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Rapanofal®

Propofol

Veterinary NADA Approved 4,732 adverse event reports

Overview

Source: Animal Drugs @ FDA
Proprietary name
Rapanofal®
Active ingredient
Propofol
Application type
NADA
Sponsor
IVAOES, INC. DBA IVAOES ANIMAL HEALTH
Applications on record
1
First published
April 29, 2022

Adverse event reports

Source: openFDA VeDDRA
4,732
Reports mentioning this ingredient
March 14, 1997 – March 26, 2026
1,933
Classified serious
per reporter assessment
401
Lack of expected efficacy
resistance signal
18
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 “PROPOFOL”. 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 377
Color, Abnormal 349
INEFFECTIVE, ANESTHESIA 305
Apnoea 253
Cardiac arrest 253
Bradycardia 206
Lack of efficacy - NOS 132
Convulsion 123
Contamination, Foreign Object 112
Cyanosis 109
Vomiting 85
Seizure NOS 84
Recovery prolonged 79
Hyperexcitation 76
Paddling 72
Tachycardia 72
Fever 65
Twitching 65
Vocalisation 53
Hypotension 53

Species affected

Source: openFDA VeDDRA
Dog 2,966 Cat 1,138 Other 22 Human 13 Turtle 4 Pig 4 Horse 2 Rabbit 2 Other Rodents 1 Alpaca 1 Wolf 1 Crustacea 1

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