In a field safety and effectiveness study, REVOLUTION PLUS was administered to cats with fleas. The study included a total of 430 cats (282 treated with REVOLUTION PLUS and 148 treated with imidacloprid + moxidectin once monthly for three treatments). Over the 90-day study period, all observations of potential adverse reactions were recorded. Reactions reported in the REVOLUTION PLUS group included those presented in the following table.
Adverse Reactions by Treatment Group
Adverse Reaction
REVOLUTION PLUS
(n = 282)
Imidacloprid + moxidectin
(n =148)
Lethargy
12 (4.3%)
1 (0.7%)
Skin lesions*
10 (3.5%)
3 (2.0%)
Anorexia
9 (3.2%)
3 (2.0%)
Pruritus
7 (2.5%)
3 (2.0%)
Conjunctivitis
7 (2.5%)
1 (0.7%)
Sneezing
6 (2.1%)
1 (0.7%)
Administration site hair changes (alopecia)
5 (1.8%)
0 (0.0%)
Administration site lesions (scabbing)
2 (0.7%)
0 (0.0%)
*Lesions not associated with application site.
In a second field safety and effectiveness study, REVOLUTION PLUS was administered to 124 cats with ear mites. Adverse reactions in cats treated with REVOLUTION PLUS included emesis, dermatitis and eczema, and pruritus.
In a third field safety and effectiveness study, REVOLUTION PLUS was administered to 70 cats with hookworms. Adverse reactions in cats treated with REVOLUTION PLUS included diarrhea, anorexia, emesis, and lethargy.
Post-Approval Experience (2022)
The following adverse events are based on post-approval adverse drug experience reporting forREVOLUTION PLUS. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the exposure using these data.
The following adverse events reported in cats are listed in decreasing order of reporting frequency:
Application site reactions (including alopecia, lesions, erythema, and pruritus), lethargy, anorexia, vomiting, generalized pruritus, behavioral disorders (including hiding, hyperactivity, and vocalization), ataxia, muscle tremor, diarrhea, generalized alopecia, and seizure.
Contact Information
To report adverse reactions call Zoetis Inc. at 1-888-963-8471. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.
revolution® PLUS
Pre-approval clinical trials:
Following treatment with selamectin, transient localized alopecia with or without inflammation at or near the site of application was observed in approximately 1% of 691 treated cats. Other signs observed (≤0.5% of 1743 treated cats and dogs) included vomiting, loose stool or diarrhea with or without blood, anorexia, lethargy, salivation, tachypnea, and muscle tremors.
Post-approval experience (2021):
The following adverse events are based on post-approval adverse drug experience reporting for selemectin. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data.
The following adverse events reported for dogs are listed in decreasing order of reporting frequency: Lethargy, vomiting, diarrhea, anorexia, generalized pruritus, seizures, application site reactions (including alopecia, lesions, erythema, pruritis, and inflammation), tremors, ataxia, death, and dermatitis.
The following adverse events reported for cats are listed in decreasing order of reporting frequency: Application site reactions (including alopecia, lesions, erythema, pruritus, inflammation, vesicles, blisters, and excoriations), lethargy, anorexia, vomiting, death, generalized pruritus, diarrhea, ataxia, fever, generalized alopecia, tremors, hypersalivation, dermatitis, and seizures.
Contact Information:
To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Aurora Pharmaceutical at 1-888-215-1256 or www.aurorapharmaceutical.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae
Revolt® (selamectin)Topical Parasiticide for Dogs and Cats
ADVERSE REACTIONS:
Pre-Approval Clinical Trials:
Following treatment with selamectin, transient localized alopecia with or without inflammation at or near the site of application was observed in approximately 1% of 691 treated cats. Other signs observed (≤0.5% of 1743 treated cats and dogs) included vomiting, loose stool or diarrhea with or without blood, anorexia, lethargy, salivation, tachypnea, and muscle tremors.
Post-Approval Experience (2021):
The following adverse events are based on post-approval adverse drug experience reporting for selamectin. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data.
The following adverse events reported for dogs are listed in decreasing order of reporting frequency:
Lethargy, vomiting, diarrhea, anorexia, generalized pruritus, seizures, application site reactions (including alopecia, lesions, erythema, pruritis, and inflammation), tremors, ataxia, death, and dermatitis.
The following adverse events reported for cats are listed in decreasing order of reporting frequency:
Application site reactions (including alopecia, lesions, erythema, pruritis, inflammation, vesicles, blisters, and excoriations), lethargy, anorexia, vomiting, death, generalized pruritis, diarrhea, ataxia, fever, generalized alopecia, tremors, hypersalivation, dermatitis, and seizures.
CONTACT INFORMATION:
Contact Bimeda, Inc. at 1-888-524-6332 or www.bimeda.com. To report suspected drug experiences, contact Bimeda, Inc. at 1-888-534-6332. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.
SelaSpot™ (selamectin)
Pre-Approval Clinical Trials:
Following treatment with Selamectin, transient localized alopecia with or without inflammation at or near the site of application was observed in approximately 1% of 691 treated cats. Other signs observed (≤0.5% of 1743 treated cats and dogs) included vomiting, loose stool or diarrhea with or without blood, anorexia, lethargy, salivation, tachypnea, and muscle tremors.
Post-Approval Experience (2021):
The following adverse events are based on post-approval adverse drug experience reporting for selamectin. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data.
The following adverse events reported for dogs are listed in decreasing order of reporting frequency:
Lethargy, vomiting, diarrhea, anorexia, generalized pruritus, seizures, application site reactions (including alopecia, lesions, erythema, pruritis, and inflammation), tremors, ataxia, death, and dermatitis.
The following adverse events reported for cats are listed in decreasing order of reporting frequency:
Application site reactions (including alopecia, lesions, erythema, pruritus, inflammation, vesicles, blisters, and excoriations), lethargy, anorexia, vomiting, death, generalized pruritus, diarrhea, ataxia, fever, generalized alopecia, tremors, hypersalivation, dermatitis, and seizures.
SelamectinTopical Parasiticide For Dogs and Cats
Pre-approval clinical trials:
Following treatment with selamectin, transient localized alopecia with or without inflammation at or near the site of application was observed in approximately 1% of 691 treated cats. Other signs observed rarely (≤0.5% of 1743 treated cats and dogs) included vomiting, loose stool or diarrhea with or without blood, anorexia, lethargy, salivation, tachypnea, and muscle tremors.
Post-approval experience:
In addition to the aforementioned clinical signs that were reported in pre-approval clinical trials, there have been reports of pruritus, urticaria, erythema, ataxia, fever, and rare reports of death. There have also been rare reports of seizures in dogs (see WARNINGS).
FDA application 200-670