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Fluoxetine

Detailed information about Fluoxetine

Official label facts Owner quick guide first Marketing clearly labeled
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Reviewed / Updated / Sources

Reviewed: Not available

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

Sources:

Pet Owner Quick Guide

Start here first for the simple next-step summary.

Used for:

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

What to watch for:

  • Whining (1 reports)
  • Vomiting (1 reports)
  • Underdose (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 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?
Safety & side effects

What to watch:

  • Whining
  • Vomiting
  • Underdose

Most reported reactions:

  • Whining (1 reports)
  • Vomiting (1 reports)
  • Underdose (1 reports)

When to call your vet:

  • 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

Data freshness: source data appears current.

Latest refresh: Mar 21, 2026, 10:01 a.m.

Data freshness
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:00 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 Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 17, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:21 AM UTC
Image coming soon
Fluoxetine

Fluoxetine

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

Species: Both

Manufacturer: Not available (source)

Quick Facts

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

Species: Both
Manufacturer: Not available
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.

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

Tracked signals
32
Reported cases
31
Serious reports
23
Species represented
2
Grouped by Body System
Digestive (3) · Vomiting, Diarrhea, Appetite loss Behavior (2) · Circling - behavioural disorder, Behavioral disorder (unspecified) Effectiveness (3) · Lack of efficacy - NOS, Lack of efficacy (protozoa) - Coccidia, Lack of efficacy (endoparasite) - whipworm Other (24) · Whining, Underdose, Proprioception deficit
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 1
Digestive 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1

Species coverage: Cat (17) Dog (15)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Other Dog Serious - 1
Digestive Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Effectiveness Dog Serious - 1
Effectiveness Dog Non-serious - 1
Effectiveness Dog Non-serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Non-serious - 1
Other Cat Serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Digestive Dog Non-serious - 1
Other Cat Serious - 1
Behavior Cat Serious - 1
Other Cat Serious - 1
Behavior Cat Serious - 1
Digestive Dog Non-serious - 1
Other Cat Serious - 1
Other Dog Unknown - -
Source metadata:

Documents

Owner handouts and official technical documents are grouped for faster access.

Owner handouts (0)
  • No owner handouts linked yet.
Official label / PI (0)
  • No official label or package insert links yet.
SPL (1)
  • Reconcile® · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/179/Reconcile%C2%AE
FOI (1)
  • ucm062326.pdf · FOI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/831
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
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:00 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 Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 17, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:21 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Reconcile®
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Tablet (Chewable) • Oral
Applications: NADA 141-272
Documents: 1 (FOI: 1) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 26 • Cat 16 • View
Case summaries: 10 (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
Whining (1) Vomiting (1) Underdose (1) Proprioception deficit (1) Polycythaemia (1) Panting (1) Pain NOS (1) Other abnormal test result NOS (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.

  • 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 4 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Official, 2026-02-12)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy - NOS, Diarrhoea, Seizure NOS, Lethargy (see also Central nervous system depression in Neurologica… (Official, 2026-02-12)
  • usage: For the treatment of canine separation anxiety in conjunction with a behavior modification plan. (Official, 2026-02-12)
Recent Revisions
  • 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, No Use Class Stated Or Implied
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

Official Documents (FDA)

Direct links to FDA-hosted PDFs and SPL packages (when available).

Documents
  • Summary
    RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan.
SPL Packages

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
Vomiting (1) • Dog Diarrhea (1) • Dog Appetite loss (1) • Dog

Showing top 5 for Digestive.

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

Showing top 5 for Behavior.

Effectiveness
Lack of efficacy - NOS (1) • Dog Lack of efficacy (protozoa) - Coccidia (1) • Dog Lack of efficacy (endoparasite) - whipworm (1) • Dog

Showing top 5 for Effectiveness.

Other
Whining (1) • Dog Underdose (1) • Dog Proprioception deficit (1) • Cat Polyuria (1) • Dog Polydipsia (1) • Dog
Show more (19)
Polycythaemia (1) • Cat Panting (1) • Dog Pain NOS (1) • Dog Other abnormal test result NOS (1) • Cat Musculoskeletal disorder NOS (1) • Cat Mast cell tumour (1) • Cat Limping (1) • Cat Knuckling (1) • Cat Intervertebral disc disease (1) • Cat Inappropriate urination (1) • Cat Hyposthenuria (1) • Dog Hemiparesis (1) • Cat Glucosuria (1) • Cat Elevated serum alkaline phosphatase (1) • Dog Elevated alanine aminotransferase (1) • Cat Death (1) • Cat Calculi (1) • Cat Abnormal radiograph finding (1) • Cat Abnormal serum protein NOS • 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, Poodle (unspecified), Male, 4 year, 9.5 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Vomiting, Pain NOS, Whining, Lack of efficacy - NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-054507
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 4.00 Year
  • Weight: 9.500 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
Reactions Reported:
Vomiting Pain NOS Whining Lack of efficacy - NOS
Outcomes: Ongoing

Dog, Shepherd Dog - German, Female, 1.5 year, 27.2 kilogram • Drug: MSK, Unknown • Reactions: Diarrhea, Lack of efficacy (protozoa) - Coccidia, Lack of efficacy (endoparasite) - whipworm • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-055405
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 1.50 Year
  • Weight: 27.200 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Diarrhea Lack of efficacy (protozoa) - Coccidia Lack of efficacy (endoparasite) - whipworm
Outcomes: Outcome Unknown

Dog, Mixed (Dog), Male, 10 year, 39 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 0.75 tablet per dose, Frequency: 1 per day • Reactions: Elevated serum alkaline phosphatase, Panting, Underdose • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-056107
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 39.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 0.75 tablet per dose
  • Frequency: 1 per day
Reactions Reported:
Elevated serum alkaline phosphatase Panting Underdose
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Female, 4 year, 5.92 kilogram • Drug: MSK, Unassigned, Oral, Frequency: 1 per day • Reactions: Elevated alanine aminotransferase, Calculi, Abnormal radiograph finding • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055609
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 4.00 Year
  • Weight: 5.920 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
  • Frequency: 1 per day
Reactions Reported:
Elevated alanine aminotransferase Calculi Abnormal radiograph finding
Outcomes: Ongoing

Cat, Domestic Shorthair, Male, 10 year • Drug: MSK, Transdermal • Reactions: Mast cell tumour • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-054371
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 10.00 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Transdermal
Reactions Reported:
Mast cell tumour
Outcomes: Ongoing

Dog, Collie - Border, Female, 4 year, 22 kilogram • Drug: MSK, Unknown • Reactions: Diarrhea, Appetite loss, Vomiting • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-055390
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 4.00 Year
  • Weight: 22.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Diarrhea Appetite loss Vomiting
Outcomes: Recovered/Normal

Dog, Pointing Dog - Hungarian Short-haired (Vizsla), Male, 9 year, 22.4 kilogram • Drug: MSK, Unknown, Frequency: 1 per day • Reactions: Polyuria, Polydipsia, Hyposthenuria • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-052881
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 9.00 Year
  • Weight: 22.400 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Frequency: 1 per day
Reactions Reported:
Polyuria Polydipsia Hyposthenuria
Outcomes: Ongoing

Cat, Domestic Shorthair, Male, 5 year, 9.616 kilogram • Drug: MSK, Unassigned, Topical • Reactions: Proprioception deficit, Musculoskeletal disorder NOS, Knuckling, Hemiparesis, Limping… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-050579
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 5.00 Year
  • Weight: 9.616 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Topical
  • Form: Unassigned
Reactions Reported:
Proprioception deficit Musculoskeletal disorder NOS Knuckling Hemiparesis Limping Intervertebral disc disease
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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