Meds A-Z
Fluoxetine
Detailed information about Fluoxetine
Pet Owner Quick Guide
Start here: what this medicine is for, what it does, and when it's usually needed.
Usually used for:
For the treatment of canine separation anxiety in conjunction with a behavior modification plan.
What it does:
For the treatment of canine separation anxiety in conjunction with a behavior modification plan.
When it's needed:
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Call your vet sooner if you notice:
- Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Commonly reported reactions:
- (1 reports)
- (1 reports)
- (1 reports)
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?
Fluoxetine
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: MSK
Quick Facts
Official label facts first, then secondary summaries. Marketing content is separated below.
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141272 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
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.
- 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.
Tap or hover a reaction to see what it means in plain language.
Most Reported Reactions
| Reaction | Cases | Species | Serious cases |
|---|---|---|---|
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Cat | 1 | |
| 1 | Cat | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Cat | 1 | |
| 1 | Cat | 1 |
Species coverage: Cat (17) Dog (15)
View detailed reaction table
| Reaction | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|
| Cat | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-055609
Storage & Handling
No storage/handling guidance is linked yet.
Documents
Official label facts are separated from secondary summaries.
Official documents: 2 • Secondary summaries: 0
- ucm062326.pdf · FOI
- Reconcile® · SPL
No source yet.
Promotional Materials (Marketing)
This content is marketing material and not clinical guidance.
No marketing assets are linked yet.
No source yet.
Technical appendix (vet reference)
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.
- Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 10:44 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Feb 16, 2026, 11:00 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 Feb 16, 2026, 11:00 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Feb 16, 2026, 11:03 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:21 AM UTC
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.
- Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| 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 & Revision History
Every non-trivial field is expected to include provenance and update timestamps.
- 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)
- 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
|
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.
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
FOI ucm062326.pdf
Summary
RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan.
- Reconcile® (ZIP)
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.
Side Effects
No approved side-effect narrative is linked yet.
openFDA reaction signals are available for Dog 56 and Cat 56 (view top reported reactions).
Top Reported Reactions (openFDA)
Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).
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
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
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
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
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
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
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
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
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.