Naxcel® Sterile Powder — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Naxcel® Sterile Powder

Active ingredient

Ceftiofur Sodium

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

September 6, 2022

Adverse event reports

Source: openFDA VeDDRA

1,375

Reports mentioning this ingredient

May 9, 1988 – March 5, 2026

93

Classified serious

per reporter assessment

70

Lack of expected efficacy

resistance signal

19

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 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
Solution, Abnormal	451
Color, Abnormal	217
Suspension, Abnormal	210
Residues in milk	135
Precipitate, Sediment	127
Death	105
No sign	70
Diarrhoea	40
Lack of efficacy (bacteria) - NOS	37
Granules/Powder, Abnormal	32
Anaphylaxis	31
Unclassifiable adverse event	27
Death by euthanasia	24
Residues in meat/offal	24
Contamination NOS	22
Lack of efficacy - NOS	21
Fever	21
Uncoded sign	21
Anorexia	20
Contamination, Foreign Object	20

Species affected

Source: openFDA VeDDRA

Cattle 252 Horse 124 Dog 78 Cat 26 Human 22 Goat 10 Pig 9 Chicken 3 Alpaca 3 Sheep 3 Other 3 Donkey 2

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