Meds A-Z
Mirtazapine
Detailed information about Mirtazapine
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Sign in to continueReviewed / Updated / Sources
Reviewed: Not available
Updated: February 12, 2026, 10:44 PM UTC
- FDA application profile · official_label
- Medication usage source · fda_animal_drugs
- openFDA case USA-USFDACVM-2025-US-055801 · adverse_reaction
- FOI · document
- SPL · document
Pet Owner Quick Guide
Start here first for the simple next-step summary.
Used for:
For body weight gain in cats with a history of weight loss.
What to watch for:
- Lack of efficacy - NOS (1 reports)
- Joint pain (1 reports)
- Inappropriate urination (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 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:
- Lack of efficacy - NOS
- Joint pain
- Inappropriate urination
Most reported reactions:
- Lack of efficacy - NOS (1 reports)
- Joint pain (1 reports)
- Inappropriate urination (1 reports)
When to call your vet:
- Repeated vomiting or diarrhea.
- Severe lethargy (hard to wake, very low energy).
- Collapse or fainting.
- Trouble breathing.
Data freshness: source data appears current.
Latest refresh: Mar 21, 2026, 10:03 a.m.
- 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 21, 2026, 10:03 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 12, 2026, 10:43 PM UTC
Mirtazapine
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.
- 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.
Tap or hover a reaction to see what it means in plain language.
Grouped by Body System
Most Reported Reactions
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Effectiveness | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 |
Species coverage: Dog (19) Cat (13)
View detailed reaction table
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Digestive | Cat | Non-serious | - | 1 | |
| Neurologic | Cat | Non-serious | - | 1 | |
| Neurologic | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Effectiveness | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Behavior | Dog | Non-serious | - | 1 | |
| Behavior | Dog | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-055801
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)
-
Mirataz®
· SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/3129/Mirataz%C2%AE
FOI (1)
-
FOI Summary oN 141-481 Approved May 4, 2018.pdf
· FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/3487
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.
- 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 21, 2026, 10:03 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 12, 2026, 10:43 PM 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.
Identifiers & Packages
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 | - |
Enriched Documents
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
-
FOI Summary oN 141-481 Approved May 4, 2018.pdf
• FOI summary • Official
• Jan. 4, 2023
FDA FOI summary for application 141481
Data Sources & Change Log
Every non-trivial field is expected to include provenance and update timestamps.
- side_effects: Top reported reactions (openFDA): Death by euthanasia, Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Anorexia, Decreased a… (Official, 2026-02-12)
- usage: For body weight gain in cats with a history of weight loss. (Official, 2026-02-12)
- 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, Ltd. | NADA 141-481 | Approved | Jan 4, 2023 |
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
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
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
Summary
For the management of weight loss in cats.
- Mirataz® (ZIP)
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).
Showing top 5 for Digestive.
Showing top 5 for Neurologic.
Showing top 5 for Behavior.
Showing top 5 for Effectiveness.
Show more (18)
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, Shar Pei, Female, 5 year, 16.23 kilogram • Drug: MSK, Unknown • Reactions: Neuromuscular disorder NOS, Unsteady gait, Nystagmus, Circling - behavioural disorder, Not himself/herself • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-055976
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Age: 5.00 Year
- Weight: 16.230 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Cat, Cat (unknown), Female, 20.5 year • Drug: MSK, Unknown • Reactions: General illness, Hiding, Joint pain, Elevated creatinine, Elevated symmetrical dimethylarginine… • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-055646
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Female
- Age: 20.50 Year
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Cat, Crossbred Feline/cat, Female, 17.83 year, 2.767 kilogram • Drug: MSK, Unknown • Reactions: Vomiting • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-054249
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Age: 17.83 Year
- Weight: 2.767 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Cat, Domestic Shorthair, Female, 18 year, 2.87 kilogram • Drug: MSK, Unknown • Reactions: Vomiting • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-054398
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Age: 18.00 Year
- Weight: 2.870 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Cat, Domestic Mediumhair, Female, 13 year, 2.858 kilogram • Drug: MSK, Auricular (Otic) • Reactions: Tiredness (lethargy), Unresponsive to stimuli, Not eating, Not drinking, Hiding… • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-055801
- Serious AE: No
- Treated For AE: Yes
- Sex: Female
- Age: 13.00 Year
- Weight: 2.858 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Auricular (Otic)
Cat, Cat (unknown), Male, 18 year, 5.1 kilogram • Drug: MSK, Ointment, Transdermal, Dose: 1.50 Other per animal, Frequency: 24 per hour • Reactions: Lack of efficacy - NOS, Death • Outcome: Died
- Report ID: USA-USFDACVM-2025-US-055952
- Serious AE: Yes
- Treated For AE: No
- Sex: Male
- Age: 18.00 Year
- Weight: 5.100 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Transdermal
- Form: Ointment
- Dose: 1.50 Other per animal
- Frequency: 24 per hour
Cat, Domestic Mediumhair, Female, 5 year, 4 kilogram • Drug: MSK, Ointment, Auricular (Otic), Frequency: 1 per day • Reactions: Unsteady walking (ataxia) • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-055804
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Age: 5.00 Year
- Weight: 4.000 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Auricular (Otic)
- Form: Ointment
- Frequency: 1 per day
Dog, ['Corgi (unspecified)', 'Terrier - Jack Russell'], Female, 15 year, 17.69 kilogram • Drug: MSK, Unknown • Reactions: Loss of appetite, Tiredness (lethargy) • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-052158
- Serious AE: No
- Treated For AE: Yes
- Sex: Female
- Age: 15.00 Year
- Weight: 17.690 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
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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This medication has not been reviewed by a veterinarian yet.