Clomipramine Hydrochloride Tablets — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Clomipramine Hydrochloride Tablets

Active ingredient

Clomipramine Hydrochloride

Application type

ANADA

Sponsor

Mizner Bioscience LLC

Applications on record

2

First published

November 1, 2019

Applications

Source: Animal Drugs @ FDA

Every Green Book application recorded for this proprietary name.
Application no.	Type	Status	Withdrawn
200635	ANADA	Approved	—
200825	ANADA	Approved	—

Adverse event reports

Source: openFDA VeDDRA

358

Reports mentioning this ingredient

December 14, 2010 – March 25, 2026

132

Classified serious

per reporter assessment

67

Lack of expected efficacy

resistance signal

16

Human operator exposure

needle-stick or splash

Not a risk measure. Veterinary adverse event reports are influenced by how many animals are treated, reporting practice and product age. Reports do not establish that the product caused the event, and a single report can cover an entire herd or flock. Attribution here is by active ingredient because the source dataset redacts brand names.

Attributed by active ingredient “CLOMIPRAMINE HYDROCHLORIDE”. Green Book ingredient names and VeDDRA ingredient names do not always agree exactly, so attribution is approximate and labelled as such.

Reported reactions

Source: openFDA VeDDRA

Clinical signs coded in the VICH VeDDRA four-level hierarchy, most frequent first.

Reaction terms reported for this ingredient, by report count.
Reaction (VeDDRA term)	Reports	Relative frequency
Tablets, Abnormal	70
Lack of efficacy - NOS	49
Uncoded sign	46
Lethargy (see also Central nervous system depression in 'Neurological')	26
Other abnormal test result NOS	23
Elevated alanine aminotransferase (ALT)	19
Vomiting	19
Behavioural disorder NOS	16
Anorexia	16
Accidental exposure	16
Diarrhoea	15
Underfilling, Bottles	14
Emesis	13
Elevated serum alkaline phosphatase (SAP)	12
Overdose	11
Aggression	10
Anxiety	10
Weight loss	10
Elevated liver enzymes	10
Vocalisation	9

Species affected

Source: openFDA VeDDRA

Dog 227 Cat 21 Human 9 Other 1

Regulatory context

Abbreviated New Animal Drug Application (ANADA). A generic animal drug demonstrating bioequivalence, pharmaceutical equivalence and identical manufacturing criteria to the pioneer application. Veterinary generics have no formal therapeutic-equivalence coding system; they match the pioneer NADA specification instead.

Extra-label use in food-producing animals is governed by the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) and 21 CFR Part 530. It requires a valid veterinarian-client-patient relationship and is prohibited outright for certain drug classes. Withdrawal times are determined by FARAD, not by this index.

Sources for this page

Animal Drugs @ FDA	FDA CVM	Applications, sponsor, status, withdrawal
Animal & Veterinary Events	FDA CVM	VeDDRA adverse event aggregates by active ingredient