Tilmovet® AC — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Tilmovet® AC

Active ingredient

Tilmicosin Phosphate

Application type

ANADA

Sponsor

Huvepharma EOOD

Applications on record

1

First published

February 1, 2022

Adverse event reports

Source: openFDA VeDDRA

3,572

Reports mentioning this ingredient

May 26, 1992 – April 29, 2025

134

Classified serious

per reporter assessment

246

Lack of expected efficacy

resistance signal

2,203

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 “TILMICOSIN PHOSPHATE”. 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
Unclassifiable adverse event	4,309
Accidental exposure	2,203
Death	712
No sign	659
Injection site pain	276
Injection site swelling	242
Sensory abnormality NOS	232
Lack of efficacy (bacteria) - NOS	229
Injection site bleeding	217
Nausea	146
Balance problem	142
Hypoaesthesia	141
Collapse (see also 'Cardio-vascular' and 'Systemic disorders')	131
Tachycardia	130
Injection site inflammation	111
Headache	109
Dyspnoea	105
Recumbency	102
Thoracic pain	89
Anxious state of mind	81

Species affected

Source: openFDA VeDDRA

Human 2,275 Cattle 825 Pig 150 Sheep 118 Goat 62 Dog 12 Rabbit 12 Other Deer 5 Horse 5 Cat 4 Other Birds 2 Other 2

Regulatory context

Abbreviated New Animal Drug Application (ANADA). A generic animal drug demonstrating bioequivalence, pharmaceutical equivalence and identical manufacturing criteria to the pioneer application. Veterinary generics have no formal therapeutic-equivalence coding system; they match the pioneer NADA specification instead.

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