Trifexis Adverse Reactions

In a well-controlled US field study, which included a total of 352 dogs (176 treated with TRIFEXIS and 176 treated with an active control), no serious adverse reactions were attributed to administration of TRIFEXIS. All reactions were regarded as mild.

Over the 180-day study period, all observations of potential adverse reactions were recorded. Reactions that occurred at an incidence >1% (average monthly rate) within any of the 6 months of observation are presented in the following table. The most frequently reported adverse reaction in dogs in the TRIFEXIS group was vomiting.

Average Monthly Rate (%) of Dogs With Adverse Reactions

an=176 dogs

Adverse Reaction TRIFEXIS Chewable
Tablets a
Active Control
Tablets a
Vomiting 6.13 3.08
Pruritus 4.00 4.91
Lethargy 2.63 1.54
Diarrhea 2.25 1.54
Dermatitis 1.47 1.45
Skin Reddening 1.37 1.26
Decreased appetite 1.27 1.35
Pinnal Reddening 1.18 0.87

In the US field study, one dog administered TRIFEXIS experienced a single mild seizure 2 ½ hours after receiving the second monthly dose. The dog remained enrolled and received four additional monthly doses after the event and completed the study without further incident.

Following concomitant extra-label use of ivermectin with spinosad alone, a component of TRIFEXIS, some dogs have experienced the following clinical signs: trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation. Spinosad alone has been shown to be safe when administered concurrently with heartworm preventatives at label directions.

In US and European field studies, no dogs experienced seizures when dosed with spinosad alone at the therapeutic dose range of 13.5-27.3 mg/lb (30-60 mg/kg), including 4 dogs with pre-existing epilepsy. Four epileptic dogs that received higher than the maximum recommended dose of 27.3 mg/lb (60 mg/kg) experienced at least one seizure within the week following the second dose of spinosad, but no seizures following the first and third doses. The cause of the seizures observed in the field studies could not be determined.

For technical assistance or to report a suspected adverse drug reaction, contact Elanco Animal Health at 1-888-545-5973. Additional information can be found at www.trifexis.com. Alternatively, suspected adverse drug reactions may be reported to FDA at 1-888-FDA-VETS or http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm

Trifexis Overview

Overall Rating
Medication Type
Animal
Approval Date
Oct 18, 2012
DEA Schedule
Not Classified

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