Roxee Medication Guide

Milbemycin

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

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

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Reference facts

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Aug 6, 2026, 7:46 p.m.

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

FDA applications

FDA application data refreshed

Aug 6, 2026, 7:46 p.m.

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

Safety reports

Safety data refreshed

Aug 6, 2026, 7:49 p.m.

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

Source timing details

Reference facts: Source Roxee | Refreshed Aug 6, 2026, 7:46 PM UTC
The reference fact projection used for browse cards and quick facts.
Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:46 PM 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 Aug 6, 2026, 7:52 PM UTC
openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC

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Milbemycin

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

Both Tablet Rx required 100% reference complete

Species: Both

Manufacturer: Multiple FDA sponsors

Medication Snapshot

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

Milbemycin

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

Brand names

Interceptor™, Milbemite™ Otic Solution, MilbeGuard™

Manufacturer

Multiple FDA sponsors

Species

Both, Dog, Dogs and puppies, Cat And Kitten

Dosage forms

Tablet, Liquid (Solution), Flavored Tablets

Prescription

Prescription required

Completeness

100%

Validation

Needs review

Brand names

Interceptor™ Milbemite™ Otic Solution MilbeGuard™

Dosage forms

Tablet Liquid (Solution) Flavored Tablets

Indications / Uses

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.

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): Lack of efficacy (endoparasite) - heartworm, Seizure NOS, Vomiting, Lethargy (see also Central nervous system depression in Neurological), Panting, Death.

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, Cat

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: Aug 6, 2026, 7:46 p.m.
Last verified: Apr 15, 2026, 10:04 a.m.
Validation status: Needs review

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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
Vomiting (1 reports)
Hyperglycaemia (1 reports)
Heavy breathing (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?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence

Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Milbemycin; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-071910

Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 10 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-071910

Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2025-US-071910

Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Vomiting (1 reports), Hyperglycaemia (1 reports), Heavy breathing (1 reports), Fracture (1 reports), Facial swelling (possible allergy) (1 reports)

Body systems represented Signal grouping

Digestive (4), Skin & allergy (2), Neurologic (3), Behavior (1)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (26 reports), Cat (6 reports)

Breed metadata in reports Metadata only

Domestic Shorthair (2), Schnauzer - Miniature (2), Retriever - Labrador (1), ['Retriever - Golden', 'Shepherd Dog - German'] (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Milbemycin fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

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

Call sooner if Escalation

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

Bottom line: Use this Milbemycin brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.

Vet source depth

openFDA case USA-USFDACVM-2025-US-071910 · adverse_reaction · adverse reactions
Contraindication source · fda_animal_drugs · warnings contraindications
FDA application profile · official_label · quick facts
FDA application profile · official_label · quick facts
Medication usage source · fda_animal_drugs · quick facts
FOI · document · documents
SPL · document · documents
FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: April 15, 2026, 10:04 AM 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-071910 · adverse_reaction

Safety & side effects

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:

Vomiting (1 reports)
Hyperglycaemia (1 reports)
Heavy breathing (1 reports)

Explore reported case details

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

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species

Cat, Cat And Kitten, Cats and kittens, Dog, Dogs and puppies

Indication / use

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 c…

Form / route / dose

Form: Flavored Tablets, Liquid (Solution), Tablet
Route: Oral, Topical
Confirm product label and patient-specific plan.

Warnings

High: Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restrict…

Adverse-event caveat

openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.

Source docs

TRIFEXIS N141321C0060.pdf Official label / PI
MilbeGuard™ SPL
Interceptor™ SPL

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.

Reported case explorer

Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.

Clear filters

openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.

Stored reports

Matching reports

Active filters

Selected filters

Body system: Neurologic Clear

Species

Breed

Size / weight

Age

Sex

Seriousness

Outcome

Reaction

Body system

Region

Received after

Received before

Reset

Drill into common report signals

Ataxia (4) Collapse of leg (3) Confusion (3) Elevated blood urea nitrogen (BUN) (3) Other (13) Neurologic (6) Digestive (4) Effectiveness (4)

Showing up to 50 matching reports.

USA-USFDACVM-2026-US-014243

Received 2026-03-19 · MSK · MSK

Non-serious

Species: Dog
Breed: Chihuahua
Size / weight: Under 10 lb (1.81 Kilogram)
Age: 1-3 years (1.5 Year)
Sex: Female Neutered
Region: USA
Reactions: Not eatingLethargy (see also Central nervous system depression in Neurological)Vomiting foamGagging
Body systems: OtherNeurologicDigestive
Outcomes: Outcome Unknown

USA-USFDACVM-2026-US-014603

Received 2026-03-18 · MSK · MSK

Non-serious

Species: Dog
Breed: Schnauzer - Miniature
Size / weight: 10-24 lb (7.212 Kilogram)
Age: 8+ years (14 Year)
Sex: Male Neutered
Region: USA
Reactions: AtaxiaCollapse of legElevated blood urea nitrogen (BUN)Elevated cholesterol (total)WeaknessConfusionHyperphosphataemiaElevated symmetrical dimethylarginine (SDMA)Hind limb ataxiaDifficulty standingDifficulty going up/down stairsCircling - neurological disorder (see also Behavioural disorders)
Body systems: NeurologicOther
Outcomes: Ongoing

USA-USFDACVM-2026-US-012493

Received 2026-03-16 · MSK · MSK

Non-serious

Species: Dog
Breed: Schnauzer - Miniature
Size / weight: 10-24 lb (7.212 Kilogram)
Age: 8+ years (14 Year)
Sex: Male Neutered
Region: USA
Reactions: AtaxiaCollapse of legElevated blood urea nitrogen (BUN)Elevated cholesterol (total)WeaknessConfusionHyperphosphataemiaElevated symmetrical dimethylarginine (SDMA)
Body systems: NeurologicOther
Outcomes: Ongoing

USA-USFDACVM-2026-US-003714

Received 2026-01-29 · MSK · MSK

Non-serious

Species: Dog
Breed: Schnauzer - Miniature
Size / weight: 10-24 lb (7.212 Kilogram)
Age: 8+ years (14 Year)
Sex: Male Neutered
Region: USA
Reactions: AtaxiaCollapse of legElevated blood urea nitrogen (BUN)Elevated cholesterol (total)WeaknessConfusionHyperphosphataemiaElevated symmetrical dimethylarginine (SDMA)Discomfort NOS
Body systems: NeurologicOther
Outcomes: Ongoing

USA-USFDACVM-2026-US-001356

Received 2026-01-15 · MSK · MSK

Serious

Species: Cat
Breed: Domestic Shorthair
Size / weight: Under 10 lb (1.78 Kilogram)
Age: Under 1 year (7 Week)
Sex: Male Intact
Region: USA
Reactions: Seizure NOS
Body systems: Neurologic
Outcomes: Recovered/Normal

USA-USFDACVM-2025-US-072281

Received 2025-12-02 · MSK · MSK

Non-serious

Species: Dog
Breed: ['Terrier - Teddy Roosevelt', 'Poodle (unspecified)']
Size / weight: 25-49 lb (19.9 Kilogram)
Age: 4-7 years (4 Year)
Sex: Male Unknown
Region: USA
Reactions: DiarrhoeaPolydipsiaLethargy (see also Central nervous system depression in Neurological)AtaxiaWound
Body systems: DigestiveOtherNeurologic
Outcomes: Ongoing

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 (4) · Vomiting, Drooling, Diarrhea Skin & allergy (2) · Hives, Facial swelling (possible allergy) Neurologic (3) · Unsteady walking (ataxia), Hind limb ataxia, Circling - neurological disorder Behavior (1) · Behavioral disorder (unspecified) Other (22) · Hyperglycaemia, Heavy breathing, Gagging

Most Reported Reactions

Body system	Cases	Species	Serious cases
Digestive	1	Dog	1
Other	1	Dog	1
Other	1	Dog	1
Other	1	Dog	1
Skin & allergy	1	Dog	1
Other	1	Dog	1
Other	1	Dog	1
Digestive	1	Dog	1

Species coverage: Dog (26) Cat (6)

View detailed reaction table

Body system	Species	Seriousness	Frequency	Reports
Digestive	Dog	Serious	-	1
Neurologic	Dog	Non-serious	-	1
Other	Dog	Serious	-	1
Skin & allergy	Dog	Non-serious	-	1
Neurologic	Dog	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Non-serious	-	1
Other	Dog	Serious	-	1
Skin & allergy	Dog	Serious	-	1
Other	Cat	Non-serious	-	1
Other	Dog	Non-serious	-	1
Other	Dog	Non-serious	-	1
Other	Dog	Non-serious	-	1
Digestive	Cat	Non-serious	-	1
Other	Dog	Non-serious	-	1
Other	Cat	Non-serious	-	1
Other	Dog	Non-serious	-	1
Other	Dog	Non-serious	-	1
Digestive	Dog	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Non-serious	-	1
Other	Cat	Non-serious	-	1
Other	Cat	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Non-serious	-	1
Other	Dog	Non-serious	-	1
Neurologic	Dog	Non-serious	-	1
Digestive	Dog	Serious	-	1
Behavior	Cat	Non-serious	-	1
Other	Dog	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1

Source metadata:

https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-071910

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

TRIFEXIS N141321C0060.pdf Official label / PI · Official label MilbeGuard™ SPL · SPL Interceptor™ SPL · SPL

Full source previews and metadata remain in the veterinary/professional layer.

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 • Cat

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 • Dogs and puppies • Cat And Kitten • Cats and kittens

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

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

Reference facts: Source Roxee | Refreshed Aug 6, 2026, 7:46 PM UTC
The reference fact projection used for browse cards and quick facts.
Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:46 PM 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 Aug 6, 2026, 7:52 PM UTC
openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM 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 33 • Cat 20 • View

Case summaries: 17 (showing 8) • 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

Vomiting (1) Hyperglycaemia (1) Heavy breathing (1) Fracture (1) Facial swelling (possible allergy) (1) Decreased bowel movements (1) Conjunctivitis (1) Bloody diarrhoea (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 123 Clinical 16 Manufacturer 0 Marketing 0

Current Field Facts

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… (Clinical, 2026-04-17)
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… (Clinical, 2026-04-15)
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… (Clinical, 2026-04-15)
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… (Clinical, 2026-04-11)
monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-21)
monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-20)
monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-19)
monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-17)
monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-15)
side_effects: Top reported reactions (openFDA): Lack of efficacy (endoparasite) - heartworm, Seizure NOS, Vomiting, Lethargy (see also Central nervous system depression in N… (Clinical, 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… (Clinical, 2026-04-17)
usage: For prevention of heartworm disease caused by Dirofilaria immitis and the removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm) infe… (Clinical, 2026-04-15)
usage: For prevention of heartworm disease caused by Dirofilaria immitis and the removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm) infe… (Clinical, 2026-04-15)
usage: For prevention of heartworm disease caused by Dirofilaria immitis and the removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm) infe… (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, 2026-04-22)
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, 2026-08-06)
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, 2026-08-05)

Recent Revisions

side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
monitoring updated 2026-04-21 10:06 by curated_loader • Clinical monitoring context for feline diabetes management.
usage updated 2026-04-21 10:06 by curated_loader • Usage statement from FDA warning letter and approved-product context.
drug_profile_type updated 2026-04-21 10:06 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
manufacturer_name updated 2026-04-21 10:06 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
brand_names updated 2026-04-21 10:06 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
approval_reference updated 2026-04-21 10:06 by curated_loader • Official FDA application reference for Senvelgo.
monitoring updated 2026-04-20 10:07 by curated_loader • Clinical monitoring context for feline diabetes management.
usage updated 2026-04-20 10:07 by curated_loader • Usage statement from FDA warning letter and approved-product context.
drug_profile_type updated 2026-04-20 10:07 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
manufacturer_name updated 2026-04-20 10:07 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
brand_names updated 2026-04-20 10:07 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
approval_reference updated 2026-04-20 10:07 by curated_loader • Official FDA application reference for Senvelgo.
monitoring updated 2026-04-19 10:07 by curated_loader • Clinical monitoring context for feline diabetes management.
usage updated 2026-04-19 10:07 by curated_loader • Usage statement from FDA warning letter and approved-product context.
drug_profile_type updated 2026-04-19 10:07 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
manufacturer_name updated 2026-04-19 10:07 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
brand_names updated 2026-04-19 10:07 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.

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 • Cat

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 • Dogs and puppies • Cat And Kitten • Cats and kittens

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

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

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.

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) • Dog Drooling (1) • Cat Diarrhea (1) • Dog Bloody diarrhoea (1) • Dog

Showing top 5 for Digestive.

Skin & allergy

Hives (1) • Dog Facial swelling (possible allergy) (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic

Unsteady walking (1) • Dog Hind limb ataxia (1) • Dog Circling - neurological disorder (1) • Dog

Showing top 5 for Neurologic.

Behavior

Behavioral disorder (1) • Cat

Showing top 5 for Behavior.

Other

Hyperglycaemia (1) • Dog Heavy breathing (1) • Dog Gagging (1) • Dog Fracture (1) • Dog Expired drug administered (1) • Cat

Show more (17)

Elevated symmetrical dimethylarginine (1) • Dog Elevated cholesterol (1) • Dog Elevated blood urea nitrogen (1) • Dog Discomfort NOS (1) • Dog Dilated pupils (1) • Cat Difficulty standing (1) • Dog Difficulty going up/down stairs (1) • Dog Decreased bowel movements (1) • Dog Death (1) • Dog Crust (1) • Cat Cough (1) • Cat Conjunctivitis (1) • Dog Confusion (1) • Dog Collapse of leg (1) • Dog Balance problem (1) • Dog Agitation (1) • Dog Abnormal stool colouration (1) • Dog

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.

Cat, Domestic Shorthair, Male, 11 month, 5.117 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal • Reactions: Suckling disorder NOS, Licking, Skin scab, Peripheral vascular disorder, Pinnal erythema… • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2026-US-014504
Serious AE: No
Treated For AE: Yes
Sex: Male
Age: 11.00 Month
Weight: 5.117 Kilogram

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

Reactions Reported:

Suckling disorder NOS Licking Skin scab Peripheral vascular disorder Pinnal erythema Crust Expired drug administered

Outcomes: Outcome Unknown

Dog, Retriever - Labrador, Male, 19 month, 32.205 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal • Reactions: Lack of efficacy (endoparasite) - tapeworm, Unclassifiable adverse event • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2026-US-014484
Serious AE: No
Treated For AE: Yes
Sex: Male
Age: 19.00 Month
Weight: 32.205 Kilogram

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

Reactions Reported:

Lack of efficacy (endoparasite) - tapeworm Unclassifiable adverse event

Outcomes: Outcome Unknown

Dog, ['Retriever - Golden', 'Shepherd Dog - German'], Male, 9 week, 5.897 kilogram • Drug: MSK, Tablet, chewable, Oral • Reactions: Agitation, Itching, Facial swelling (possible allergy) • Outcome: Ongoing

Report ID: USA-USFDACVM-2026-US-014469
Serious AE: Yes
Treated For AE: Yes
Sex: Male
Age: 9.00 Week
Weight: 5.897 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Oral
Form: Tablet, chewable

Reactions Reported:

Agitation Itching Facial swelling (possible allergy)

Outcomes: Ongoing

Dog, Chihuahua, Female, 1.5 year, 1.81 kilogram • Drug: MSK, Tablet, Unknown • Reactions: Not eating, Tiredness (lethargy), Vomiting foam, Gagging • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2026-US-014243
Serious AE: No
Treated For AE: No
Sex: Female
Age: 1.50 Year
Weight: 1.810 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Tablet

Reactions Reported:

Not eating Tiredness (lethargy) Vomiting foam Gagging

Outcomes: Outcome Unknown

Dog, Schnauzer - Miniature, Male, 14 year, 7.212 kilogram • Drug: MSK, Tablet, chewable, Unknown • Reactions: Unsteady walking (ataxia), Collapse of leg, Elevated blood urea nitrogen, Elevated cholesterol, Weakness… • Outcome: Ongoing

Report ID: USA-USFDACVM-2026-US-014603
Serious AE: No
Treated For AE: No
Sex: Male
Age: 14.00 Year
Weight: 7.212 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Tablet, chewable

Reactions Reported:

Unsteady walking (ataxia) Collapse of leg Elevated blood urea nitrogen Elevated cholesterol Weakness Confusion Hyperphosphataemia Elevated symmetrical dimethylarginine Hind limb ataxia Difficulty standing Difficulty going up/down stairs Circling - neurological disorder

Outcomes: Ongoing

Dog, Schnauzer - Miniature, Male, 14 year, 7.212 kilogram • Drug: MSK, Tablet, Unknown • Reactions: Unsteady walking (ataxia), Collapse of leg, Elevated blood urea nitrogen, Elevated cholesterol, Weakness… • Outcome: Ongoing

Report ID: USA-USFDACVM-2026-US-012493
Serious AE: No
Treated For AE: No
Sex: Male
Age: 14.00 Year
Weight: 7.212 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Tablet

Reactions Reported:

Unsteady walking (ataxia) Collapse of leg Elevated blood urea nitrogen Elevated cholesterol Weakness Confusion Hyperphosphataemia Elevated symmetrical dimethylarginine

Outcomes: Ongoing

Dog, American Pit Bull Terrier, Male, 6 year, 34.5 kilogram • Drug: MSK, Tablet, Unknown • Reactions: Hives • Outcome: Recovered/Normal

Report ID: USA-USFDACVM-2026-US-012216
Serious AE: No
Treated For AE: No
Sex: Male
Age: 6.00 Year
Weight: 34.500 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Tablet

Reactions Reported:

Hives

Outcomes: Recovered/Normal

Cat, Domestic Shorthair, Male, 3 year • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal, Frequency: 1 per month • Reactions: Cough, Lack of efficacy (endoparasite) - heartworm, Respiratory signs • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2026-US-011201
Serious AE: No
Treated For AE: No
Sex: Male
Age: 3.00 Year

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

Reactions Reported:

Cough Lack of efficacy (endoparasite) - heartworm Respiratory signs

Outcomes: Outcome Unknown

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.

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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

Data freshness

Milbemycin

Medication Snapshot

Milbemycin

Indications / Uses

Warnings / Contraindications

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FAQ

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Species and breed lens

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Reported case explorer

USA-USFDACVM-2026-US-014243

USA-USFDACVM-2026-US-014603

USA-USFDACVM-2026-US-012493

USA-USFDACVM-2026-US-003714

USA-USFDACVM-2026-US-001356

USA-USFDACVM-2025-US-072281

Grouped by Body System

Most Reported Reactions

Source 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)