Roxee Meds Catalog

Clomipramine

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

Both Catalog complete FDA data linked Rx required Tablet Multiple FDA labelers Official label facts Owner quick guide first

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Sponsor, product, and application records imported from Animal Drugs @ FDA.

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Source timing details

Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
The storefront fact projection used for browse cards and quick facts.
Animal Drugs @ FDA: Source FDA | Refreshed May 5, 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 May 5, 2026, 10:00 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: February 12, 2026

Updated: February 12, 2026, 10:44 PM UTC

Sources:

FDA application profile · official_label
FDA application profile · official_label
Medication usage source · fda_animal_drugs
Clomipramine Hydrochloride Tablets · official_label
openFDA case FIN-USFDACVM-2025-FI-000002 · adverse_reaction

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Clomipramine

Drug type: Generic ingredient • Branded profile • FDA branded products available

Both Tablet Rx required 100% storefront ready

Species: Both

Manufacturer: Multiple FDA labelers

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Clomipramine

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. Species commonly shown: Both, Dog, No Use Class Stated Or Implied.

Generic name

Clomipramine

Brand names

CLOMICALM®, Clomipramine Hydrochloride Tablets, CaniQuell, clomipramine hydrochloride

Manufacturer

Multiple FDA labelers

Species

Both, Dog, No Use Class Stated Or Implied

Dosage forms

Tablet

Prescription

Prescription required

Completeness

100%

Validation

Complete

Brand names

CLOMICALM® Clomipramine Hydrochloride Tablets CaniQuell clomipramine hydrochloride CLOMICALM Calmera Clomipramine HCl

Dosage forms

Tablet

Indications / Uses

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.

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

Top reported reactions (openFDA): Lack of efficacy - NOS, Vomiting, Diarrhoea, Lethargy (see also Central nervous system depression in 'Neurological'), Underdose, Behavioural disorder NOS.

FAQ

Both, Dog, No Use Class Stated Or Implied

Yes. Roxee shows this as prescription-only.

Tablet

Related Conditions

Seizures (idiopathic/structural) Separation anxiety

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://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/647
Last refreshed: May 5, 2026, 10:00 a.m.
Last verified: Feb 12, 2026, 10:44 p.m.
Validation status: Complete

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Used for:

For use as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.

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:

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
very low energy (1 reports)
Other abnormal test result NOS (1 reports)
Lameness (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?

Major cautions & emergency warning signs

Side effects to monitor:

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
very low energy

Most reported reactions:

Tiredness (lethargy) (1 reports)
Other abnormal test result NOS (1 reports)
Lameness (1 reports)

Emergency warning signs:

Repeated vomiting or diarrhea.
Severe lethargy (hard to wake, very low energy).
Collapse or fainting.
Trouble breathing.

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Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both

Manufacturer: Multiple FDA labelers

Form: Tablet

Identifiers:

ANADA: 200635 ANADA: 200825 NADA: 141120 NDC Package: 11695-6950-3 NDC Package: 11695-6951-3 NDC Package: 11695-6952-3 NDC Package: 11695-6953-3 NDC Package: 13985-974-30 NDC Package: 13985-975-30 NDC Package: 13985-976-30 NDC Package: 13985-977-30 NDC Package: 46066-131-36 NDC Package: 46066-132-36 NDC Package: 46066-133-36 NDC Package: 46066-134-36 NDC Package: 51311-140-05 NDC Package: 51311-141-20 NDC Package: 51311-142-80 NDC Package: 73377-196-04 NDC Package: 86039-113-30

Source metadata:

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

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.

Source metadata:

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.

Tracked signals

Reported cases

Serious reports

Species represented

Grouped by Body System

Digestive (3) · Vomiting, Decreased appetite, Appetite loss Neurologic (3) · Unsteady walking (ataxia), Tiredness (lethargy), Head tilt - neurological disorder Behavior (1) · Behavioral disorder (unspecified) Effectiveness (1) · Lack of efficacy - NOS Other (24) · Vestibular disorder NOS, Sleepiness - systemic disorder, Self mutilation

Most Reported Reactions

Body system	Cases	Species	Serious cases
Neurologic	1	Dog	1
Other	1	Cat	1
Other	1	Cat	1
Effectiveness	1	Dog	1
Other	1	Cat	1
Other	1	Cat	1
Other	1	Cat	1
Other	1	Cat	1

Species coverage: Dog (20) Cat (12)

View detailed reaction table

Body system	Species	Seriousness	Frequency	Reports
Digestive	Dog	Non-serious	-	1
Other	Dog	Non-serious	-	1
Neurologic	Dog	Non-serious	-	1
Neurologic	Dog	Serious	-	1
Other	Dog	Non-serious	-	1
Other	Cat	Non-serious	-	1
Other	Dog	Non-serious	-	1
Other	Dog	Non-serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Non-serious	-	1
Other	Cat	Serious	-	1
Effectiveness	Dog	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Non-serious	-	1
Other	Cat	Serious	-	1
Neurologic	Dog	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	Cat	Serious	-	1
Other	Cat	Serious	-	1
Digestive	Dog	Serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Non-serious	-	1
Other	Dog	Non-serious	-	1
Behavior	Dog	Non-serious	-	1
Digestive	Cat	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Non-serious	-	1

Source metadata:

https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case FIN-USFDACVM-2025-FI-000002

Documents

Owner handouts and official technical documents open on-page first, with the original source still one click away.

Owner handouts

No owner handouts linked yet.

Official label / PI

No official label or package insert links yet.

SPL

FOI

Clomipramine Hydrochloride Tablets

SPL · SPL

Open original

FDA Structured Product Label

Clomipramine Hydrochloride Tablets

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Felix Pharmaceuticals Pvt. Ltd.
ANADA: 200-825
Status: RX
Form: Tablet
Route: Oral

Composition / specifications

5 mg, 20 mg, 40 mg, and 80 mg

Dogs

Indication

For use as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.

Dosage

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.

CLOMICALM®

SPL · SPL

Open original

FDA Structured Product Label

CLOMICALM®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Virbac AH, Inc.
NADA: 141-120
Status: RX
Form: Tablet
Route: Oral
Species: Dog, No Use Class Stated Or Implied

Composition / specifications

Each tablet contains 5, 20, 40, or 80 milligrams of clomipramine hydrochloride.

Dogs (6 Months of Age and Older)

Indication

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.

Dosage

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.

Limitations

Clomipramine Hydrochloride Tablets

SPL · SPL

Open original

FDA Structured Product Label

Clomipramine Hydrochloride Tablets

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Mizner Bioscience LLC
ANADA: 200-635
Status: RX
Form: Tablet
Route: Oral
Species: Dog, No Use Class Stated Or Implied

Composition / specifications

5 mg, 20 mg, 40 mg, and 80 mg

Dogs

Indication

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.

Dosage

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.