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Roxee Medication Guide

Lotilaner

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 Chewable Tablets Elanco US Inc. Official label facts Owner quick guide first
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Data freshness

Reference facts
Reference refreshed
Aug 6, 2026, 7:47 p.m.

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

FDA applications
FDA application data refreshed
Aug 6, 2026, 7:47 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
Source timing details
  • Reference facts: Source Roxee | Refreshed Aug 6, 2026, 7:47 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.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • 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
Illustration placeholder
Lotilaner

Lotilaner

Drug type: Generic ingredient • Branded profile • FDA branded products available

Both Chewable Tablets Rx required 100% reference complete

Species: Both

Manufacturer: Elanco US Inc.

Medication Snapshot

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

Lotilaner

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.

Generic name
Lotilaner
Brand names
Credelio™, Credelio™ CAT, Credelio
Manufacturer
Elanco US Inc.
Species
Both, Dog, Cat
Dosage forms
Chewable Tablets
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Credelio™ Credelio™ CAT Credelio
Dosage forms
Chewable Tablets

Indications / Uses

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.

Side Effects

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.

FAQ

Both, Dog, Cat

Yes. Roxee shows this as prescription-only.

Chewable Tablets

Related Medications

Afoxolaner Same category: Flea & Tick Doxycycline Same category: Flea & Tick Fluralaner 13.64% 12-Week Chew Same category: Flea & Tick Fluralaner Chew Tablets Same category: Flea & Tick Fluralaner Spot-On Solution Same category: Flea & Tick Imidacloprid Same category: Flea & Tick

Related Conditions

Fleas (Flea Infestation) Myiasis (fly strike) Tick infestation

Source Transparency

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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 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:

  • Dehydration (1 reports)
  • Decreased appetite (1 reports)
  • Death (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.

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 Lotilaner; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2026-US-004595
Safety signal coverage Reported signals

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.

Source: openFDA case USA-USFDACVM-2026-US-004595
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-2026-US-004595
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

Dehydration (1 reports), Decreased appetite (1 reports), Death (1 reports), Cystitis (1 reports), Cyst NOS (1 reports)

Body systems represented Signal grouping

Digestive (3), Skin & allergy (2), Behavior (3), Other (24)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (18 reports), Cat (14 reports)

Breed metadata in reports Metadata only

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.

What your vet may verify

Fit for this patient Vet check

Verify whether Lotilaner 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

Dehydration, Decreased appetite, Death

Call sooner if Escalation

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

Bottom line: Use this Lotilaner 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
  1. openFDA case USA-USFDACVM-2026-US-004595 · adverse_reaction · adverse reactions
  2. FDA application profile · official_label · quick facts
  3. FDA application profile · official_label · quick facts
  4. Medication usage source · fda_animal_drugs · quick facts
  5. FOI · document · documents
  6. SPL · document · documents
  7. FOI · document · documents
  8. SPL · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

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

Sources:
Safety & side effects

Side effects to monitor:

  • Dehydration
  • Decreased appetite
  • Death

Most reported reactions:

  • Dehydration (1 reports)
  • Decreased appetite (1 reports)
  • Death (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, Dog
Indication / use
For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in dogs and puppies.
Form / route / dose
Form: Chewable Tablets
Route: Oral
Confirm product label and patient-specific plan.
Warnings
No structured warnings linked yet.
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

Quick Facts

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

Species: Both
Manufacturer: Elanco US Inc.
Form: Chewable Tablets
Identifiers:
NADA: 141494 NADA: 141528 NADA: 141581 NADA: 141619 NADA: 6662 NADA: 6664 NDC Package: 58198-5451-1 NDC Package: 58198-5451-2 NDC Package: 58198-5451-3 NDC Package: 58198-5451-4 NDC Package: 58198-5451-6 NDC Package: 58198-5451-7 NDC Package: 58198-5452-1 NDC Package: 58198-5452-2 NDC Package: 58198-5452-3 NDC Package: 58198-5452-4 NDC Package: 58198-5452-5 NDC Package: 58198-5452-6 NDC Package: 58198-5452-7 NDC Package: 58198-5454-1
Source metadata:

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
42
Matching reports
2
Active filters
2
Selected filters
Reaction: Behavioural disorder NOS Clear Body system: Skin & allergy Clear
Reset
Drill into common report signals
Other abnormal test result NOS (7) Vomiting (7) Behavioural disorder NOS (5) Bloody stool (5) Other (30) Digestive (17) Effectiveness (16) Skin & allergy (12)
Showing up to 50 matching reports.

USA-USFDACVM-2026-US-004595

Received 2026-01-26 · MSK · MSK

Serious
Species
Dog
Breed
Bulldog - American
Age
4-7 years (5.16 Year)
Sex
Female Neutered
Region
USA
Reactions
Other abnormal test result NOSTooth disorderBumps on skinCyst NOSAllergy NOSLoose stoolCrustLocal erythemaLickingDermal noduleOtitis NOSScratchingSneezingDermatitisBehavioural disorder NOSHair loss NOSNasal dischargeWeight gainSkin disorders NOSAlopecia generalAbnormal cytologyLocalised pain NOS (see other SOCs for specific pain)Salivary stainingAnxietySkin lumpMast cell tumourReddening of the skinSkin lesion NOSLack of efficacy (bacteria) - Ehrlichia
Body systems
OtherBehaviorSkin & allergyDigestiveEffectiveness
Outcomes
Ongoing

USA-USFDACVM-2025-US-070191

Received 2025-11-21 · MSK · MSK

Non-serious
Species
Dog
Breed
['Terrier (unspecified)', 'Dog (unknown)']
Size / weight
10-24 lb (5.987 Kilogram)
Age
Under 1 year (5 Month)
Sex
Female Unknown
Region
USA
Reactions
AlopeciaBacterial skin infection NOSRingwormVomitingCoughBloody diarrhoeaBehavioural disorder NOSLack of efficacy (bacteria) - Anaplasma
Body systems
Skin & allergyOtherDigestiveBehaviorEffectiveness
Outcomes
Outcome Unknown

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

Tracked signals
32
Reported cases
32
Serious reports
22
Species represented
2
Grouped by Body System
Digestive (3) · Loss of appetite, Decreased appetite, Bloody diarrhoea Skin & allergy (2) · Hair loss, Alopecia general Behavior (3) · Biting -aggression, Behavioral disorder (unspecified), Anxiety Other (24) · Dehydration, Death, Cystitis
Most Reported Reactions
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)

View detailed reaction table
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
Source metadata:

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.

Credelio™ SPL · SPL Credelio™ CAT SPL · SPL Credelio™ SPL · SPL

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

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

9

FOI

11

Credelio™

SPL · SPL

Open original
FDA Structured Product Label

Credelio™

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.
E
6662
Status
RX
Form
Chewable Tablets
Route
Oral
Composition / specifications
Each chewable tablet contains 56.25 mg, 112.5 mg, 225 mg, 450 mg, or 900 mg lotilaner

Dogs

Indication

For the treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in dogs and puppies.

Dosage

Administer orally at the minimum dosage of 9 mg/lb (20 mg/kg) with food.

Credelio™ CAT

SPL · SPL

Open original
FDA Structured Product Label

Credelio™ CAT

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.
E
6664
Status
RX
Form
Chewable Tablets
Route
Oral
Composition / specifications
Each chewable tablet contains 12 mg or 48 mg lotilaner

Cats

Indication

For the treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in cats and kittens.

Dosage

Administer orally at the minimum dosage of 2.7 mg/lb (6 mg/kg) with food.

Credelio™

SPL · SPL

Open original
FDA Structured Product Label

Credelio™

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
141-494
Status
RX
Form
Chewable Tablets
Route
Oral
Species
Dog
Composition / specifications
Each chewable tablet contains 56.25 mg, 112.5 mg, 225 mg, 450 mg, or 900 mg lotilaner.

Dogs

Indication

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.

Dosage

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.

Credelio™ CAT

SPL · SPL

Open original
FDA Structured Product Label

Credelio™ CAT

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
141-528
Status
RX
Form
Chewable Tablets
Route
Oral
Species
Cat
Composition / specifications
Each chewable tablet contains 12 mg or 48 mg lotilaner.

Cats

Indication

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.

Dosage

Administer orally once a month at the minimum dosage of 2.7 mg/lb (6 mg/kg). Must be administered with food.

Credelio SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Credelio. Use the source link for the full official labeling record.

Credelio SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Credelio. Use the source link for the full official labeling record.

Credelio SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Credelio. Use the source link for the full official labeling record.

Credelio SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Credelio. Use the source link for the full official labeling record.

Credelio SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Credelio. Use the source link for the full official labeling record.

FOI Summary oV 006-662 Authorized October 24, 2025.pdf

FOI · FOI

Open original

FOI oV 006-664 Authorized November 21, 2025.pdf

FOI · FOI

Open original

FOI Summary sN 141-494 Approved October 24, 2025.pdf

FOI · FOI

Open original

FOI Summary sN 141-494 Approved September 3, 2019.pdf

FOI · FOI

Open original

FOI Summary oN 141-494 Approved January 19, 2017.pdf

FOI · FOI

Open original

FOI Summary sN 141-528 Approved April 12, 2021.pdf

FOI · FOI

Open original

FOI Summary oN 141-528 Approved December 9, 2019.pdf

FOI · FOI

Open original

FOI Summary oN 141-581 Approved October 7, 2024.pdf

FOI · FOI summary

Open original

FOI Summary sN 141-581 Approved May 21, 2025.pdf

FOI · FOI summary

Open original

FOI Summary sN 141-581 Approved October 20, 2025.pdf

FOI · FOI summary

Open original

FOI Summary o 141-619 Approved December 17, 2025 (2).pdf

FOI · FOI summary

Open original
Source metadata:
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, 7:47 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.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • 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 • FDA branded products available
Official FDA brands: Credelio
Manufacturer mapping: Elanco US Inc.
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Cat, Dog
Rx/OTC: RX
Form/route: Chewable Tablets • Oral
Applications: E 6662 • E 6664 • NADA 141-494 • NADA 141-528
NDC: Packages 58198-5451-1 58198-5451-2 58198-5451-3 58198-5451-4 58198-5451-6 58198-5451-7 • Products 58198
Documents: 7 (FOI: 7) • SPL: 4 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 88 • Cat 83 • View
Case summaries: 42 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95), Fda_Label (0.95)
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.

Top reaction signals
Dehydration (1) Decreased appetite (1) Death (1) Cystitis (1) Cyst NOS (1) Crust (1) Constipation (1) Conjunctivitis (1)

Identifiers & Packages

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

Identifiers
NADA: 141494 NADA: 141528 NADA: 141581 NADA: 141619 NADA: 6662 NADA: 6664 NDC Package: 58198-5451-1 NDC Package: 58198-5451-2 NDC Package: 58198-5451-3 NDC Package: 58198-5451-4 NDC Package: 58198-5451-6 NDC Package: 58198-5451-7 NDC Package: 58198-5452-1 NDC Package: 58198-5452-2 NDC Package: 58198-5452-3 NDC Package: 58198-5452-4 NDC Package: 58198-5452-5 NDC Package: 58198-5452-6 NDC Package: 58198-5452-7 NDC Package: 58198-5454-1 NDC Package: 58198-5454-2 NDC Package: 58198-5454-3 NDC Package: 58198-5454-4 NDC Package: 58198-5454-6
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 -

Enriched Documents

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

Data Sources & Change Log

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

Official 135 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Vomiting, Diarrhoea, Lack of efficacy (ectoparasite) - tick NOS, Other abnormal test result NOS, Lethargy (see also Central n… (Clinical, 2026-04-11)
  • indications: Credelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations … (Official, 2026-08-06)
  • indications: Credelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations … (Official, 2026-08-05)
  • indications: Credelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations … (Official, 2026-08-04)
  • indications: Credelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations … (Official, 2026-08-03)
  • indications: Credelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations … (Official, 2026-08-02)
  • indications: Credelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations … (Official, 2026-08-01)
  • indications: Credelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations … (Official, 2026-07-31)
  • indications: Credelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations … (Official, 2026-07-30)
  • indications: Credelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations … (Official, 2026-07-29)
  • indications: Credelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations … (Official, 2026-07-28)
  • indications: Credelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations … (Official, 2026-07-27)
  • indications: Credelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations … (Official, 2026-07-26)
  • indications: Credelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations … (Official, 2026-07-25)
  • indications: Credelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations … (Official, 2026-07-25)
  • indications: Credelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations … (Official, 2026-07-22)
  • indications: Credelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations … (Official, 2026-07-22)
  • indications: Credelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations … (Official, 2026-07-22)
  • indications: Credelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations … (Official, 2026-07-20)
  • indications: Credelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations … (Official, 2026-07-19)
Recent Revisions
  • side_effects updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

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

Product Sponsor Application Status Published
Credelio™
RX
Lotilaner
Chewable Tablets • Oral
Label highlights
Official documents
Elanco US Inc. E 6662 G Jan 26, 2026
Credelio™ CAT
RX
Lotilaner
Chewable Tablets • Oral
Label highlights
Official documents
Elanco US Inc. E 6664 G Jan 26, 2026
Credelio™
RX
Lotilaner
Chewable Tablets • Oral
Label highlights
Official documents
Elanco US Inc. NADA 141-494 Approved Nov 3, 2025
Credelio™ CAT
RX
Lotilaner
Chewable Tablets • Oral
Label highlights
Official documents
Elanco US Inc. NADA 141-528 Approved May 3, 2021

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.

Composition / specifications
Each chewable tablet contains 56.25 mg, 112.5 mg, 225 mg, 450 mg, or 900 mg lotilaner
Dogs
Indication

For the treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in dogs and puppies.

Dosage

Administer orally at the minimum dosage of 9 mg/lb (20 mg/kg) with food.

Limitations

FDA page: Open in Animal Drugs @ FDA

Composition / specifications
Each chewable tablet contains 12 mg or 48 mg lotilaner
Cats
Indication

For the treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in cats and kittens.

Dosage

Administer orally at the minimum dosage of 2.7 mg/lb (6 mg/kg) with food.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog
Composition / specifications
Each chewable tablet contains 56.25 mg, 112.5 mg, 225 mg, 450 mg, or 900 mg lotilaner.
Dogs
Indication

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.

Dosage

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.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Cat
Composition / specifications
Each chewable tablet contains 12 mg or 48 mg lotilaner.
Cats
Indication

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.

Dosage

Administer orally once a month at the minimum dosage of 2.7 mg/lb (6 mg/kg). Must be administered with food.

Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

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

Top Reported Reactions (openFDA)

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

Digestive
Loss of appetite (1) • Dog Decreased appetite (1) • Cat Bloody diarrhoea (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Hair loss (1) • Dog Alopecia general (1) • Dog

Showing top 5 for Skin & allergy.

Behavior
Biting -aggression (1) • Dog Behavioral disorder (1) • Cat Anxiety (1) • Dog

Showing top 5 for Behavior.

Other
Dehydration (1) • Cat Death (1) • Cat Cystitis (1) • Dog Cyst NOS (1) • Dog Cyanotic spots/blotchy skin (1) • Dog
Show more (19)
Crust (1) • Dog Cough (1) • Dog Constipation (1) • Cat Conjunctivitis (1) • Dog Bumps on skin (1) • Dog Bloody stool (1) • Cat Bloodshot eye (1) • Dog Bilirubinuria (1) • Cat Bacterial skin infection NOS (1) • Dog Arched back (1) • Cat Anuria (1) • Cat Allergy NOS (1) • Dog Agitation (1) • Cat Adipsia (1) • Cat Accidental exposure (1) • Dog Abnormal radiograph finding (1) • Cat Abnormal posture NOS (1) • Cat Abnormal posture (1) • Cat Abnormal cytology (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.

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

  • Report ID: USA-USFDACVM-2026-US-014498
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 10.00 Year
  • Weight: 5.120 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
  • Frequency: 1 per month
Reactions Reported:
Lack of efficacy (bacteria) - Borrelia Other abnormal test result NOS
Outcomes: 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

  • Report ID: USA-USFDACVM-2026-US-014202
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 1.00 Year
  • Weight: 44.100 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 2 tablet per animal
Reactions Reported:
Drooping eyelid Bloodshot eye Accidental exposure
Outcomes: 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

  • Report ID: USA-USFDACVM-2026-US-014201
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 16.00 Year
  • Weight: 13.600 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
Reactions Reported:
Vomiting
Outcomes: 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

  • Report ID: USA-USFDACVM-2026-US-014234
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 10.00 Year
  • Weight: 9.979 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
  • Frequency: 1 per month
Reactions Reported:
Lack of efficacy (bacteria) - Anaplasma
Outcomes: 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

  • Report ID: USA-USFDACVM-2026-US-013846
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 4.60 Year
  • Weight: 24.500 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
  • Frequency: 1 per month
Reactions Reported:
Lack of efficacy (endoparasite) - hookworm Other abnormal test result NOS
Outcomes: 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

  • Report ID: USA-USFDACVM-2026-US-013647
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 2.00 Year
  • Weight: 19.680 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 dose per animal
  • Frequency: 1 per month
Reactions Reported:
Hiding Vocalisation Pacing Loss of appetite Generalised itching Drooling Vomiting
Outcomes: 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

  • Report ID: USA-USFDACVM-2026-US-013808
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 26.260 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 dose per animal
Reactions Reported:
Vomiting Not eating Bloody stool Haematemesis Anxiety Lack of efficacy - NOS Intentional misuse Low thyroxine Elevated blood urea nitrogen Elevated amylase Gastritis
Outcomes: Ongoing

Cat, Domestic Shorthair, Female, 13 year, 6.427 kilogram • Drug: MSK, Tablet, chewable, Unknown • Reactions: Itching, Skin lesion NOS, Skin scab • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013313
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 13.00 Year
  • Weight: 6.427 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Tablet, chewable
Reactions Reported:
Itching Skin lesion NOS Skin scab
Outcomes: Ongoing

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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