Metacam® 5 mg/mL Solution for Injection — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Metacam® 5 mg/mL Solution for Injection

Active ingredient

Meloxicam

Application type

NADA

Sponsor

Boehringer lngelheim Animal Health USA, Inc.

Applications on record

1

First published

March 1, 2024

Adverse event reports

Source: openFDA VeDDRA

17,042

Reports mentioning this ingredient

January 9, 2002 – March 26, 2026

3,234

Classified serious

per reporter assessment

430

Lack of expected efficacy

resistance signal

445

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 “MELOXICAM”. 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	2,667
Anorexia	2,322
Elevated blood urea nitrogen (BUN)	1,788
Vials, Leaking	1,709
Elevated creatinine	1,702
Depression	1,643
Diarrhoea	1,034
Renal failure	883
Death	870
Death by euthanasia	823
Hyperphosphataemia	794
Azotaemia	625
Dispenser, Abnormal	539
Anaemia NOS	509
Elevated alanine aminotransferase (ALT)	508
Lethargy (see also Central nervous system depression in 'Neurological')	505
Containers, Abnormal	487
Weight loss	486
Caps, Abnormal	483
Vials, Damaged	479

Species affected

Source: openFDA VeDDRA

Dog 7,913 Cat 3,587 Human 163 Rabbit 77 Other Birds 20 Guinea Pig 13 Cattle 13 Other 10 Mouse 8 Ferret 7 Parrot 6 Pig 6

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