Dog — Shepherd Dog - Australian — Sarolaner

Stop the medication immediately and call your veterinarian. For severe reactions — seizures, facial swelling, difficulty breathing, extreme lethargy, or collapse — go to an emergency veterinary clinic without waiting. Note the exact time the drug was given and when symptoms first appeared. Do not give any additional medications without guidance. Bring the drug packaging when you go to the vet. After stabilization, ask your vet about reporting the reaction to the FDA CVM, and consider switching to an alternative drug if available.

Not necessarily. Adverse event reports document that a drug was given and that the animal later died — but they do not establish causation. The animal may have died from its underlying condition, from concurrent medications, or from unrelated causes. The FDA applies a structured causality assessment to each report to determine whether the drug was likely, possibly, or unlikely responsible. Still, all death reports are reviewed and tracked because they contribute to safety signal detection, even when individual causality is uncertain.

You can report a suspected adverse drug reaction to the FDA Center for Veterinary Medicine through the FDA Safety Reporting Portal at SafetyReporting.hhs.gov or by calling 1-888-FDA-VETS (1-888-332-8387). You can also contact the drug manufacturer directly — they are required to forward serious adverse event reports to the FDA. Include the drug name and dose, the animal's species, breed, age, and weight, the duration of treatment, and a detailed description of the symptoms observed and their timeline.