SMZ-Med® 454 — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

SMZ-Med® 454

Active ingredient

Sodium sulfamethazine

Application type

ANADA

Sponsor

Bimeda Animal Health Ltd.

Applications on record

1

First published

October 2, 2018

Adverse event reports

Source: openFDA VeDDRA

152

Reports mentioning this ingredient

January 3, 2012 – January 26, 2026

86

Classified serious

per reporter assessment

28

Lack of expected efficacy

resistance signal

3

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 “SODIUM CHLORIDE”. 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
Product Defect, General	5
Seal, Abnormal	4
Contamination, Particulate Matter	4
Expired drug administered	3
Localised pain NOS (see other 'SOCs' for specific pain)	2
Vomiting	2
Ataxia	1
Dilated pupils	1
Agitation	1
Perivascular necrosis	1
Solution, Abnormal	1
Precipitate, Sediment	1
Shaking	1
Skin warmth	1
Erythema (for urticaria see Immune SOC)	1
Injection site oedema	1
Aggression	1
Hypotension	1
Death	1
Respiratory arrest	1

Species affected

Source: openFDA VeDDRA

Dog 98 Cat 33 Cattle 5 Horse 3 Human 2 Turtle 1

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