Adverse Event Reporting

Workflow

Querying Existing Adverse Event Data

1. Search the openFDA animal adverse events endpoint by drug name, species, or reaction type.
2. Aggregate results by reaction type, species, and outcome severity.
3. Present findings with appropriate context (reporting bias, denominator unknown).
4. Note any FDA safety communications or label changes resulting from adverse event signals.

Reporting a New Adverse Event

1. Gather required information:
   • Animal signalment (species, breed, age, weight, sex)
   • Product involved (name, manufacturer, lot number if available)
   • Adverse event description (signs, timing, severity)
   • Outcome (recovered, ongoing, died)
   • Concurrent medications
   • Whether the veterinarian considers the event drug-related
2. Guide the user through FDA CVM reporting options:
   • Online: FDA Safety Reporting Portal
   • Phone: 1-888-FDA-VETS (1-888-332-8387)
   • Manufacturer reporting (companies are required to forward reports to FDA)

Limitations

• openFDA adverse event data represents spontaneous reports, not incidence rates. Reporting rates are unknown.
• Absence of adverse event reports does not mean a product is safe.
• Adverse event reports do not establish causality.
• The openFDA API has rate limits and data may lag behind real-time reporting.