DIROBAN® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

DIROBAN®

Active ingredient

Melarsomine Dihydrochloride

Application type

ANADA

Sponsor

Anzac Animal Health, LLC

Applications on record

1

First published

January 28, 2020

Adverse event reports

Source: openFDA VeDDRA

17,019

Reports mentioning this ingredient

December 27, 1995 – March 27, 2026

3,910

Classified serious

per reporter assessment

3,112

Lack of expected efficacy

resistance signal

76

Human operator exposure

needle-stick or splash

Not a risk measure. Veterinary adverse event reports are influenced by how many animals are treated, reporting practice and product age. Reports do not establish that the product caused the event, and a single report can cover an entire herd or flock. Attribution here is by active ingredient because the source dataset redacts brand names.

Attributed by active ingredient “MELARSOMINE DIHYDROCHLORIDE”. Green Book ingredient names and VeDDRA ingredient names do not always agree exactly, so attribution is approximate and labelled as such.

Reported reactions

Source: openFDA VeDDRA

Clinical signs coded in the VICH VeDDRA four-level hierarchy, most frequent first.

Reaction terms reported for this ingredient, by report count.
Reaction (VeDDRA term)	Reports	Relative frequency
INEFFECTIVE, HEARTWORM ADULTS	2,557
Vomiting	1,916
Injection site swelling	1,718
Lack of efficacy (endoparasite) - heartworm	1,626
Injection site pain	1,043
Anorexia	1,038
Depression	1,020
Pain NOS	932
Diarrhoea	844
Fever	798
Death	754
Hypersalivation	717
Polypnoea	676
Cough	629
Elevated alanine aminotransferase (ALT)	618
Injection site lump	558
Lethargy (see also Central nervous system depression in 'Neurological')	519
Bloody diarrhoea	492
Anaphylaxis	457
Ataxia	439

Species affected

Source: openFDA VeDDRA

Dog 16,492 Human 80 Other 24 Cat 6

Regulatory context

Abbreviated New Animal Drug Application (ANADA). A generic animal drug demonstrating bioequivalence, pharmaceutical equivalence and identical manufacturing criteria to the pioneer application. Veterinary generics have no formal therapeutic-equivalence coding system; they match the pioneer NADA specification instead.

Extra-label use in food-producing animals is governed by the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) and 21 CFR Part 530. It requires a valid veterinarian-client-patient relationship and is prohibited outright for certain drug classes. Withdrawal times are determined by FARAD, not by this index.

Sources for this page

Animal Drugs @ FDA	FDA CVM	Applications, sponsor, status, withdrawal
Animal & Veterinary Events	FDA CVM	VeDDRA adverse event aggregates by active ingredient