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Roxee Medication Guide

Dirlotapide

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 (Solution) Zoetis Inc. Official label facts Owner quick guide first
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Showing simplified owner view. Switch to Vet View for full technical detail.

Data freshness

Reference facts
Reference refreshed
Jun 22, 2026, 10:40 a.m.

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

FDA applications
FDA application data refreshed
Jun 22, 2026, 10:40 a.m.

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

Safety reports
No safety reports linked
No refresh timestamp yet

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

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:40 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 AM 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.
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Dirlotapide

Dirlotapide

Drug type: Generic ingredient • Generic profile • No FDA branded products linked

Both Liquid (Solution) Rx required 100% reference complete

Species: Both

Manufacturer: Zoetis Inc.

Medication Snapshot

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

Dirlotapide

For the management of obesity. Species commonly shown: Both, Dog.

Generic name
Dirlotapide
Brand names
Slentrol®
Manufacturer
Zoetis Inc.
Species
Both, Dog
Dosage forms
Liquid (Solution)
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Slentrol®
Dosage forms
Liquid (Solution)

Indications / Uses

For the management of obesity.

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only.

  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only.

Side Effects

Top reported reactions (openFDA): Hyperextension, INEFFECTIVE, WEIGHT LOSS.

FAQ

Both, Dog

Yes. Roxee shows this as prescription-only.

Liquid (Solution)

Related Conditions

Obesity Obesity Weight loss

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 management of obesity.

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 dogs only
  • INEFFECTIVE, WEIGHT LOSS (1 reports)
  • Hyperextension (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.

Regulatory restrictions are shown in Vet View.

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

Source: openFDA case USA-USFDACVM-2018-US-043995
Safety signal coverage Reported signals

2 tracked reaction signals; 2 reported cases; 1 species group. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2018-US-043995
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-2018-US-043995
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

INEFFECTIVE, WEIGHT LOSS (1 reports), Hyperextension (1 reports)

Body systems represented Signal grouping

Other (2)

Species and breed lens

Species represented in reports Species lens

Dog (2 reports)

What your vet may verify

Fit for this patient Vet check

Verify whether Dirlotapide 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 dogs only, INEFFECTIVE, WEIGHT LOSS, Hyperextension

Call sooner if Escalation

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

Bottom line: Use this Dirlotapide 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-2018-US-043995 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  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

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:

  • For oral use in dogs only
  • INEFFECTIVE, WEIGHT LOSS
  • Hyperextension

Most reported reactions:

  • INEFFECTIVE, WEIGHT LOSS (1 reports)
  • Hyperextension (1 reports)

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
Dog
Indication / use
For the management of obesity.
Form / route / dose
Form: Liquid (Solution)
Route: Oral
Confirm product label and patient-specific plan.
Warnings
  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only.
Adverse-event caveat
No stored openFDA case explorer rows are linked yet.
Source docs

Quick Facts

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

Species: Both
Manufacturer: Zoetis Inc.
Form: Liquid (Solution)
Identifiers:
NADA: 141260
Source metadata:

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only.

  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only.
Source metadata:

Adverse Reactions

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

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

Tracked signals
2
Reported cases
2
Serious reports
0
Species represented
1
Grouped by Body System
Other (2) · INEFFECTIVE, WEIGHT LOSS, Hyperextension
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 0
Other 1 Dog 0

Species coverage: Dog (2)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Other Dog Non-serious - 1
Other Dog Non-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.

Slentrol® SPL · SPL UCM050063.pdf FOI · FOI

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

1

FOI

1

Slentrol®

SPL · SPL

Open original
FDA Structured Product Label

Slentrol®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Zoetis Inc.
NADA
141-260
Status
RX
Form
Liquid (Solution)
Route
Oral
Species
Dog
Composition / specifications
Each milliliter (mL) of solution contains 5 milligrams (mg) dirlotapide.

Dogs

Indication
For the management of obesity.
Dosage
The initial dosage is 0.01 mL/kg (0.0045 mL/lb body weight for the first 14 days. After the first 14 days of treatment, the dose volume is doubled to 0.02 mL/kg (0.009 mL/lb) body weight for the next 14 days (days 15 to 28 of treatment). Dogs should be weighed monthly and the dose volume adjusted every month, as necessary, to maintain a target percent weight loss until the desired weight is achieved.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only.

UCM050063.pdf

FOI · FOI

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 Jun 22, 2026, 10:40 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 AM 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.
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Liquid (Solution) • Oral
Applications: NADA 141-260
Documents: 1 (FOI: 1) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 0 • Cat 0 • View
Case summaries: 0
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Obesity Obesity Weight loss
Linked using: Fda_Label (0.95), Fda_Label (0.95), Fda_Label (0.95)
Diagnosis Codes
ICD10_CM: E66.9
Obesity, unspecified

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
  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. (Contraindication, High)
Top reaction signals
INEFFECTIVE, WEIGHT LOSS (1) Hyperextension (1)

Identifiers & Packages

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

Identifiers
NADA: 141260

Enriched Documents

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

  • UCM050063.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 141260

Data Sources & Change Log

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

Official 6 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Hyperextension, INEFFECTIVE, WEIGHT LOSS. (Clinical, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. (Official, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. (Official, 2026-02-12)
  • side_effects: Top reported reactions (openFDA): Hyperextension, INEFFECTIVE, WEIGHT LOSS. (Official, 2026-02-12)
  • usage: For the management of obesity. (Official, 2026-04-11)
  • usage: For the management of obesity. (Official, 2026-02-12)
Recent Revisions
  • 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
Slentrol®
RX
Dirlotapide
Liquid (Solution) • Oral
Label highlights
Official documents
Zoetis Inc. NADA 141-260 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
Composition / specifications
Each milliliter (mL) of solution contains 5 milligrams (mg) dirlotapide.
Dogs
Indication
For the management of obesity.
Dosage
The initial dosage is 0.01 mL/kg (0.0045 mL/lb body weight for the first 14 days. After the first 14 days of treatment, the dose volume is doubled to 0.02 mL/kg (0.009 mL/lb) body weight for the next 14 days (days 15 to 28 of treatment). Dogs should be weighed monthly and the dose volume adjusted every month, as necessary, to maintain a target percent weight loss until the desired weight is achieved.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only.

FDA page: Open in Animal Drugs @ FDA

Usage

For the management of obesity.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only.

Top Reported Reactions (openFDA)

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

Other
INEFFECTIVE, WEIGHT LOSS (1) • Dog Hyperextension (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.

No case-level openFDA reports are linked for this medication yet.

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.

This medication has not been reviewed by a veterinarian yet.