Lufenuron: adverse event reports in all combinations

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

Active ingredient, alone and in combinations

Brand names with this ingredient: Program, Sentinel.

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

FDA reports received through 26 Jun 2026. Counts include this ingredient alone and in combinations. Why brand names have no separate count.

From January 1995 to June 2026, FDA received 39,985 adverse event reports that name a drug with lufenuron, alone or in a combination. 4 sets of active ingredients with lufenuron have a drug page.

Of the 39,985 reports, 36,856 (92.2%) are about dogs. 1,149 reports are about cats (2.9%). In January to March 2026, FDA received 237 reports that name lufenuron, alone or in a combination. The signs that appear in the largest number of the 39,985 reports are "Ineffective, heartworm larvae" and "Vomiting". A report is not proof that a drug caused a sign.

Reports that name this ingredient fell by 7.5% in the 12 months to June 2026, compared with the 12 months before. Reports for all animal drugs fell by 4.6% in the same periods. The newest months can get more reports in a later update. Reports about dogs are 92.2% of the reports that name this ingredient, and 72.6% of all reports.

Reports in the latest closed quarter

Reports that name lufenuron, by the quarter in which FDA received them
Species	Jan to Mar 2026	Oct to Dec 2025	Jan to Mar 2025
All species	237	282	240
Dog	235	280	234
Cat	0	0	0
Horse	0	0	0
Other or not given	2	2	6

January to March 2026 is the latest closed quarter in the data.

All updates Feed of updates (RSS)

Drug pages with lufenuron

A report names a drug by its set of active ingredients. Each set with lufenuron that has a drug page is in the table, in order of name. The table has 4 sets.

Drug pages with lufenuron, in order of name, with the reports of each page
Active ingredients	Reports, all years	Reports, latest 12 months
Lufenuron	2,371	3
Lufenuron + Milbemycin Oxime	27,608	360
Lufenuron + Milbemycin Oxime + Praziquantel	6,893	747
Lufenuron + Praziquantel	3,526	0

A report can name more than one set, so the counts of the sets can add to more than the count of the page.

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.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices

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 39,985 reports that list the sign. One report can list more than one sign and more than one drug.

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

Ineffective, heartworm larvae[legacy FDA term: the product did not have the expected effect (heartworm larvae)]14.3%5,705 reports
Vomiting14.2%5,667 reports
Lack of efficacy (endoparasite) - hookworm[the product did not have the expected effect: hookworms]10.7%4,283 reports
Lack of efficacy (endoparasite) - heartworm[the product did not have the expected effect: heartworm]9%3,591 reports
Diarrhoea[diarrhea]7.9%3,153 reports
Lethargy[unusually tired or inactive]5.3%2,109 reports
Ineffective, ascarids NOS[legacy FDA term: the product did not have the expected effect (ascarids nos)]5%2,000 reports
Ineffective, hooks[legacy FDA term: the product did not have the expected effect (hooks)]4.7%1,869 reports
Lack of efficacy - NOS[the product did not have the expected effect]3.4%1,374 reports
Depression[dull, quiet or withdrawn]3.4%1,344 reports
Lack of efficacy (endoparasite) - whipworm[the product did not have the expected effect: whipworms]3.3%1,334 reports
Lack of efficacy (ectoparasite) - flea[the product did not have the expected effect: fleas]3.3%1,309 reports
Anorexia[not eating]3.2%1,294 reports
Pruritus[itching]2.6%1,053 reports

Show the next 16 signs

Emesis[vomiting]2.3%939 reports
Lack of efficacy (endoparasite) - roundworm NOS[the product did not have the expected effect: roundworms]2.2%871 reports
Seizure NOS[seizure, type not specified]2%807 reports
Emesis (multiple)[vomiting more than once]1.8%710 reports
Ataxia[unsteady, uncoordinated movement]1.7%671 reports
Underfilling, Package[a product quality report, not a sign in an animal]1.7%664 reports
Lack of efficacy (endoparasite) - tapeworm[the product did not have the expected effect: tapeworms]1.4%572 reports
Bloody diarrhoea[diarrhea with blood]1.4%547 reports
Product problem[a product quality report, not a sign in an animal]1.3%529 reports
Drug dose omission[a scheduled administration was missed]1.3%512 reports
Overdose[more than the labelled amount was given]1.3%507 reports
Underdose[less than the labelled amount was given]1.2%469 reports
Lack of efficacy (roundworm)[the product did not have the expected effect: roundworms]1.1%456 reports
Death1.1%455 reports
Convulsion[seizure]1.1%451 reports
Other abnormal test result NOS[abnormal laboratory result, type not specified]1.1%445 reports

Download all signs (CSV)

Reports by species

Dog92.2%36,856
Cat2.9%1,149
Human exposure0.3%108
Ferretunder 0.1%3
Otherunder 0.1%3
Goatunder 0.1%2

Reports for each month, Jul 2021 to Jun 2026

Dog6,105 reports. Largest count in one month: 158 (Jul 2021)

Cat2 reports

No chart: no month has 5 or more reports.

Horse0 reports

No chart: no month has 5 or more reports.

Other or not given189 reports. Largest count in one month: 9 (May 2024)

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, by the year in which FDA received them and by species
Year	Dog	Cat	Other or not given	All species
2026	471	1	2	474
2025	1,184	0	27	1,211
2024	1,225	0	37	1,262
2023	1,180	0	52	1,232
2022	1,333	1	46	1,380
2021	1,554	7	52	1,613
2020	2,076	9	133	2,218
2019	2,432	27	142	2,601
2018	2,665	43	136	2,844
2017	3,028	38	131	3,197
2016	3,110	38	127	3,275
2015	2,989	14	131	3,134
2014	2,791	18	132	2,941
2013	1,165	45	69	1,279
2012	963	49	57	1,069
2011	1,143	58	42	1,243
2010	1,074	26	95	1,195
2009	1,155	41	60	1,256
2008	1,051	32	42	1,125
2007	897	36	38	971
2006	674	36	39	749
2005	487	41	24	552
2004	438	40	53	531
2003	168	31	25	224
2002	86	29	79	194
2001	146	30	79	255
2000	278	55	76	409
1999	342	107	50	499
1998	155	115	0	270
1997	91	30	2	123
1996	316	114	2	432
1995	189	38	0	227

2026 has the reports that FDA received through Jun 2026. Download the years (CSV)

What the reports record

Outcome at the time of the report

Recovered/Normal21.1%8,426
Recovered with Sequela[recovered, with a lasting effect]0.4%172
Ongoing18.9%7,556
Died1.6%647
Euthanized0.6%245
Outcome Unknown29.4%11,760

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 39,985 reports that name lufenuron.

Kind of report

Safety issue49.6%19,838
Lack of expected effectiveness36.9%14,747
Both safety and lack of expected effectiveness8.4%3,353
Manufacturing or product defect5.1%2,044
Otherunder 0.1%3

Age of the animal

Under 1 year10.4%4,174
1 to 3 years33.5%13,398
4 to 7 years25.6%10,217
8 to 11 years16%6,387
12 years and over6.2%2,462
Age not given8.4%3,347

Each share of kind and age is of the 39,985 reports that name lufenuron.

Approved animal drugs with this active ingredient (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.

Brand names

Program
Sentinel

What the Green Book records give

Applications with an approval in force: 8
Approved species: Cats, Dogs
Dose forms: Tablet, Liquid (Suspension), Chewable Tablets, Tablet (Chewable)
Routes: Oral, Subcutaneous
Sale: RX (prescription), OTC (over the counter)
Earliest approval date in the records: 23 Nov 1994

The species, dose forms and routes are the words of the Green Book records for all the applications together. One product can have fewer. The label of a product gives its approved use.

Applications in the Green Book of 2 Nov 2026, pioneer applications (NADA) first
Brand name	Active ingredients	Sponsor	Approved species	Application
Program Suspension	Lufenuron	Elanco US Inc.	Cats	NADA 141-026
Program Flavor Tabs	Lufenuron	Elanco US Inc.	Dogs, Cats	NADA 141-035
Program Cat Flavor Tabs	Lufenuron	Elanco US Inc.	Cats	NADA 141-062
Sentinel Flavor Tabs	Lufenuron, Milbemycin Oxime	Intervet, Inc.	Dogs	NADA 141-084
Program 6 Month Injectable for Cats	Lufenuron	Elanco US Inc.	Cats	NADA 141-105
Sentinel Flavor Tabs and Capstar Flea Management System	Lufenuron, Milbemycin Oxime, Nitenpyram	Intervet, Inc.	Dogs	NADA 141-204
Program Flavor Tabs and Capstar Flea Management System	Lufenuron, Nitenpyram	Elanco US Inc.	Dogs, Cats	NADA 141-205
Sentinel Spectrum	Lufenuron, Milbemycin Oxime, Praziquantel	Intervet, Inc.	Dogs	NADA 141-333

FDA pages for this ingredient

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.
Green Book record of NADA 141-035The FDA record of the application for Program Flavor Tabs.
Green Book record of NADA 141-084The FDA record of the application for Sentinel Flavor Tabs.
Green Book record of NADA 141-204The FDA record of the application for Sentinel Flavor Tabs and Capstar Flea Management System.
Green Book record of NADA 141-205The FDA record of the application for Program Flavor Tabs and Capstar Flea Management System.
Green Book record of NADA 141-333The FDA record of the application for Sentinel Spectrum.
Green Book record of NADA 141-026The FDA record of the application for Program Suspension.
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, all combinations: adverse event reports that FDA received. https://petdrugreports.com/ingredient/lufenuron/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of 30 Oct 2026. Reports received through 26 Jun 2026.

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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. Ingredient names follow the Green Book, with salts and forms as FDA lists them.

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 section of this page lists brand names with this active ingredient.
Do the reports show that the ingredient caused the signs?: No. A report can name more than one drug, and a drug can have more than one active ingredient. 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 1,093 reports in the 12 months to June 2026. It received 1,182 reports 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 39,985 reports received from January 1995 to June 2026, 49.6% are about a safety issue only. 45.3% are about a lack of expected effectiveness, alone or with a safety issue. 5.1% are about a defect of the product or its package.