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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 • Branded profile • FDA branded products available
Species: Both
Manufacturer: Multiple FDA labelers
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
For the treatment of flea infestations. The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets is indicated to kill adult fleas and prevent flea eggs from hatching. In cats and kittens, the concurrent use of PROGRAM® Flavor Tabs® and CAPSTAR® Tablets is indicated to kill adult fleas and prevent flea eggs from hatching. The effects of PROGRAM® Flavor Tabs®, which control flea populations, and CAP STAR® Tablets, which treat flea infestations, are combined to provide a FLEA MANAGEMENT SYSTEM™. Species commonly shown: Both, Dog, Excluding Under 2 Pounds, Dogs and puppies, excluding puppies under 4 weeks age.
For the treatment of flea infestations. The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets is indicated to kill adult fleas and prevent flea eggs from hatching. In cats and kittens, the concurrent use of PROGRAM® Flavor Tabs® and CAPSTAR® Tablets is indicated to kill adult fleas and prevent flea eggs from hatching. The effects of PROGRAM® Flavor Tabs®, which control flea populations, and CAP STAR® Tablets, which treat flea infestations, are combined to provide a FLEA MANAGEMENT SYSTEM™.
For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater. The concurrent use of nitenpyram tablets and flavored milbemycin/lufenuron tablets shall be by or on the order of a licensed veterinarian. For use in cats and kittens 4 weeks of age and older. The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets shall be by or on the order of a licensed veterinarian.
Top reported reactions (openFDA): Lack of efficacy (ectoparasite) - flea, Lack of efficacy (flea), Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Scratching, Diarrhoea.
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Used for:
For the treatment of flea infestations on dogs and puppies 4 weeks of age and older and 2 lbs of body weight or greater.
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:
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 Nitenpyram; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 21 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.
Loss of appetite (1 reports), Increased heart rate (1 reports), Hypersensitivity reaction (1 reports), Haemorrhage NOS (1 reports), Gagging (1 reports)
Digestive (6), Skin & allergy (3), Behavior (3), Effectiveness (1)
Dog (16 reports), Cat (16 reports)
Domestic Shorthair (3), Treeing Feist (1), ['Siberian Husky', 'Poodle (unspecified)'] (1), Spitz - German Pomeranian (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Nitenpyram 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.
For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or, The concurrent use of nitenpyram tablets and flavored milbemycin/lufenuron tablets shall be by or on, For use in cats and kittens 4 weeks of age and older, The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets shall, Loss of appetite
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.
For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater. The concurrent use of nitenpyram tablets and flavored milbemycin/lufenuron tablets shall be by or on the order of a licensed veterinarian. For use in cats and kittens 4 weeks of age and older. The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets shall be by or on the order of a licensed veterinarian.
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 2026-03-24 · MSK · MSK
Received 2026-03-23 · MSK · MSK
Received 2026-03-22 · MSK · MSK
Received 2026-03-20 · MSK · MSK
Received 2026-03-20 · MSK · MSK
Received 2026-03-20 · MSK · MSK
Received 2026-03-18 · MSK · MSK
Received 2025-12-11 · MSK · MSK
Received 2025-12-11 · MSK · MSK
Received 2025-12-05 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Digestive | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 |
Species coverage: Dog (16) Cat (16)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Digestive | Dog | Serious | - | 1 | |
| Effectiveness | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Behavior | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Skin & allergy | Cat | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Skin & allergy | Dog | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Digestive | Dog | Serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Cat | Serious | - | 1 | |
| Skin & allergy | Cat | Serious | - | 1 | |
| Behavior | Dog | Non-serious | - | 1 | |
| Digestive | Cat | Serious | - | 1 | |
| Behavior | Cat | Non-serious | - | 1 | |
| Other | Dog | 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.
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 the treatment of flea infestations on dogs and puppies 4 weeks of age and older and 2 lbs of body weight or greater.
One 11.4-mg tablet for dogs weighing less than 25 pounds (lb) or one 57-mg tablet for dogs weighing more than 25 lb, as needed.
For the treatment of flea infestations on cats and kittens 4 weeks of age and older and 2 lbs of body weight or greater.
One 11.4-mg tablet, as needed.
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.
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
FOI · FOI
FOI · FOI
FOI · FOI
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 |
|---|---|---|---|
| 21091-141-01 | 21091 | - | |
| 21091-141-05 | 21091 | - | |
| 21091-142-01 | 21091 | - | |
| 21091-142-05 | 21091 | - | |
| 21091-175-01 | 21091 | - | |
| 21091-175-03 | 21091 | - | |
| 21091-175-04 | 21091 | - | |
| 21091-175-05 | 21091 | - | |
| 21091-178-01 | 21091 | - | |
| 21091-178-03 | 21091 | - | |
| 21091-178-04 | 21091 | - | |
| 21091-178-05 | 21091 | - | |
| 62157-725-01 | 62157 | - | |
| 73309-146-01 | 73309 | - | |
| 73309-146-02 | 73309 | - | |
| 86101-123-06 | 86101 | - | |
| 86101-123-08 | 86101 | - | |
| 86101-123-09 | 86101 | - | |
| 86101-123-10 | 86101 | - | |
| 86101-124-06 | 86101 | - |
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 |
|---|---|---|---|---|
|
Nitenpyram Tablets
OTC
Nitenpyram
Tablet
• Oral
|
Felix Pharmaceuticals Pvt. Ltd. | ANADA 200-858 | Approved | Jul 1, 2026 |
|
CAPSTAR®
OTC
Nitenpyram
Tablet
• Oral
|
Sergeant’s Pet Care Products LLC | NADA 141-175 | Approved | May 17, 2021 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
For the treatment of flea infestations on dogs and puppies 4 weeks of age and older and 2 lbs of body weight or greater.
One 11.4-mg tablet for dogs weighing less than 25 pounds (lb) or one 57-mg tablet for dogs weighing more than 25 lb, as needed.
For the treatment of flea infestations on cats and kittens 4 weeks of age and older and 2 lbs of body weight or greater.
One 11.4-mg tablet, as needed.
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
For the treatment of flea infestations. The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets is indicated to kill adult fleas and prevent flea eggs from hatching. In cats and kittens, the concurrent use of PROGRAM® Flavor Tabs® and CAPSTAR® Tablets is indicated to kill adult fleas and prevent flea eggs from hatching. The effects of PROGRAM® Flavor Tabs®, which control flea populations, and CAP STAR® Tablets, which treat flea infestations, are combined to provide a FLEA MANAGEMENT SYSTEM™.
Source: FDA Animal Drugs @ FDA • Reference
For use in dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds of body weight or greater. The concurrent use of nitenpyram tablets and flavored milbemycin/lufenuron tablets shall be by or on the order of a licensed veterinarian. For use in cats and kittens 4 weeks of age and older. The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets shall be by or on the order of a licensed veterinarian.
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 Skin & allergy.
Showing top 5 for Behavior.
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, Treeing Feist, Male, 1 year, 11.34 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per dose, Frequency: 1 per day • Reactions: Tiredness (lethargy), Loss of appetite, Not drinking, Unable to rise, Recumbency… • Outcome: Outcome Unknown
Dog, ['Siberian Husky', 'Poodle (unspecified)'], Male, 5 year, 29.484 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per dose, Frequency: 48 per hour • Reactions: Diarrhea • Outcome: Recovered/Normal
Dog, Spitz - German Pomeranian, Male, 2 year, 8.165 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per dose, Frequency: 48 per hour • Reactions: Panting, Scratching, Diarrhea, Rubbing, Head shake - behavioural disorder… • Outcome: Outcome Unknown
Cat, Norwegian Forest, Male, 14 year, 9.072 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per dose, Frequency: 1 per day • Reactions: Lack of efficacy (ectoparasite) - flea, Expired drug administered • Outcome: Outcome Unknown
Cat, Domestic Shorthair, Female, 4 month, 1.361 kilogram • Drug: MSK, Tablet, Oral, Frequency: 1 per day • Reactions: Hyperactivity, Panting, Generalised itching, Vocalisation • Outcome: Recovered/Normal
Dog, Shih Tzu, Female, 12 week, 1.361 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per dose, Frequency: 1 per day • Reactions: Lack of efficacy (ectoparasite) - flea • Outcome: Outcome Unknown
Cat, Domestic Shorthair, Female, 3 year, 6.35 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per dose, Frequency: 1 per day • Reactions: Generalised itching, Panting • Outcome: Outcome Unknown
Cat, Domestic Shorthair, Male, 2 year, 0.907 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per dose, Frequency: 1 per day • Reactions: Generalised itching, Panting, Licking, Anxiety • Outcome: Outcome Unknown
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.