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Roxee Medication Guide

Clomipramine

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 Tablet Multiple FDA labelers Official label facts Owner quick guide first
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Data freshness

Reference facts
Reference refreshed
Jun 22, 2026, 10:41 a.m.

These are the reference facts Roxee uses on browse cards and quick facts.

FDA applications
FDA application data refreshed
Jun 22, 2026, 10:41 a.m.

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

Safety reports
No safety reports linked
No refresh timestamp yet

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 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 Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
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Clomipramine

Clomipramine

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

Both Tablet 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.

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.

Generic name
Clomipramine
Brand names
CLOMICALM®, Clomipramine Hydrochloride Tablets, CaniQuell, CLOMICALM
Manufacturer
Multiple FDA labelers
Species
Both, Dog
Dosage forms
Tablet
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
CLOMICALM® Clomipramine Hydrochloride Tablets CaniQuell CLOMICALM clomipramine hydrochloride Calmera Clomipramine HCl
Dosage forms
Tablet

Indications / Uses

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.

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

Yes. Roxee shows this as prescription-only.

Tablet

Related Conditions

Seizures (idiopathic/structural) Separation anxiety

Source Transparency

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

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?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence
Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Clomipramine; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case FIN-USFDACVM-2025-FI-000002
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 17 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case FIN-USFDACVM-2025-FI-000002
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 FIN-USFDACVM-2025-FI-000002
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

Tiredness (lethargy) (1 reports), Other abnormal test result NOS (1 reports), Lameness (1 reports), Lack of efficacy - NOS (1 reports), Knuckling (1 reports)

Body systems represented Signal grouping

Digestive (3), Neurologic (3), Behavior (1), Effectiveness (1)

Species and breed lens

Species represented in reports Species lens

Dog (20 reports), Cat (12 reports)

What your vet may verify

Fit for this patient Vet check

Verify whether Clomipramine 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

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 wi, CLOMICALM Tablets are contraindicated for use in dogs with a history of seizures or concomitantly wi, very low energy

Call sooner if Escalation

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

Bottom line: Use this Clomipramine 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
  1. openFDA case FIN-USFDACVM-2025-FI-000002 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. SPL · document · documents
  8. FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

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

Sources:
Safety & side effects

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.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Dog
Indication / use
For use as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.
Form / route / dose
Form: Tablet
Route: Oral
Confirm product label and patient-specific plan.
Warnings
  • High: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. CLOMICALM Tablets should no…
Adverse-event caveat
No stored openFDA case explorer rows are linked yet.
Source docs

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:

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.
Source metadata:

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
32
Reported cases
32
Serious reports
17
Species represented
2
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
Reaction 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
Reaction 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:

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.

Clomipramine Hydrochloride Tablets SPL · SPL CLOMICALM® SPL · SPL Clomipramine Hydrochloride Tablets SPL · SPL

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

10

FOI

4

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
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
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.

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
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.

Clomipramine HCl SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Clomipramine HCl. Use the source link for the full official labeling record.

Calmera SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Calmera. Use the source link for the full official labeling record.

Clomipramine Hydrochloride SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Clomipramine Hydrochloride. Use the source link for the full official labeling record.

clomipramine hydrochloride SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for clomipramine hydrochloride. Use the source link for the full official labeling record.

clomipramine hydrochloride SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for clomipramine hydrochloride. Use the source link for the full official labeling record.

CaniQuell SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for CaniQuell. Use the source link for the full official labeling record.

CLOMICALM SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for CLOMICALM. Use the source link for the full official labeling record.

FOI Summary oA 200-825 Approved October 21, 2025.pdf

FOI · FOI

Open original

ucm117166.pdf

FOI · FOI

Open original

ucm117165.pdf

FOI · FOI

Open original

FOI Summary oA 200-635 Approved October 29, 2019.pdf

FOI · FOI

Open original
Source metadata:
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 Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 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 Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: CLOMICALM Calmera CaniQuell Clomipramine HCl Clomipramine Hydrochloride clomipramine hydrochloride
Manufacturer mapping: Multiple FDA labelers
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Tablet • Oral
Applications: ANADA 200-825 • NADA 141-120 • ANADA 200-635
NDC: Packages 11695-6950-3 11695-6951-3 11695-6952-3 11695-6953-3 13985-974-30 13985-975-30 • Products 11695 13985 46066 51311 73377 86039
Documents: 4 (FOI: 4) • SPL: 3 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 0 • Cat 0 • View
Case summaries: 0
openFDA reports are unverified and do not prove causation.
Explore
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.

Owner-facing counseling points
  • 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)
Top reaction signals
Tiredness (lethargy) (1) Other abnormal test result NOS (1) Lameness (1) Lack of efficacy - NOS (1) Knuckling (1) Ketosis (1) Hind limb paresis (1) Elevated globulins (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

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 NDC Package: 86039-114-30 NDC Package: 86039-115-30 NDC Package: 86039-116-30 NDC Package: 86101-035-30
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 -
73377-196-04 73377 -
86039-113-30 86039 -
86039-114-30 86039 -
86039-115-30 86039 -
86039-116-30 86039 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

  • Clomipramine HCl SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Calmera SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Clomipramine Hydrochloride SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • clomipramine hydrochloride SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • clomipramine hydrochloride SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • CaniQuell SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • CLOMICALM SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • 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 & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 130 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Vomiting, Diarrhoea, Lethargy (see also Central nervous system depression in 'Neurological'), Underdo… (Clinical, 2026-04-11)
  • 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, 2026-04-11)
  • 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)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-22)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-22)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-21)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-20)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-13)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-12)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-12)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-11)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-11)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-10)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-09)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-08)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-07)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-06)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-05)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-04)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-03)
Recent Revisions
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications 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
  • 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
Label highlights
Official documents
Felix Pharmaceuticals Pvt. Ltd. ANADA 200-825 Approved Nov 3, 2025
CLOMICALM®
RX
Clomipramine Hydrochloride
Tablet • Oral
Label highlights
Official documents
Virbac AH, Inc. NADA 141-120 Approved Mar 12, 2025
Clomipramine Hydrochloride Tablets
RX
Clomipramine Hydrochloride
Tablet • Oral
Label highlights
Official documents
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
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.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog
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
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.

FDA page: Open in Animal Drugs @ FDA

Species: Dog
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.

Limitations

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.

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Vomiting (1) • Dog Decreased appetite (1) • Dog Appetite loss (1) • Cat

Showing top 5 for Digestive.

Neurologic
Unsteady walking (1) • Dog Tiredness (1) • Dog Head tilt - neurological disorder (1) • Dog

Showing top 5 for Neurologic.

Behavior
Behavioral disorder (1) • Dog

Showing top 5 for Behavior.

Effectiveness
Lack of efficacy - NOS (1) • Dog

Showing top 5 for Effectiveness.

Other
Vestibular disorder NOS (1) • Dog Sleepiness - systemic disorder (1) • Dog Self mutilation (1) • Cat Reduced responses (1) • Dog Proprioception deficit (1) • Dog
Show more (19)
Other abnormal test result NOS (1) • Cat Nystagmus (1) • Dog Lameness (1) • Cat Knuckling (1) • Cat Ketosis (1) • Cat Hypotension (1) • Dog Hind limb paresis (1) • Cat Elevated globulins (1) • Cat Elevated creatinine (1) • Dog Elevated blood urea nitrogen (1) • Dog Elevated alanine aminotransferase (1) • Cat Dull (1) • Dog Diabetic ketoacidosis (1) • Cat Depressed reflexes (1) • Cat Death by euthanasia (1) • Cat Death (1) • Dog Bradycardia (1) • Dog Abnormal ultrasound finding (1) • Dog Abnormal electrocardiogram (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.

No case-level openFDA reports are linked for this medication yet.

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.

Share Your Thoughts

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This medication has not been reviewed by a veterinarian yet.