FOLLTROPIN® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

FOLLTROPIN®

Active ingredient

Porcine pituitary-derived follicle stimulating hormone

Application type

NADA

Sponsor

Vetoquinol USA, Inc.

Applications on record

1

First published

May 14, 2026

Adverse event reports

Source: openFDA VeDDRA

2,117

Reports mentioning this ingredient

January 11, 2005 – March 24, 2026

5

Classified serious

per reporter assessment

13

Lack of expected efficacy

resistance signal

15

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 “PORCINE INSULIN”. 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
INEFFECTIVE, GLYCEMIC CONTROL	690
INEFFECTIVE, LOSS OF EFFECT	396
Hypoglycaemia	384
Polydipsia	331
Polyuria	308
Hyperglycaemia	289
Depression	268
Suspension, Abnormal	234
Anorexia	174
Convulsion	166
Vomiting	148
Death by euthanasia	140
Ataxia	82
Death	81
Confusion	78
Solution, Abnormal	72
Diarrhoea	69
Weight loss	68
Weakness	62
Vials, Damaged	59

Species affected

Source: openFDA VeDDRA

Dog 1,304 Cat 422 Human 11 Other 1 Pig 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