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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: Elanco US Inc.
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in dogs and puppies. For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in cats and kittens. Credelio™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of tick infestations [ Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick)] for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater. Credelio™ is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. Species commonly shown: Both, Dog, Cat.
For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in dogs and puppies. For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in cats and kittens. Credelio™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of tick infestations [ Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick)] for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater. Credelio™ is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.
Top reported reactions (openFDA): Vomiting, Diarrhoea, Lack of efficacy (ectoparasite) - tick NOS, Other abnormal test result NOS, Lethargy (see also Central nervous system depression in 'Neurological'), Seizure NOS.
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Used for:
For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in dogs and puppies.
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 Lotilaner; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 22 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.
Dehydration (1 reports), Decreased appetite (1 reports), Death (1 reports), Cystitis (1 reports), Cyst NOS (1 reports)
Digestive (3), Skin & allergy (2), Behavior (3), Other (24)
Dog (18 reports), Cat (14 reports)
Chinese Crested Dog (unspecified) (1), Retriever - Golden (1), ['Beagle', 'Dog (unknown)'] (1), Schnauzer - Miniature (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Lotilaner 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.
Dehydration, Decreased appetite, Death
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.
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 2026-03-23 · MSK · MSK
Received 2026-03-16 · MSK · MSK
Received 2026-03-16 · MSK · MSK
Received 2026-03-14 · MSK · MSK
Received 2026-03-02 · MSK · MSK
Received 2026-02-24 · MSK · MSK
Received 2026-02-19 · MSK · MSK
Received 2026-01-26 · MSK · MSK
Received 2025-12-15 · MSK · MSK
Received 2025-12-12 · MSK · MSK
Received 2025-11-21 · MSK · MSK
Received 2025-10-22 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Other | 1 | Cat | 1 | |
| Digestive | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 |
Species coverage: Dog (18) Cat (14)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Digestive | Dog | Non-serious | - | 1 | |
| Skin & allergy | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Digestive | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Behavior | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Behavior | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Behavior | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Skin & allergy | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | 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 infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in dogs and puppies.
Administer orally at the minimum dosage of 9 mg/lb (20 mg/kg) with food.
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 infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in cats and kittens.
Administer orally at the minimum dosage of 2.7 mg/lb (6 mg/kg) with food.
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.
Credelio™ kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick)] for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater. Credelio™ is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.
Credelio™ chewable tablets are given orally once a month at the recommended minimum dosage of 9 mg/lb (20 mg/kg). Credelio™ must be administered with food.
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.
Kills adult fleas, and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) for one month in cats and kittens 8 weeks of age and older and weighing 2.0 pounds or greater. It also indicated for the treatment and control of Ixodes scapularis (black-legged tick) infestations for one month in cats and kittens 6 months of age and older, and weighing 2.0 pounds or greater.
Administer orally once a month at the minimum dosage of 2.7 mg/lb (6 mg/kg). Must be administered with food.
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
FOI · FOI
FOI · FOI
FOI · FOI
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 |
|---|---|---|---|
| 58198-5451-1 | 58198 | - | |
| 58198-5451-2 | 58198 | - | |
| 58198-5451-3 | 58198 | - | |
| 58198-5451-4 | 58198 | - | |
| 58198-5451-6 | 58198 | - | |
| 58198-5451-7 | 58198 | - | |
| 58198-5452-1 | 58198 | - | |
| 58198-5452-2 | 58198 | - | |
| 58198-5452-3 | 58198 | - | |
| 58198-5452-4 | 58198 | - | |
| 58198-5452-5 | 58198 | - | |
| 58198-5452-6 | 58198 | - | |
| 58198-5452-7 | 58198 | - | |
| 58198-5454-1 | 58198 | - | |
| 58198-5454-2 | 58198 | - | |
| 58198-5454-3 | 58198 | - | |
| 58198-5454-4 | 58198 | - | |
| 58198-5454-6 | 58198 | - | |
| 58198-5454-7 | 58198 | - | |
| 58198-5456-1 | 58198 | - |
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 |
|---|---|---|---|---|
|
Credelio™
RX
Lotilaner
Chewable Tablets
• Oral
|
Elanco US Inc. | E 6662 | G | Jan 26, 2026 |
|
Credelio™ CAT
RX
Lotilaner
Chewable Tablets
• Oral
|
Elanco US Inc. | E 6664 | G | Jan 26, 2026 |
|
Credelio™
RX
Lotilaner
Chewable Tablets
• Oral
|
Elanco US Inc. | NADA 141-494 | Approved | Nov 3, 2025 |
|
Credelio™ CAT
RX
Lotilaner
Chewable Tablets
• Oral
|
Elanco US Inc. | NADA 141-528 | Approved | May 3, 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 infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in dogs and puppies.
Administer orally at the minimum dosage of 9 mg/lb (20 mg/kg) with food.
FDA page: Open in Animal Drugs @ FDA
For the treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in cats and kittens.
Administer orally at the minimum dosage of 2.7 mg/lb (6 mg/kg) with food.
FDA page: Open in Animal Drugs @ FDA
Credelio™ kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick)] for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater. Credelio™ is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.
Credelio™ chewable tablets are given orally once a month at the recommended minimum dosage of 9 mg/lb (20 mg/kg). Credelio™ must be administered with food.
FDA page: Open in Animal Drugs @ FDA
Kills adult fleas, and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) for one month in cats and kittens 8 weeks of age and older and weighing 2.0 pounds or greater. It also indicated for the treatment and control of Ixodes scapularis (black-legged tick) infestations for one month in cats and kittens 6 months of age and older, and weighing 2.0 pounds or greater.
Administer orally once a month at the minimum dosage of 2.7 mg/lb (6 mg/kg). Must be administered with food.
FDA page: Open in Animal Drugs @ FDA
For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in dogs and puppies. For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in cats and kittens. Credelio™ kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of tick infestations [ Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick)] for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater. Credelio™ is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.
Source: FDA Animal Drugs @ FDA • Reference
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 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, Chinese Crested Dog (unspecified), Female, 10 year, 5.12 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal, Frequency: 1 per month • Reactions: Lack of efficacy (bacteria) - Borrelia, Other abnormal test result NOS • Outcome: Outcome Unknown
Dog, Retriever - Golden, Male, 1 year, 44.1 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 2 tablet per animal • Reactions: Drooping eyelid, Bloodshot eye, Accidental exposure • Outcome: Ongoing
Dog, ['Beagle', 'Dog (unknown)'], Female, 16 year, 13.6 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Vomiting • Outcome: Ongoing
Dog, Schnauzer - Miniature, Female, 10 year, 9.979 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal, Frequency: 1 per month • Reactions: Lack of efficacy (bacteria) - Anaplasma • Outcome: Outcome Unknown
Dog, Dog (other), Female, 4.6 year, 24.5 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal, Frequency: 1 per month • Reactions: Lack of efficacy (endoparasite) - hookworm, Other abnormal test result NOS • Outcome: Outcome Unknown
Dog, ['Retriever - Labrador', 'Poodle - Miniature'], Female, 2 year, 19.68 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 dose per animal, Frequency: 1 per month • Reactions: Hiding, Vocalisation, Pacing, Loss of appetite, Generalised itching… • Outcome: Ongoing
Dog, Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog), Male, 10 year, 26.26 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 dose per animal • Reactions: Vomiting, Not eating, Bloody stool, Haematemesis, Anxiety… • Outcome: Ongoing
Cat, Domestic Shorthair, Female, 13 year, 6.427 kilogram • Drug: MSK, Tablet, chewable, Unknown • Reactions: Itching, Skin lesion NOS, Skin scab • Outcome: Ongoing
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.