Lufenuron + Praziquantel: adverse event reports that FDA received

Name: Lufenuron + Praziquantel: adverse event reports that FDA received, by year and species
Creator: Pet Drug Reports
License: https://creativecommons.org/publicdomain/zero/1.0/

Combination of 2 active ingredients

The Green Book lists no brand name for exactly these active ingredients.

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.

Read this first. FDA says this about the data:

An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another. When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event. This dataset should not be the sole source of information for clinical decision-making or other assumptions about the safety or effectiveness of a product. The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.
FDA Center for Veterinary Medicine publishes these words. Source: Adverse Event Reports for Animal Drugs and Devices, read on 2 Oct 2026. The data have the reports that FDA received through 26 Jun 2026.

This page is not veterinary advice. For an animal that is ill, speak to a veterinarian.

Contacting a veterinarian How to report to FDA

From February 2014 to May 2025, FDA received 3,526 adverse event reports that name a drug with lufenuron and praziquantel as its active ingredients. Of the 3,526 reports, 3,330 (94.4%) are about dogs.

In January to March 2026, FDA received no reports that name this drug. The signs that appear in the largest number of the 3,526 reports are "Vomiting" and "Lack of efficacy (endoparasite) - hookworm". A report is not proof that a drug caused a sign.

Fewer than 20 reports named this drug in the 12 months before June 2026, so this page gives no change. Reports about dogs are 94.4% of the reports that name this drug, and 72.6% of all reports.

Search engines list a drug page with 500 reports or more in all years. The page also needs 30 reports or more in the 12 months to June 2026. This page is under one of these numbers. The site keeps the page and keeps it out of search engines.

Since the last update of the FDA data

The latest update of the FDA data, recorded on 11 Oct 2026, changed no count of this page.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 0 reports that name lufenuron + praziquantel: 0 dog, 0 cat, 0 horse, 0 other or not given.

All updates Feed of updates (RSS)

Signs that the reports list

A sign is a coded term from the report. The words in brackets are a plain gloss of the term. The percentage is the share of the 3,526 reports that list the sign. One report can list more than one sign.

The sign that is in the largest number of the reports comes first.

Vomiting16.4%580 reports
Lack of efficacy (endoparasite) - hookworm[the product did not have the expected effect: hookworms]15.4%544 reports
Ineffective, heartworm larvae[legacy FDA term: the product did not have the expected effect (heartworm larvae)]15.1%532 reports
Diarrhoea[diarrhea]8.9%315 reports
Ineffective, ascarids NOS[legacy FDA term: the product did not have the expected effect (ascarids nos)]8.3%292 reports
Lethargy[unusually tired or inactive]7%248 reports
Lack of efficacy (endoparasite) - tapeworm[the product did not have the expected effect: tapeworms]6.1%216 reports
Lack of efficacy - NOS[the product did not have the expected effect]5.4%189 reports
Lack of efficacy (endoparasite) - whipworm[the product did not have the expected effect: whipworms]4.3%153 reports
Emesis[vomiting]3.6%127 reports
Lack of efficacy (ectoparasite) - flea[the product did not have the expected effect: fleas]3.6%127 reports
Ineffective, hooks[legacy FDA term: the product did not have the expected effect (hooks)]3.2%112 reports
Containers, Damaged[a product quality report, not a sign in an animal]2.9%103 reports
Seizure NOS[seizure, type not specified]2.4%86 reports

Show the next 16 signs

Anorexia[not eating]2.3%80 reports
Ataxia[unsteady, uncoordinated movement]1.8%63 reports
Emesis (multiple)[vomiting more than once]1.7%59 reports
Bloody diarrhoea[diarrhea with blood]1.6%56 reports
Itching1.6%56 reports
Product problem[a product quality report, not a sign in an animal]1.6%55 reports
Pruritus[itching]1.5%53 reports
Inappetence[reduced appetite]1.3%46 reports
Loose stool1.3%46 reports
Lack of efficacy (protozoa) - Coccidia[the product did not have the expected effect: coccidia]1%37 reports
Not eating1%36 reports
Product Defect, General[a product quality report, not a sign in an animal]1%36 reports
Underfilling, Container[a product quality report, not a sign in an animal]1%36 reports
Drug dose administration interval too long1%35 reports
Panting0.9%33 reports
Overdose[more than the labelled amount was given]0.9%32 reports

The list shows 30 of 550 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

Dog94.4%3,330
Human exposure0.1%3
Cat0.1%2
Other Canidsunder 0.1%1

The share is of all 3,526 reports that name lufenuron + praziquantel. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog1 report

No chart: no month has 5 or more reports.

Cat0 reports

No chart: no month has 5 or more reports.

Horse0 reports

No chart: no month has 5 or more reports.

Other or not given0 reports

No chart: no month has 5 or more reports.

The month is the month in which FDA received the report. Each chart has its own scale. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.

Reports by year

Dog
Cat
Horse
Other or not given

Reports that name lufenuron + praziquantel, by the year in which FDA received them and by species
Year	Dog	Cat	Other or not given	All species
2025	1	0	0	1
2018	109	1	4	114
2017	932	1	59	992
2016	964	0	59	1,023
2015	803	0	56	859
2014	521	0	16	537

2025 has the reports that FDA received through May 2025. Download the years (CSV)

What the reports record

Outcome at the time of the report

Recovered/Normal33.1%1,167
Recovered with Sequela[recovered, with a lasting effect]0.3%11
Ongoing4.7%166
Died0.7%26
Euthanized0.4%15
Outcome Unknown55.4%1,954

An outcome in a report is not proof that the drug caused it. The person who sends the report gives the outcome. Each share is of the 3,526 reports that name lufenuron + praziquantel.

A report about more than one animal can have more than one outcome.

Kind of report

Safety issue36.7%1,294
Lack of expected effectiveness50.3%1,772
Both safety and lack of expected effectiveness7.5%264
Manufacturing or product defect5.6%196
Other0%0

3,336 reports say if the event was serious. 16.2% of them have the serious flag. The person who sends the report sets the flag.

Show age, weight, breed and route

Age of the animal

Under 1 year12.9%454
1 to 3 years32.5%1,146
4 to 7 years25.1%885
8 to 11 years15.5%547
12 years and over4.8%168
Age not given9.2%326

Weight of the animal

Under 5 kg (11 lb)10.1%355
5 to 9.9 kg (11 to 22 lb)16.8%594
10 to 24.9 kg (22 to 55 lb)31.6%1,114
25 to 44.9 kg (55 to 99 lb)28.8%1,017
45 kg and over (99 lb and over)3.2%112
Weight not given9.5%334

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

Oral94.6%3,334
Otherunder 0.1%1
Topicalunder 0.1%1

Each bar is on a scale of 0 to 100%.

Approved animal drugs with these active ingredients (FDA Green Book)

This section is reference data. It has no report count.

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.

No approved product has exactly this set of active ingredients. The ingredient field of a report can be incomplete. The approved products below have all the ingredients of this page and one or more other ingredients.

Applications in the Green Book of 2 Nov 2026, pioneer applications (NADA) first
Brand name	Active ingredients	Sponsor	Approved species	Application
Sentinel Spectrum	Lufenuron, Milbemycin Oxime, Praziquantel	Intervet, Inc.	Dogs	NADA 141-333

Other pages with one of these ingredients

A report names a drug by its set of active ingredients. Each set has its own page. The list is in order of name.

Next in the A to Z list

All drugs by active ingredient. Brand names A to Z

FDA pages for this drug

How to Report Animal Drug and Device Side Effects and Product ProblemsThe FDA page that tells an owner or a veterinarian how to send a report.
Animal Drugs @ FDAThe search page of the Green Book, the FDA list of approved animal drugs.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Pet Drug Reports. Lufenuron + Praziquantel: adverse event reports that FDA received. https://petdrugreports.com/drug/lufenuron-praziquantel/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of 30 Oct 2026. Reports received through 26 Jun 2026.

Where the data come from

The counts come from the openFDA Animal and Veterinary adverse event files, export of 30 Oct 2026. The files have the reports that the FDA Center for Veterinary Medicine received through 26 Jun 2026. The files mask brand and manufacturer names. The site counts a drug by the active ingredients that each record gives, and gives no count to a brand, an application or a company. Ingredient names and the lists of approved products follow the FDA Green Book of 2 Nov 2026. The site does not use the application number that a record has.

The site does not publish report text, lot numbers or details of a reporter. FDA's record is the authority. See how the site counts reports, the data sources and the corrections page.

Questions about these reports

Which brand are these reports about?: The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand. The Green Book lists no brand name for exactly these active ingredients.
Do the reports show that the drug caused the signs?: No. FDA states this about the data.
When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event.
The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
How many reports did FDA receive in the latest 12 months?: FDA received no reports in the 12 months to June 2026. It received 1 report in the 12 months before. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.
What kinds of report are in the count?: Of the 3,526 reports received from February 2014 to May 2025, 36.7% are about a safety issue only. 57.7% are about a lack of expected effectiveness, alone or with a safety issue. 5.6% are about a defect of the product or its package.