Ampicillin Trihydrate — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Ampicillin Trihydrate

Active ingredient

Ampicillin Trihydrate

Application type

ANADA

Sponsor

HQ Specialty Pharma Corp.

Applications on record

1

First published

August 1, 2019

Adverse event reports

Source: openFDA VeDDRA

644

Reports mentioning this ingredient

July 11, 1989 – February 9, 2026

179

Classified serious

per reporter assessment

30

Lack of expected efficacy

resistance signal

10

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 “AMPICILLIN TRIHYDRATE”. 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
Death	88
Solution, Abnormal	65
Suspension, Abnormal	56
Death by euthanasia	32
Anaphylaxis	31
Injection site swelling	30
Anorexia	27
Residues in milk	24
Injection site pain	24
Dyspnoea	23
Vomiting	22
Color, Abnormal	20
Residues in meat/offal	20
Fever	17
Diarrhoea	17
Other abnormal test result NOS	17
Anaemia NOS	16
Lethargy (see also Central nervous system depression in 'Neurological')	16
Vials, Damaged	15
Lack of efficacy (bacteria) - NOS	15

Species affected

Source: openFDA VeDDRA

Dog 179 Cattle 163 Cat 73 Horse 7 Other 4 Human 2 Pig 1 Sheep 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