Drug Information for COMFORTIS (spinosad) Chewable Tablets (Elanco Animal Health Co): Post Approval Experience (June 2009):

The following adverse reactions are based on post-approval adverse drug event reporting. The adverse reactions are listed in decreasing order of frequency: vomiting, depression/lethargy, anorexia, ataxia, diarrhea, pruritus, trembling, hypersalivation and seizures.

Following concomitant extra label use of ivermectin with COMFORTIS, some dogs have experienced the following clinical signs: trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation.

Post approval experience continues to support the safety of COMFORTIS when used concurrently with heartworm preventatives according to label directions.

For technical assistance or to report an adverse drug reaction, call 1-888-545-5973. Additional information can be found at www.comfortis4dogs.com. For a complete listing of adverse reactions for spinosad reported to the CVM see http://www.fda.gov/AnimalVeterinary/ SafetyHealth/ProductSafetyInformation/ucm055394.htm