Levamisole Hydrochloride;Doramectin

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111 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.
111
Total Reports
21
Deaths Reported
1890.0%
Death Rate

Active Ingredients

Levamisole Hydrochloride;Doramectin

Administration Routes

SubcutaneousUnknownRespiratory (Inhalation)Topical

Species Affected

Cattle 59
Unknown 42
Human 7
Goat 2
Pig 1

Most Affected Breeds

Unknown 49
Mixed (Cattle) 46
Aberdeen Angus 7
Goat (unknown) 2
Hereford cattle 2
Red Angus 1
Pig (unknown) 1
Charolais 1
Brangus 1
Holstein-Friesian also known as Holstein 1

Most Reported Reactions

Injection site swelling 18
Death 17
Closure, Abnormal 12
Containers, Damaged 11
Lack of efficacy - NOS 9
Closure, Missing 8
Inappropriate packaging or design 8
Injection site abscess 6
Necropsy performed 5
Containers, Abnormal 5
Containers, Leaking 4
Intentional misuse 4

Outcome Breakdown

Outcome Unknown
39 (50.0%)
Died
20 (25.6%)
Recovered/Normal
10 (12.8%)
Ongoing
8 (10.3%)
Euthanized
1 (1.3%)

Data Summary

Metric Value
Total adverse event reports 111
Reports involving death 21
Case-fatality rate (reported events) 1890.0%
Distinct species in reports 5
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.

Levamisole Hydrochloride;Doramectin Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 111 adverse event reports referencing Levamisole Hydrochloride;Doramectin, including 21 reports in which the animal died — a 1890.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Levamisole Hydrochloride;Doramectin. Reported administration routes include Subcutaneous, Unknown, Respiratory (Inhalation), 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 Levamisole Hydrochloride;Doramectin reports are Cattle (59 reports), Unknown (42 reports), Human (7 reports), with Cattle accounting for the largest share. Within those species, Unknown (49), Mixed (Cattle) (46), Aberdeen Angus (7) 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 Levamisole Hydrochloride;Doramectin are Injection site swelling (18), Death (17), Closure, Abnormal (12), Containers, Damaged (11). Of the 78 reports with a coded outcome, Outcome Unknown is the leading category at 50.0%. 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 Levamisole Hydrochloride;Doramectin.

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