Banamine® Transdermal — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Banamine® Transdermal

Active ingredient

Flunixin

Application type

NADA

Sponsor

Intervet, Inc.

Applications on record

1

First published

January 3, 2023

Adverse event reports

Source: openFDA VeDDRA

76

Reports mentioning this ingredient

September 23, 1999 – March 10, 2026

38

Classified serious

per reporter assessment

6

Lack of expected efficacy

resistance signal

0

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 “FLUNIXIN”. 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
Contamination, Particulate Matter	6
Solution/Suspension, crystals	3
Death	2
DEATH-SLAUGHTERED	2
Residues in meat/offal	2
Haematuria	1
Hind limb paralysis	1
Musculoskeletal pain	1
Sudden death	1
Injection site reaction NOS	1
Residues in milk	1
RESIDUE, URINE	1
Product label issues	1
Contamination, Foreign Object	1
Precipitate, Sediment	1
Seizure NOS	1
Recumbency	1
Elevated temperature	1
Pneumonia	1
Death by euthanasia	1

Species affected

Source: openFDA VeDDRA

Horse 44 Cattle 12 Dog 4 Sheep 1 Donkey 1 Pig 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