Credelio QuattroTM — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Credelio QuattroTM

Active ingredient

Lotilaner Moxidectin Praziquantel Pyrantel Pamoate

Application type

NADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

March 9, 2026

Adverse event reports

Source: openFDA VeDDRA

11,341

Reports mentioning this ingredient

August 5, 2015 – March 26, 2026

1,575

Classified serious

per reporter assessment

3,461

Lack of expected efficacy

resistance signal

84

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 “LOTILANER”. 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	2,105
Diarrhoea	883
Lack of efficacy (ectoparasite) - tick NOS	629
UNPALATABLE	606
Seizure NOS	539
Lethargy (see also Central nervous system depression in 'Neurological')	525
Other abnormal test result NOS	521
Lack of efficacy (ectoparasite) - flea	514
Lack of efficacy (bacteria) - Borrelia	488
Behavioural disorder NOS	395
Lethargy (see also Central nervous system depression in Neurological)	324
Not eating	321
Ataxia	234
Itching	220
Lack of efficacy (endoparasite) - heartworm	214
Panting	207
Decreased appetite	170
Scratching	168
Lack of efficacy (flea)	165
Shaking	165

Species affected

Source: openFDA VeDDRA

Dog 9,648 Cat 857 Human 24 Pig 1 Cattle 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