Profender Topical Solution Side Effects

Please note - some side effects for Profender Topical Solution may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Profender Topical Solution Side Effects - for the Professional

Profender Topical Solution

Field study: In a controlled, double-masked field safety study, owners administered Profender Topical Solution to 606 cats. Adverse reactions reported by the cat owners included licking/ excessive grooming in 18 cats (3.0%), scratching treatment site in 15 cats (2.5%), salivation in 10 cats (1.7%), lethargy in 10 cats (1.7%), alopecia in 8 cats (1.3%), agitation/nervousness in 7 cats (1.2%), vomiting in 6 cats (1.0%), diarrhea in 3 cats (0.5%), eye irritation in 3 cats (0.5%), respiratory irritation in 1 cat (0.2%) and shaking/tremors in 1 cat (0.2%). All adverse reactions were self-limiting.

Laboratory effectiveness studies: One cat died 10 days after receiving Profender Topical Solution. The necropsy showed chronic active cholangiohepatitis. While the use of the drug did not appear to be the direct cause of death, treatment with the drug cannot be ruled out as a contributing factor (See PRECAUTIONS:). One cat treated with a vehicle placebo (formulation minus the active ingredients) showed salivation, gagging, lethargy and a swollen tongue.

Foreign Market Experience: The following adverse events were reported voluntarily during post-approval use of the product in foreign markets: application site reaction (hair loss, dermatitis, pyoderma, edema, and erythema), salivation, pruritus, lethargy, vomiting, diarrhea, dehydration, ataxia, loss of appetite, facial swelling, rear leg paresis, seizures, hyperesthesia, twitching, and death.

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