Excenel® Sterile Powder Excenel® RTU Excenel Sterile Suspension

Overview

Source: Animal Drugs @ FDA

Proprietary name

Excenel® Sterile Powder Excenel® RTU Excenel Sterile Suspension

Active ingredient

Ceftiofur Hydrochloride

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

December 18, 2017

Adverse event reports

Source: openFDA VeDDRA

1,222

Reports mentioning this ingredient

December 28, 1998 – March 25, 2026

268

Classified serious

per reporter assessment

227

Lack of expected efficacy

resistance signal

37

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 HYDROCHLORIDE”. 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
Suspension, Abnormal	228
Residues in milk	175
Lack of efficacy (bacteria) - NOS	163
Residues in meat/offal	99
No sign	87
Death	65
Closure, Abnormal	65
Lack of efficacy - NOS	61
Uncoded sign	40
Accidental exposure	35
Unclassifiable adverse event	34
Product Defect, General	28
Underfilling, Package	23
Color, Abnormal	21
Closure, Missing	20
Containers, Leaking	19
Caps, Abnormal	18
Solution, Abnormal	17
Containers, Damaged	17
Injection site swelling	14

Species affected

Source: openFDA VeDDRA

Cattle 659 Human 39 Goat 12 Horse 10 Pig 5 Dog 4 Sheep 2 Other 1 Alpaca 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