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Roxee Medication Guide
Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
Veterinary professional?
These are the reference facts Roxee uses on browse cards and quick facts.
Sponsor, product, and application records imported from Animal Drugs @ FDA.
openFDA reaction terms and case summaries are supporting evidence, not proof of causality.
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: Pegasus Laboratories, Inc.
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
For the treatment of canine separation anxiety in conjunction with a behavior modification plan. Species commonly shown: Both, Dog.
For the treatment of canine separation anxiety in conjunction with a behavior modification plan.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Top reported reactions (openFDA): Vomiting, Lack of efficacy - NOS, Diarrhoea, Seizure NOS, Lethargy (see also Central nervous system depression in Neurological), Decreased appetite.
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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:
When to call the vet:
Regulatory restrictions are shown in Vet View.
What to tell or ask your vet today:
A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.
Roxee has limited cited overview evidence for Fluoxetine; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 20 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.
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.
Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.
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.
Unsteady walking (ataxia) (1 reports), Drooling (1 reports), Dehydration (1 reports), Decreased mean corpuscular volume (1 reports), Decreased mean corpuscular haemoglobin concentration (1 reports)
Digestive (4), Neurologic (1), Behavior (3), Other (24)
Dog (19 reports), Cat (13 reports)
Crossbred Canine/dog (2), Samoyed (1), Catahoula Leopard Dog (1), Coonhound (unspecified) (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Fluoxetine fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.
Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.
wobbly/unsteady walking, Drooling, Dehydration
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Review status / Updated / Sources
Review status: Clinical reviewer not listed
Updated: February 12, 2026, 10:44 PM UTC
Side effects to monitor:
Most reported reactions:
Emergency warning signs:
Source-backed clinical checkpoints for quick review.
Official label facts first, then secondary summaries. Marketing content is separated below.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.
Received 2026-03-25 · MSK · MSK
Received 2026-03-23 · MSK · MSK
Received 2026-03-17 · MSK · MSK
Received 2026-03-17 · MSK · MSK
Received 2026-03-16 · MSK · MSK
Received 2026-03-13 · MSK · MSK
Received 2026-03-12 · MSK · MSK
Received 2026-02-24 · MSK · MSK
Received 2026-01-19 · MSK · MSK
Received 2026-01-19 · MSK · MSK
Received 2026-01-16 · MSK · MSK
Received 2026-01-15 · MSK · MSK
Received 2025-12-17 · MSK · MSK
Received 2025-12-16 · MSK · MSK
Received 2025-12-16 · MSK · MSK
Received 2025-12-15 · MSK · MSK
Received 2025-12-12 · MSK · MSK
Received 2025-12-11 · MSK · MSK
Received 2025-12-09 · MSK · MSK
Received 2025-12-05 · MSK · MSK
Received 2025-12-03 · MSK · MSK
Received 2025-12-01 · MSK · MSK
Received 2025-11-28 · MSK · MSK
Received 2025-11-21 · MSK · MSK
Received 2025-11-18 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Neurologic | 1 | Dog | 1 | |
| Digestive | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Digestive | 1 | Cat | 1 |
Species coverage: Dog (19) Cat (13)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Neurologic | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Digestive | Cat | 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 | Cat | Serious | - | 1 | |
| Digestive | Cat | 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 | 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 | Dog | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 |
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.
Full source previews and metadata remain in the veterinary/professional layer.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
FOI · FOI
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
Quick facts and links to official labeling and safety signals.
Diagnosis-code mappings are not available for this medication yet.
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
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 | - |
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
Every non-trivial field is expected to include provenance and update timestamps.
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).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
FDA page: Open in Animal Drugs @ FDA
For the treatment of canine separation anxiety in conjunction with a behavior modification plan.
Source: FDA Animal Drugs @ FDA • Reference
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Showing top 5 for Digestive.
Showing top 5 for Neurologic.
Showing top 5 for Behavior.
Showing top 5 for Other.
Data source: FDA openFDA Animal & Veterinary adverse event reports.
These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.
Dog, Crossbred Canine/dog, Female, 7 year, 18.144 kilogram • Drug: MSK, Unassigned, Oral, Dose: 16 Milligram per animal, Frequency: 1 per day • Reactions: Seizure NOS, Shaking, Increased salivation, Chattering of teeth • Outcome: Ongoing
Dog, Samoyed, Female, 13 year, 30.391 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Limb weakness, Musculoskeletal disorder NOS, Abnormal movement NOS • Outcome: Recovered/Normal
Dog, Catahoula Leopard Dog, Male, 3.5 year, 34 kilogram • Drug: MSK, Tablet, Oral, Dose: 20 Milligram per animal • Reactions: Behavioral disorder (unspecified), Vocalisation, Growling, Agitation • Outcome: Ongoing
Dog, Coonhound (unspecified), Female, 7 year, 36.696 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Leukopenia NOS, Neutropenia, Elevated alanine aminotransferase, Elevated cholesterol • Outcome: Ongoing
Dog, Great Pyrenees, Male, 13 year, 40.37 kilogram • Drug: MSK, Unassigned, Oral, Dose: 40 Milligram per animal, Frequency: 24 per hour • Reactions: Vestibular disorder NOS, Unsteady walking (ataxia), Nystagmus, Tympanic rupture • Outcome: Ongoing
Dog, Crossbred Canine/dog, Female, 10 year, 15.876 kilogram • Drug: MSK, Unknown • Reactions: Itching, Licking • Outcome: Ongoing
Dog, Bulldog - English, Female, 4 year, 22.68 kilogram • Drug: MSK, Unknown • Reactions: Head tremor, Fly biting behaviour, Lack of efficacy - NOS, Polydipsia, Itching… • Outcome: Outcome Unknown
Cat, Domestic Shorthair, Male, 4 year, 4.808 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Head bobbing, Drooling, Not eating, Elevated temperature, Tiredness (lethargy)… • Outcome: Ongoing
Data source: FDA openFDA Animal & Veterinary adverse event reports.
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.