Doramectin

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2,065 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.
2,065
Total Reports
361
Deaths Reported
1750.0%
Death Rate

Active Ingredients

Doramectin

Administration Routes

TopicalUnknownSubcutaneousOralIntramuscularParenteralOtherOphthalmicAuricular (Otic)Intravenous

Species Affected

Cattle 1,357
Unknown 541
Human 71
Dog 51
Pig 17
Sheep 7
Goat 6
Cat 5
Horse 2
Buffalo 2

Most Affected Breeds

Unknown 619
Mixed (Cattle) 609
Cattle (other) 263
Aberdeen Angus 197
Cattle (unknown) 95
Crossbred Bovine/Cattle 85
Red Angus 18
Simmental 17
Charolais 17
Holstein-Friesian also known as Holstein 12

Most Reported Reactions

Lack of efficacy (ectoparasite) - lice 364
Death 280
Lack of efficacy (lice) 279
Caps, Abnormal 242
Lack of efficacy - NOS 141
Vials, Leaking 105
INEFFECTIVE, LICE BITING 94
Containers, Leaking 86
Lack of efficacy (bacteria) - NOS 85
Closure, Abnormal 84
Accidental exposure 61
Seal, Abnormal 53

Outcome Breakdown

Outcome Unknown
918 (60.3%)
Died
353 (23.2%)
Ongoing
118 (7.7%)
Recovered/Normal
112 (7.4%)
Euthanized
16 (1.1%)
Recovered with Sequela
6 (0.4%)

Data Summary

Metric Value
Total adverse event reports 2,065
Reports involving death 361
Case-fatality rate (reported events) 1750.0%
Distinct species in reports 10
Distinct breeds in reports 20
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.

Doramectin Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 2,065 adverse event reports referencing Doramectin, including 361 reports in which the animal died — a 1750.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Doramectin. Reported administration routes include Topical, Unknown, Subcutaneous, Oral. 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 Doramectin reports are Cattle (1,357 reports), Unknown (541 reports), Human (71 reports), with Cattle accounting for the largest share. Within those species, Unknown (619), Mixed (Cattle) (609), Cattle (other) (263) 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 Doramectin are Lack of efficacy (ectoparasite) - lice (364), Death (280), Lack of efficacy (lice) (279), Caps, Abnormal (242). Of the 1,523 reports with a coded outcome, Outcome Unknown is the leading category at 60.3%. 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 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