Cefpodoxime Proxetil Tablets — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Cefpodoxime Proxetil Tablets

Active ingredient

Cefpodoxime proxetil

Application type

ANADA

Sponsor

Dechra Veterinary Products LLC

Applications on record

2

First published

March 16, 2019

Applications

Source: Animal Drugs @ FDA

Every Green Book application recorded for this proprietary name.
Application no.	Type	Status	Withdrawn
200543	ANADA	Approved	—
200815	ANADA	Approved	—

Adverse event reports

Source: openFDA VeDDRA

2,851

Reports mentioning this ingredient

October 6, 2004 – March 26, 2026

794

Classified serious

per reporter assessment

468

Lack of expected efficacy

resistance signal

11

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 “CEFPODOXIME PROXETIL”. 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
Vomiting	319
Anorexia	214
Lethargy (see also Central nervous system depression in 'Neurological')	154
Depression	150
Lack of efficacy (bacteria) - NOS	135
Diarrhoea	127
Elevated alanine aminotransferase (ALT)	122
Elevated serum alkaline phosphatase (SAP)	120
Death	98
Death by euthanasia	88
Polydipsia	81
Anaemia NOS	80
Leucocytosis NOS	76
Elevated blood urea nitrogen (BUN)	73
Pruritus	73
Lack of efficacy - NOS	71
Fever	70
Polyuria	67
Other abnormal test result NOS	67
Convulsion	62

Species affected

Source: openFDA VeDDRA

Dog 2,698 Cat 59 Human 4 Horse 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