Dog — Retriever - Labrador — Fluralaner Chew Tablets
FDA Veterinary Adverse Event Report #N141426 — November 11, 2017 — Serious Event
Animal Information
| Species | Dog |
| Breed | Retriever - Labrador |
| Gender | Male |
| Age | 7.00 Year |
| Weight | 36.741 Kilogram |
Event Summary
| Report ID | N141426 |
| Date | November 11, 2017 |
| Serious | Yes |
| Outcome | Euthanized |
Drug Information
| Active Ingredients | Fluralaner Chew Tablets |
| Manufacturer | MSK |
Reported Reactions
Decreased appetite; Decreased drinking; Emesis (multiple); Abdominal pain; Thrombocytopenia; Hypoalbuminaemia; Inversion of albumin/globulin ratio; Elevated creatinine; Hyperphosphataemia; Other abnormal test result NOS; Elevated amylase; Hyperkalaemia; Haematuria; Urine abnormalities NOS; Crystalluria; Elevated blood urea nitrogen (BUN); Weight gain; Fluid in abdomen NOS; Generalised weakness; Renal failure; Death by euthanasia; Elevated globulins; Decreased red blood cell count; Decreased haemoglobin; Decreased packed cell volume (PCV); Neutrophilia; Hyperchloraemia; Polyuria; Polydipsia; Hypersalivation; Joint oedema; Discomfort NOS; Lymphadenopathy; Abnormal ultrasound finding; Enlarged kidney(s); Elevated serum alkaline phosphatase (SAP); Elevated total bilirubin; Nausea; Laboured breathing; Cardiomyopathy; Vasculitis; Glomerulonephritis; Pleural effusion; Bronchopneumonia; Muscle atrophy (see also 'Muscle wasting'); Disorder of gastrointestinal flora
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| N141330 | Pug | Loss of hearing; Ear canal inflammation | Outcome Unknown | Dec 29, 2025 |
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Frequently Asked Questions
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.
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