Comfortis Side Effects

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

Comfortis Side Effects - for the Professional

Comfortis

In a well-controlled US field study, which included a total of 470 dogs (330 dogs treated with Comfortis chewable tablets and 140 dogs treated with an active control), no serious adverse reactions were observed with Comfortis chewable tablets. All reactions were regarded as mild and did not result in any dog being removed from the study.

Over the 90-day study period, all observations of potential adverse reactions were recorded. Reactions that occurred at an incidence > 1% within any of the 3 months of observation are presented in the following table. The most frequently reported adverse reaction in dogs in the Comfortis chewable tablets and active control groups was vomiting. The occurrence of vomiting, most commonly within 48 hours after treatment, decreased with repeated doses of Comfortis chewable tablets.

Percentage of Dogs (%) with Adverse Reactions

a This number (n=139) is less than the total number of dogs in the safety population for the active control group (n=140) because one dog joined the study late and was only dosed at Month 3.

Month 1 Month 2 Month 3
Comfortis
Chewable
Tablets
(N=330)
Active Topical Control (N=139a) Comfortis
Chewable
Tablets
(N=282)
Active Topical Control (N=124) Comfortis
Chewable
Tablets
(N=260)
Active Topical Control (N=125)
Vomiting 12.7 12.2 7.8 3.2 5.8 4.8
Decreased Appetite 9.1 5.0 2.8 1.6 1.9 0.8
Lethargy 7.6 5.0 3.5 4.0 1.2 0.8
Diarrhea 6.7 5.0 4.3 0.8 1.2 0.0
Cough 3.9 5.0 0.4 2.4 0.0 0.0
Polydipsia 2.4 1.4 0.7 0.0 0.4 0.0
Vocalization 1.8 0.0 0.4 0.0 0.4 0.0
Increased Appetite 1.5 0.0 0.4 0.8 0.4 0.0
Erythema 1.5 0.0 0.4 0.0 0.4 0.0
Hyperactivity 1.2 1.4 0.0 0.0 0.4 0.0
Excessive Salivation 1.2 0.0 0.4 0.0 0.0 0.0

In US and European field studies, no dogs experienced seizures when dosed with Comfortis chewable tablets 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 Comfortis chewable tablets, but no seizures following the first and third doses. The cause of the seizures observed in the field studies could not be determined.

Top

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web2)