Pet Drug Reports

Milbemycin Oxime: adverse event reports in all combinations

Active ingredient, alone and in combinations

Brand names with this ingredient: Interceptor, Sentinel, Trifexis, MilbeGuard, Milbemite.

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

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

From August 1990 to June 2026, FDA received 237,768 adverse event reports that name a drug with milbemycin oxime, alone or in a combination. 6 sets of active ingredients with milbemycin oxime have a drug page.

Of the 237,768 reports, 220,330 (92.7%) are about dogs. In January to March 2026, FDA received 983 reports that name milbemycin oxime, alone or in a combination. The signs that appear in the largest number of the 237,768 reports are "Vomiting", "Emesis" and "Lethargy". A report is not proof that a drug caused a sign.

Reports that name this ingredient fell by 19.4% 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 92.7% of the reports that name this ingredient, and 72.6% of all reports.

Reports in the latest closed quarter

Reports that name milbemycin oxime, by the quarter in which FDA received them
SpeciesJan to Mar 2026Oct to Dec 2025Jan to Mar 2025
All species9831,0681,075
Dog9441,019986
Cat437
Horse000
Other or not given354682

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

All updatesFeed of updates (RSS)

Drug pages with milbemycin oxime

A report names a drug by its set of active ingredients. Each set with milbemycin oxime that has a drug page is in the table, in order of name. The table has 6 sets.

Drug pages with milbemycin oxime, in order of name, with the reports of each page
Active ingredientsReports, all yearsReports, latest 12 months
Afoxolaner + Milbemycin Oxime366
Lufenuron + Milbemycin Oxime27,608360
Lufenuron + Milbemycin Oxime + Praziquantel6,893747
Milbemycin Oxime32,619383
Milbemycin Oxime + Praziquantel33,6722,240
Milbemycin Oxime + Spinosad140,813659

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 237,768 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.

  1. Vomiting19.5%46,468 reports
  2. Emesis[vomiting]18.1%43,057 reports
  3. Lethargy[unusually tired or inactive]9.9%23,428 reports
  4. Ineffective, heartworm larvae[legacy FDA term: the product did not have the expected effect (heartworm larvae)]9.3%22,060 reports
  5. Lack of efficacy (endoparasite) - heartworm[the product did not have the expected effect: heartworm]7%16,759 reports
  6. Diarrhoea[diarrhea]6%14,159 reports
  7. Unpalatable[legacy FDA term: the animal would not take it]5.9%14,002 reports
  8. Lack of efficacy - NOS[the product did not have the expected effect]5.5%13,099 reports
  9. Lack of efficacy (endoparasite) - hookworm[the product did not have the expected effect: hookworms]4.8%11,425 reports
  10. Lack of efficacy (ectoparasite) - flea[the product did not have the expected effect: fleas]3.6%8,483 reports
  11. Seizure NOS[seizure, type not specified]2.5%6,044 reports
  12. Ineffective, ascarids NOS[legacy FDA term: the product did not have the expected effect (ascarids nos)]2.2%5,225 reports
  13. Behavioural disorder NOS[behaviour change, type not specified]2.1%5,098 reports
  14. Ineffective, hooks[legacy FDA term: the product did not have the expected effect (hooks)]2.1%4,974 reports
Show the next 16 signs
  1. Anorexia[not eating]2.1%4,943 reports
  2. Other abnormal test result NOS[abnormal laboratory result, type not specified]2%4,762 reports
  3. Lack of efficacy (endoparasite) - whipworm[the product did not have the expected effect: whipworms]1.8%4,317 reports
  4. Ataxia[unsteady, uncoordinated movement]1.8%4,285 reports
  5. Depression[dull, quiet or withdrawn]1.7%4,069 reports
  6. Not eating1.6%3,712 reports
  7. Emesis (multiple)[vomiting more than once]1.5%3,646 reports
  8. Shaking1.4%3,445 reports
  9. Death1.4%3,412 reports
  10. Weight gain1.4%3,315 reports
  11. Product problem[a product quality report, not a sign in an animal]1.3%3,208 reports
  12. Pruritus[itching]1.3%3,202 reports
  13. Weight loss1.3%3,069 reports
  14. Decreased appetite1.2%2,916 reports
  15. Overdose[more than the labelled amount was given]1.2%2,891 reports
  16. Itching1.2%2,809 reports

Download all signs (CSV)

Reports by species

  • Dog92.7%220,330
  • Cat0.3%759
  • Human exposure0.2%491
  • Otherunder 0.1%64
  • Other Canidsunder 0.1%10
  • Rabbitunder 0.1%4

Reports for each month, Jul 2021 to Jun 2026

Dog27,119 reports. Largest count in one month: 757 (Jul 2021)
Cat91 reports. Largest count in one month: 5 (Oct 2024)
Horse0 reports

No chart: no month has 5 or more reports.

Other or not given1,506 reports. Largest count in one month: 72 (Jul 2021)

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 milbemycin oxime, by the year in which FDA received them and by species
YearDogCatHorseOther or not givenAll species
20261,824120611,897
20254,6382002924,950
20245,5841902545,857
20235,3621902935,674
20226,1301503556,500
20218,1332005748,727
202011,14041085912,040
201912,87926075113,656
201813,5474201,08514,674
201714,0934301,17315,309
201614,9548301,11916,156
201517,5115301,61219,176
201420,2753502,04722,357
201324,5906402,21826,872
201223,7876401,67025,521
201111,14132049311,666
20103,9521902184,189
20094,4581601714,645
20084,1021101534,266
20073,5122301773,712
20062,6422201422,806
20051,8922101252,038
20041,3362101901,547
200348210058550
2002245110133389
200135210208561
200058180149738
19996652099766
1998199300202
19975710058
19966310064
19952610027
19941600016
19932900029
19923800038
19916800068
19902700027

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/Normal38.6%91,729
  • Recovered with Sequela[recovered, with a lasting effect]2.9%6,965
  • Ongoing8.9%21,115
  • Died1.8%4,185
  • Euthanized0.8%1,924
  • Outcome Unknown26.8%63,785

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 237,768 reports that name milbemycin oxime.

Kind of report

  • Safety issue65%154,635
  • Lack of expected effectiveness19%45,134
  • Both safety and lack of expected effectiveness5.5%13,061
  • Manufacturing or product defect10.5%24,862
  • Otherunder 0.1%76

Age of the animal

  • Under 1 year13.6%32,223
  • 1 to 3 years34%80,796
  • 4 to 7 years23.4%55,583
  • 8 to 11 years12.7%30,206
  • 12 years and over4.9%11,626
  • Age not given11.5%27,334

Each share of kind and age is of the 237,768 reports that name milbemycin oxime.

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

  • Interceptor
  • Sentinel
  • Trifexis
  • MilbeGuard
  • Milbemite

What the Green Book records give

Applications with an approval in force
8
Approved species
Dogs, Cats
Dose forms
Chewable Tablets, Tablet, Flavored Tablets, Liquid (Solution)
Routes
Oral, Topical
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
InterceptorMilbemycin OximeElanco US Inc.Dogs, CatsNADA 140-915
Sentinel Flavor TabsLufenuron, Milbemycin OximeIntervet, Inc.DogsNADA 141-084
Milbemite Otic SolutionMilbemycin OximeElanco US Inc.CatsNADA 141-163
Sentinel Flavor Tabs and Capstar Flea Management SystemLufenuron, Milbemycin Oxime, NitenpyramIntervet, Inc.DogsNADA 141-204
TrifexisMilbemycin Oxime, SpinosadElanco US Inc.DogsNADA 141-321
Sentinel SpectrumLufenuron, Milbemycin Oxime, PraziquantelIntervet, Inc.DogsNADA 141-333
Interceptor PlusMilbemycin Oxime, PraziquantelElanco US Inc.DogsNADA 141-338
MilbeGuardMilbemycin OximeCeva Sante AnimaleDogs, CatsANADA 200-629

FDA pages for this ingredient

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

Cite this page

Pet Drug Reports. Milbemycin Oxime, all combinations: adverse event reports that FDA received. https://petdrugreports.com/ingredient/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. 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 4,308 reports in the 12 months to June 2026. It received 5,348 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 237,768 reports received from August 1990 to June 2026, 65% are about a safety issue only. 24.5% are about a lack of expected effectiveness, alone or with a safety issue. 10.5% are about a defect of the product or its package.