VarenzinTM-CA1 — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

VarenzinTM-CA1

Active ingredient

Molidustat

Application type

NADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

May 14, 2026

Adverse event reports

Source: openFDA VeDDRA

383

Reports mentioning this ingredient

September 22, 2023 – November 19, 2025

104

Classified serious

per reporter assessment

105

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 “MOLIDUSTAT”. 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
Lack of efficacy - NOS	99
Vomiting	45
Decreased haematocrit	34
Weight loss	34
Pica NOS	31
Elevated creatinine	30
Death by euthanasia	29
Lethargy (see also Central nervous system depression in Neurological)	27
Other abnormal test result NOS	26
Elevated blood urea nitrogen (BUN)	26
Decreased appetite	25
Not eating	23
Behavioural disorder NOS	17
Containers, Leaking	14
High blood pressure	13
Elevated symmetrical dimethylarginine (SDMA)	13
Decreased packed cell volume (PCV)	12
Death	12
Product syringe issue	11
Hyperphosphataemia	11

Species affected

Source: openFDA VeDDRA

Cat 339 Dog 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