Clos P*2/Cl Oth*4/H.Somnus Kb

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119 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.
119
Total Reports
98
Deaths Reported
8240.0%
Death Rate

Active Ingredients

Clos P*2/Cl Oth*4/H.Somnus Kb

Administration Routes

SubcutaneousUnknownSubconjunctival

Species Affected

Cattle 119

Most Affected Breeds

Cattle (other) 55
Aberdeen Angus 29
Crossbred Bovine/Cattle 18
Holstein-Friesian also known as Holstein 6
Red Angus 3
Charolais 3
Mixed (Cattle) 2
Unknown 1
Cattle (unspecified) 1
Simmental 1

Most Reported Reactions

Death 83
Lack of efficacy - NOS 48
Lack of efficacy (bacteria) - NOS 18
Found dead 10
Lack of efficacy (endoparasite NOS) 9
Respiratory signs 7
Anaphylaxis 7
NT - Abnormal necropsy finding NOS 7
Lack of efficacy (virus) - coronavirus - NOS 5
Not eating 4
Pneumonia 4
Foam in the nose 4

Outcome Breakdown

Died
97 (44.7%)
Ongoing
64 (29.5%)
Recovered/Normal
38 (17.5%)
Outcome Unknown
13 (6.0%)
Euthanized
4 (1.8%)
Recovered with Sequela
1 (0.5%)

Data Summary

Metric Value
Total adverse event reports 119
Reports involving death 98
Case-fatality rate (reported events) 8240.0%
Distinct species in reports 1
Distinct breeds in reports 10
Distinct reactions reported 20
Active ingredients on file 1

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

Clos P*2/Cl Oth*4/H.Somnus Kb Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 119 adverse event reports referencing Clos P*2/Cl Oth*4/H.Somnus Kb, including 98 reports in which the animal died — a 8240.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Clos P*2/Cl Oth*4/H.Somnus Kb. Reported administration routes include Subcutaneous, Unknown, Subconjunctival. 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 Clos P*2/Cl Oth*4/H.Somnus Kb reports are Cattle (119 reports), with Cattle accounting for the largest share. Within those species, Cattle (other) (55), Aberdeen Angus (29), Crossbred Bovine/Cattle (18) 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 Clos P*2/Cl Oth*4/H.Somnus Kb are Death (83), Lack of efficacy - NOS (48), Lack of efficacy (bacteria) - NOS (18), Found dead (10). Of the 217 reports with a coded outcome, Died is the leading category at 44.7%. 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 Clos P*2/Cl Oth*4/H.Somnus Kb.

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