Roxee Medication Guide

Lufenuron

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 Liquid (Suspension) Multiple FDA labelers Official label facts Owner quick guide first

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Data freshness

Reference facts

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

FDA applications

FDA application data refreshed

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

Safety reports

Safety data refreshed

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

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

Source timing details

Reference facts: Source Roxee | Refreshed Aug 6, 2026, 7:47 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

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Lufenuron

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

Both Liquid (Suspension) Rx required 100% reference complete

Species: Both

Manufacturer: Multiple FDA labelers

Medication Snapshot

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

Lufenuron

For control of flea populations. For use in cats and kittens, 4 weeks of age and older, for the control of flea populations. 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. For use in dogs and puppies, 4 weeks of age and older, for the prevention and control of flea populations. 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. Species commonly shown: Both, Cats and kittens, excluding kittens under 6 weeks age, Dog, Excluding Under 6 Weeks Age.

Generic name

Lufenuron

Brand names

Program™ Suspension, Program® Flavor Tabs®, Program® Cat Flavor Tabs™, Program™ 6 Month Injectable for Cats

Manufacturer

Multiple FDA labelers

Species

Both, Cats and kittens, Dog

Dosage forms

Liquid (Suspension), Tablet, Tablet (Chewable)

Prescription

Prescription required

Completeness

100%

Validation

Complete

Brand names

Program™ Suspension Program® Flavor Tabs® Program® Cat Flavor Tabs™ Program™ 6 Month Injectable for Cats AX Pharmaceutical Corp LUFENURON

Dosage forms

Liquid (Suspension) Tablet Tablet (Chewable)

Indications / Uses

Warnings / Contraindications

For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in conjunction with a full meal to ensure adequate absorption. Treat all cats in the household to ensure maximum benefits. Because the drug has no affect on adult fleas, the concurrent use of insecticides that kill adults may be necessary depending on the severity of the infestation. Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month. All cats in a household should be treated to achieve maximum efficacy. Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month.. All dogs in a household should be treated to achieve maximum efficacy.

For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in conjunction with a full meal to ensure adequate absorption. Treat all cats in the household to ensure maximum benefits. Because the drug has no affect on adult fleas, the concurrent use of insecticides that kill adults may be necessary depending on the severity of the infestation. Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month. All cats in a household should be treated to achieve maximum efficacy. Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month.. All dogs in a household should be treated to achieve maximum efficacy.

Side Effects

Top reported reactions (openFDA): INEFFECTIVE, HOOKS, Vomiting, Lack of efficacy (endoparasite) - heartworm, Diarrhoea, Lack of efficacy (heartworm), Lack of efficacy (roundworm).

FAQ

Both, Cats and kittens, excluding kittens under 6 weeks age, Dog, Excluding Under 6 Weeks Age

Yes. Roxee shows this as prescription-only.

Liquid (Suspension), Tablet, Tablet (Chewable)

Related Medications

Related Conditions

Fleas (Flea Infestation)

Source Transparency

Verified source: https://www.roxee.ai/meds/
Verified source: https://animaldrugsatfda.fda.gov
Verified source: https://animaldrugsatfda.fda.gov/adafda/views/#/search
Verified source: https://api.fda.gov/animalandveterinary/event.json
Verified source: https://www.roxee.ai/conditions/
Verified source: https://www.accessdata.fda.gov/spl/data/98e66cf0-7502-4742-9d17-f8f84858437a/98e66cf0-7502-4742-9d17-f8f84858437a.xml
Last refreshed: Aug 6, 2026, 7:47 p.m.
Last verified: Feb 12, 2026, 10:44 p.m.
Validation status: Complete

Add to My Pet's Medications

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

For use in cats and kittens, 4 weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of...

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:

For oral use in cats 6 weeks of age or older, once a month, mixed with food
Administer in conjunction with a full meal to ensure adequate absorption
Treat all cats in the household to ensure maximum benefits
Because the drug has no affect on adult fleas, the concurrent use of insecticides that kill adults may be necessary depending on the severity of the infestation
Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption
Administer tablet(s) once a month
All cats in a household should be treated to achieve maximum efficacy
All dogs in a household should be treated to achieve maximum efficacy
very low energy (1 reports)
Ocular discharge (1 reports)
Not eating (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 Lufenuron; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-017856

Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 27 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-017856

Interpretation guardrail Not causation

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

Evidence tension

Stronger signal Label / review

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

Source: openFDA case USA-USFDACVM-2025-US-017856

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

Tiredness (lethargy) (1 reports), Ocular discharge (1 reports), Not eating (1 reports), Neurogenic keratoconjunctivitis sicca (1 reports), Loose stool (1 reports)

Body systems represented Signal grouping

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

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (26 reports), Cat (6 reports)

Breed metadata in reports Metadata only

Shiba Inu (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 Lufenuron 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

For oral use in cats 6 weeks of age or older, once a month, mixed with food, Administer in conjunction with a full meal to ensure adequate absorption, Treat all cats in the household to ensure maximum benefits, Because the drug has no affect on adult fleas, the concurrent use of insecticides that kill adults m, Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption

Call sooner if Escalation

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

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

Vet source depth

openFDA case USA-USFDACVM-2025-US-017856 · adverse_reaction · adverse reactions
Contraindication source · fda_animal_drugs · warnings contraindications
FDA application profile · official_label · quick facts
FDA application profile · official_label · quick facts
Medication usage source · fda_animal_drugs · quick facts
FOI · document · documents
FOI · document · documents
FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

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

Sources:

FDA application profile · official_label
FDA application profile · official_label
Medication usage source · fda_animal_drugs
Program™ 6 Month Injectable for Cats · official_label
openFDA case USA-USFDACVM-2025-US-017856 · adverse_reaction

Safety & side effects

Side effects to monitor:

For oral use in cats 6 weeks of age or older, once a month, mixed with food
Administer in conjunction with a full meal to ensure adequate absorption
Treat all cats in the household to ensure maximum benefits
Because the drug has no affect on adult fleas, the concurrent use of insecticides that kill adults may be necessary depending on the severity of the infestation
Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption

Most reported reactions:

Tiredness (lethargy) (1 reports)
Ocular discharge (1 reports)
Not eating (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

Cats and kittens, Dog

Indication / use

For use in cats and kittens, 4 weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea eggs and does…

Form / route / dose

Form: Liquid (Suspension), Tablet, Tablet (Chewable)
Route: Oral, Subcutaneous
Confirm product label and patient-specific plan.

Warnings

High: For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in conjunction with a full meal…

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

Program® Flavor Tabs® SPL
Program™ Suspension SPL
Program™ 6 Month Injectable for Cats SPL

Quick Facts

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

Species: Both

Manufacturer: Multiple FDA labelers

Form: Liquid (Suspension), Tablet, Tablet (Chewable)

Identifiers:

NADA: 141026 NADA: 141035 NADA: 141062 NADA: 141084 NADA: 141105 NADA: 141204 NADA: 141205 NADA: 141333 NDC Package: 0061-5350-01 NDC Package: 0061-5350-02 NDC Package: 0061-5351-01 NDC Package: 0061-5351-02 NDC Package: 0061-5352-01 NDC Package: 0061-5352-02 NDC Package: 0061-5353-01 NDC Package: 0061-5353-02 NDC Package: 0061-5354-01 NDC Package: 0061-5354-02 NDC Package: 0061-5355-01 NDC Package: 0061-5355-02

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141035 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141026 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source

Warnings / Contraindications

High: For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in conjunction with a full meal to ensure adequate absorption. Treat all cats in the household to ensure maximum benefits. Because the drug has no affect on adult fleas, the concurrent use of insecticides that kill adults may be necessary depending on the severity of the infestation. Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month. All cats in a household should be treated to achieve maximum efficacy. Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month.. All dogs in a household should be treated to achieve maximum efficacy.

Source metadata:

https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Reported case explorer

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

Clear filters

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

Stored reports

Matching reports

Active filters

Species

Breed

Size / weight

Age

Sex

Seriousness

Outcome

Reaction

Body system

Region

Received after

Received before

Reset

Drill into common report signals

Crying (1) Ear canal disorder (1) Facial paralysis (1) Hiding (1) Other (1)

Showing up to 50 matching reports.

USA-USFDACVM-2026-US-013281

Received 2026-03-09 · MSK · MSK

Serious

Species: Dog
Breed: Shiba Inu
Size / weight: 10-24 lb (11.3 Kilogram)
Age: 4-7 years (4.5 Year)
Sex: Female Neutered
Region: USA
Reactions: SquintingHorner's syndromeNeurogenic keratoconjunctivitis sicca (KCS)HyperaemiaOcular dischargeFacial paralysisEar canal disorderCryingHidingPain NOSTympanic alterationPalpebral disorder NOS
Body systems: Other
Outcomes: Ongoing

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

Tracked signals

Reported cases

Serious reports

Species represented

Grouped by Body System

Digestive (3) · Haemorrhagic diarrhoea, Diarrhea, Appetite loss Skin & allergy (3) · Injection site swelling, Hives, Facial swelling (possible allergy) Neurologic (1) · Tiredness (lethargy) Behavior (1) · Behavioral disorder (unspecified) Effectiveness (4) · Lack of efficacy (fungi) - NOS, Lack of efficacy (endoparasite) - tapeworm, Lack of efficacy (endoparasite) - heartworm Other (20) · Ocular discharge, Not eating, Neurogenic keratoconjunctivitis sicca

Most Reported Reactions

Body system	Cases	Species	Serious cases
Neurologic	1	Dog	1
Other	1	Dog	1
Other	1	Dog	1
Other	1	Dog	1
Other	1	Dog	1
Effectiveness	1	Dog	1
Effectiveness	1	Dog	1
Other	1	Dog	1

Species coverage: Dog (26) Cat (6)

View detailed reaction table

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

Source metadata:

https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-017856

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.

Program® Flavor Tabs® SPL · SPL Program™ Suspension SPL · SPL Program™ 6 Month Injectable for Cats SPL · SPL

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

Owner handouts

No owner handouts linked yet.

Official label / PI

No official label or package insert links yet.

SPL

FOI

Program® Flavor Tabs®

SPL · SPL

Open original

FDA Structured Product Label

Program® Flavor Tabs®

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: 141-035
Status: OTC
Form: Tablet
Route: Oral
Species: Dog • Cats and kittens

Composition / specifications

Each tablet contains either 45, 90, 204.9, or 409.8 milligrams of lufenuron.

Cats and Kittens (4 Weeks of Age and Older)

Indication

Dosage

Minimum of 30 milligrams of lufenuron per kilogram (13.6 milligrams per pound) of body weight.

Limitations

Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month. All cats in a household should be treated to achieve maximum efficacy.

Dogs (4 Weeks of Age and Older)

Indication

For use in dogs and puppies, 4 weeks of age and older, for the prevention and control of flea populations. 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.

Dosage

Minimum of 10 milligrams of lufenuron per kilogram (4.5 milligrams per pound of body weight).

Limitations

Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month.. All dogs in a household should be treated to achieve maximum efficacy.

Program™ Suspension

SPL · SPL

Open original

FDA Structured Product Label

Program™ Suspension

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: 141-026
Status: OTC
Form: Liquid (Suspension)
Route: Oral
Species: Cats and kittens

Composition / specifications

Each individual dose pack contains either 135 or 270 milligrams of lufenuron.

Cats and Kittens (6 Weeks of Age and Older)

Indication

For control of flea populations.

Dosage

Minimum of 13.6 milligrams per pound of body weight (30 milligrams per kilogram). Recommended dose of 135 milligrams for up to 10 pounds of body weight or 270 milligrams for 11 to 20 pounds. Cats over 20 pounds are provided the appropriate combination of packs.

Limitations

Program™ 6 Month Injectable for Cats

SPL · SPL

Open original

FDA Structured Product Label

Program™ 6 Month Injectable for Cats

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: 141-105
Status: RX
Form: Liquid (Suspension)
Route: Subcutaneous
Species: Cats and kittens

Composition / specifications

Each milliliter of sterile aqueous suspension contains 10 milligrams of lufenuron.

Cats (6 Weeks of Age and Older)

Indication

For use in cats 6 weeks of age and older, for control of flea populations. 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.

Dosage

PROGRAM 6 Month Injectable for Cats is injected subcutaneously once every six months at the recommended minimum dosage of 4.54 mg lufenuron per pound (10 mg/kg) of body weight.

Limitations

Do not use in dogs. A severe local reaction may occur in dogs that is not seen in cats.

Program® Cat Flavor Tabs™

SPL · SPL

Open original

FDA Structured Product Label

Program® Cat Flavor Tabs™

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: 141-062
Status: OTC
Form: Tablet (Chewable)
Route: Oral
Species: Cats and kittens

Composition / specifications

Each flavor tablet contains 135 or 270 milligrams lufenuron.

Cats and Kittens (6 Weeks of Age and Older)

Indication

For control of flea populations.

Dosage

FOI · FOI summary

Open original

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1370 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1371 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/568 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1372 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/567 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1858/Program%C2%AE%20Flavor%20Tabs%C2%AE · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/2507 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/561 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1831/Program%E2%84%A2%20Suspension · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/2222 · document · FOI

Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness

Reference facts: Source Roxee | Refreshed Aug 6, 2026, 7:47 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: AX Pharmaceutical Corp LUFENURON Lufenuron

Manufacturer mapping: Multiple FDA labelers

Case-reported brands (openFDA): MSK

Catalog species: Both • FDA-labeled species: Cats and kittens, Dog

Rx/OTC: OTC, RX

Form/route: Liquid (Suspension), Tablet, Tablet (Chewable) • Oral, Subcutaneous

Applications: NADA 141-035 • NADA 141-026 • NADA 141-105 • NADA 141-062

NDC: Packages 62157-587-01 62157-588-01 72969-114-10 73377-136-01 73377-136-02 73377-136-03 • Products 62157 72969 73377 86154

Documents: 9 (FOI: 9) • SPL: 4 • Label highlights • Official documents

Safety (openFDA)

Top reactions: Dog 12 • Cat 0 • View

Case summaries: 1 (showing 1) • View

openFDA reports are unverified and do not prove causation.

Explore

Related conditions: Fleas (Flea Infestation)

Linked using: 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.

Owner-facing counseling points

For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in conjunction with a full meal to ensure adequate absorption. Treat all cats in the household to ensure maximum benefits. Because the drug has no affect on adult fleas, the concurrent use of insecticides that kill adults may be necessary depending on the severity of the infestation. Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month. All cats in a household should be treated to achieve maximum efficacy. Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month.. All dogs in a household should be treated to achieve maximum efficacy. (Contraindication, High)

Top reaction signals

Tiredness (lethargy) (1) Ocular discharge (1) Not eating (1) Neurogenic keratoconjunctivitis sicca (1) Loose stool (1) Lack of efficacy (fungi) - NOS (1) Lack of efficacy (endoparasite) - heartworm (1) Hyperphosphataemia (1)

Identifiers & Packages

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

Identifiers

Package NDC	Product NDC	Status
0061-5350-01	0061	-
0061-5350-02	0061	-
0061-5351-01	0061	-
0061-5351-02	0061	-
0061-5352-01	0061	-
0061-5352-02	0061	-
0061-5353-01	0061	-
0061-5353-02	0061	-
0061-5354-01	0061	-
0061-5354-02	0061	-
0061-5355-01	0061	-
0061-5355-02	0061	-
0061-5356-01	0061	-
0061-5356-02	0061	-
0061-5357-01	0061	-
0061-5357-02	0061	-
62157-587-01	62157	-
62157-588-01	62157	-
72969-114-10	72969	-
73377-136-01	73377	-

Enriched Documents

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

Lufenuron SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Lufenuron SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
AX Pharmaceutical Corp SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
LUFENURON SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
AX Pharmaceutical Corp SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Lufenuron SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
UCM292003.pdf • FOI summary • Official • Aug. 3, 2020
FDA FOI summary for application 141333
FOI Summary sN-141-333 Approved September 28, 2017.pdf • FOI summary • Official • Aug. 3, 2020
FDA FOI summary for application 141333
ucm117654.pdf • FOI summary • Official • Aug. 3, 2020
FDA FOI summary for application 141204
N141084_Orig_4_10_1997.pdf • FOI summary • Official • Aug. 3, 2020
FDA FOI summary for application 141084
N141084_Supp_6_17_1998.pdf • FOI summary • Official • Aug. 3, 2020
FDA FOI summary for application 141084
ucm117024.pdf • FOI summary • Official • Aug. 3, 2020
FDA FOI summary for application 141084
UCM487821.pdf • FOI summary • Official • Nov. 26, 2018
FDA FOI summary for application 141035
N141035_Supp_12_31_1996.pdf • FOI summary • Official • Nov. 26, 2018
FDA FOI summary for application 141035
UCM472708.pdf • FOI summary • Official • Nov. 26, 2018
FDA FOI summary for application 141035
N141035_Supp_8_1_1998.pdf • FOI summary • Official • Nov. 26, 2018
FDA FOI summary for application 141035
N141035_Supp_6_11_2003.pdf • FOI summary • Official • Nov. 26, 2018
FDA FOI summary for application 141035
UCM487816.pdf • FOI summary • Official • Dec. 7, 2017
FDA FOI summary for application 141026
N141026 Supp_12_31_1996.pdf • FOI summary • Official • Dec. 7, 2017
FDA FOI summary for application 141026
N141105 Orig_3_31_1998.pdf • FOI summary • Official • Aug. 24, 2017
FDA FOI summary for application 141105
UCM455993.pdf • FOI summary • Official • June 1, 2016
FDA FOI summary for application 141062
ucm117656.pdf • FOI summary • Official • June 1, 2016
FDA FOI summary for application 141205

Data Sources & Change Log

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

Official 141 Clinical 1 Manufacturer 0 Marketing 0

Current Field Facts

side_effects: Top reported reactions (openFDA): INEFFECTIVE, HOOKS, Vomiting, Lack of efficacy (endoparasite) - heartworm, Diarrhoea, Lack of efficacy (heartworm), Lack of e… (Clinical, 2026-04-11)
contraindications: For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in conjunction with a full meal to ensure adequate absorption. Treat al… (Official, 2026-07-03)
contraindications: For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in conjunction with a full meal to ensure adequate absorption. Treat al… (Official, 2026-04-11)
contraindications: For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in conjunction with a full meal to ensure adequate absorption. Treat al… (Official, 2026-02-12)
indications: For use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea egg… (Official, 2026-08-06)
indications: For use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea egg… (Official, 2026-08-05)
indications: For use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea egg… (Official, 2026-08-04)
indications: For use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea egg… (Official, 2026-08-03)
indications: For use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea egg… (Official, 2026-08-02)
indications: For use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea egg… (Official, 2026-08-01)
indications: For use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea egg… (Official, 2026-07-31)
indications: For use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea egg… (Official, 2026-07-30)
indications: For use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea egg… (Official, 2026-07-29)
indications: For use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea egg… (Official, 2026-07-28)
indications: For use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea egg… (Official, 2026-07-27)
indications: For use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea egg… (Official, 2026-07-26)
indications: For use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea egg… (Official, 2026-07-25)
indications: For use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea egg… (Official, 2026-07-25)
indications: For use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea egg… (Official, 2026-07-22)
indications: For use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea egg… (Official, 2026-07-22)

Recent Revisions

side_effects updated 2026-07-03 11:05 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-07-03 11:05 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-07-03 11:05 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
contraindications 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
contraindications 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
Program® Flavor Tabs® OTC Lufenuron Tablet • Oral Label highlights Official documents	Elanco US Inc.	NADA 141-035	Approved	Nov 26, 2018
Program™ Suspension OTC Lufenuron Liquid (Suspension) • Oral Label highlights Official documents	Elanco US Inc.	NADA 141-026	Approved	Dec 7, 2017
Program™ 6 Month Injectable for Cats RX Lufenuron Liquid (Suspension) • Subcutaneous Label highlights Official documents	Elanco US Inc.	NADA 141-105	Approved	Aug 24, 2017
Program® Cat Flavor Tabs™ OTC Lufenuron Tablet (Chewable) • Oral Label highlights Official documents	Elanco US Inc.	NADA 141-062	Approved	Jun 1, 2016

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Dog • Cats and kittens

Composition / specifications

Each tablet contains either 45, 90, 204.9, or 409.8 milligrams of lufenuron.

Cats and Kittens (4 Weeks of Age and Older)

Indication

Dosage

Minimum of 30 milligrams of lufenuron per kilogram (13.6 milligrams per pound) of body weight.

Limitations

Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month. All cats in a household should be treated to achieve maximum efficacy.

Dogs (4 Weeks of Age and Older)

Indication

Dosage

Minimum of 10 milligrams of lufenuron per kilogram (4.5 milligrams per pound of body weight).

Limitations

Administer tablet(s) after or in conjunction with a full meal to ensure adequate absorption. Administer tablet(s) once a month.. All dogs in a household should be treated to achieve maximum efficacy.

FDA page: Open in Animal Drugs @ FDA

Species: Cats and kittens

Composition / specifications

Each individual dose pack contains either 135 or 270 milligrams of lufenuron.

Cats and Kittens (6 Weeks of Age and Older)

Indication

For control of flea populations.

Dosage

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Cats and kittens

Composition / specifications

Each milliliter of sterile aqueous suspension contains 10 milligrams of lufenuron.

Cats (6 Weeks of Age and Older)

Indication

Dosage

PROGRAM 6 Month Injectable for Cats is injected subcutaneously once every six months at the recommended minimum dosage of 4.54 mg lufenuron per pound (10 mg/kg) of body weight.

Limitations

Do not use in dogs. A severe local reaction may occur in dogs that is not seen in cats.

FDA page: Open in Animal Drugs @ FDA

Species: Cats and kittens

Composition / specifications

Each flavor tablet contains 135 or 270 milligrams lufenuron.

Cats and Kittens (6 Weeks of Age and Older)

Indication

For control of flea populations.

Dosage

Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Top Reported Reactions (openFDA)

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

Digestive

Haemorrhagic diarrhoea (1) • Dog Diarrhea (1) • Dog Appetite loss (1) • Dog

Showing top 5 for Digestive.

Skin & allergy

Injection site swelling (1) • Cat Hives (1) • Dog Facial swelling (possible allergy) (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic

Tiredness (1) • Dog

Showing top 5 for Neurologic.

Behavior

Behavioral disorder (1) • Dog

Showing top 5 for Behavior.

Effectiveness

Lack of efficacy (fungi) - NOS (1) • Dog Lack of efficacy (endoparasite) - tapeworm (1) • Cat Lack of efficacy (endoparasite) - heartworm (1) • Dog Lack of efficacy (ectoparasite) - flea (1) • Cat

Showing top 5 for Effectiveness.

Other

Ocular discharge (1) • Dog Not eating (1) • Dog Neurogenic keratoconjunctivitis sicca (1) • Dog Loose stool (1) • Dog Injection site mucopurulent discharge (1) • Cat

Show more (15)

Injection site abscess (1) • Cat Hyperphosphataemia (1) • Dog Hyperaemia (1) • Dog Horner's syndrome (1) • Dog High pancreatic-specific lipase (1) • Dog Hiding (1) • Dog Haematuria (1) • Dog Facial paralysis (1) • Dog Elevated creatinine (1) • Dog Ear canal disorder (1) • Dog Digestive tract disorder NOS (1) • Dog Decreased bowel movements (1) • Dog Death (1) • Cat Crying (1) • Dog Anaphylaxis (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, Shiba Inu, Female, 4.5 year, 11.3 kilogram • Drug: MSK • Reactions: Squinting, Horner's syndrome, Neurogenic keratoconjunctivitis sicca, Hyperaemia, Ocular discharge… • Outcome: Ongoing

Report ID: USA-USFDACVM-2026-US-013281
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 4.50 Year
Weight: 11.300 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK

Reactions Reported:

Squinting Horner's syndrome Neurogenic keratoconjunctivitis sicca Hyperaemia Ocular discharge Facial paralysis Ear canal disorder Crying Hiding Pain NOS Tympanic alteration Palpebral disorder NOS

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.

Share Your Thoughts

Let others know your experience or advice regarding this medication.

No community reviews yet. Be the first to share your experience.

This medication has not been reviewed by a veterinarian yet.

Medical Disclaimer: The medication details provided on Roxee are for informational purposes only and are not a substitute for professional veterinary advice. Always consult your veterinarian about your pet's specific needs.

Lufenuron

Data freshness

Lufenuron

Medication Snapshot

Lufenuron

Indications / Uses

Warnings / Contraindications

Side Effects

FAQ

What species is this commonly shown for?

Does this usually require a prescription?

What dosage forms are listed?

Related Medications

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Medication Research Insights

What to know

Evidence tension

Reaction signal map

Species and breed lens

What your vet may verify

What to watch next

Evidence

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Quick Facts

Warnings / Contraindications

Adverse Reactions

Reported case explorer

USA-USFDACVM-2026-US-013281

Grouped by Body System

Most Reported Reactions

Source Documents

Owner handouts

Official label / PI

SPL

FOI

Program® Flavor Tabs®

Program® Flavor Tabs®

Cats and Kittens (4 Weeks of Age and Older)

Dogs (4 Weeks of Age and Older)

Program™ Suspension

Program™ Suspension

Cats and Kittens (6 Weeks of Age and Older)

Program™ 6 Month Injectable for Cats

Program™ 6 Month Injectable for Cats

Cats (6 Weeks of Age and Older)

Program® Cat Flavor Tabs™

Program® Cat Flavor Tabs™

Cats and Kittens (6 Weeks of Age and Older)

Lufenuron SPL

Lufenuron SPL

AX Pharmaceutical Corp SPL

LUFENURON SPL

AX Pharmaceutical Corp SPL

Lufenuron SPL

N141035_Supp_6_11_2003.pdf

N141035_Supp_8_1_1998.pdf

UCM472708.pdf

N141035_Supp_12_31_1996.pdf

UCM487821.pdf

N141026 Supp_12_31_1996.pdf

UCM487816.pdf

N141105 Orig_3_31_1998.pdf

UCM455993.pdf

UCM292003.pdf

FOI Summary sN-141-333 Approved September 28, 2017.pdf

ucm117654.pdf

N141084_Orig_4_10_1997.pdf

N141084_Supp_6_17_1998.pdf

ucm117024.pdf

ucm117656.pdf

At a Glance

Counseling and Monitoring Highlights

Identifiers & Packages

Enriched Documents

Data Sources & Change Log

FDA Products & Applications (Animal Drugs @ FDA)