Pet Drug Reports

Lufenuron + Milbemycin Oxime (Sentinel Flavor Tabs): adverse event reports that FDA received

Combination of 2 active ingredients

The name in brackets is a brand name with 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 . 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 July 1997 to June 2026, FDA received 27,608 adverse event reports that name a drug with lufenuron and milbemycin oxime as its active ingredients. Of the 27,608 reports, 26,274 (95.2%) are about dogs.

In January to March 2026, FDA received 75 reports that name this drug. The signs that appear in the largest number of the 27,608 reports are "Ineffective, heartworm larvae" and "Vomiting". A report is not proof that a drug caused a sign.

Reports that name this drug fell by 19.1% 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 95.2% of the reports that name this drug, and 72.6% of all reports.

Since the last update of the FDA data

The site recorded an update of the FDA data on . FDA changed these counts for January to March 2026:

  • All species: from 68 to 75.
  • Dog: from 68 to 73.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 75 reports that name lufenuron + milbemycin oxime: 73 dog, 0 cat, 0 horse, 2 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 27,608 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. Ineffective, heartworm larvae[legacy FDA term: the product did not have the expected effect (heartworm larvae)]18.8%5,187 reports
  2. Vomiting13.2%3,649 reports
  3. Lack of efficacy (endoparasite) - hookworm[the product did not have the expected effect: hookworms]11.1%3,056 reports
  4. Diarrhoea[diarrhea]8.1%2,243 reports
  5. Lack of efficacy (endoparasite) - heartworm[the product did not have the expected effect: heartworm]7.2%1,994 reports
  6. Ineffective, ascarids NOS[legacy FDA term: the product did not have the expected effect (ascarids nos)]6.2%1,713 reports
  7. Lethargy[unusually tired or inactive]5.3%1,450 reports
  8. Lack of efficacy - NOS[the product did not have the expected effect]4.4%1,225 reports
  9. Ineffective, hooks[legacy FDA term: the product did not have the expected effect (hooks)]4.3%1,174 reports
  10. Lack of efficacy (endoparasite) - whipworm[the product did not have the expected effect: whipworms]3.8%1,058 reports
  11. Depression[dull, quiet or withdrawn]3.3%911 reports
  12. Anorexia[not eating]3%841 reports
  13. Lack of efficacy (ectoparasite) - flea[the product did not have the expected effect: fleas]2.9%806 reports
  14. Emesis[vomiting]2.8%773 reports
Show the next 16 signs
  1. Pruritus[itching]2.8%760 reports
  2. Seizure NOS[seizure, type not specified]2%547 reports
  3. Underfilling, Package[a product quality report, not a sign in an animal]2%546 reports
  4. Ataxia[unsteady, uncoordinated movement]1.7%465 reports
  5. Lack of efficacy (endoparasite) - roundworm NOS[the product did not have the expected effect: roundworms]1.5%417 reports
  6. Emesis (multiple)[vomiting more than once]1.5%404 reports
  7. Bloody diarrhoea[diarrhea with blood]1.4%393 reports
  8. Convulsion[seizure]1.3%368 reports
  9. Overdose[more than the labelled amount was given]1.3%356 reports
  10. Other abnormal test result NOS[abnormal laboratory result, type not specified]1.3%350 reports
  11. Underdose[less than the labelled amount was given]1.2%332 reports
  12. Lack of efficacy (protozoa) - Coccidia[the product did not have the expected effect: coccidia]1.2%329 reports
  13. Product problem[a product quality report, not a sign in an animal]1.2%325 reports
  14. Loose stool1.1%317 reports
  15. Accidental exposure[exposure that was not intended]1.1%316 reports
  16. Lack of efficacy (roundworm)[the product did not have the expected effect: roundworms]1.1%300 reports

The list shows 30 of 1,429 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

  • Dog95.2%26,274
  • Human exposure0.3%90
  • Cat0.1%38
  • Goatunder 0.1%2
  • Wolfunder 0.1%2
  • Otherunder 0.1%1

The share is of all 27,608 reports that name lufenuron + milbemycin oxime. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog2,639 reports. Largest count in one month: 80 (Jul 2021)
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 given94 reports. Largest count in one month: 6 (Oct 2022)

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 + milbemycin oxime, by the year in which FDA received them and by species
YearDogCatHorseOther or not givenAll species
2026143002145
20254400010450
20244710019490
20235030022525
20226770026703
20218930034927
20201,261101101,372
20191,54220691,613
20181,73160721,809
20172,06230672,132
20162,16340632,230
20152,22230732,298
20142,337101102,448
20131,14710571,205
20129351040976
20111,11810311,150
20101,04720791,128
20091,12520461,173
20081,02100321,053
20078662033901
20066392034675
20054361012449
20044082040450
20031492010161
2002800052132
20011410063204
20002651053319
19993151037353
1998129000129
199780008

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/Normal20.4%5,636
  • Recovered with Sequela[recovered, with a lasting effect]0.4%124
  • Ongoing15.8%4,371
  • Died1.5%416
  • Euthanized0.6%169
  • Outcome Unknown29%8,015

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 27,608 reports that name lufenuron + milbemycin oxime.

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

Kind of report

  • Safety issue52.7%14,540
  • Lack of expected effectiveness35.5%9,799
  • Both safety and lack of expected effectiveness7%1,924
  • Manufacturing or product defect4.9%1,344
  • Otherunder 0.1%1

18,461 reports say if the event was serious. 33.7% 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 year9.8%2,692
  • 1 to 3 years34.1%9,424
  • 4 to 7 years26.2%7,225
  • 8 to 11 years16.1%4,455
  • 12 years and over5.9%1,630
  • Age not given7.9%2,182

Weight of the animal

  • Under 5 kg (11 lb)10.2%2,804
  • 5 to 9.9 kg (11 to 22 lb)17%4,688
  • 10 to 24.9 kg (22 to 55 lb)30.4%8,405
  • 25 to 44.9 kg (55 to 99 lb)31.1%8,585
  • 45 kg and over (99 lb and over)3.1%856
  • Weight not given8.2%2,270

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

  • Oral93.3%25,759
  • Topical0.1%22
  • Intrauterineunder 0.1%2
  • Ophthalmicunder 0.1%2
  • Otherunder 0.1%2
  • Buccalunder 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.

Brand names

  • Sentinel Flavor Tabs

What the Green Book records give

Applications with an approval in force
1
Approved species
Dogs
Dose forms
Tablet
Routes
Oral
Sale
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
Sentinel Flavor TabsLufenuron, Milbemycin OximeIntervet, Inc.DogsNADA 141-084

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

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

Cite this page

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

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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. 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 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 360 reports in the 12 months to June 2026. It received 445 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 27,608 reports received from July 1997 to June 2026, 52.7% are about a safety issue only. 42.5% are about a lack of expected effectiveness, alone or with a safety issue. 4.9% are about a defect of the product or its package.