Cefovecin Sodium for Injection — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Cefovecin Sodium for Injection

Active ingredient

Cefovecin sodium

Application type

ANADA

Sponsor

Qilu Animal Health Products Co., Ltd.

Applications on record

1

First published

July 1, 2025

Adverse event reports

Source: openFDA VeDDRA

3,925

Reports mentioning this ingredient

May 30, 2008 – March 24, 2026

740

Classified serious

per reporter assessment

562

Lack of expected efficacy

resistance signal

24

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 “CEFOVECIN SODIUM”. 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
Anorexia	522
Depression	454
Vomiting	382
Lack of efficacy (bacteria) - NOS	364
Death	274
Death by euthanasia	226
Anaemia NOS	219
Diarrhoea	210
Ataxia	199
Anaphylaxis	175
Fever	172
Elevated blood urea nitrogen (BUN)	152
Dyspnoea	150
Convulsion	140
Elevated alanine aminotransferase (ALT)	137
Weight loss	129
Abnormal radiograph finding	126
Skin lesion NOS	120
Dehydration	113
Elevated creatinine	104

Species affected

Source: openFDA VeDDRA

Cat 2,897 Dog 912 Human 6 Guinea Pig 5 Mouse 2 Pig 1 Cougar 1 Other Birds 1 Rabbit 1 Other 1 Ferret 1 Tiger 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