 7,991 | 7.7% | 712 (8.9%) |
| 5 | Firocoxib | 7,670 | 7.3% | 1,299 (16.9%) |
| 6 | Robenacoxib | 3,520 | 3.4% | 540 (15.3%) |
| 7 | Flunixin | 2,093 | 2.0% | 733 (35.0%) |
| 8 | Tepoxalin | 1,166 | 1.1% | 201 (17.2%) |
| 9 | Ketoprofen | 611 | 0.6% | 246 (40.3%) |
| 10 | Phenylbutazone | 217 | 0.2% | 50 (23.0%) |
| 11 | Acetaminophen | 90 | 0.1% | 21 (23.3%) |
Carprofen alone accounts for nearly half of all NSAID-related reports. This mirrors its market dominance — Rimadyl (carprofen) was the first FDA-approved NSAID for dogs (1996) and remains the most prescribed.
The combined death-and-euthanasia rate varies significantly by ingredient. Ketoprofen (40.3%) and flunixin (35.0%) have the highest fatality share, but these are largely large-animal NSAIDs used in cattle and horses with more severe underlying conditions, and their report counts are much smaller. Among the six major companion-animal NSAIDs, the combined fatality rate ranges from 8.9% (grapiprant) to 19.2% (deracoxib).
Species breakdown
NSAID adverse-event reports are overwhelmingly companion-animal:
| Species | Reports | Share |
|---|---|---|
| Dog | 81,072 | 77.6% |
| Unknown | 10,997 | 10.5% |
| Cat | 8,597 | 8.2% |
| Horse | 1,284 | 1.2% |
| Human exposure | 1,240 | 1.2% |
| Cattle | 870 | 0.8% |
Dogs dominate because NSAIDs are most extensively labeled and prescribed for canine osteoarthritis and post-surgical pain. The 1,240 human-exposure reports reflect accidental ingestion of veterinary NSAID products — particularly chewable carprofen tablets, which are palatable and therefore attractive to pets and children.
Cats represent only 8.2% of NSAID reports despite being the second-largest companion-animal species in the database, reflecting the limited number of FDA-approved NSAID products for cats (only meloxicam injection as a single dose and robenacoxib for up to three days).
The reaction profile: GI, hepatic, and renal
The top 10 reactions across all NSAID reports paint a consistent clinical picture:
| Reaction | Reports | % of NSAID total |
|---|---|---|
| Vomiting | 23,563 | 22.6% |
| Anorexia | 16,884 | 16.2% |
| Elevated ALT | 11,797 | 11.3% |
| Elevated SAP | 10,868 | 10.4% |
| Depression | 10,770 | 10.3% |
| Diarrhea | 10,347 | 9.9% |
| Elevated BUN | 8,773 | 8.4% |
| Death | 8,468 | 8.1% |
| Accidental exposure | 8,440 | 8.1% |
| Elevated creatinine | 7,627 | 7.3% |
Gastrointestinal signs (vomiting, anorexia, diarrhea) head the list. Hepatic monitoring markers (elevated ALT, elevated SAP) follow — reflecting the well-documented hepatotoxicity risk, particularly with carprofen. Renal markers (elevated BUN, elevated creatinine) appear in 7–8% of reports, consistent with the known renal perfusion effects of NSAIDs mediated through COX-1 inhibition of prostaglandin synthesis.
The FDA's own guidance for veterinarians advises baseline blood work (liver and kidney panels) before starting NSAID therapy and periodic monitoring during treatment — exactly the monitoring pattern reflected in these adverse-event reports.
Carprofen: the bellwether NSAID (50,978 reports)
Carprofen's 50,978 reports make it the single most-reported NSAID in the database by a wide margin. Key metrics:
- Species: 90.1% dog, 3.3% cat, 1.6% human exposure
- Top reactions: Vomiting 24.8%, Anorexia 19.0%, Elevated ALT 16.7%, Elevated SAP 14.8%, Depression 12.1%
- Outcomes: Died 13.8%, Euthanized 3.1%, Ongoing 14.3%, Recovered/Normal 8.1%
The Merck Veterinary Manual notes that carprofen's adverse-event rate is approximately 2 events per 1,000 dogs treated — a low rate in absolute terms. The large report count reflects billions of doses administered over nearly 30 years.
Carprofen's hepatic signal is distinctive: elevated ALT (16.7%) and elevated SAP (14.8%) together appear in nearly one-third of reports. The Merck Veterinary Manual identifies Labrador Retrievers as overrepresented among carprofen hepatopathies (approximately one-third of hepatic cases), though a true breed predisposition has not been definitively established.
The 11.8% "accidental exposure" rate reflects the palatable chewable formulation — dogs consuming an entire bottle of their own medication is a well-documented overdose pathway.
Meloxicam: the renal signal (16,916 reports)
Meloxicam has a broader species range — it is the most commonly reported NSAID in cats (21.0% of meloxicam reports are feline, compared to 3.3% for carprofen). Key metrics:
- Species: 46.7% dog, 30.2% unknown, 21.0% cat
- Top reactions: Vomiting 18.0%, Anorexia 15.1%, Elevated BUN 11.2%, Elevated creatinine 10.5%, Leaking vials 10.0%
- Outcomes: Recovered/Normal 10.5%, Died 10.1%, Outcome Unknown 8.9%
Meloxicam's reaction profile tilts toward renal markers more prominently than carprofen's. Elevated BUN (11.2%) and creatinine (10.5%) rank higher relative to hepatic markers (ALT 3.7%), and "renal failure" appears explicitly at 5.3%. This renal dominance is consistent with meloxicam's pharmacology and the populations in which it is used — including older cats with chronic kidney disease.
The unusual "Vials, Leaking" entry (10.0%) reflects a product-quality issue rather than a pharmacological adverse effect.
Robenacoxib: the feline NSAID (3,520 reports)
Robenacoxib is the most cat-specific NSAID in the database — 87.0% of its reports are feline. Its reaction profile differs from the canine-dominant NSAIDs:
- Top reactions: Lethargy 11.6%, Not eating 10.8%, Lack of efficacy 8.7%, Anorexia 8.6%, Fever 8.3%
- Outcomes: Ongoing 29.2%, Outcome Unknown 23.6%, Recovered/Normal 21.8%, Died 8.4%, Euthanized 6.9%
The lack-of-efficacy signal (8.7%) is notable — robenacoxib is labeled for a maximum of three days in cats, and the short treatment window may contribute to reports of insufficient pain control in chronic conditions.
Grapiprant: the EP4 receptor antagonist (7,991 reports)
Grapiprant (Galliprant) is the newest NSAID class on the list — an EP4 prostaglandin E2 receptor antagonist rather than a COX enzyme inhibitor. Its profile shows:
- Species: 91.8% dog
- Top reactions: Vomiting 17.5%, Diarrhea 15.4%, Lack of efficacy 11.9%
- Outcomes: Outcome Unknown 31.4%, Ongoing 31.0%, Recovered/Normal 20.5%, Euthanized 5.7%, Died 3.2%
Grapiprant has the lowest combined fatality rate among the major companion-animal NSAIDs (8.9%), though this may reflect its newer approval date (2017 vs. 1996 for carprofen), its use in younger/milder osteoarthritis populations, and shorter accumulated market exposure. The high "Outcome Unknown" rate (31.4%) reflects the incomplete follow-up common with newer products.
Outcome overview
Across all 104,441 NSAID reports:
| Outcome | Reports | Share |
|---|---|---|
| Died | 13,683 | 13.1% |
| Ongoing | 13,440 | 12.9% |
| Outcome Unknown | 10,508 | 10.1% |
| Recovered/Normal | 10,133 | 9.7% |
| Euthanized | 3,347 | 3.2% |
| Recovered with Sequela | 431 | 0.4% |
Combined, 16.3% of NSAID reports list Died or Euthanized as an outcome. This is a serious number, but it requires context: NSAIDs are used disproportionately in geriatric animals with multiple comorbidities. Death in a 13-year-old Labrador with osteoarthritis, chronic kidney disease, and a three-year carprofen history is not necessarily an NSAID-caused death — but it generates a report because the NSAID was part of the clinical picture.
Reporting trend over time
NSAID adverse-event reporting has fluctuated between 2,500 and 5,000 reports per year over the past decade, with a notable spike in 2024 (4,508 reports) and 2025 (4,238 reports). The 2012 peak (4,807 reports) coincided with expanded post-market surveillance activities by FDA CVM. The recent uptick may reflect increased reporting of newer products like grapiprant and the monoclonal antibodies that are displacing NSAIDs in some osteoarthritis protocols.
What the data tells veterinary teams
Three patterns stand out for clinical practice:
The monitoring lab panel is reflected in the data. Elevated ALT, SAP, BUN, and creatinine are among the top 10 reactions — exactly the values veterinarians are advised to check at baseline and during therapy. These reports are the pharmacovigilance echo of real-world monitoring.
Accidental exposure is a significant reporting category. Chewable carprofen and other palatable formulations generate thousands of overdose reports. Secure storage counseling is a pharmacovigilance intervention.
Cats remain pharmacovigilance orphans for NSAIDs. Only two products are FDA-approved for cats (meloxicam single injection dose, robenacoxib up to three days). The low feline report count reflects limited approved options, not necessarily lower risk.
Sources
- FDA Center for Veterinary Medicine, Adverse Event Reporting System. openFDA Animal Drug Adverse Event API. Available at: https://open.fda.gov/apis/animalandveterinary/event/
- FDA CVM, "Veterinary Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)." Available at: https://www.fda.gov/animal-veterinary/product-safety-information/veterinary-nonsteroidal-anti-inflammatory-drugs-nsaids
- FDA CVM, "What Veterinarians Should Advise Clients About Pain Control and NSAIDs in Dogs and Cats." Available at: https://www.fda.gov/animal-veterinary/resources-you/what-veterinarians-should-advise-clients-about-pain-control-and-nonsteroidal-anti-inflammatory-drugs
- Merck Veterinary Manual, "Nonsteroidal Anti-inflammatory Drugs in Animals — Pharmacology." Available at: https://www.merckvetmanual.com/pharmacology/inflammation/nonsteroidal-anti-inflammatory-drugs-in-animals
- FDA CVM, "Animal Drug Safety-Related Labeling Changes." Available at: https://www.fda.gov/animal-veterinary/drug-labels/animal-drug-safety-related-labeling-changes
