Optimmune® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Optimmune®

Active ingredient

Cyclosporine

Application type

NADA

Sponsor

Intervet, Inc.

Applications on record

1

First published

December 7, 2017

Adverse event reports

Source: openFDA VeDDRA

16,537

Reports mentioning this ingredient

August 31, 1995 – March 27, 2026

1,240

Classified serious

per reporter assessment

777

Lack of expected efficacy

resistance signal

87

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 “CYCLOSPORINE”. 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	4,490
Diarrhoea	2,070
Depression	1,331
Anorexia	1,108
Pruritus	993
Elevated serum alkaline phosphatase (SAP)	548
Weight loss	528
UNPALATABLE	508
INEFFECTIVE, ATOPY CONTROL	464
Elevated alanine aminotransferase (ALT)	447
Gingival hyperplasia	428
Lack of efficacy - NOS	397
Polydipsia	366
Product problem	365
Death by euthanasia	351
Trembling	337
Polyuria	332
Polypnoea	330
Labelled drug-drug interaction medication error	322
Difficulty of Use	307

Species affected

Source: openFDA VeDDRA

Dog 11,610 Cat 2,093 Human 61 Other 2

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