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Roxee Medication Guide

Fluoxetine

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 Tablet (Chewable) Pegasus Laboratories, Inc. Official label facts Owner quick guide first
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Data freshness

Reference facts
Reference refreshed
Jun 22, 2026, 10:41 a.m.

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

FDA applications
FDA application data refreshed
Jun 22, 2026, 10:41 a.m.

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

Safety reports
Safety data refreshed
Jun 13, 2026, 11:29 a.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 Jun 22, 2026, 10:41 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.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
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Fluoxetine

Fluoxetine

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

Both Tablet (Chewable) Rx required 100% reference complete

Species: Both

Manufacturer: Pegasus Laboratories, Inc.

Medication Snapshot

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

Fluoxetine

For the treatment of canine separation anxiety in conjunction with a behavior modification plan. Species commonly shown: Both, Dog.

Generic name
Fluoxetine
Brand names
Reconcile®, RECONCILE
Manufacturer
Pegasus Laboratories, Inc.
Species
Both, Dog
Dosage forms
Tablet (Chewable)
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Reconcile® RECONCILE
Dosage forms
Tablet (Chewable)

Indications / Uses

For the treatment of canine separation anxiety in conjunction with a behavior modification plan.

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Vomiting, Lack of efficacy - NOS, Diarrhoea, Seizure NOS, Lethargy (see also Central nervous system depression in Neurological), Decreased appetite.

FAQ

Both, Dog

Yes. Roxee shows this as prescription-only.

Tablet (Chewable)

Related Conditions

Separation anxiety

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 canine separation anxiety in conjunction with a behavior modification plan.

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:

  • Elevated gamma-glutamyl transferase (1 reports)
  • Dehydration (1 reports)
  • Decreased mean corpuscular volume (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 Fluoxetine; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-072107
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 17 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-072107
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-072107
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

Elevated gamma-glutamyl transferase (1 reports), Dehydration (1 reports), Decreased mean corpuscular volume (1 reports), Decreased mean corpuscular haemoglobin concentration (1 reports), Decreased haemoglobin (1 reports)

Body systems represented Signal grouping

Digestive (3), Neurologic (1), Behavior (3), Other (25)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (22 reports), Cat (10 reports)

Breed metadata in reports Metadata only

Domestic Shorthair (2), ['Shepherd Dog - Australian', 'Cattle Dog - Australian (blue heeler, red heeler, (1), Chihuahua (1), Weimaraner (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 Fluoxetine 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

Elevated gamma-glutamyl transferase, Dehydration, Decreased mean corpuscular volume

Call sooner if Escalation

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

Bottom line: Use this Fluoxetine 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-2025-US-072107 · 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
  7. Structured Product Label · document · documents
  8. Structured Product Label · 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:

  • Elevated gamma-glutamyl transferase
  • Dehydration
  • Decreased mean corpuscular volume

Most reported reactions:

  • Elevated gamma-glutamyl transferase (1 reports)
  • Dehydration (1 reports)
  • Decreased mean corpuscular volume (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
Dog
Indication / use
For the treatment of canine separation anxiety in conjunction with a behavior modification plan.
Form / route / dose
Form: Tablet (Chewable)
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.
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: Pegasus Laboratories, Inc.
Form: Tablet (Chewable)
Identifiers:
NADA: 141272 NDC Package: 49427-340-44 NDC Package: 49427-340-57 NDC Package: 49427-341-44 NDC Package: 49427-341-57 NDC Package: 49427-342-44 NDC Package: 49427-342-57 NDC Package: 49427-343-44 NDC Package: 49427-343-57 NDC Product: 49427
Source metadata:

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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
13
Matching reports
7
Active filters
1
Selected filters
Body system: Neurologic Clear
Reset
Drill into common report signals
Lethargy (see also Central nervous system depression in Neurological) (4) Vomiting (3) Weight loss (3) Abnormal tail posture (2) Other (10) Neurologic (7) Digestive (4) Behavior (3)
Showing up to 50 matching reports.

USA-USFDACVM-2025-US-074927

Received 2025-12-17 · MSK · MSK

Serious
Species
Dog
Breed
['Shepherd Dog - Australian', 'Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog)']
Size / weight
25-49 lb (14.969 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Neutered
Region
USA
Reactions
AnxietyClenched jawShakingLoss of voluntary movementStiffness limbFallingBumping into wallsVomitingDehydrationHyperglycaemiaOther abnormal test result NOSLethargy (see also Central nervous system depression in Neurological)Abnormal tail postureStranguriaHaematuria
Body systems
BehaviorOtherDigestiveNeurologic
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-072784

Received 2025-12-11 · MSK · MSK

Serious
Species
Dog
Breed
Mountain Dog - Bernese
Size / weight
50-99 lb (28.576 Kilogram)
Age
1-3 years (3 Year)
Sex
Female Unknown
Region
USA
Reactions
Seizure NOS
Body systems
Neurologic
Outcomes
Recovered/Normal

USA-USFDACVM-2025-US-072729

Received 2025-12-05 · MSK · MSK

Non-serious
Species
Dog
Breed
Terrier - Bull
Size / weight
25-49 lb (17.6 Kilogram)
Age
4-7 years (7 Year)
Sex
Female Neutered
Region
USA
Reactions
Leucopenia NOSAnaemia NOSHypoalbuminaemiaNeutropeniaPyodermaReduced globulinsHypophosphataemiaNon-regenerative anaemiaLow serum alkaline phosphatase (ALP)Pale mucous membraneElevated alanine aminotransferase (ALT)Decreased packed cell volume (PCV)Lethargy (see also Central nervous system depression in Neurological)HypocalcaemiaElevated aspartate aminotransferase (AST)HypoproteinaemiaProteinuriaElectrolyte disorderDisorder of red blood cell NOSElevated creatine-kinase (CK)Other coagulation investigation abnormalityIncreased band neutrophiliaElevated mean corpuscular volume (MCV)LymphopeniaOther abnormal test result NOSDiarrhoeaPanleucopeniaEosinopeniaDecreased haematocritIncreased percentage reticulocytes
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-071530

Received 2025-12-03 · MSK · MSK

Serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (36.3 Kilogram)
Age
4-7 years (7 Year)
Sex
Male Intact
Region
USA
Reactions
Seizure NOS
Body systems
Neurologic
Outcomes
Recovered/Normal

USA-USFDACVM-2025-US-072107

Received 2025-12-01 · MSK · MSK

Serious
Species
Dog
Breed
Shepherd Dog - German
Size / weight
50-99 lb (40.1 Kilogram)
Age
8+ years (10.5 Year)
Sex
Male Neutered
Region
USA
Reactions
VocalisationAbnormal tail posturePain NOSWeight lossDecreased appetiteVomitingChewing disorderPantingTremblingLying downAnxietyExcessive chewing, licking and/or groomingMuscle atrophy (see also Muscle wasting)Musculoskeletal disorder NOSAbnormal radiograph findingSpondylosisJoint effusionElevated gamma-glutamyl transferase (GGT)LymphopeniaLethargy (see also Central nervous system depression in Neurological)Thoracic painDeath by euthanasiaMedication error NOS
Body systems
OtherDigestiveBehaviorNeurologic
Outcomes
Euthanized

USA-USFDACVM-2025-US-071839

Received 2025-11-28 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (7.257 Kilogram)
Age
1-3 years (2 Year)
Sex
Male Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)Stumbling gaitNot eatingNot drinkingCold feeling to the touchWobblinessNot urinatingUncomfortableFeverWeak pulseStiffness limbDecreased haematocritDecreased haemoglobinDecreased mean corpuscular volume (MCV)Decreased mean corpuscular haemoglobin concentration (MCHC)Red blood cell disorderHyperglycaemiaLow blood urea nitrogen (BUN)Low pancreatic enzymesUnable to walkEosinopenia
Body systems
NeurologicOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-068770

Received 2025-11-21 · MSK · MSK

Non-serious
Species
Cat
Breed
Maine Coon
Size / weight
10-24 lb (10.43 Kilogram)
Age
1-3 years (3 Year)
Sex
Male Neutered
Region
USA
Reactions
Weight lossNystagmusThird eyelid protrusionLimb weaknessAtaxia
Body systems
OtherNeurologic
Outcomes
Ongoing

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

Tracked signals
32
Reported cases
32
Serious reports
17
Species represented
2
Grouped by Body System
Digestive (3) · Diarrhea, Decreased appetite, Appetite loss Neurologic (1) · Unsteady walking (ataxia) Behavior (3) · Circling - behavioural disorder, Behavioral disorder (unspecified), Anxiety Other (25) · Elevated mean corpuscular volume, Elevated gamma-glutamyl transferase, Elevated creatine-kinase
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Digestive 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1

Species coverage: Dog (22) Cat (10)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Neurologic Cat Non-serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Digestive Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Non-serious - 1
Digestive Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Behavior Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Behavior Cat Non-serious - 1
Digestive Dog Non-serious - 1
Behavior Dog Serious - 1
Other Dog Non-serious - 1
Other Cat Non-serious - 1
Other Dog 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.

Reconcile® SPL · SPL RECONCILE SPL SPL · Structured Product Label RECONCILE SPL SPL · Structured Product Label

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

5

FOI

1

Reconcile®

SPL · SPL

Open original
FDA Structured Product Label

Reconcile®

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

Sponsor
Pegasus Laboratories, Inc.
NADA
141-272
Status
RX
Form
Tablet (Chewable)
Route
Oral
Species
Dog
Composition / specifications
Each chewable tablet contains 8, 16, 32, or 64 milligrams (mg) fluoxetine hydrochloride.

Dogs

Indication
For the treatment of canine separation anxiety in conjunction with a behavior modification plan.
Dosage
1 to 2 mg/kg body weight (0.5-0.9 mg/lb) once daily.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

RECONCILE SPL

SPL · Structured Product Label

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

RECONCILE SPL

SPL · Structured Product Label

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

RECONCILE SPL

SPL · Structured Product Label

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

RECONCILE SPL

SPL · Structured Product Label

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

ucm062326.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, 10:41 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.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: RECONCILE
Manufacturer mapping: Pegasus Laboratories, Inc.
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Tablet (Chewable) • Oral
Applications: NADA 141-272
NDC: Packages 49427-340-44 49427-340-57 49427-341-44 49427-341-57 49427-342-44 49427-342-57 • Products 49427
Documents: 1 (FOI: 1) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 69 • Cat 39 • View
Case summaries: 13 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Separation anxiety
Linked using: Fda_Label (0.95)
Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

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. (Contraindication, High)
Top reaction signals
Elevated gamma-glutamyl transferase (1) Dehydration (1) Decreased mean corpuscular volume (1) Decreased mean corpuscular haemoglobin concentration (1) Decreased haemoglobin (1) Decreased appetite (1) Death by euthanasia (1) Death (1)

Identifiers & Packages

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

Identifiers
NADA: 141272 NDC Package: 49427-340-44 NDC Package: 49427-340-57 NDC Package: 49427-341-44 NDC Package: 49427-341-57 NDC Package: 49427-342-44 NDC Package: 49427-342-57 NDC Package: 49427-343-44 NDC Package: 49427-343-57 NDC Product: 49427
Package NDC Product NDC Form / Route Status
49427-340-44 49427 -
49427-340-57 49427 -
49427-341-44 49427 -
49427-341-57 49427 -
49427-342-44 49427 -
49427-342-57 49427 -
49427-343-44 49427 -
49427-343-57 49427 -

Enriched Documents

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

  • RECONCILE SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • RECONCILE SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • RECONCILE SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • RECONCILE SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • ucm062326.pdf • FOI summary • Official • Jan. 30, 2017
    FDA FOI summary for application 141272

Data Sources & Change Log

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

Official 124 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy - NOS, Diarrhoea, Seizure NOS, Lethargy (see also Central nervous system depression in Neurologica… (Clinical, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Official, 2026-04-12)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Official, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Official, 2026-02-12)
  • indications: RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan. (Official, 2026-06-22)
  • indications: RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan. (Official, 2026-06-22)
  • indications: RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan. (Official, 2026-06-21)
  • indications: RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan. (Official, 2026-06-20)
  • indications: RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan. (Official, 2026-06-13)
  • indications: RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan. (Official, 2026-06-12)
  • indications: RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan. (Official, 2026-06-12)
  • indications: RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan. (Official, 2026-06-11)
  • indications: RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan. (Official, 2026-06-11)
  • indications: RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan. (Official, 2026-06-10)
  • indications: RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan. (Official, 2026-06-09)
  • indications: RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan. (Official, 2026-06-08)
  • indications: RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan. (Official, 2026-06-07)
  • indications: RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan. (Official, 2026-06-06)
  • indications: RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan. (Official, 2026-06-05)
  • indications: RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan. (Official, 2026-06-04)
Recent Revisions
  • side_effects updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications 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
  • 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
Reconcile®
RX
Fluoxetine hydrochloride
Tablet (Chewable) • Oral
Label highlights
Official documents
Pegasus Laboratories, Inc. NADA 141-272 Approved Jan 30, 2017

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 chewable tablet contains 8, 16, 32, or 64 milligrams (mg) fluoxetine hydrochloride.
Dogs
Indication
For the treatment of canine separation anxiety in conjunction with a behavior modification plan.
Dosage
1 to 2 mg/kg body weight (0.5-0.9 mg/lb) once daily.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Usage

For the treatment of canine separation anxiety in conjunction with a behavior modification plan.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Top Reported Reactions (openFDA)

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

Digestive
Diarrhea (1) • Dog Decreased appetite (1) • Dog Appetite loss (1) • Dog

Showing top 5 for Digestive.

Neurologic
Unsteady walking (1) • Cat

Showing top 5 for Neurologic.

Behavior
Circling - behavioural disorder (1) • Cat Behavioral disorder (1) • Cat Anxiety (1) • Dog

Showing top 5 for Behavior.

Other
Elevated mean corpuscular volume (1) • Dog Elevated gamma-glutamyl transferase (1) • Dog Elevated creatine-kinase (1) • Dog Elevated aspartate aminotransferase (1) • Dog Elevated alanine aminotransferase (1) • Dog
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Electrolyte disorder (1) • Dog Disorder of red blood cell NOS (1) • Dog Dehydration (1) • Dog Decreased urine concentration (1) • Dog Decreased packed cell volume (1) • Dog Decreased mean corpuscular volume (1) • Cat Decreased mean corpuscular haemoglobin concentration (1) • Cat Decreased haemoglobin (1) • Cat Decreased haematocrit (1) • Dog Death by euthanasia (1) • Dog Death (1) • Cat Cold feeling to the touch (1) • Cat Clenched jaw (1) • Dog Chewing disorder (1) • Dog Calculi (1) • Cat Bumping into walls (1) • Dog Anaemia NOS (1) • Dog Administration error NOS (1) • Cat Abnormal tail posture (1) • Dog Abnormal radiograph finding (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, ['Shepherd Dog - Australian', 'Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog)'], Male, 5 year, 14.969 kilogram • Drug: MSK, Frequency: 1 per day • Reactions: Anxiety, Clenched jaw, Shaking, Loss of voluntary movement, Stiffness limb… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074927
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 5.00 Year
  • Weight: 14.969 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Frequency: 1 per day
Reactions Reported:
Anxiety Clenched jaw Shaking Loss of voluntary movement Stiffness limb Falling Bumping into walls Vomiting Dehydration Hyperglycaemia Other abnormal test result NOS Tiredness (lethargy) Abnormal tail posture Stranguria Haematuria
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Female, 10 year, 3.18 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Lack of efficacy (bacteria) - NOS, Upper respiratory sounds, Ocular discharge, Periorbital oedema, Vasculitis… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074596
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 10.00 Year
  • Weight: 3.180 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
Reactions Reported:
Lack of efficacy (bacteria) - NOS Upper respiratory sounds Ocular discharge Periorbital oedema Vasculitis Skin discolouration NOS Flaking skin Skin disorders NOS
Outcomes: Ongoing

Dog, Chihuahua, Male, 6 year, 7.7 kilogram • Drug: MSK, Unknown • Reactions: Decreased urine concentration, Proteinuria, Inappropriate urination, Weight loss • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-073869
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 6.00 Year
  • Weight: 7.700 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Decreased urine concentration Proteinuria Inappropriate urination Weight loss
Outcomes: Ongoing

Dog, Weimaraner, Female, 12 year, 34.019 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Recumbency, Limb weakness, Reduced reflexes, Proprioception deficit, Hind limb paresis • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-072759
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 12.00 Year
  • Weight: 34.019 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Recumbency Limb weakness Reduced reflexes Proprioception deficit Hind limb paresis
Outcomes: Ongoing

Cat, Domestic Shorthair, Female, 9 year, 3.175 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 0.50 tablet per dose, Frequency: 1 per day • Reactions: Administration error NOS, Lack of efficacy - NOS, Intentional misuse • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075469
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 9.00 Year
  • Weight: 3.175 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 0.50 tablet per dose
  • Frequency: 1 per day
Reactions Reported:
Administration error NOS Lack of efficacy - NOS Intentional misuse
Outcomes: Outcome Unknown

Dog, Mountain Dog - Bernese, Female, 3 year, 28.576 kilogram • Drug: MSK, Unassigned, Oral, Dose: 50 Milligram per animal • Reactions: Seizure NOS • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-072784
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 3.00 Year
  • Weight: 28.576 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
  • Dose: 50 Milligram per animal
Reactions Reported:
Seizure NOS
Outcomes: Recovered/Normal

Dog, ['Terrier (unspecified)', 'Dog (unknown)'], Female, 7 year, 5.262 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Vomiting • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-072866
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 7.00 Year
  • Weight: 5.262 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
Reactions Reported:
Vomiting
Outcomes: Recovered/Normal

Dog, Terrier - Bull, Female, 7 year, 17.6 kilogram • Drug: MSK, Oral, Dose: 32 Milligram per animal, Frequency: 1 per day • Reactions: Leucopenia NOS, Anaemia NOS, Hypoalbuminaemia, Neutropenia, Pyoderma… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-072729
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 7.00 Year
  • Weight: 17.600 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Dose: 32 Milligram per animal
  • Frequency: 1 per day
Reactions Reported:
Leucopenia NOS Anaemia NOS Hypoalbuminaemia Neutropenia Pyoderma Reduced globulins Hypophosphataemia Non-regenerative anaemia Low serum alkaline phosphatase Pale mucous membrane Elevated alanine aminotransferase Decreased packed cell volume Tiredness (lethargy) Hypocalcaemia Elevated aspartate aminotransferase Hypoproteinaemia Proteinuria Electrolyte disorder Disorder of red blood cell NOS Elevated creatine-kinase Other coagulation investigation abnormality Increased band neutrophilia Elevated mean corpuscular volume Lymphopenia Other abnormal test result NOS Diarrhea Panleucopenia Eosinopenia Decreased haematocrit Increased percentage reticulocytes
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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