USA-USFDACVM-2025-US-072544
Received 2025-12-10 · MSK · MSK
- Species
- Cat
- Breed
- Cat (unknown)
- Age
- Under 1 year (14 Week)
- Sex
- Unknown Unknown
- Region
- USA
- Reactions
- Scratching
- Body systems
- Other
- Outcomes
- Ongoing
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Roxee Medication Guide
Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
Veterinary professional?
These are the reference facts Roxee uses on browse cards and quick facts.
Sponsor, product, and application records imported from Animal Drugs @ FDA.
openFDA reaction terms and case summaries are supporting evidence, not proof of causality.
Drug type: Generic ingredient • Generic profile • No FDA branded products linked
Species: Both
Manufacturer: Multiple FDA sponsors
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
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.
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.
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..
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.
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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:
When to call the vet:
Regulatory restrictions are shown in Vet View.
What to tell or ask your vet today:
A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.
Roxee has limited cited overview evidence for Milbemycin Oxime; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 17 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.
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.
Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.
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.
Unsteady walking (ataxia) (1 reports), Unclassifiable adverse event (1 reports), Thrombocytopenia (1 reports), Star-gazing (1 reports), Respiratory tract infection NOS (1 reports)
Digestive (3), Neurologic (3), Effectiveness (5), Other (21)
Dog (18 reports), Cat (14 reports)
Cat (unknown) (2), Dog (unknown) (1), ['Terrier - Teddy Roosevelt', 'Poodle (unspecified)'] (1), ['Shepherd (unspecified)', 'Dog (unknown)'] (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Milbemycin Oxime fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.
Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.
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
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Review status / Updated / Sources
Review status: Clinical reviewer not listed
Updated: February 12, 2026, 10:44 PM UTC
Side effects to monitor:
Most reported reactions:
Emergency warning signs:
Source-backed clinical checkpoints for quick review.
Official label facts first, then secondary summaries. Marketing content is separated below.
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..
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.
Received 2025-12-10 · MSK · MSK
Received 2025-12-02 · MSK · MSK
Received 2025-11-19 · MSK · MSK
Received 2025-11-12 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Neurologic | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 |
Species coverage: Dog (18) Cat (14)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Digestive | Cat | Non-serious | - | 1 | |
| Neurologic | Cat | 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 | Dog | 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 | Dog | 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 |
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.
Full source previews and metadata remain in the veterinary/professional layer.
Official label / PI · Official label
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
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.
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).
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.
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).
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
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).
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI summary
FOI · FOI summary
FOI · FOI summary
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FOI · FOI summary
FOI · FOI summary
FOI · FOI summary
FOI · FOI summary
FOI · FOI summary
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
Quick facts and links to official labeling and safety signals.
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | 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 | - |
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
Every non-trivial field is expected to include provenance and update timestamps.
Official sponsor/proprietary-name/application-status records linked by active ingredient.
| Product | Sponsor | Application | Status | Published |
|---|---|---|---|---|
|
MilbeGuard™
RX
Milbemycin Oxime
Flavored Tablets
• Oral
|
Ceva Sante Animale | ANADA 200-629 | Approved | Jan 7, 2019 |
|
Interceptor™
RX
Milbemycin Oxime
Tablet
• Oral
|
Elanco US Inc. | NADA 140-915 | Approved | Aug 3, 2017 |
|
Milbemite™ Otic Solution
RX
Milbemycin Oxime
Liquid (Solution)
• Topical
|
Elanco US Inc. | NADA 141-163 | Approved | Jun 1, 2016 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
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.
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).
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.
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).
FDA page: Open in Animal Drugs @ FDA
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).
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
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
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..
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Showing top 5 for Digestive.
Showing top 5 for Neurologic.
Showing top 5 for Effectiveness.
Showing top 5 for Other.
Data source: FDA openFDA Animal & Veterinary adverse event reports.
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
Cat, Cat (unknown), Unknown, 14 week • Drug: MSK, Solution, Auricular (Otic), Dose: 1 tube per animal • Reactions: Scratching • Outcome: 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
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
Cat, Domestic Shorthair, Male, 18 month, 4.3 kilogram • Drug: MSK, Solution, Auricular (Otic) • Reactions: Drooling, Vomiting • Outcome: 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
Data source: FDA openFDA Animal & Veterinary adverse event reports.
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.