Pet Adverse Events by Species

A veterinary adverse event report is a submission to the FDA Center for Veterinary Medicine (CVM) documenting an unexpected or harmful reaction in an animal following administration of a veterinary drug. Reports can be submitted by veterinarians, pet owners, or drug manufacturers. The FDA uses these reports to monitor the post-market safety of approved animal drugs. Reporting is voluntary for veterinarians and pet owners, but drug manufacturers are required by law to submit reports of serious adverse events they become aware of.

A serious adverse event in FDA veterinary reporting is one that results in death, is life-threatening, requires veterinary hospitalization, results in persistent or significant disability or incapacity, requires medical or surgical intervention to prevent permanent impairment, or is considered medically significant by the reporting veterinarian. Non-serious events include mild reactions like temporary lethargy, brief gastrointestinal upset, or minor skin reactions that resolve without treatment.

A high report count for a species does not mean veterinary drugs are unsafe for that species. Dogs have by far the most reports because they receive the most veterinary medications, the reporting volume reflects drug usage volume, not inherent danger. What matters more is the ratio of serious events to total events, and whether those serious events are associated with specific drugs. If you have concerns about a medication your pet is taking, consult your veterinarian about the risk profile for your specific animal.

To report a suspected adverse drug reaction in your pet, contact the FDA Center for Veterinary Medicine through the FDA Safety Reporting Portal at SafetyReporting.hhs.gov, or call 1-888-FDA-VETS (1-888-332-8387). You can also ask your veterinarian to submit the report on your behalf. Include the drug name, dose, duration of treatment, the animal's species/breed/age/weight, and a detailed description of the reactions observed. Even if causation is uncertain, reports are valuable for tracking patterns across many animals.