Semintra® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Semintra®

Active ingredient

Telmisartan

Application type

NADA

Sponsor

Boehringer lngelheim Animal Health USA, Inc.

Applications on record

1

First published

May 17, 2021

Adverse event reports

Source: openFDA VeDDRA

558

Reports mentioning this ingredient

July 8, 2014 – March 16, 2026

203

Classified serious

per reporter assessment

133

Lack of expected efficacy

resistance signal

0

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 “TELMISARTAN”. 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
Lack of efficacy - NOS	94
Vomiting	68
Weight loss	30
Appearance, Abnormal	27
Lethargy (see also Central nervous system depression in 'Neurological')	22
Elevated creatinine	20
Decreased appetite	16
Diarrhoea	16
Inappetence	14
Dehydration	13
Heart murmur	12
Urinary tract infection	12
Anaemia NOS	12
Device breakage/fracture	11
Death by euthanasia	10
Vocalisation	10
Sneezing	10
Constipation	9
Hypotension	9
Elevated blood urea nitrogen (BUN)	8

Species affected

Source: openFDA VeDDRA

Cat 293 Dog 189 Human 2

Regulatory context

New Animal Drug Application (NADA). A pioneer approval evaluated for target animal safety, therapeutic effectiveness, manufacturing controls and — for food-producing species — human food safety including residue depletion.

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