EXCEDE® For Swine — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

EXCEDE® For Swine

Active ingredient

Ceftiofur Crystalline Free Acid

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

February 28, 2024

Adverse event reports

Source: openFDA VeDDRA

2,132

Reports mentioning this ingredient

June 1, 2011 – March 25, 2026

1,438

Classified serious

per reporter assessment

668

Lack of expected efficacy

resistance signal

46

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 “CEFTIOFUR CRYSTALLINE FREE ACID”. 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
Injection site swelling	472
Death	431
Lack of efficacy (bacteria) - NOS	260
Injection site pain	231
Lack of efficacy - NOS	198
Fever	158
Death by euthanasia	98
Injection site inflammation	83
Colic	80
CULTURE/TITER DATA ABNORMAL	78
INEFFECTIVE, ANTIBIOTIC	76
Residues in meat/offal	75
Sudden death	69
Injection site abscess	67
Abnormal test result	62
Lethargy (see also Central nervous system depression in 'Neurological')	59
Other abnormal test result NOS	58
Injection site warmth	54
Injection site oedema	48
Muscle stiffness	47

Species affected

Source: openFDA VeDDRA

Cattle 967 Horse 882 Human 77 Pig 33 Cat 14 Donkey 12 Dog 8 Goat 6 Other Equids 4 Sheep 4 Fish 1 Chicken 1

Regulatory context

New Animal Drug Application (NADA). A pioneer approval evaluated for target animal safety, therapeutic effectiveness, manufacturing controls and — for food-producing species — human food safety including residue depletion.

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