Melarsomine Dihydrocloride Injectable 25Mg/Ml

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612 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.
612
Total Reports
23
Deaths Reported
380.0%
Death Rate

Active Ingredients

Melarsomine Dihydrocloride Injectable 25Mg/Ml

Administration Routes

IntramuscularUnknownSubcutaneousIntravenous

Species Affected

Dog 502
Unknown 106
Human 3
Other Canids 1

Most Affected Breeds

Unknown 109
Dog (other) 82
Retriever - Labrador 62
Crossbred Canine/dog 33
Dog (unknown) 27
Shepherd Dog - German 19
Boxer (German Boxer) 19
Chihuahua 19
Pit Bull 17
Beagle 17

Most Reported Reactions

INEFFECTIVE, HEARTWORM ADULTS 127
Vials, Damaged 78
Vomiting 67
Lethargy (see also Central nervous system depression in 'Neurological') 61
INEFFECTIVE, HEARTWORM LARVAE 41
Injection site swelling 38
Panting 37
Injection site lump 36
Injection site pain 36
Elevated alanine aminotransferase (ALT) 29
Other abnormal test result NOS 27
Lack of efficacy - NOS 26

Outcome Breakdown

Outcome Unknown
317 (62.4%)
Ongoing
74 (14.6%)
Recovered/Normal
54 (10.6%)
Recovered with Sequela
40 (7.9%)
Died
16 (3.1%)
Euthanized
7 (1.4%)

Data Summary

Metric Value
Total adverse event reports 612
Reports involving death 23
Case-fatality rate (reported events) 380.0%
Distinct species in reports 4
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.

Melarsomine Dihydrocloride Injectable 25Mg/Ml Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 612 adverse event reports referencing Melarsomine Dihydrocloride Injectable 25Mg/Ml, including 23 reports in which the animal died — a 380.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Melarsomine Dihydrocloride Injectable 25Mg/Ml. Reported administration routes include Intramuscular, Unknown, Subcutaneous, Intravenous. 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 Melarsomine Dihydrocloride Injectable 25Mg/Ml reports are Dog (502 reports), Unknown (106 reports), Human (3 reports), with Dog accounting for the largest share. Within those species, Unknown (109), Dog (other) (82), Retriever - Labrador (62) 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 Melarsomine Dihydrocloride Injectable 25Mg/Ml are INEFFECTIVE, HEARTWORM ADULTS (127), Vials, Damaged (78), Vomiting (67), Lethargy (see also Central nervous system depression in 'Neurological') (61). Of the 508 reports with a coded outcome, Outcome Unknown is the leading category at 62.4%. 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 Melarsomine Dihydrocloride Injectable 25Mg/Ml.

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