Rofenaid® 40 — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Rofenaid® 40

Active ingredient

Ormetoprim Sulfadimethoxine

Application type

NADA

Sponsor

Phibro Animal Health Corp.

Applications on record

1

First published

June 17, 2025

Adverse event reports

Source: openFDA VeDDRA

980

Reports mentioning this ingredient

January 10, 1990 – August 13, 2012

0

Classified serious

per reporter assessment

40

Lack of expected efficacy

resistance signal

22

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 “ORMETOPRIM, SULFADIMETHOXINE”. 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
Depression	154
Anorexia	119
Vomiting	111
Fever	104
Ataxia	102
Convulsion	91
Thrombocytopenia	83
Elevated alanine aminotransferase (ALT)	70
Elevated serum alkaline phosphatase (SAP)	70
Death	68
Trembling	59
Anaemia NOS	56
Keratoconjunctivitis sicca	44
Elevated total bilirubin	43
Hyperactivity	42
Aggression	41
Death by euthanasia	40
Behavioural disorder NOS	38
Apprehension	37
Restlessness	37

Species affected

Source: openFDA VeDDRA

Dog 896 Cat 38 Human 10 Fish 2 Goat 2 Other 2 Horse 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