USA-USFDACVM-2026-US-013917
Received 2026-03-25 · MSK · MSK
- Species
- Dog
- Size / weight
- 10-24 lb (4.536 Kilogram)
- Age
- 8+ years (12 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- Lateral recumbencyAgonal breathingDeath
- Body systems
- Other
- Outcomes
- Died
Roxee Medication Guide
Mirtazapine
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
Transdermal ointment
Multiple FDA labelers
Official label facts
Owner quick guide first
Veterinary professional?
Showing simplified owner view. Switch to Vet View for full technical detail.
Data freshness
Reference facts
Reference refreshed
Aug 6, 2026, 7:47 p.m.
These are the reference facts Roxee uses on browse cards and quick facts.
FDA applications
FDA application data refreshed
Aug 6, 2026, 7:47 p.m.
Sponsor, product, and application records imported from Animal Drugs @ FDA.
Safety reports
Safety data refreshed
Aug 6, 2026, 7:49 p.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 Aug 6, 2026, 7:47 PM UTC
The reference fact projection used for browse cards and quick facts.
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Aug 6, 2026, 7:47 PM 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 Aug 6, 2026, 7:47 PM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Illustration placeholder
Mirtazapine
Mirtazapine
Drug type: Generic ingredient • Branded profile • FDA branded products available
Both
Transdermal ointment
Rx required
100% reference complete
Species: Both
Manufacturer: Multiple FDA labelers
Medication Snapshot
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
Mirtazapine
For body weight gain in cats with a history of weight loss. Species commonly shown: Both, Cat.
Generic name
Mirtazapine
Brand names
Mirataz®, AX Pharmaceutical Corp, Mirataz, Mirtazapine Anhydrous
Manufacturer
Multiple FDA labelers
Species
Both, Cat
Dosage forms
Transdermal ointment
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Mirataz®
AX Pharmaceutical Corp
Mirataz
Mirtazapine Anhydrous
Dosage forms
Transdermal ointment
Indications / Uses
For body weight gain in cats with a history of weight loss.
Side Effects
Top reported reactions (openFDA): Death by euthanasia, Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Anorexia, Decreased appetite, Diarrhoea.
FAQ
Both, Cat
Yes. Roxee shows this as prescription-only.
Transdermal ointment
Related Conditions
Source Transparency
- Verified source: https://www.roxee.ai/meds/
- Verified source: https://animaldrugsatfda.fda.gov
- Verified source: https://animaldrugsatfda.fda.gov/adafda/views/#/search
- Verified source: https://api.fda.gov/animalandveterinary/event.json
- Verified source: https://www.roxee.ai/conditions/
- Verified source: https://www.accessdata.fda.gov/spl/data/896b3255-350a-45bc-93f8-9b4354feca14/896b3255-350a-45bc-93f8-9b4354feca14.xml
- Last refreshed: Aug 6, 2026, 7:47 p.m.
- Last verified: Feb 12, 2026, 10:44 p.m.
- Validation status: Complete
Add to My Pet's Medications
Choose a pet, confirm current or past, and optionally add reminder notes.
Sign in to save this medication to your pet profile.
Sign in to continuePet Owner Quick Guide
Start here first for the safest next-step summary before the deeper medication detail.
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:
- wobbly/unsteady walking (1 reports)
- Loss of appetite (1 reports)
- Blood in urine (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.
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?
Research brief
Medication Research Insights
A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.
What to know
Evidence-backed context
Limited
Roxee has limited cited overview evidence for Mirtazapine; use the official documents and your veterinarian's instructions for product-specific decisions.
Source: openFDA case USA-USFDACVM-2026-US-003268
Safety signal coverage
Reported signals
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.
Source: openFDA case USA-USFDACVM-2026-US-003268
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-2026-US-003268
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
Unsteady walking (ataxia) (1 reports), Loss of appetite (1 reports), Blood in urine (1 reports), Bladder distension (1 reports), Bilirubinuria (1 reports)
Body systems represented
Signal grouping
Digestive (1), Skin & allergy (1), Neurologic (1), Behavior (2)
Species and breed lens
Species represented in reports
Species lens
Cat (21 reports), Dog (11 reports)
Breed metadata in reports
Metadata only
Domestic Shorthair (4), Domestic Longhair (1), American Shorthair (1), Dalmatian (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 Mirtazapine 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
wobbly/unsteady walking, Loss of appetite, Blood in urine
Call sooner if
Escalation
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Bottom line: Use this Mirtazapine 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
- openFDA case USA-USFDACVM-2026-US-003268 · adverse_reaction · adverse reactions
- FDA application profile · official_label · quick facts
- Medication usage source · fda_animal_drugs · quick facts
- FOI · document · documents
- SPL · document · documents
- Structured Product Label · document · documents
- Structured Product Label · document · documents
- 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:
- FDA application profile · official_label
- Medication usage source · fda_animal_drugs
- openFDA case USA-USFDACVM-2026-US-003268 · adverse_reaction
- FOI · document
- SPL · document
Safety & side effects
Side effects to monitor:
- wobbly/unsteady walking
- Loss of appetite
- Blood in urine
Most reported reactions:
- Unsteady walking (ataxia) (1 reports)
- Loss of appetite (1 reports)
- Blood in urine (1 reports)
Emergency warning signs:
- Repeated vomiting or diarrhea.
- Severe lethargy (hard to wake, very low energy).
- Collapse or fainting.
- Trouble breathing.
Vet Fast Scan
Source-backed clinical checkpoints for quick review.
FDA-labeled species
Cat
Indication / use
For body weight gain in cats with a history of weight loss.
Form / route / dose
Form: Transdermal ointment
Route: Topical (transdermal)
Confirm product label and patient-specific plan.
Route: Topical (transdermal)
Confirm product label and patient-specific plan.
Warnings
No structured warnings linked yet.
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: Multiple FDA labelers
Form: Transdermal ointment
Identifiers:
NADA: 141481
NDC Package: 17033-060-05
NDC Package: 62157-466-01
NDC Package: 62157-506-01
NDC Package: 73377-003-01
NDC Package: 73377-090-01
NDC Package: 73377-090-02
NDC Package: 73377-090-04
NDC Package: 86032-071-01
NDC Product: 17033
NDC Product: 62157
NDC Product: 73377
NDC Product: 86032
Source metadata:
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141481 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
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.
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
50
Matching reports
50
Active filters
0
Drill into common report signals
Showing up to 50 matching reports.
USA-USFDACVM-2026-US-014720
Received 2026-03-17 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- Under 10 lb (2.5 Kilogram)
- Age
- 8+ years (24 Year)
- Sex
- Female Neutered
- Region
- USA
- Reactions
- Lack of efficacy - NOSApplication site reaction NOS
- Body systems
- EffectivenessOther
- Outcomes
- Outcome Unknown
USA-USFDACVM-2026-US-013837
Received 2026-03-17 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Longhair
- Size / weight
- 10-24 lb (5.534 Kilogram)
- Age
- 8+ years (1 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- HyperglycaemiaDiarrhoeaWatery diarrhoeaInappetenceElevated betahydroxybutyrate (BHBA)
- Body systems
- OtherDigestive
- Outcomes
- Ongoing
USA-USFDACVM-2026-US-012583
Received 2026-03-16 · MSK · MSK
- Species
- Cat
- Breed
- American Shorthair
- Size / weight
- Under 10 lb (3.311 Kilogram)
- Sex
- Female Unknown
- Region
- USA
- Reactions
- Decreased appetiteBehavioural disorder NOSPulmonary oedemaDyspnoeaIntentional misuse
- Body systems
- DigestiveBehaviorOther
- Outcomes
- Recovered/Normal
USA-USFDACVM-2026-US-012294
Received 2026-03-16 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- 10-24 lb (6.26 Kilogram)
- Age
- 8+ years (11 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- Not eatingHypersalivationHypoglycaemiaHypotensionAbnormal ultrasound findingHidingBehavioural disorder NOSLethargy (see also Central nervous system depression in Neurological)HypothermiaDehydrationNeutropeniaDiarrhoeaSoft stool
- Body systems
- OtherDigestiveBehaviorNeurologic
- Outcomes
- Ongoing
USA-USFDACVM-2026-US-012695
Received 2026-03-13 · MSK · MSK
- Species
- Dog
- Breed
- Dalmatian
- Size / weight
- 50-99 lb (36.741 Kilogram)
- Age
- 8+ years (1 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- AgitationDroolingFebrilePantingAnaphylaxisUnwellDecreased appetiteUrinary incontinenceVomitingDiarrhoeaLeukocytosis NOSNeutrophiliaLymphocytosisMonocytosisElevated globulinsElevated serum alkaline phosphatase (ALP)Anaemia NOSElevated alanine aminotransferase (ALT)Elevated C-reactive proteinAggressionUrolithiasisAutoimmune disorder NOSThrombocytopenia
- Body systems
- OtherDigestiveBehavior
- Outcomes
- Ongoing
USA-USFDACVM-2026-US-012574
Received 2026-03-13 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- Under 10 lb (2.9 Kilogram)
- Age
- 8+ years (1 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- Decreased appetiteLack of efficacy - NOSWeight loss
- Body systems
- DigestiveEffectivenessOther
- Outcomes
- Outcome Unknown
USA-USFDACVM-2026-US-012224
Received 2026-03-13 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- Under 10 lb (3 Kilogram)
- Age
- 8+ years (12.5 Year)
- Sex
- Female Neutered
- Region
- USA
- Reactions
- Tongue disorder NOSTongue ulcerationDroolingUnwellTracheal and laryngeal disorder NOSCrustDecreased appetiteLaryngeal oedemaCoughHead tilt - neurological disorder (see also Head tilt - ear disorder)Swallowing disorder NOSLocal swelling (not application site)Lethargy (see also Central nervous system depression in Neurological)Nasal dischargeMalaiseDehydrationOcular discharge
- Body systems
- OtherDigestiveNeurologicSkin & allergy
- Outcomes
- Recovered/Normal
USA-USFDACVM-2026-US-011867
Received 2026-03-11 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- Under 10 lb (3.992 Kilogram)
- Age
- 8+ years (16 Year)
- Sex
- Female Unknown
- Region
- USA
- Reactions
- Tendon rupture
- Body systems
- Other
- Outcomes
- Ongoing
USA-USFDACVM-2026-US-011648
Received 2026-03-10 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- 10-24 lb (5.126 Kilogram)
- Age
- 4-7 years (5 Year)
- Sex
- Female Neutered
- Region
- USA
- Reactions
- Emesis (multiple)Weight lossLethargy (see also Central nervous system depression in Neurological)Blood in vomitAbnormal ultrasound findingWeaknessDecreased appetiteINEFFECTIVE, ANTIEMETICDigestive tract disorder NOS
- Body systems
- DigestiveOtherNeurologic
- Outcomes
- Ongoing
USA-USFDACVM-2026-US-010813
Received 2026-03-09 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- Under 10 lb (3.7 Kilogram)
- Age
- 8+ years (12 Year)
- Sex
- Female Neutered
- Region
- USA
- Reactions
- DullBradycardiaLow blood pressure
- Body systems
- Other
- Outcomes
- Recovered/Normal
USA-USFDACVM-2026-US-010089
Received 2026-03-07 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- 10-24 lb (5.4 Kilogram)
- Age
- 8+ years (14 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- HypotensionBradycardiaHypernatraemiaLying downLethargy (see also Central nervous system depression in Neurological)Reduced responses
- Body systems
- OtherNeurologic
- Outcomes
- Recovered/Normal
USA-USFDACVM-2026-US-009771
Received 2026-03-02 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- 10-24 lb (5.44 Kilogram)
- Age
- 4-7 years (4 Year)
- Sex
- Female Neutered
- Region
- USA
- Reactions
- Lethargy (see also Central nervous system depression in Neurological)AnorexiaAnuriaAdipsiaSeizure NOSDeathConstipationStaringHead twitching
- Body systems
- NeurologicDigestiveOtherSkin & allergy
- Outcomes
- Died
USA-USFDACVM-2026-US-008769
Received 2026-02-28 · MSK · MSK
- Species
- Cat
- Breed
- Russian
- Size / weight
- Under 10 lb (4.3 Kilogram)
- Age
- 8+ years (19 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- Not drinkingNot eatingDullnessAnaemia NOSCardiac disorder NOSHeart murmurPale mucous membraneAtaxiaOliguriaRenal failureDeath by euthanasiaInappetenceLethargy (see also Central nervous system depression in Neurological)AscitesThird eyelid protrusionLateral recumbencyAcute renal failureDehydrationProlonged capillary refill timeHyperglycaemiaSplenic neoplasm NOSHead bobbingElevated blood urea nitrogen (BUN)Elevated creatinineAbnormal radiograph findingAzotaemiaDecreased packed cell volume (PCV)DullHypernatraemia
- Body systems
- OtherNeurologic
- Outcomes
- Euthanized
USA-USFDACVM-2026-US-008761
Received 2026-02-27 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- Under 10 lb (3.5 Kilogram)
- Age
- 8+ years (17 Year)
- Sex
- Female Neutered
- Region
- USA
- Reactions
- Decreased mean corpuscular volume (MCV)Decreased haematocritDecreased mean corpuscular haemoglobin concentration (MCHC)Lack of efficacy - NOSIron deficiency anaemia
- Body systems
- OtherEffectiveness
- Outcomes
- Ongoing
USA-USFDACVM-2026-US-009056
Received 2026-02-26 · MSK · MSK
- Species
- Dog
- Breed
- Terrier - Bull - American Pit
- Size / weight
- 50-99 lb (28.49 Kilogram)
- Age
- 8+ years (8.42 Year)
- Sex
- Female Unknown
- Region
- USA
- Reactions
- Weight lossLethargy (see also Central nervous system depression in Neurological)Limb weakness
- Body systems
- OtherNeurologic
- Outcomes
- Ongoing
USA-USFDACVM-2026-US-011611
Received 2026-02-14 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- 10-24 lb (6.3 Kilogram)
- Age
- 4-7 years (6 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- DeathDullNot himself/herselfHead pressingHypotensionUnresponsive to stimuli
- Body systems
- Other
- Outcomes
- Died
USA-USFDACVM-2026-US-007418
Received 2026-02-09 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- 10-24 lb (8.7 Kilogram)
- Age
- 1-3 years (2.8 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- Lack of efficacy - NOSNot eatingLethargy (see also Central nervous system depression in Neurological)General pain (see other SOCs for specific pain)Facial oedemaTrigeminus paralysisOral ulcerationIntentional misuse
- Body systems
- EffectivenessOtherNeurologic
- Outcomes
- Ongoing
USA-USFDACVM-2026-US-005800
Received 2026-02-02 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- 10-24 lb (6.3 Kilogram)
- Age
- 4-7 years (6 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- DeathDullNot himself/herselfHead pressingHypotensionUnresponsive to stimuli
- Body systems
- Other
- Outcomes
- Died
USA-USFDACVM-2026-US-004302
Received 2026-01-27 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Mediumhair
- Size / weight
- 10-24 lb (4.62 Kilogram)
- Age
- 1-3 years (2 Year)
- Sex
- Female Neutered
- Region
- USA
- Reactions
- EmesisNot eatingHidingHyperglycaemiaFeverTachycardiaTachypnoeaBloody stoolWeight lossGall bladder & bile duct disorder NOSGastric distensionIntestinal thickeningDiarrhoea
- Body systems
- DigestiveOther
- Outcomes
- Ongoing
USA-USFDACVM-2026-US-005566
Received 2026-01-14 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- 10-24 lb (6.169 Kilogram)
- Age
- 8+ years (1 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- DiarrhoeaHypotensionVomitingIncreased respiratory rateWeight loss
- Body systems
- DigestiveOther
- Outcomes
- Outcome Unknown
USA-USFDACVM-2026-US-003666
Received 2026-01-14 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- 10-24 lb (4.59 Kilogram)
- Age
- 8+ years (9 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- Pulmonary neoplasmIncreased lung soundsTachypnoeaLaboured breathingWeak pulseCrackles on auscultationDeath by euthanasiaAbnormal ultrasound findingHaemorrhage NOS
- Body systems
- Other
- Outcomes
- Euthanized
USA-USFDACVM-2026-US-003268
Received 2026-01-14 · MSK · MSK
- Species
- Dog
- Breed
- Dachshund (unspecified)
- Size / weight
- 10-24 lb (5.8 Kilogram)
- Age
- 8+ years (15 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- VomitingLethargy (see also Central nervous system depression in Neurological)RetchingDental diseaseDry mucous membraneDehydrationAnorexiaBloody diarrhoeaIncreased heart rateIncreased respiratory ratePale mucous membraneJaundiceHeart murmurTense abdomenLeukocytosis NOSNeutrophiliaLymphocytosisMonocytosisLow platelet countAzotaemiaElevated blood urea nitrogen (BUN)HyperphosphataemiaElevated alanine aminotransferase (ALT)Elevated serum alkaline phosphatase (ALP)Elevated total bilirubinElevated cholesterol (total)Blood in urineProteinuriaLiver disorder NOSPancreas disorderIntestinal thickeningUrinary tract disorder NOSNon-regenerative anaemiaHypokalaemiaNot eatingDecreased red blood cell countDecreased haematocritPolyuriaPolydipsiaAbdominal discomfortIncreased percentage reticulocytesPlatelet disorder NOSLack of efficacy - NOSGut sounds decreasedOther blood disorder NOSBilirubinuriaAbnormal ultrasound findingElevated gamma-glutamyl transferase (GGT)ThrombocytosisIleus
- Body systems
- DigestiveNeurologicOtherEffectiveness
- Outcomes
- Ongoing
USA-USFDACVM-2026-US-001377
Received 2026-01-12 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Longhair
- Size / weight
- Under 10 lb (4.064 Kilogram)
- Age
- 8+ years (15 Year)
- Sex
- Female Unknown
- Region
- USA
- Reactions
- DermatitisSkin ulcerLack of efficacy - NOSAbnormal histology NOSBehavioural disorder NOSVocalisationTachycardiaHigh blood pressureRetinal disorder NOSGranulomaDecreased appetitePain NOSWeight lossAbnormal menace reflex testDilated pupilsLoss of visionSkin irritationInjection site dermatitisElevated blood urea nitrogen (BUN)PacingElevated amylaseHypokalaemiaElevated symmetrical dimethylarginine (SDMA)Vomiting bile
- Body systems
- OtherEffectivenessBehaviorDigestive
- Outcomes
- Ongoing
USA-USFDACVM-2026-US-004204
Received 2026-01-07 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- 10-24 lb (6.26 Kilogram)
- Age
- 8+ years (1 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- DroolingDecreased appetiteHiding
- Body systems
- DigestiveOther
- Outcomes
- Outcome Unknown
USA-USFDACVM-2026-US-001285
Received 2026-01-06 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- Under 10 lb (3.2 Kilogram)
- Age
- 4-7 years (6 Year)
- Sex
- Female Intact
- Region
- USA
- Reactions
- Swollen eye (see also Immune system disorders)Ocular dischargeSquinting
- Body systems
- Other
- Outcomes
- Outcome Unknown
USA-USFDACVM-2025-US-074713
Received 2025-12-19 · MSK · MSK
- Species
- Cat
- Breed
- Cat (unknown)
- Size / weight
- 10-24 lb (4.98 Kilogram)
- Age
- 8+ years (17 Year)
- Sex
- Male Unknown
- Region
- USA
- Reactions
- Accidental exposureBehavioural disorder NOS
- Body systems
- OtherBehavior
- Outcomes
- Ongoing
USA-USFDACVM-2025-US-073852
Received 2025-12-17 · MSK · MSK
- Species
- Cat
- Breed
- ['Cat (unknown)', 'Cat (unknown)']
- Size / weight
- Under 10 lb (3.58 Kilogram)
- Age
- 8+ years (17 Year)
- Sex
- Female Neutered
- Region
- USA
- Reactions
- VomitingCollapse NOS (see also Cardio-vascular and Neurological disorders)Decreased haematocrit
- Body systems
- DigestiveNeurologicOther
- Outcomes
- Outcome Unknown
USA-USFDACVM-2025-US-072694
Received 2025-12-15 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Longhair
- Size / weight
- 10-24 lb (5.05 Kilogram)
- Age
- 8+ years (11 Year)
- Sex
- Female Unknown
- Region
- USA
- Reactions
- CrustAbrasionSkin irritationAlopecia localLocal erythemaSkin ulcerSkin scab
- Body systems
- OtherSkin & allergy
- Outcomes
- Ongoing
USA-USFDACVM-2025-US-074363
Received 2025-12-14 · MSK · MSK
- Species
- Dog
- Breed
- Retriever - Labrador
- Size / weight
- 50-99 lb (37.8 Kilogram)
- Age
- 8+ years (11.3 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- WoundLick granulomaExternal ear disorder NOSPerianal inflammationMusculoskeletal disorder NOSHeavy breathingPantingDecreased appetiteScootingActive urine sedimentFungal skin infection NOSSkin lesion NOSLack of efficacy - NOS
- Body systems
- OtherDigestiveEffectiveness
- Outcomes
- Ongoing
USA-USFDACVM-2025-US-074835
Received 2025-12-12 · MSK · MSK
- Species
- Cat
- Breed
- ['British cat', 'Cat (unknown)']
- Size / weight
- 10-24 lb (6.73 Kilogram)
- Age
- 8+ years (13 Year)
- Sex
- Female Neutered
- Region
- USA
- Reactions
- Application site skin scaling
- Body systems
- Other
- Outcomes
- Outcome Unknown
USA-USFDACVM-2025-US-073622
Received 2025-12-11 · MSK · MSK
- Species
- Dog
- Breed
- Collie - Border
- Size / weight
- 25-49 lb (17.23 Kilogram)
- Age
- 8+ years (11 Year)
- Sex
- Female Neutered
- Region
- USA
- Reactions
- GaggingDroolingArthritisUNPALATABLEMedication error NOSINEFFECTIVE, OTHER DRUG(S)
- Body systems
- OtherDigestive
- Outcomes
- Outcome Unknown
USA-USFDACVM-2025-US-073181
Received 2025-12-11 · MSK · MSK
- Species
- Cat
- Breed
- American Curl Shorthair
- Size / weight
- 10-24 lb (5.62 Kilogram)
- Age
- 4-7 years (4 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- Anaemia NOSLeucocytosis NOSMonocytosisBasophiliaNeutrophiliaLymphocytosisAscitesAbnormal cytologyCardiac enlargementVascular disorder NOS (see also endocarditis)Pleural effusionPeritoneal fluid, abnormal NOSIntentional misuse
- Body systems
- Other
- Outcomes
- Outcome Unknown
USA-USFDACVM-2025-US-072755
Received 2025-12-10 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Mediumhair
- Size / weight
- 10-24 lb (4.627 Kilogram)
- Age
- 1-3 years (2 Year)
- Sex
- Female Unknown
- Region
- USA
- Reactions
- EmesisNot eatingHidingHyperglycaemiaFeverTachycardiaTachypnoeaBloody stoolWeight lossGall bladder & bile duct disorder NOSGastric distensionIntestinal thickeningDiarrhoea
- Body systems
- DigestiveOther
- Outcomes
- Ongoing
USA-USFDACVM-2025-US-074690
Received 2025-12-09 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- Under 10 lb (4.2 Kilogram)
- Age
- 1-3 years (2.2 Year)
- Sex
- Female Neutered
- Region
- USA
- Reactions
- Not eatingHidingFeverPyrexiaEmesis (multiple)Low platelet countPlatelet disorder NOSHyperglycaemiaDistressHypothyroidismOther abnormal test result NOSProteinuriaBilirubinuriaTarry or black stool (see also haemorrhagic diarrhoea)Behavioural disorder NOSWarm feeling to the touchReddening of the skinAbnormal radiograph findingDistension of abdomenPancreatitis NOSVomiting
- Body systems
- OtherDigestiveBehavior
- Outcomes
- Ongoing
USA-USFDACVM-2025-US-073329
Received 2025-12-03 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- Under 10 lb (4.454 Kilogram)
- Age
- 8+ years (19.5 Year)
- Sex
- Female Neutered
- Region
- USA
- Reactions
- Glucosuria
- Body systems
- Other
- Outcomes
- Outcome Unknown
USA-USFDACVM-2025-US-072712
Received 2025-12-01 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- Under 10 lb (3.175 Kilogram)
- Age
- 8+ years (15 Year)
- Sex
- Female Neutered
- Region
- USA
- Reactions
- Not eatingHead tilt - ear disorderElevated blood urea nitrogen (BUN)
- Body systems
- Other
- Outcomes
- Ongoing
USA-USFDACVM-2025-US-072451
Received 2025-12-01 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- 10-24 lb (5.69 Kilogram)
- Age
- 4-7 years (7 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- Lethargy (see also Central nervous system depression in Neurological)AnorexiaElevated total bilirubinElevated gamma-glutamyl transferase (GGT)Elevated serum alkaline phosphatase (ALP)Elevated alanine aminotransferase (ALT)JaundiceEnlarged liverHidingNausea
- Body systems
- NeurologicDigestiveOther
- Outcomes
- Ongoing
USA-USFDACVM-2025-US-071120
Received 2025-12-01 · MSK · MSK
- Species
- Cat
- Breed
- Maine Coon
- Size / weight
- 10-24 lb (5.942 Kilogram)
- Age
- 8+ years (8 Year)
- Sex
- Male Unknown
- Region
- USA
- Reactions
- Pain NOSLamenessNot eatingFeverHigh pancreatic-specific lipaseLethargy (see also Central nervous system depression in Neurological)VomitingLack of efficacy - NOS
- Body systems
- OtherNeurologicDigestiveEffectiveness
- Outcomes
- Recovered/Normal
USA-USFDACVM-2025-US-074528
Received 2025-11-25 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Mediumhair
- Size / weight
- Under 10 lb (4.13 Kilogram)
- Age
- 1-3 years (2 Year)
- Sex
- Female Neutered
- Region
- USA
- Reactions
- AnorexiaReluctant to moveVocalisationLoss of bowel controlNot urinatingEosinopeniaBasophiliaHypernatremiaThrombocytopeniaAbnormal radiograph findingThird eyelid protrusionOther ear disorder NOS
- Body systems
- DigestiveOther
- Outcomes
- Ongoing
USA-USFDACVM-2025-US-072580
Received 2025-11-25 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Mediumhair
- Size / weight
- Under 10 lb (4.13 Kilogram)
- Age
- 1-3 years (2 Year)
- Sex
- Female Neutered
- Region
- USA
- Reactions
- Reluctant to moveVocalisationLoss of bowel controlNot urinatingEosinopeniaBasophiliaHypernatremiaThrombocytopeniaAbnormal radiograph findingThird eyelid protrusionOther ear disorder NOSNasal dischargeFalling
- Body systems
- Other
- Outcomes
- Outcome Unknown
USA-USFDACVM-2025-US-069596
Received 2025-11-24 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- 10-24 lb (6.2 Kilogram)
- Age
- 8+ years (13 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- Not eatingVomitingCardiac enlargementSplenomegalyAbnormal ultrasound findingHaematuriaPyuriaNon-regenerative anaemiaDecreased haematocritHypokalaemiaBladder distensionDehydrationElevated creatinineNot urinatingIntentional misuseUrinary tract disorder NOS
- Body systems
- OtherDigestive
- Outcomes
- Ongoing
CAN-USFDACVM-2025-CA-000104
Received 2025-11-19 · MSK · MSK
- Species
- Dog
- Breed
- Shih Tzu
- Size / weight
- 10-24 lb (7.6 Kilogram)
- Age
- 8+ years (1 Year)
- Sex
- Female Neutered
- Region
- USA
- Reactions
- Lack of efficacy - NOS
- Body systems
- Effectiveness
- Outcomes
- Outcome Unknown
CAN-USFDACVM-2025-CA-000103
Received 2025-11-19 · MSK · MSK
- Species
- Dog
- Breed
- ['Retriever - Labrador', 'Dog (unknown)']
- Size / weight
- 50-99 lb (27.5 Kilogram)
- Age
- 8+ years (13 Year)
- Sex
- Female Intact
- Region
- USA
- Reactions
- Lack of efficacy - NOSDeath by euthanasia
- Body systems
- EffectivenessOther
- Outcomes
- Euthanized
USA-USFDACVM-2025-US-072705
Received 2025-11-18 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Shorthair
- Size / weight
- 10-24 lb (6.35 Kilogram)
- Age
- 4-7 years (6 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- Mouth ulcerLethargy (see also Central nervous system depression in Neurological)Not eatingNervousHidingMonocytosisLow blood urea nitrogen (BUN)NeutrophiliaHyperglycaemiaLeucocytosis NOSElevated alanine aminotransferase (ALT)Decreased haematocritAbdominal painLocalised pain NOS (see other SOCs for specific pain)GingivitisConstipation
- Body systems
- OtherNeurologic
- Outcomes
- Outcome Unknown
USA-USFDACVM-2025-US-068768
Received 2025-11-14 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Mediumhair
- Size / weight
- Under 10 lb (4.13 Kilogram)
- Age
- 1-3 years (2 Year)
- Sex
- Female Neutered
- Region
- USA
- Reactions
- AnorexiaReluctant to moveVocalisationLoss of bowel controlNot urinatingEosinopeniaBasophiliaHypernatremiaThrombocytopeniaAbnormal radiograph findingThird eyelid protrusionOther ear disorder NOS
- Body systems
- DigestiveOther
- Outcomes
- Ongoing
USA-USFDACVM-2025-US-069642
Received 2025-11-12 · MSK · MSK
- Species
- Dog
- Breed
- ['Retriever - Labrador', 'Deutsche Dogge, Great Dane']
- Size / weight
- 50-99 lb (38.465 Kilogram)
- Age
- 8+ years (13 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- Lack of efficacy (endoparasite) - roundworm NOS
- Body systems
- Effectiveness
- Outcomes
- Recovered/Normal
USA-USFDACVM-2025-US-068234
Received 2025-11-12 · MSK · MSK
- Species
- Cat
- Breed
- Cat (unknown)
- Sex
- Mixed Unknown
- Region
- USA
- Reactions
- DeathHaematocheziaDecreased appetiteRegurgitationLethargy (see also Central nervous system depression in Neurological)DiarrhoeaDeath by euthanasia
- Body systems
- OtherDigestiveNeurologic
- Outcomes
- DiedEuthanizedOutcome Unknown
USA-USFDACVM-2025-US-067945
Received 2025-11-12 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Longhair
- Size / weight
- 10-24 lb (5.7 Kilogram)
- Age
- 8+ years (14 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- Hind limb paresisHidingNot eatingNot drinkingDry mucous membraneWeak pulseHyperthermiaDepressionLethargy (see also Central nervous system depression in Neurological)
- Body systems
- OtherNeurologic
- Outcomes
- Ongoing
USA-USFDACVM-2025-US-066416
Received 2025-10-28 · MSK · MSK
- Species
- Cat
- Breed
- Domestic Mediumhair
- Size / weight
- 10-24 lb (5 Kilogram)
- Age
- 8+ years (14.6 Year)
- Sex
- Male Neutered
- Region
- USA
- Reactions
- Not eatingLimpingLow sodium-potassium ratio (Na:K ratio)Elevated alanine aminotransferase (ALT)Gait abnormalityHard stoolSkin inflammation NOSArthritisSwelling NOS
- Body systems
- OtherSkin & allergy
- Outcomes
- Ongoing
Tap or hover a reaction to see what it means in plain language.
Tracked signals
32
Reported cases
32
Serious reports
27
Species represented
2
Grouped by Body System
Digestive (1)
· Loss of appetite
Skin & allergy (1)
· Alopecia local
Neurologic (1)
· Unsteady walking (ataxia)
Behavior (2)
· Behavioral disorder (unspecified), Aggression
Other (27)
· Blood in urine, Bladder distension, Bilirubinuria
Most Reported Reactions
| 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)
View detailed reaction table
| 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 |
Source metadata:
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2026-US-003268
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.
Mirataz®
SPL · SPL
Mirtazapine Anhydrous SPL
SPL · Structured Product Label
Mirtazapine anhydrous SPL
SPL · Structured Product Label
Full source previews and metadata remain in the veterinary/professional layer.
Owner handouts
0No owner handouts linked yet.
Official label / PI
0No official label or package insert links yet.
SPL
5FOI
1Mirataz®
SPL · SPL
FDA Structured Product Label
Mirataz®
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
- Sponsor
- Dechra Veterinary Products LLC
- NADA
- 141-481
- Status
- RX
- Form
- Transdermal ointment
- Route
- Topical (transdermal)
- Species
- Cat
Composition / specifications
Each 1 g of Mirataz™ contains 20 mg of mirtazapine (2%).
Cats
Indication
For body weight gain in cats with a history of weight loss.
Dosage
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.
Mirtazapine Anhydrous SPL
SPL · Structured Product Label
FDA Structured Product Label XML for Mirtazapine Anhydrous. Use the source link for the full official labeling record.
Mirtazapine anhydrous SPL
SPL · Structured Product Label
FDA Structured Product Label XML for Mirtazapine anhydrous. Use the source link for the full official labeling record.
Mirataz SPL
SPL · Structured Product Label
FDA Structured Product Label XML for Mirataz. Use the source link for the full official labeling record.
AX Pharmaceutical Corp SPL
SPL · Structured Product Label
FDA Structured Product Label XML for AX Pharmaceutical Corp. Use the source link for the full official labeling record.
FOI Summary oN 141-481 Approved May 4, 2018.pdf
FOI · FOI
Source metadata:
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/3487 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/3129/Mirataz%C2%AE · document · SPL
- https://www.accessdata.fda.gov/spl/data/642434df-7cae-43e9-b063-46066ec7c81e/642434df-7cae-43e9-b063-46066ec7c81e.xml · document · Structured Product Label
- https://www.accessdata.fda.gov/spl/data/896b3255-350a-45bc-93f8-9b4354feca14/896b3255-350a-45bc-93f8-9b4354feca14.xml · document · Structured Product Label
- https://www.accessdata.fda.gov/spl/data/6d65921e-0d65-48eb-8d28-3dd8f15080bf/6d65921e-0d65-48eb-8d28-3dd8f15080bf.xml · document · Structured Product Label
- https://www.accessdata.fda.gov/spl/data/2ef46c24-189d-425c-aadb-be44edb2b336/2ef46c24-189d-425c-aadb-be44edb2b336.xml · document · Structured Product Label
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 Aug 6, 2026, 7:47 PM UTC
The reference fact projection used for browse cards and quick facts.
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Aug 6, 2026, 7:47 PM 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 Aug 6, 2026, 7:47 PM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Official (FDA)
Identity: Generic ingredient
• FDA branded products available
Official FDA brands:
AX Pharmaceutical Corp
Mirataz
Mirtazapine Anhydrous
Mirtazapine anhydrous
Manufacturer mapping:
Multiple FDA labelers
Case-reported brands (openFDA):
MSK
Catalog species: Both
•
FDA-labeled species: Cat
Rx/OTC: RX
Form/route:
Transdermal ointment
• Topical (transdermal)
Applications: NADA 141-481
NDC:
Packages
17033-060-05
62157-466-01
73377-090-01
73377-090-02
73377-090-04
86032-071-01
•
Products
17033
62157
73377
86032
Explore
Related conditions:
Pica
Weight loss
Linked using:
Fda_Label (0.95),
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.
Top reaction signals
Unsteady walking (ataxia) (1)
Loss of appetite (1)
Blood in urine (1)
Bladder distension (1)
Bilirubinuria (1)
Behavioral disorder (unspecified) (1)
Basophilia (1)
Azotaemia (1)
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
Identifiers
NADA: 141481
NDC Package: 17033-060-05
NDC Package: 62157-466-01
NDC Package: 62157-506-01
NDC Package: 73377-003-01
NDC Package: 73377-090-01
NDC Package: 73377-090-02
NDC Package: 73377-090-04
NDC Package: 86032-071-01
NDC Product: 17033
NDC Product: 62157
NDC Product: 73377
NDC Product: 86032
| 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 | - |
Enriched Documents
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
-
Mirtazapine Anhydrous SPL
• Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
-
Mirtazapine anhydrous SPL
• Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
-
Mirataz SPL
• Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
-
AX Pharmaceutical Corp SPL
• Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
-
FOI Summary oN 141-481 Approved May 4, 2018.pdf
• FOI summary • Official
• July 14, 2026
FDA FOI summary for application 141481
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): Death by euthanasia, Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Anorexia, Decreased a… (Clinical, 2026-04-11)
- manufacturer_name: Multiple FDA labelers (Official, 2026-08-06)
- manufacturer_name: Multiple FDA labelers (Official, 2026-08-05)
- manufacturer_name: Multiple FDA labelers (Official, 2026-08-04)
- manufacturer_name: Multiple FDA labelers (Official, 2026-08-03)
- manufacturer_name: Multiple FDA labelers (Official, 2026-08-02)
- manufacturer_name: Multiple FDA labelers (Official, 2026-08-01)
- manufacturer_name: Multiple FDA labelers (Official, 2026-07-31)
- manufacturer_name: Multiple FDA labelers (Official, 2026-07-30)
- manufacturer_name: Multiple FDA labelers (Official, 2026-07-29)
- manufacturer_name: Multiple FDA labelers (Official, 2026-07-28)
- manufacturer_name: Multiple FDA labelers (Official, 2026-07-27)
- manufacturer_name: Multiple FDA labelers (Official, 2026-07-26)
- manufacturer_name: Multiple FDA labelers (Official, 2026-07-25)
- manufacturer_name: Multiple FDA labelers (Official, 2026-07-25)
- manufacturer_name: Multiple FDA labelers (Official, 2026-07-22)
- manufacturer_name: Multiple FDA labelers (Official, 2026-07-22)
- manufacturer_name: Multiple FDA labelers (Official, 2026-07-22)
- manufacturer_name: Multiple FDA labelers (Official, 2026-07-20)
- manufacturer_name: Multiple FDA labelers (Official, 2026-07-19)
Recent Revisions
- side_effects 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
- 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
- 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 |
|---|---|---|---|---|
|
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).
What It's For (FDA Label Highlights)
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
Species: Cat
Composition / specifications
Each 1 g of Mirataz™ contains 20 mg of mirtazapine (2%).
Cats
Indication
For body weight gain in cats with a history of weight loss.
Dosage
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.
Limitations
FDA page: Open in Animal Drugs @ FDA
Usage
For body weight gain in cats with a history of weight loss.
Source: FDA Animal Drugs @ FDA • Reference
Top Reported Reactions (openFDA)
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Digestive
Loss of appetite (1)
• Dog
Showing top 5 for Digestive.
Skin & allergy
Alopecia local (1)
• Cat
Showing top 5 for Skin & allergy.
Neurologic
Unsteady walking (1)
• Cat
Showing top 5 for Neurologic.
Behavior
Behavioral disorder (1)
• Dog
Aggression (1)
• Dog
Showing top 5 for Behavior.
Other
Blood in urine (1)
• Dog
Bladder distension (1)
• Cat
Bilirubinuria (1)
• Dog
Basophilia (1)
• Cat
Azotaemia (1)
• Cat
Show more (22)
Autoimmune disorder NOS (1)
• Dog
Ascites (1)
• Cat
Arthritis (1)
• Cat
Application site skin scaling (1)
• Cat
Application site reaction NOS (1)
• Cat
Anuria (1)
• Cat
Anaphylaxis (1)
• Dog
Anaemia NOS (1)
• Cat
Agonal breathing (1)
• Dog
Agitation (1)
• Dog
Adipsia (1)
• Cat
Acute renal failure (1)
• Cat
Active urine sediment (1)
• Dog
Accidental exposure (1)
• Cat
Abrasion (1)
• Cat
Abnormal ultrasound finding (1)
• Cat
Abnormal radiograph finding (1)
• Cat
Abnormal menace reflex test (1)
• Cat
Abnormal histology NOS (1)
• Cat
Abnormal cytology (1)
• Cat
Abdominal pain (1)
• Cat
Abdominal discomfort (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, 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
- Report ID: USA-USFDACVM-2026-US-013917
- Serious AE: Yes
- Treated For AE: No
- Sex: Male
- Age: 12.00 Year
- Weight: 4.536 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Tablet
- Dose: 3.75 Milligram per dose
- Frequency: 1 per day
Reactions Reported:
Lateral recumbency
Agonal breathing
Death
Outcomes: 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
- Report ID: USA-USFDACVM-2026-US-014720
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Age: 24.00 Year
- Weight: 2.500 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Transdermal
- Form: Ointment
- Dose: 0.75 Other per animal
- Frequency: 24 per hour
Reactions Reported:
Lack of efficacy - NOS
Application site reaction NOS
Outcomes: 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
- Report ID: USA-USFDACVM-2026-US-013837
- Serious AE: No
- Treated For AE: Yes
- Sex: Male
- Age: 10.00 Year
- Weight: 5.534 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Unassigned
Reactions Reported:
Hyperglycaemia
Diarrhea
Watery diarrhoea
Inappetence
Elevated betahydroxybutyrate
Outcomes: 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
- Report ID: USA-USFDACVM-2026-US-012583
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Female
- Weight: 3.311 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Reactions Reported:
Decreased appetite
Behavioral disorder (unspecified)
Pulmonary oedema
Trouble breathing (dyspnea)
Intentional misuse
Outcomes: 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
- Report ID: USA-USFDACVM-2026-US-012294
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 11.00 Year
- Weight: 6.260 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Reactions Reported:
Not eating
Drooling
Hypoglycaemia
Hypotension
Abnormal ultrasound finding
Hiding
Behavioral disorder (unspecified)
Tiredness (lethargy)
Hypothermia
Dehydration
Neutropenia
Diarrhea
Soft stool
Outcomes: Ongoing
Dog, Dalmatian, Male, 10 year, 36.741 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Agitation, Drooling, Febrile, Panting, Anaphylaxis… • Outcome: Ongoing
- Report ID: USA-USFDACVM-2026-US-012695
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 10.00 Year
- Weight: 36.741 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Unassigned
Reactions Reported:
Agitation
Drooling
Febrile
Panting
Anaphylaxis
Unwell
Decreased appetite
Urinary incontinence
Vomiting
Diarrhea
Leukocytosis NOS
Neutrophilia
Lymphocytosis
Monocytosis
Elevated globulins
Elevated serum alkaline phosphatase
Anaemia NOS
Elevated alanine aminotransferase
Elevated C-reactive protein
Aggression
Urolithiasis
Autoimmune disorder NOS
Thrombocytopenia
Outcomes: 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
- Report ID: USA-USFDACVM-2026-US-012574
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 10.00 Year
- Weight: 2.900 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Reactions Reported:
Decreased appetite
Lack of efficacy - NOS
Weight loss
Outcomes: 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
- Report ID: USA-USFDACVM-2026-US-012224
- Serious AE: No
- Treated For AE: Yes
- Sex: Female
- Age: 12.50 Year
- Weight: 3.000 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Reactions Reported:
Tongue disorder NOS
Tongue ulceration
Drooling
Unwell
Tracheal and laryngeal disorder NOS
Crust
Decreased appetite
Laryngeal oedema
Cough
Head tilt - neurological disorder
Swallowing disorder NOS
Local swelling
Tiredness (lethargy)
Nasal discharge
Malaise
Dehydration
Ocular discharge
Outcomes: Recovered/Normal
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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Medical Disclaimer: The medication details provided on Roxee are for informational purposes only and are not a substitute for professional veterinary advice. Always consult your veterinarian about your pet's specific needs.