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Amp-Equine

Ampicillin Sodium

Veterinary NADA Approved 17 adverse event reports

Overview

Source: Animal Drugs @ FDA
Proprietary name
Amp-Equine
Active ingredient
Ampicillin Sodium
Application type
NADA
Sponsor
Zoetis Inc.
Applications on record
1
First published
June 1, 2016

Adverse event reports

Source: openFDA VeDDRA
17
Reports mentioning this ingredient
January 19, 1989 – April 17, 2018
3
Classified serious
per reporter assessment
0
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 “AMPICILLIN SODIUM”. 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
Vials, Damaged 6
Emphysema NOS (see 'Respiratory' for pulmonary emphysema) 2
Diarrhoea 1
Urticaria 1
Injection site oedema 1
Injection site swelling 1
Abdominal pain 1
Death 1
Weakness 1
Vials, Leaking 1
Face and neck swelling (see also 'Skin') 1
Death by euthanasia 1
Pneumothorax 1
Dyspnoea 1
Laryngeal oedema 1
Stumbling gait 1
Hind limb ataxia 1
Unable to stand 1
Proprioception abnormality 1

Species affected

Source: openFDA VeDDRA
Horse 5 Dog 3 Cat 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