Pet Drug Reports

Lufenuron (Program): adverse event reports that FDA received

Active ingredient

The name in brackets is a brand name with this active ingredient.

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 . The data have the reports that FDA received through .

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

Contacting a veterinarianHow to report to FDA

From January 1995 to June 2026, FDA received 2,371 adverse event reports that name a drug with lufenuron as its active ingredient. Of the 2,371 reports, 1,108 (46.7%) are about cats. 1,018 reports are about dogs (42.9%).

In January to March 2026, FDA received 1 report that names this drug. The signs that appear in the largest number of the 2,371 reports are "Vomiting", "Depression" and "Anorexia". 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 cats are 46.7% of the reports that name this drug, and 11% 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 , changed no count of this page.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 1 report that names lufenuron: 1 dog, 0 cat, 0 horse, 0 other or not given.

All updatesFeed 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 2,371 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.

  1. Vomiting22.2%526 reports
  2. Depression[dull, quiet or withdrawn]17%402 reports
  3. Anorexia[not eating]13.4%318 reports
  4. Diarrhoea[diarrhea]10%238 reports
  5. Pruritus[itching]9.4%223 reports
  6. Fever5.1%120 reports
  7. Death5%118 reports
  8. Injection site mass[mass where the injection was given]4.7%111 reports
  9. Lack of efficacy (ectoparasite) - flea[the product did not have the expected effect: fleas]4.4%104 reports
  10. Injection site swelling[swelling where the injection was given]3.8%89 reports
  11. Alopecia NOS[hair loss, type not specified]3.5%82 reports
  12. Product syringe issue[a product quality report, not a sign in an animal]3.1%73 reports
  13. Convulsion[seizure]3%72 reports
  14. Injection site abscess[abscess where the injection was given]3%71 reports
Show the next 16 signs
  1. Underfilling, Package[a product quality report, not a sign in an animal]3%70 reports
  2. Urticaria[hives]2.9%69 reports
  3. Skin hyperaemia[reddened skin]2.9%68 reports
  4. Weight loss2.7%64 reports
  5. Ataxia[unsteady, uncoordinated movement]2.4%57 reports
  6. Injection site lump[lump where the injection was given]2.2%53 reports
  7. PR-injection site, lesion(s)[legacy FDA term: lesions found in the injection site]2.1%50 reports
  8. Death by euthanasia[the animal was euthanized]2%47 reports
  9. Leucocytosis NOS[high white blood cell count]2%47 reports
  10. Skin lesion NOS[NOS: not otherwise specified]1.9%46 reports
  11. Injection site pain[pain where the injection was given]1.9%44 reports
  12. Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]1.7%41 reports
  13. Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]1.7%41 reports
  14. Dehydration1.7%40 reports
  15. Dyspnoea[difficulty breathing]1.7%40 reports
  16. Lethargy[unusually tired or inactive]1.7%40 reports

The list shows 30 of 609 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

  • Cat46.7%1,108
  • Dog42.9%1,018
  • Human exposure0.5%13
  • Ferret0.1%3
  • Other0.1%2
  • Fishunder 0.1%1

The share is of all 2,371 reports that name lufenuron. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog15 reports

No chart: no month has 5 or more reports.

Cat1 report

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, by the year in which FDA received them and by species
YearDogCatHorseOther or not givenAll species
202620002
202530003
202410001
202340004
202241005
202117008
2020280111
20192250330
20183360746
20177340445
20162340440
20154110823
20141170624
2013154401271
2012254801689
2011245701192
2010272401667
2009303901483
2008303201072
200731340570
200635340574
20055140012103
2004303801381
2003192901563
200262902762
200153001651
2000135402390
199927106013146
19982611500141
1997833002115
199631611402432
19951893800227

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/Normal3.9%93
  • Recovered with Sequela[recovered, with a lasting effect]0.1%2
  • Ongoing4.7%111
  • Died6.7%160
  • Euthanized0.4%9
  • Outcome Unknown5.2%124

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 2,371 reports that name lufenuron.

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

Kind of report

  • Safety issue85.7%2,032
  • Lack of expected effectiveness3.5%83
  • Both safety and lack of expected effectiveness0.5%13
  • Manufacturing or product defect10.2%243
  • Other0%0

347 reports say if the event was serious. 36% 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 year9.3%220
  • 1 to 3 years23.6%560
  • 4 to 7 years22.6%537
  • 8 to 11 years17.6%418
  • 12 years and over11.6%274
  • Age not given15.3%362

Weight of the animal

  • Under 5 kg (11 lb)32.9%779
  • 5 to 9.9 kg (11 to 22 lb)27.3%647
  • 10 to 24.9 kg (22 to 55 lb)13%308
  • 25 to 44.9 kg (55 to 99 lb)9.8%232
  • 45 kg and over (99 lb and over)1.5%35
  • Weight not given15.6%370

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

  • Oral58.8%1,395
  • Subcutaneous26.1%618
  • Parenteral2.5%60
  • Topical0.3%6
  • Intramuscular0.2%5
  • Intradermal0.1%2

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

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

What the Green Book records give

Applications with an approval in force
4
Approved species
Cats, Dogs
Dose forms
Liquid (Suspension), Tablet, Tablet (Chewable)
Routes
Oral, Subcutaneous
Sale
OTC (over the counter), RX (prescription)
Earliest approval date in the records

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 nameActive ingredientsSponsorApproved speciesApplication
Program SuspensionLufenuronElanco US Inc.CatsNADA 141-026
Program Flavor TabsLufenuronElanco US Inc.Dogs, CatsNADA 141-035
Program Cat Flavor TabsLufenuronElanco US Inc.CatsNADA 141-062
Program 6 Month Injectable for CatsLufenuronElanco US Inc.CatsNADA 141-105

Other pages with this ingredient

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

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

Cite this page

Pet Drug Reports. Lufenuron: adverse event reports that FDA received. https://petdrugreports.com/drug/lufenuron/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of . Reports received through .

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 section of this page lists the brand names with this active ingredient.

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 3 reports in the 12 months to June 2026. It received 2 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 2,371 reports received from January 1995 to June 2026, 85.7% are about a safety issue only. 4% are about a lack of expected effectiveness, alone or with a safety issue. 10.2% are about a defect of the product or its package.