Chlorhexidine Gluconate + Miconazole Nitrate + Phytosphingosine Salicyloyl

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17 adverse event reports submitted to the FDA

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
17
Total Reports
2
Deaths Reported
1180.0%
Death Rate

Active Ingredients

Chlorhexidine GluconateMiconazole NitratePhytosphingosine Salicyloyl

Administration Routes

Topical

Species Affected

Dog 15
Human 1
Cat 1

Most Affected Breeds

Crossbred Canine/dog 5
Mixed (Dog) 2
Dog (unknown) 2
Terrier - Jack Russell 1
Lhasa Apso 1
Havanese 1
Spitz - German Pomeranian 1
Chihuahua 1
Unknown 1
Sphynx 1

Most Reported Reactions

Application site erythema 5
Death by euthanasia 2
Panting 1
Anxiety 1
Application site reddening 1
Application site pruritus 1
Application site irritation 1
Walking difficulty 1
Behavioural disorder NOS 1
Stroke 1
Skin irritation 1
Vocalisation 1

Outcome Breakdown

Recovered/Normal
9 (52.9%)
Ongoing
5 (29.4%)
Euthanized
2 (11.8%)
Outcome Unknown
1 (5.9%)

Data Summary

Metric Value
Total adverse event reports 17
Reports involving death 2
Case-fatality rate (reported events) 1180.0%
Distinct species in reports 3
Distinct breeds in reports 11
Distinct reactions reported 20
Active ingredients on file 3

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Chlorhexidine Gluconate + Miconazole Nitrate + Phytosphingosine Salicyloyl Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 17 adverse event reports referencing Chlorhexidine Gluconate + Miconazole Nitrate + Phytosphingosine Salicyloyl, including 2 reports in which the animal died — a 1180.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredients on file: Chlorhexidine Gluconate, Miconazole Nitrate, Phytosphingosine Salicyloyl. Reported administration route is Topical. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in Chlorhexidine Gluconate + Miconazole Nitrate + Phytosphingosine Salicyloyl reports are Dog (15 reports), Human (1 reports), Cat (1 reports), with Dog accounting for the largest share. Within those species, Crossbred Canine/dog (5), Mixed (Dog) (2), Dog (unknown) (2) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with Chlorhexidine Gluconate + Miconazole Nitrate + Phytosphingosine Salicyloyl are Application site erythema (5), Death by euthanasia (2), Panting (1), Anxiety (1). Of the 17 reports with a coded outcome, Recovered/Normal is the leading category at 52.9%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Chlorhexidine Gluconate + Miconazole Nitrate + Phytosphingosine Salicyloyl.

Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial