TylanTM and Banminth® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

TylanTM and Banminth®

Active ingredient

Pyrantel Tartrate Tylosin Phosphate

Application type

NADA

Sponsor

Phibro Animal Health Corp.

Applications on record

1

First published

December 2, 2018

Adverse event reports

Source: openFDA VeDDRA

52,060

Reports mentioning this ingredient

April 15, 2020 – March 27, 2026

28,374

Classified serious

per reporter assessment

27,688

Lack of expected efficacy

resistance signal

109

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 “PYRANTEL PAMOATE;SAROLANER”. 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	8,802
Lack of efficacy (bacteria) - Borrelia	5,949
Lack of efficacy (endoparasite) - heartworm	5,242
Lack of efficacy (endoparasite) - hookworm	4,160
Seizure NOS	4,006
Diarrhoea	3,712
Lack of efficacy (endoparasite) - roundworm NOS	3,229
Lack of efficacy (ectoparasite) - tick NOS	2,948
Lack of efficacy (endoparasite) - tapeworm	2,117
Lethargy (see also Central nervous system depression in 'Neurological')	1,927
Lack of efficacy (bacteria) - Anaplasma	1,732
Lack of efficacy (ectoparasite) - flea	1,644
Intentional misuse	1,642
Medication error NOS	1,473
Lethargy (see also Central nervous system depression in Neurological)	1,390
Lack of efficacy (bacteria) - Ehrlichia	1,249
Tremor	1,014
Emesis (multiple)	963
Lack of efficacy (bacteria) - NOS	952
Ataxia	940

Species affected

Source: openFDA VeDDRA

Dog 50,473 Cat 45 Human 26 Other Canids 2 Marsupial 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