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DrontalTM Tablets

Praziquantel Pyrantel Pamoate

Veterinary NADA Approved 34 adverse event reports

Overview

Source: Animal Drugs @ FDA
Proprietary name
DrontalTM Tablets
Active ingredient
Praziquantel Pyrantel Pamoate
Application type
NADA
Sponsor
Elanco US Inc.
Applications on record
1
First published
May 10, 2022

Adverse event reports

Source: openFDA VeDDRA
34
Reports mentioning this ingredient
April 15, 2020 – December 16, 2025
25
Classified serious
per reporter assessment
16
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 “PRAZIQUANTEL PYRANTEL PAMOATE”. Green Book ingredient names and VeDDRA ingredient names do not always agree exactly, so attribution is approximate and labelled as such.

Species affected

Source: openFDA VeDDRA
Dog 27 Cat 7

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