Meds A-Z
Clomipramine
Detailed information about Clomipramine
Pet Owner Quick Guide
Start here: what this medicine is for, what it does, and when it's usually needed.
Usually used for:
For use as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.
What it does:
CLOMICALM Tablets are to be used as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age. Clomipramine Hydrochloride Tablets are to be used as part of a c...
When it's needed:
Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. CLOMICALM Tablets should not be used in male breeding dogs. CLOMICALM Tablets should not be given in combination, or within 14 d...
Call your vet sooner if you notice:
- Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. CLOMICALM Tablets should not be used in male breeding dogs. CLOMICALM Tablets should not be given in combination, or within 14 days before or after treatment with a monoamine oxidase inhibitor [e.g., selegiline hydrochloride (L-deprenyl), amitraz]. CLOMICALM Tablets are contraindicated for use in dogs with a history of seizures or concomitantly with drugs which lower the seizure threshold.
Commonly reported reactions:
- (2 reports)
- (2 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?
Clomipramine
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/200825 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141120 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
Warnings / Contraindications
Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. CLOMICALM Tablets should not be used in male breeding dogs. CLOMICALM Tablets should not be given in combination, or within 14 days before or after treatment with a monoamine oxidase inhibitor [e.g., selegiline hydrochloride (L-deprenyl), amitraz]. CLOMICALM Tablets are contraindicated for use in dogs with a history of seizures or concomitantly with drugs which lower the seizure threshold.
- High: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. CLOMICALM Tablets should not be used in male breeding dogs. CLOMICALM Tablets should not be given in combination, or within 14 days before or after treatment with a monoamine oxidase inhibitor [e.g., selegiline hydrochloride (L-deprenyl), amitraz]. CLOMICALM Tablets are contraindicated for use in dogs with a history of seizures or concomitantly with drugs which lower the seizure threshold.
- 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 |
|---|---|---|---|
| 2 | Cat, Dog | 1 | |
| 2 | Cat, Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Cat | 1 | |
| 1 | Cat | 1 | |
| 1 | Cat | 1 | |
| 1 | Cat | 1 | |
| 1 | Cat | 1 |
Species coverage: Dog (19) Cat (13)
View detailed reaction table
| Reaction | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Non-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 | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case FIN-USFDACVM-2025-FI-000002
Storage & Handling
No storage/handling guidance is linked yet.
Documents
Official label facts are separated from secondary summaries.
Official documents: 7 • Secondary summaries: 0
No source yet.
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/17687 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/17969/Clomipramine%20Hydrochloride%20Tablets · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/647 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/646 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1826/CLOMICALM%C2%AE · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/7832 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/7890/Clomipramine%20Hydrochloride%20Tablets · document · SPL
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 (USA) law restricts this drug to use by or on the order of a licensed veterinarian. CLOMICALM Tablets should not be used in male breeding dogs. CLOMICALM Tablets should not be given in combination, or within 14 days before or after treatment with a monoamine oxidase inhibitor [e.g., selegiline hydrochloride (L-deprenyl), amitraz]. CLOMICALM Tablets are contraindicated for use in dogs with a history of seizures or concomitantly with drugs which lower the seizure threshold. (Contraindication, High)
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 11695-6950-3 | 11695 | - | |
| 11695-6951-3 | 11695 | - | |
| 11695-6952-3 | 11695 | - | |
| 11695-6953-3 | 11695 | - | |
| 13985-974-30 | 13985 | - | |
| 13985-975-30 | 13985 | - | |
| 13985-976-30 | 13985 | - | |
| 13985-977-30 | 13985 | - | |
| 46066-131-36 | 46066 | - | |
| 46066-132-36 | 46066 | - | |
| 46066-133-36 | 46066 | - | |
| 46066-134-36 | 46066 | - | |
| 51311-140-05 | 51311 | - | |
| 51311-141-20 | 51311 | - | |
| 51311-142-80 | 51311 | - | |
| 86039-113-30 | 86039 | - | |
| 86039-114-30 | 86039 | - | |
| 86039-115-30 | 86039 | - | |
| 86039-116-30 | 86039 | - | |
| 86101-035-30 | 86101 | - |
Enriched Documents
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
-
FOI Summary oA 200-825 Approved October 21, 2025.pdf
• FOI summary • Official
• Nov. 3, 2025
FDA FOI summary for application 200825
-
ucm117165.pdf
• FOI summary • Official
• March 12, 2025
FDA FOI summary for application 141120
-
ucm117166.pdf
• FOI summary • Official
• March 12, 2025
FDA FOI summary for application 141120
-
FOI Summary oA 200-635 Approved October 29, 2019.pdf
• FOI summary • Official
• Nov. 1, 2019
FDA FOI summary for application 200635
Data Sources & Revision History
Every non-trivial field is expected to include provenance and update timestamps.
- contraindications: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. CLOMICALM Tablets should not be used in male breeding dogs. CLOMICA… (Official, 2026-02-12)
- side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Vomiting, Diarrhoea, Lethargy (see also Central nervous system depression in 'Neurological'), Underdo… (Official, 2026-02-12)
- usage: CLOMICALM Tablets are to be used as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age. Clo… (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 |
|---|---|---|---|---|
|
Clomipramine Hydrochloride Tablets
RX
Clomipramine Hydrochloride
Tablet
• Oral
|
Felix Pharmaceuticals Pvt. Ltd. | ANADA 200-825 | Approved | Nov 3, 2025 |
|
CLOMICALM®
RX
Clomipramine Hydrochloride
Tablet
• Oral
|
Virbac AH, Inc. | NADA 141-120 | Approved | Mar 12, 2025 |
|
Clomipramine Hydrochloride Tablets
RX
Clomipramine Hydrochloride
Tablet
• Oral
|
Mizner Bioscience LLC | ANADA 200-635 | Approved | Nov 1, 2019 |
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 use as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.
2 to 4 milligrams of clomipramine hydrochloride per kilogram (0.9 to 1.8 milligrams per pound) of body weight per day, administered as a single daily dose or divided twice daily.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
Clomipramine Hydrochloride Tablets are to be used as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than
6 months of age.
The recommended daily dose of Clomipramine Hydrochloride Tablets is 2 to 4 mg/kg/day (0.9 – 1.8 mg/lb/day). It can be administered as a single daily dose or divided twice daily based on patient response and/or
tolerance of the side effects.
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
Summary
For use as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.
FDA page: Open in Animal Drugs @ FDA
-
FOI ucm117166.pdf
Summary
This supplement provides for the addition of a 5 mg tablet size. -
FOI ucm117165.pdf
Summary
To be used apart of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.
- CLOMICALM® (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
Summary
Clomipramine Hydrochloride Tablets are to be used as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.
FDA page: Open in Animal Drugs @ FDA
Usage
CLOMICALM Tablets are to be used as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age. Clomipramine Hydrochloride Tablets are to be used as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age. For use as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.
Source: FDA Animal Drugs @ FDA • Reference
Contraindications
Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. CLOMICALM Tablets should not be used in male breeding dogs. CLOMICALM Tablets should not be given in combination, or within 14 days before or after treatment with a monoamine oxidase inhibitor [e.g., selegiline hydrochloride (L-deprenyl), amitraz]. CLOMICALM Tablets are contraindicated for use in dogs with a history of seizures or concomitantly with drugs which lower the seizure threshold.
Side Effects
No approved side-effect narrative is linked yet.
openFDA reaction signals are available for Dog 50 and Cat 8 (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, Beagle, Mixed, 7.3 kilogram • Drug: MSK, Tablet, Oral • Reactions: Sleepiness - systemic disorder, Hypotension, Bradycardia, Vomiting, Abnormal electrocardiogram… • Outcome: Recovered/Normal
- Report ID: FIN-USFDACVM-2025-FI-000002
- Serious AE: No
- Treated For AE: No
- Sex: Mixed
- Weight: 7.300 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Tablet
Dog, Terrier - Yorkshire, Male, 10 year, 3.8 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 dose per animal • Reactions: Lack of efficacy - NOS, Weight loss, Tiredness (lethargy), Decreased appetite, Elevated creatinine… • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-028470
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 10.00 Year
- Weight: 3.800 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Tablet
- Dose: 1 dose per animal
Dog, Bulldog - French, Male, 8 year, 13.68 kilogram • Drug: MSK, Tablet, Oral, Dose: 40 Milligram per animal, Frequency: 1 per day • Reactions: Death • Outcome: Died
- Report ID: USA-USFDACVM-2025-US-030539
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 8.00 Year
- Weight: 13.680 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Tablet
- Dose: 40 Milligram per animal
- Frequency: 1 per day
Dog, Shepherd Dog - German, Male, 9 year, 35 kilogram • Drug: MSK, Oral • Reactions: Vestibular disorder NOS, Nystagmus, Proprioception deficit, Unsteady walking (ataxia), Dull… • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-017653
- Serious AE: No
- Treated For AE: Yes
- Sex: Male
- Age: 9.00 Year
- Weight: 35.000 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
Dog, ['Crossbred Canine/dog', 'Shepherd Dog - German'], Male, 9 year, 35 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Vestibular disorder NOS, Nystagmus, Proprioception deficit, Unsteady walking (ataxia), Dull… • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-013287
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 9.00 Year
- Weight: 35.000 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Unassigned
Cat, Domestic Shorthair, Female, 9 year, 6.849 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Lack of efficacy - NOS • Outcome: Ongoing
- Report ID: USA-USFDACVM-2024-US-018682
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Age: 9.00 Year
- Weight: 6.849 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Unassigned
Cat, Domestic Mediumhair, Male, 6 year, 5.761 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Self mutilation • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2024-US-017229
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 6.00 Year
- Weight: 5.761 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Unassigned
Cat, Domestic Shorthair, Male, 7 year, 4.8 kilogram • Drug: MSK, Unknown • Reactions: Appetite loss, Elevated alanine aminotransferase, Ketosis, Elevated globulins, Diabetic ketoacidosis… • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2023-US-037931
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 7.00 Year
- Weight: 4.800 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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Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.