Roxee Meds Catalog

Milbemycin Oxime

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

Both Catalog complete FDA data linked Rx required Tablet Multiple FDA sponsors Official label facts Owner quick guide first

Start Symptom Intake Talk to a Vet / Find a Vet Near You

Veterinary professional?

Showing simplified owner view. Switch to Vet View for full technical detail.

Data freshness

Storefront facts

Catalog refreshed

May 5, 2026, 10:00 a.m.

These are the storefront facts Roxee uses on browse cards and quick facts.

FDA applications

FDA application data refreshed

May 5, 2026, 10:00 a.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports

Safety data refreshed

May 5, 2026, 10:01 a.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details

Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
The storefront fact projection used for browse cards and quick facts.
Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
Applications/products are imported from FDA export data.
Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: February 12, 2026

Updated: February 12, 2026, 10:44 PM UTC

Sources:

FDA application profile · official_label
FDA application profile · official_label
Medication usage source · fda_animal_drugs
Milbemite™ Otic Solution · official_label
openFDA case USA-USFDACVM-2025-US-052101 · adverse_reaction

Image coming soon

Milbemycin Oxime

Drug type: Generic ingredient • Generic profile • No FDA branded products linked

Both Tablet Rx required 100% storefront ready

Species: Both

Manufacturer: Multiple FDA sponsors

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Milbemycin Oxime

For prevention of heartworm disease caused by Dirofilaria immitis and the removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm) infections. For prevention of heartworm disease caused by Dirofilaria immitis . For control of hookworm infections caused by Ancylostoma caninum , and removal and control of adult roundworm infections caused by Toxocara canis and Toxascaris leonine and whipworm infections caused by Trichuris vulpis . For use in dogs and puppies for the prevention of heartworm disease caused by Dirofilaria immitis , for prevention and control of flea populations, control of adult Ancylostoma caninum (hookworm), and removal and control of adult Toxocara canis , Toxascaris leonine (roundworm), and Trichuris vulpis (whipworm) infections. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas. The concurrent use of flavored milbemycin oxime and lufenuron tablets is indicated to kill adult fleas and prevent flea eggs from hatching. Species commonly shown: Both, Dog, Excluding Under 2 Pounds, Dogs and puppies, excluding puppies under 4 weeks age.

Generic name

Milbemycin Oxime

Brand names

Interceptor™, Milbemite™ Otic Solution, MilbeGuard™

Manufacturer

Multiple FDA sponsors

Species

Both, Dog, Excluding Under 2 Pounds, Dogs and puppies, excluding puppies under 4 weeks age, Cat And Kitten, Excluding Under 1.5 Pounds Weight

Dosage forms

Tablet, Liquid (Solution), Flavored Tablets

Prescription

Prescription required

Completeness

100%

Validation

Complete

Brand names

Interceptor™ Milbemite™ Otic Solution MilbeGuard™

Dosage forms

Tablet Liquid (Solution) Flavored Tablets

Indications / Uses

Warnings / Contraindications

Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restricts this drug to use by or on the order of a licensed veterinarian.Safety in heartworm-positive cats has not been established. Safety in breeding, pregnant, and lactating queens and breeding toms has not been established. Do not use in puppies less than 4 weeks of age and less than 2 pounds of body weight. Administer once a month. First dose given within 1 month after first exposure to mosquitoes and continue regular use until at least 1 month after end of mosquito season. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Prior to initiation of the INTERCEPTOR treatment program, dogs should be tested for existing heartworm infections. Infected dogs should be treated to remove adult heartworms and microfilariae prior to initiating treatment with INTERCEPTOR. Mild, transient hypersensitivity reactions manifested as labored respiration, vomiting, salivation and lethargy, have been noted in some treated dogs carrying a high number of circulating microfilariae. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each time. All dogs in a household should be treated to achieve maximum efficacy. Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal..

Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restricts this drug to use by or on the order of a licensed veterinarian.Safety in heartworm-positive cats has not been established. Safety in breeding, pregnant, and lactating queens and breeding toms has not been established. Do not use in puppies less than 4 weeks of age and less than 2 pounds of body weight. Administer once a month. First dose given within 1 month after first exposure to mosquitoes and continue regular use until at least 1 month after end of mosquito season. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Prior to initiation of the INTERCEPTOR treatment program, dogs should be tested for existing heartworm infections. Infected dogs should be treated to remove adult heartworms and microfilariae prior to initiating treatment with INTERCEPTOR. Mild, transient hypersensitivity reactions manifested as labored respiration, vomiting, salivation and lethargy, have been noted in some treated dogs carrying a high number of circulating microfilariae. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each time. All dogs in a household should be treated to achieve maximum efficacy. Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal..

Side Effects

Top reported reactions (openFDA): Vomiting, Lack of efficacy (endoparasite) - heartworm, Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea, INEFFECTIVE, HOOKS, Lack of efficacy (endoparasite) - hookworm.

FAQ

Both, Dog, Excluding Under 2 Pounds, Dogs and puppies, excluding puppies under 4 weeks age, Cat And Kitten, Excluding Under 1.5 Pounds Weight, Cats and kittens, excluding kittens under 6 weeks age, Cat And Kitten, Excluding Under 4 Weeks Of Age, Dog, No Use Class Stated Or Implied, Cat, No Use Class Stated Or Implied

Yes. Roxee shows this as prescription-only.

Tablet, Liquid (Solution), Flavored Tablets

Related Medications

Related Conditions

Heartworm Disease Pica Fleas (Flea Infestation)

Source Transparency

Verified source: https://www.roxee.ai/meds/
Verified source: https://animaldrugsatfda.fda.gov
Verified source: https://api.fda.gov/animalandveterinary/event.json
Verified source: https://www.roxee.ai/conditions/
Verified source: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/722
Verified source: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/618
Last refreshed: May 5, 2026, 10:00 a.m.
Last verified: Feb 12, 2026, 10:44 p.m.
Validation status: Complete

Add to My Pet's Meds

Choose a pet, confirm current or past, and optionally add reminder notes.

Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

For use in the prevention of heartworm disease caused by Dirofilaria immitis , the control of adult Ancylostoma caninum (hookworm), and the removal and control of adult Toxocara canis and Toxascaris leonina (roundworms)...

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight
Administer once a month
Safety in breeding, pregnant, and lactating queens and breeding toms has not been established
Do not use in puppies less than 4 weeks of age and less than 2 pounds of body weight
First dose given within 1 month after first exposure to mosquitoes and continue regular use until at least 1 month after end of mosquito season
Prior to initiation of the INTERCEPTOR treatment program, dogs should be tested for existing heartworm infections
Infected dogs should be treated to remove adult heartworms and microfilariae prior to initiating treatment with INTERCEPTOR
Mild, transient hypersensitivity reactions manifested as labored respiration, vomiting, salivation and lethargy, have been noted in some treated dogs carrying a high number of circulating microfilariae
Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian
Administer tablets once a month, preferably on the same date each time
All dogs in a household should be treated to achieve maximum efficacy
Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal
Unclassifiable adverse event (1 reports)
Thrombocytopenia (1 reports)
Star-gazing (1 reports)

When to call the vet:

Repeated vomiting or diarrhea.
Severe lethargy (hard to wake, very low energy).
Collapse or fainting.
Trouble breathing.
Facial swelling or hives.
Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

What to tell or ask your vet today:

Is this medicine the right fit for my pet’s current symptoms?
Which warning signs mean I should call back right away?
How should I handle missed doses or refusal to take the medicine?

Major cautions & emergency warning signs

Side effects to monitor:

Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight
Administer once a month
Safety in breeding, pregnant, and lactating queens and breeding toms has not been established
Do not use in puppies less than 4 weeks of age and less than 2 pounds of body weight
First dose given within 1 month after first exposure to mosquitoes and continue regular use until at least 1 month after end of mosquito season

Most reported reactions:

Unclassifiable adverse event (1 reports)
Thrombocytopenia (1 reports)
Star-gazing (1 reports)

Emergency warning signs:

Repeated vomiting or diarrhea.
Severe lethargy (hard to wake, very low energy).
Collapse or fainting.
Trouble breathing.

Talk to a Vet / Find a Vet Near You Start Symptom Intake

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both

Manufacturer: Multiple FDA sponsors

Form: Flavored Tablets, Liquid (Solution), Tablet

Identifiers:

ANADA: 200629 NADA: 140915 NADA: 141084 NADA: 141163 NADA: 141204 NADA: 141321 NADA: 141333 NADA: 141338 NDC Package: 0061-5350-01 NDC Package: 0061-5350-02 NDC Package: 0061-5351-01 NDC Package: 0061-5351-02 NDC Package: 0061-5352-01 NDC Package: 0061-5352-02 NDC Package: 0061-5353-01 NDC Package: 0061-5353-02 NDC Package: 0061-5354-01 NDC Package: 0061-5354-02 NDC Package: 0061-5355-01 NDC Package: 0061-5355-02

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200629 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/140915 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source

Warnings / Contraindications

High: Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restricts this drug to use by or on the order of a licensed veterinarian.Safety in heartworm-positive cats has not been established. Safety in breeding, pregnant, and lactating queens and breeding toms has not been established. Do not use in puppies less than 4 weeks of age and less than 2 pounds of body weight. Administer once a month. First dose given within 1 month after first exposure to mosquitoes and continue regular use until at least 1 month after end of mosquito season. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Prior to initiation of the INTERCEPTOR treatment program, dogs should be tested for existing heartworm infections. Infected dogs should be treated to remove adult heartworms and microfilariae prior to initiating treatment with INTERCEPTOR. Mild, transient hypersensitivity reactions manifested as labored respiration, vomiting, salivation and lethargy, have been noted in some treated dogs carrying a high number of circulating microfilariae. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each time. All dogs in a household should be treated to achieve maximum efficacy. Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal..

Source metadata:

https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Tap or hover a reaction to see what it means in plain language.

Tracked signals

Reported cases

Serious reports

Species represented

Grouped by Body System

Digestive (3) · Vomiting, Drooling, Diarrhea Neurologic (3) · Unsteady walking (ataxia), Tiredness (lethargy), Muscle tremor Effectiveness (5) · Lack of efficacy (endoparasite) - whipworm, Lack of efficacy (endoparasite) - tapeworm, Lack of efficacy (endoparasite) - roundworm NOS Other (21) · Unclassifiable adverse event, Thrombocytopenia, Stiffness limb

Most Reported Reactions

Body system	Cases	Species	Serious cases
Other	1	Dog	1
Other	1	Dog	1
Other	1	Cat	1
Other	1	Dog	1
Other	1	Cat	1
Other	1	Cat	1
Neurologic	1	Cat	1
Other	1	Cat	1

Species coverage: Dog (17) Cat (15)

View detailed reaction table

Body system	Species	Seriousness	Frequency	Reports
Digestive	Cat	Non-serious	-	1
Neurologic	Dog	Non-serious	-	1
Other	Dog	Serious	-	1
Neurologic	Dog	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Non-serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Non-serious	-	1
Other	Cat	Non-serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Non-serious	-	1
Other	Cat	Serious	-	1
Neurologic	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Effectiveness	Dog	Non-serious	-	1
Effectiveness	Dog	Serious	-	1
Effectiveness	Dog	Non-serious	-	1
Effectiveness	Dog	Non-serious	-	1
Effectiveness	Cat	Non-serious	-	1
Other	Dog	Non-serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Serious	-	1
Digestive	Cat	Non-serious	-	1
Other	Cat	Serious	-	1
Digestive	Dog	Non-serious	-	1
Other	Dog	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Cat	Non-serious	-	1
Other	Cat	Serious	-	1

Source metadata:

https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-052101

Documents

Owner handouts and official technical documents open on-page first, with the original source still one click away.

Owner handouts

No owner handouts linked yet.

Official label / PI

SPL

FOI

TRIFEXIS N141321C0060.pdf

Official label / PI · Official label

Open original

MilbeGuard™

SPL · SPL

Open original

FDA Structured Product Label

MilbeGuard™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Ceva Sante Animale
ANADA: 200-629
Status: RX
Form: Flavored Tablets
Route: Oral
Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied

Composition / specifications

2.3 mg, 5.75 mg, 11.5 mg, or 23.0 mg milbemycin oxime per tablet

Dogs

Indication

For use in the prevention of heartworm disease caused by Dirofilaria immitis, the control of adult Ancylostoma caninum(hookworm), and the removal and control of adult Toxocara canis and Toxascaris leonina (roundworms) and Trichuris vulpis (whipworm) infections in dogs and in puppies four weeks of age or greater and two pounds body weight or greater.

Dosage

MilbeGuard™ Flavored Tablets are given orally, once a month, at the recommended minimum dosage rate of 0.23 mg milbemycin oxime per pound of body weight (0.5 mg/kg).

Cats

Indication

For use in the prevention of heartworm disease caused by Dirofilaria immitis, and the removal of adult Ancylostoma tubaeforme (hookworm) and Toxocara cati (roundworm) in cats and kittens six weeks of age or greater and 1.5 lbs. body weight or greater.

Dosage

MilbeGuard™ Flavored Tablets are given orally, once a month, at the recommended minimum dosage rate of 0.9 mg milbemycin oxime per pound of body weight (2.0 mg/kg).

Interceptor™

SPL · SPL

Open original

FDA Structured Product Label

Interceptor™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Elanco US Inc.
NADA: 140-915
Status: RX
Form: Tablet
Route: Oral
Species: Dog, Excluding Under 2 Pounds • Dogs and puppies, excluding puppies under 4 weeks age • Cat And Kitten, Excluding Under 1.5 Pounds Weight • Cats and kittens, excluding kittens under 6 weeks age

Composition / specifications

Each tablet contains 2.3, 5.75, 11.5, or 23.0 milligrams of milbemycin oxime.

Cats and Kittens (6 Weeks of Age or Greater and 1.5 Lbs. Body Weight or Greater)

Indication

For prevention of heartworm disease caused by Dirofilaria immitis and the removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm) infections.

Dosage

INTERCEPTOR for Cats is given orally, once a month, at the recommended minimum dosage rate of 0.9 mg milbemycin oxime per pound of body weight (2.0 mg/kg).

Limitations

Dogs and Puppies (4 Weeks of Age and Older and 2 Pounds of Body Weight and Greater)

Indication

For prevention of heartworm disease caused by Dirofilaria immitis. For control of hookworm infections caused by Ancylostoma caninum, and removal and control of adult roundworm infections caused by Toxocara canis and Toxascaris leonine and whipworm infections caused by Trichuris vulpis.

Dosage

INTERCEPTOR is given orally, once a month, at the recommended minimum dosage rate of 0.23 mg milbemycin oxime per pound of body weight (0.5 mg/kg).

Limitations

Do not use in puppies less than 4 weeks of age and less than 2 pounds of body weight. Administer once a month. First dose given within 1 month after first exposure to mosquitoes and continue regular use until at least 1 month after end of mosquito season. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Prior to initiation of the INTERCEPTOR treatment program, dogs should be tested for existing heartworm infections. Infected dogs should be treated to remove adult heartworms and microfilariae prior to initiating treatment with INTERCEPTOR. Mild, transient hypersensitivity reactions manifested as labored respiration, vomiting, salivation and lethargy, have been noted in some treated dogs carrying a high number of circulating microfilariae.

Milbemite™ Otic Solution

SPL · SPL

Open original

FDA Structured Product Label

Milbemite™ Otic Solution

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Elanco US Inc.
NADA: 141-163
Status: RX
Form: Liquid (Solution)
Route: Topical
Species: Cat And Kitten, Excluding Under 4 Weeks Of Age

Composition / specifications

Each tube contains 0.25 milliliter of a 0.1 percent solution of milbemycin oxime.

Cats and Kittens (4 Weeks of Age and Older)

Indication

FOI · FOI summary

Open original

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/6607 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/6669/MilbeGuard%E2%84%A2 · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1996 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/530 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/2001 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/529 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/2007 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/528 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1373/Interceptor%E2%84%A2 · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/535 · document · FOI

Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness

Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
The storefront fact projection used for browse cards and quick facts.
Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
Applications/products are imported from FDA export data.
Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC

Official (FDA)

Identity: Generic ingredient • No FDA branded products linked

No official FDA brand rows linked yet for this ingredient.

Case-reported brands (openFDA): MSK

Catalog species: Both • FDA-labeled species: Cat, Cat And Kitten, Cats and kittens, Dog, Dogs and puppies

Rx/OTC: RX

Form/route: Flavored Tablets, Liquid (Solution), Tablet • Oral, Topical

Applications: ANADA 200-629 • NADA 140-915 • NADA 141-163

Documents: 9 (FOI: 9) • SPL: 3 • Label highlights • Official documents

Safety (openFDA)

Top reactions: Dog 14 • Cat 5 • View

Case summaries: 6 (showing 6) • View

openFDA reports are unverified and do not prove causation.

Explore

Related conditions: Heartworm Disease Pica Fleas (Flea Infestation)

Linked using: Fda_Label (0.95), Fda_Label (0.95), Usage_Inferred (0.78)

Diagnosis Codes

ICD10_CM: B74.8 ICD10_CM: B88.1

Other filariases

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points

Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restricts this drug to use by or on the order of a licensed veterinarian.Safety in heartworm-positive cats has not been established. Safety in breeding, pregnant, and lactating queens and breeding toms has not been established. Do not use in puppies less than 4 weeks of age and less than 2 pounds of body weight. Administer once a month. First dose given within 1 month after first exposure to mosquitoes and continue regular use until at least 1 month after end of mosquito season. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Prior to initiation of the INTERCEPTOR treatment program, dogs should be tested for existing heartworm infections. Infected dogs should be treated to remove adult heartworms and microfilariae prior to initiating treatment with INTERCEPTOR. Mild, transient hypersensitivity reactions manifested as labored respiration, vomiting, salivation and lethargy, have been noted in some treated dogs carrying a high number of circulating microfilariae. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each time. All dogs in a household should be treated to achieve maximum efficacy. Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal.. (Contraindication, High)

Top reaction signals

Unclassifiable adverse event (1) Thrombocytopenia (1) Star-gazing (1) Respiratory tract infection NOS (1) Open mouth breathing (1) Musculoskeletal disorder NOS (1) Muscle tremor (1) Medication error NOS (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers

Package NDC	Product NDC	Status
0061-5350-01	0061	-
0061-5350-02	0061	-
0061-5351-01	0061	-
0061-5351-02	0061	-
0061-5352-01	0061	-
0061-5352-02	0061	-
0061-5353-01	0061	-
0061-5353-02	0061	-
0061-5354-01	0061	-
0061-5354-02	0061	-
0061-5355-01	0061	-
0061-5355-02	0061	-
0061-5356-01	0061	-
0061-5356-02	0061	-
0061-5357-01	0061	-
0061-5357-02	0061	-
13744-510-10	13744	-
13744-511-10	13744	-
13744-512-10	13744	-
13744-513-10	13744	-

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

TRIFEXIS N141321C0060.pdf • Official label • Official • May 17, 2021
FDA official labeling for application 141321
UCM252248.pdf • FOI summary • Official • May 17, 2021
FDA FOI summary for application 141321
UCM292003.pdf • FOI summary • Official • Aug. 3, 2020
FDA FOI summary for application 141333
FOI Summary sN-141-333 Approved September 28, 2017.pdf • FOI summary • Official • Aug. 3, 2020
FDA FOI summary for application 141333
ucm117654.pdf • FOI summary • Official • Aug. 3, 2020
FDA FOI summary for application 141204
N141084_Orig_4_10_1997.pdf • FOI summary • Official • Aug. 3, 2020
FDA FOI summary for application 141084
N141084_Supp_6_17_1998.pdf • FOI summary • Official • Aug. 3, 2020
FDA FOI summary for application 141084
ucm117024.pdf • FOI summary • Official • Aug. 3, 2020
FDA FOI summary for application 141084
FOI Summary oA 200-629 Approved December 19, 2018.pdf • FOI summary • Official • Jan. 7, 2019
FDA FOI summary for application 200629
UCM318617.pdf • FOI summary • Official • Jan. 10, 2018
FDA FOI summary for application 141338
FOI Summary sN 141-338 Approved June 21, 2017.pdf • FOI summary • Official • Jan. 10, 2018
FDA FOI summary for application 141338
UCM478241.pdf • FOI summary • Official • Aug. 3, 2017
FDA FOI summary for application 140915
N140915_Supp_12_29_1992.pdf • FOI summary • Official • Aug. 3, 2017
FDA FOI summary for application 140915
UCM454279.pdf • FOI summary • Official • Aug. 3, 2017
FDA FOI summary for application 140915
N140915 Supp_9_9_1996.pdf • FOI summary • Official • Aug. 3, 2017
FDA FOI summary for application 140915
ucm115749.pdf • FOI summary • Official • Aug. 3, 2017
FDA FOI summary for application 140915
N140915 Supp_6_4_1998.pdf • FOI summary • Official • Aug. 3, 2017
FDA FOI summary for application 140915
ucm117236.pdf • FOI summary • Official • June 1, 2016
FDA FOI summary for application 141163
ucm117228.pdf • FOI summary • Official • June 1, 2016
FDA FOI summary for application 141163

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 36 Clinical 1 Manufacturer 0 Marketing 0

Current Field Facts

side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (endoparasite) - heartworm, Lethargy (see also Central nervous system depression in 'Neurological'… (Clinical, 2026-04-11)
contraindications: Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restricts this drug to use by or on the order of… (Official, 2026-04-12)
contraindications: Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restricts this drug to use by or on the order of… (Official, 2026-04-11)
contraindications: Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restricts this drug to use by or on the order of… (Official, 2026-02-12)
indications: For use in the prevention of heartworm disease caused by Dirofilaria immitis, the control of adult Ancylostoma caninum (hookworm), and the removal and control … (Official, 2026-05-05)
indications: For use in the prevention of heartworm disease caused by Dirofilaria immitis, the control of adult Ancylostoma caninum (hookworm), and the removal and control … (Official, 2026-05-03)
indications: For use in the prevention of heartworm disease caused by Dirofilaria immitis, the control of adult Ancylostoma caninum (hookworm), and the removal and control … (Official, 2026-05-02)
indications: For use in the prevention of heartworm disease caused by Dirofilaria immitis, the control of adult Ancylostoma caninum (hookworm), and the removal and control … (Official, 2026-04-29)
indications: For use in the prevention of heartworm disease caused by Dirofilaria immitis, the control of adult Ancylostoma caninum (hookworm), and the removal and control … (Official, 2026-04-28)
indications: For use in the prevention of heartworm disease caused by Dirofilaria immitis, the control of adult Ancylostoma caninum (hookworm), and the removal and control … (Official, 2026-04-27)
indications: For use in the prevention of heartworm disease caused by Dirofilaria immitis, the control of adult Ancylostoma caninum (hookworm), and the removal and control … (Official, 2026-04-26)
indications: For use in the prevention of heartworm disease caused by Dirofilaria immitis, the control of adult Ancylostoma caninum (hookworm), and the removal and control … (Official, 2026-04-25)
indications: For use in the prevention of heartworm disease caused by Dirofilaria immitis, the control of adult Ancylostoma caninum (hookworm), and the removal and control … (Official, 2026-04-22)
side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (endoparasite) - heartworm, Lethargy (see also Central nervous system depression in 'Neurological'… (Official, 2026-04-12)
side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (endoparasite) - heartworm, Lethargy (see also Central nervous system depression in 'Neurological'… (Official, 2026-02-12)
usage: For prevention of heartworm disease caused by Dirofilaria immitis and the removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm) infe… (Official, 2026-04-12)
usage: For prevention of heartworm disease caused by Dirofilaria immitis and the removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm) infe… (Official, 2026-04-11)
usage: For prevention of heartworm disease caused by Dirofilaria immitis and the removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm) infe… (Official, 2026-02-12)

Recent Revisions

side_effects updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product	Sponsor	Application	Status	Published
MilbeGuard™ RX Milbemycin Oxime Flavored Tablets • Oral Label highlights Official documents	Ceva Sante Animale	ANADA 200-629	Approved	Jan 7, 2019
Interceptor™ RX Milbemycin Oxime Tablet • Oral Label highlights Official documents	Elanco US Inc.	NADA 140-915	Approved	Aug 3, 2017
Milbemite™ Otic Solution RX Milbemycin Oxime Liquid (Solution) • Topical Label highlights Official documents	Elanco US Inc.	NADA 141-163	Approved	Jun 1, 2016

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied

Composition / specifications

2.3 mg, 5.75 mg, 11.5 mg, or 23.0 mg milbemycin oxime per tablet

Dogs

Indication

Dosage

MilbeGuard™ Flavored Tablets are given orally, once a month, at the recommended minimum dosage rate of 0.23 mg milbemycin oxime per pound of body weight (0.5 mg/kg).

Limitations

Cats

Indication

Dosage

MilbeGuard™ Flavored Tablets are given orally, once a month, at the recommended minimum dosage rate of 0.9 mg milbemycin oxime per pound of body weight (2.0 mg/kg).

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, Excluding Under 2 Pounds • Dogs and puppies, excluding puppies under 4 weeks age • Cat And Kitten, Excluding Under 1.5 Pounds Weight • Cats and kittens, excluding kittens under 6 weeks age

Composition / specifications

Each tablet contains 2.3, 5.75, 11.5, or 23.0 milligrams of milbemycin oxime.

Cats and Kittens (6 Weeks of Age or Greater and 1.5 Lbs. Body Weight or Greater)

Indication

For prevention of heartworm disease caused by Dirofilaria immitis and the removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm) infections.

Dosage

INTERCEPTOR for Cats is given orally, once a month, at the recommended minimum dosage rate of 0.9 mg milbemycin oxime per pound of body weight (2.0 mg/kg).

Limitations

Dogs and Puppies (4 Weeks of Age and Older and 2 Pounds of Body Weight and Greater)

Indication

Dosage

INTERCEPTOR is given orally, once a month, at the recommended minimum dosage rate of 0.23 mg milbemycin oxime per pound of body weight (0.5 mg/kg).

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Cat And Kitten, Excluding Under 4 Weeks Of Age

Composition / specifications

Each tube contains 0.25 milliliter of a 0.1 percent solution of milbemycin oxime.

Cats and Kittens (4 Weeks of Age and Older)

Indication

For the treatment of ear mite (Otodectes cynotis) infestations in cats and kittens 4 weeks of age and older. Effectiveness is maintained throughout the life cycle of the ear mite.

Dosage

One tube (aproximately .2 mL) administered topically into each external ear canal.

Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive

Vomiting (1) • Cat Drooling (1) • Cat Diarrhea (1) • Dog

Showing top 5 for Digestive.

Neurologic

Unsteady walking (1) • Dog Tiredness (1) • Dog Muscle tremor (1) • Cat

Showing top 5 for Neurologic.

Effectiveness

Lack of efficacy (endoparasite) - whipworm (1) • Dog Lack of efficacy (endoparasite) - tapeworm (1) • Dog Lack of efficacy (endoparasite) - roundworm NOS (1) • Dog Lack of efficacy (endoparasite) - hookworm (1) • Dog Lack of efficacy (endoparasite) - heartworm (1) • Cat

Showing top 5 for Effectiveness.

Other

Unclassifiable adverse event (1) • Dog Thrombocytopenia (1) • Dog Stiffness limb (1) • Dog Star-gazing (1) • Cat Scratching (1) • Cat

Show more (16)

Respiratory tract infection NOS (1) • Dog Polydipsia (1) • Dog Other abnormal test result NOS (1) • Cat Open mouth breathing (1) • Cat Not eating (1) • Dog Musculoskeletal disorder NOS (1) • Cat Medication error NOS (1) • Cat Malaise (1) • Cat Inappropriate defecation (1) • Dog Hypoglycaemia (1) • Cat Fracture (1) • Dog Disorientation (1) • Cat Cyst NOS (1) • Dog Conjunctivitis (1) • Dog Anaemia NOS (1) • Cat Administration error NOS (1) • Cat

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Dog, Dog (unknown), Unknown • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal, Frequency: 1 per month • Reactions: Lack of efficacy (endoparasite) - roundworm NOS, Lack of efficacy (endoparasite) - hookworm • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2025-US-075055
Serious AE: No
Treated For AE: No
Sex: Unknown

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Oral
Form: Tablet
Dose: 1 tablet per animal
Frequency: 1 per month

Reactions Reported:

Lack of efficacy (endoparasite) - roundworm NOS Lack of efficacy (endoparasite) - hookworm

Outcomes: Outcome Unknown

Cat, Cat (unknown), Unknown, 14 week • Drug: MSK, Solution, Auricular (Otic), Dose: 1 tube per animal • Reactions: Scratching • Outcome: Ongoing

Report ID: USA-USFDACVM-2025-US-072544
Serious AE: No
Treated For AE: No
Sex: Unknown
Age: 14.00 Week

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Auricular (Otic)
Form: Solution
Dose: 1 tube per animal

Reactions Reported:

Scratching

Outcomes: Ongoing

Dog, ['Terrier - Teddy Roosevelt', 'Poodle (unspecified)'], Male, 4 year, 19.9 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal, Frequency: 1 per day • Reactions: Diarrhea, Polydipsia, Tiredness (lethargy), Unsteady walking (ataxia), Wound • Outcome: Ongoing

Report ID: USA-USFDACVM-2025-US-072281
Serious AE: No
Treated For AE: Yes
Sex: Male
Age: 4.00 Year
Weight: 19.900 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Oral
Form: Tablet
Dose: 1 tablet per animal
Frequency: 1 per day

Reactions Reported:

Diarrhea Polydipsia Tiredness (lethargy) Unsteady walking (ataxia) Wound

Outcomes: Ongoing

Dog, ['Shepherd (unspecified)', 'Dog (unknown)'], Female, 11 month • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal, Frequency: 1 per month • Reactions: Fracture, Thrombocytopenia, Respiratory tract infection NOS, Conjunctivitis, Unclassifiable adverse event… • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2025-US-068774
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 11.00 Month

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Oral
Form: Tablet
Dose: 1 tablet per animal
Frequency: 1 per month

Reactions Reported:

Fracture Thrombocytopenia Respiratory tract infection NOS Conjunctivitis Unclassifiable adverse event Other abnormal test result NOS Lack of efficacy (endoparasite) - tapeworm

Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Male, 18 month, 4.3 kilogram • Drug: MSK, Solution, Auricular (Otic) • Reactions: Drooling, Vomiting • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2025-US-068375
Serious AE: No
Treated For AE: No
Sex: Male
Age: 18.00 Month
Weight: 4.300 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Auricular (Otic)
Form: Solution

Reactions Reported:

Drooling Vomiting

Outcomes: Outcome Unknown

Cat, Cat (unknown), Female, 5 year, 4.536 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 11.50 Milligram per dose, Frequency: 30 per day • Reactions: Vomiting, UNPALATABLE • Outcome: Recovered/Normal

Report ID: USA-USFDACVM-2025-US-066648
Serious AE: No
Treated For AE: Yes
Sex: Female
Age: 5.00 Year
Weight: 4.536 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Oral
Form: Tablet, chewable
Dose: 11.50 Milligram per dose
Frequency: 30 per day

Reactions Reported:

Vomiting UNPALATABLE

Outcomes: Recovered/Normal

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

Share Your Thoughts

Let others know your experience or advice regarding this medication.

No community reviews yet. Be the first to share your experience.

This medication has not been reviewed by a veterinarian yet.

Medical Disclaimer: The medication details provided on Roxee are for informational purposes only and are not a substitute for professional veterinary advice. Always consult your veterinarian about your pet's specific needs.

Milbemycin Oxime

Data freshness

Evidence

Milbemycin Oxime

Medication Snapshot

Milbemycin Oxime

Indications / Uses

Warnings / Contraindications

Side Effects

FAQ

What species is this commonly shown for?

Does this usually require a prescription?

What dosage forms are listed?

Related Medications

Related Conditions

Source Transparency

Add to My Pet's Meds

Pet Owner Quick Guide

Quick Facts

Warnings / Contraindications

Adverse Reactions

Grouped by Body System

Most Reported Reactions

Documents

Owner handouts

Official label / PI

SPL

FOI

TRIFEXIS N141321C0060.pdf

MilbeGuard™

MilbeGuard™

Dogs

Cats

Interceptor™

Interceptor™

Cats and Kittens (6 Weeks of Age or Greater and 1.5 Lbs. Body Weight or Greater)

Dogs and Puppies (4 Weeks of Age and Older and 2 Pounds of Body Weight and Greater)

Milbemite™ Otic Solution

Milbemite™ Otic Solution

Cats and Kittens (4 Weeks of Age and Older)

FOI Summary oA 200-629 Approved December 19, 2018.pdf

N140915 Supp_6_4_1998.pdf

ucm115749.pdf

N140915 Supp_9_9_1996.pdf

UCM454279.pdf

N140915_Supp_12_29_1992.pdf

UCM478241.pdf

ucm117228.pdf

ucm117236.pdf

UCM252248.pdf

UCM292003.pdf

FOI Summary sN-141-333 Approved September 28, 2017.pdf

ucm117654.pdf

N141084_Orig_4_10_1997.pdf

N141084_Supp_6_17_1998.pdf

ucm117024.pdf

UCM318617.pdf

FOI Summary sN 141-338 Approved June 21, 2017.pdf

At a Glance

Counseling and Monitoring Highlights

Identifiers & Packages

Enriched Documents

Data Sources & Change Log

FDA Products & Applications (Animal Drugs @ FDA)

What It's For (FDA Label Highlights)

MilbeGuard™ • Flavored Tablets • Oral

Interceptor™ • Tablet • Oral

Milbemite™ Otic Solution • Liquid (Solution) • Topical

Usage

Contraindications

Top Reported Reactions (openFDA)

Adverse Event Case Summaries (openFDA)

Dec 24, 2025 • Dog • Dog (unknown) • Lack of efficacy (endoparasite) - roundworm NOS, Lack of efficacy (endoparasite) - hookworm • Outcome Unknown

Dec 10, 2025 • Cat • Cat (unknown) • Scratching • Ongoing

Dec 2, 2025 • Dog • ['Terrier - Teddy Roosevelt', 'Poodle (unspecified)'] • Diarrhea, Polydipsia • Ongoing

Nov 19, 2025 • Dog • ['Shepherd (unspecified)', 'Dog (unknown)'] • Fracture, Thrombocytopenia • Outcome Unknown

Nov 19, 2025 • Cat • Domestic Shorthair • Drooling, Vomiting • Outcome Unknown

Nov 12, 2025 • Cat • Cat (unknown) • Vomiting, UNPALATABLE • Recovered/Normal

Overdose Information

Storage & Handling