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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: Multiple FDA labelers
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
For body weight gain in cats with a history of weight loss. Species commonly shown: Both, Cat.
For body weight gain in cats with a history of weight loss.
Top reported reactions (openFDA): Death by euthanasia, Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Anorexia, Decreased appetite, Diarrhoea.
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Used for:
For body weight gain in cats with a history of weight loss.
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:
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 Mirtazapine; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 27 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), Loss of appetite (1 reports), Blood in urine (1 reports), Bladder distension (1 reports), Bilirubinuria (1 reports)
Digestive (1), Skin & allergy (1), Neurologic (1), Behavior (2)
Cat (21 reports), Dog (11 reports)
Domestic Shorthair (4), Domestic Longhair (1), American Shorthair (1), Dalmatian (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Mirtazapine 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, Loss of appetite, Blood in urine
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.
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 2026-02-09 · MSK · MSK
Received 2026-01-14 · MSK · MSK
Received 2025-12-01 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Neurologic | 1 | Cat | 1 | |
| Digestive | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Behavior | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 |
Species coverage: Cat (21) Dog (11)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Neurologic | Cat | Serious | - | 1 | |
| Digestive | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Behavior | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Skin & allergy | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Behavior | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | 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.
For body weight gain in cats with a history of weight loss.
Administer topically by applying a 1.5-inch ribbon of ointment (approximately 2 mg/cat) on the inner pinna of the cat’s ear once daily for 14 days.
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 |
|---|---|---|---|
| 17033-060-05 | 17033 | - | |
| 62157-466-01 | 62157 | - | |
| 62157-506-01 | 62157 | - | |
| 73377-003-01 | 73377 | - | |
| 73377-090-01 | 73377 | - | |
| 73377-090-02 | 73377 | - | |
| 73377-090-04 | 73377 | - | |
| 86032-071-01 | 86032 | - |
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 |
|---|---|---|---|---|
|
Mirataz®
RX
Mirtazapine
Transdermal ointment
• Topical (transdermal)
|
Dechra Veterinary Products LLC | NADA 141-481 | Approved | Jul 14, 2026 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
For body weight gain in cats with a history of weight loss.
Administer topically by applying a 1.5-inch ribbon of ointment (approximately 2 mg/cat) on the inner pinna of the cat’s ear once daily for 14 days.
FDA page: Open in Animal Drugs @ FDA
For body weight gain in cats with a history of weight loss.
Source: FDA Animal Drugs @ FDA • Reference
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 Skin & allergy.
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, Male, 12 year, 4.536 kilogram • Drug: MSK, Tablet, Oral, Dose: 3.75 Milligram per dose, Frequency: 1 per day • Reactions: Lateral recumbency, Agonal breathing, Death • Outcome: Died
Cat, Domestic Shorthair, Female, 24 year, 2.5 kilogram • Drug: MSK, Ointment, Transdermal, Dose: 0.75 Other per animal, Frequency: 24 per hour • Reactions: Lack of efficacy - NOS, Application site reaction NOS • Outcome: Outcome Unknown
Cat, Domestic Longhair, Male, 10 year, 5.534 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Hyperglycaemia, Diarrhea, Watery diarrhoea, Inappetence, Elevated betahydroxybutyrate • Outcome: Ongoing
Cat, American Shorthair, Female, 3.311 kilogram • Drug: MSK, Unknown • Reactions: Decreased appetite, Behavioral disorder (unspecified), Pulmonary oedema, Trouble breathing (dyspnea), Intentional misuse • Outcome: Recovered/Normal
Cat, Domestic Shorthair, Male, 11 year, 6.26 kilogram • Drug: MSK, Unknown • Reactions: Not eating, Drooling, Hypoglycaemia, Hypotension, Abnormal ultrasound finding… • Outcome: Ongoing
Dog, Dalmatian, Male, 10 year, 36.741 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Agitation, Drooling, Febrile, Panting, Anaphylaxis… • Outcome: Ongoing
Cat, Domestic Shorthair, Male, 10 year, 2.9 kilogram • Drug: MSK, Unknown • Reactions: Decreased appetite, Lack of efficacy - NOS, Weight loss • Outcome: Outcome Unknown
Cat, Domestic Shorthair, Female, 12.5 year, 3 kilogram • Drug: MSK, Unknown • Reactions: Tongue disorder NOS, Tongue ulceration, Drooling, Unwell, Tracheal and laryngeal disorder NOS… • Outcome: Recovered/Normal
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.