Felimazole Side Effects

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

Felimazole Side Effects - for the Professional

Felimazole

Applies to: oral tablet, sugar coated

In a US field study with 113 cats, the most common adverse reactions included change in food consumption (increase or decrease), lethargy, vomiting, diarrhea/loose stool, skin lesions, and abnormal vocalization. Three cats were withdrawn early from the study, one due to unmasking of latent renal disease and two due to the development of skin lesions. Over the course of the study there was a decreasing trend in the mean counts of red blood cells, lymphocytes, neutrophils and monocytes; however, means remained within or near normal ranges for the testing laboratory.

In the extended use phase of the US field study with 101 cats, the most common adverse reactions reported in the study above (lethargy, anorexia) were also observed. Additional signs occurring more frequently in the long-term study were: depression/withdrawn behavior, weight loss, haircoat abnormalities, increased blood urea nitrogen (BUN), weakness, agitation and diarrhea. Most of the adverse reactions reported were mild and transient.

Serum chemistry and hematology results in the extended use study were consistent with the trends noted during the field study. The mean alanine transaminase (ALT) was above the reference range at the first two quarterly visits, but within the normal reference range (10-100 U/L) through the next two quarterly visits. Mean lymphocyte counts decreased consistently during the study period, to slightly below the reference range (1200-8000 cells/mcL) at the fourth quarterly visit.

Sixteen cats experienced elevated ANA titers at one or more points during long-term therapy with Felimazole Coated Tablets, but the significance was not determined.

Eighteen cats died or were euthanized during the extended use study, four of which may have been related to Felimazole Coated Tablets due to the unmasking/acceleration of chronic renal failure. See PRECAUTIONS.

In a foreign field study with 26 cats using a starting dose of 5 mg twice daily (twice the recommended starting dose), one cat was withdrawn due to lethargy, vomiting and facial excoriations. Marked thrombocytopenia was reported in two cats; the platelet count returned to normal in one cat when Felimazole Coated Tablets was discontinued. Two cats collapsed and died within 12 days of starting Felimazole Coated Tablets at a dose of 5 mg twice daily. Both cats were reported with lethargy, vomiting, anorexia, and bloody diarrhea; one cat also had pallor.

In a second foreign field study with 78 cats using a starting dose of 2.5 mg twice daily, 4 cats were withdrawn due to suspected adverse reactions to Felimazole Coated Tablets including anemia, cholangiohepatitis, excoriations, vomiting, lethargy, jaundice, and anorexia. One cat receiving 2.5 mg three times daily collapsed and died after 8 weeks of treatment. Adverse reactions included pallor, anorexia, dehydration, jaundice, bleeding diathesis, and anemia. The most frequently reported adverse reactions included mild, transient, self-limiting vomiting, lethargy, and anorexia.

Foreign Market Experience

The following events were reported voluntarily during post-approval use of Felimazole Coated Tablets in foreign markets: facial pruritus, self-induced excoriations of the head and neck, generalized lymphadenopathy, thrombocytopenia, hematemesis, epistaxis, and elevation of serum liver enzymes and bilirubin.

If overdosage occurs, stop treatment and give symptomatic and supportive care.

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