opAFP-GHc2 rDNA construct (AquAdvantage Salmon): adverse event reports that FDA received

Name: opAFP-GHc2 rDNA construct: adverse event reports that FDA received, by year and species
Creator: Pet Drug Reports
License: https://creativecommons.org/publicdomain/zero/1.0/

Active ingredient

The name in brackets is a brand name with this active ingredient.

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.

Read this first. FDA says this about the data:

An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another. When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event. This dataset should not be the sole source of information for clinical decision-making or other assumptions about the safety or effectiveness of a product. The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.
FDA Center for Veterinary Medicine publishes these words. Source: Adverse Event Reports for Animal Drugs and Devices, read on 2 Oct 2026. The data have the reports that FDA received through 26 Jun 2026.

This page is not veterinary advice. For an animal that is ill, speak to a veterinarian.

Contacting a veterinarian How to report to FDA

From April 2016 to April 2024, FDA received 98 adverse event reports that name a drug with opafp-ghc2 rdna construct as its active ingredient. Of the 98 reports, 97 (99%) are about fish.

In January to March 2026, FDA received no reports that name this drug. The signs that appear in the largest number of the 98 reports are "Death" and "IGA Animal mortality greater than expected". A report is not proof that a drug caused a sign.

Fewer than 20 reports named this drug in the 12 months before June 2026, so this page gives no change.

Search engines list a drug page with 500 reports or more in all years. The page also needs 30 reports or more in the 12 months to June 2026. This page is under one of these numbers. The site keeps the page and keeps it out of search engines.

Since the last update of the FDA data

The latest update of the FDA data, recorded on 11 Oct 2026, changed no count of this page.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 0 reports that name opafp-ghc2 rdna construct: 0 dog, 0 cat, 0 horse, 0 other or not given.

All updates Feed of updates (RSS)

Signs that the reports list

A sign is a coded term from the report. The words in brackets are a plain gloss of the term. The percentage is the share of the 98 reports that list the sign. One report can list more than one sign.

The sign that is in the largest number of the reports comes first.

Death70.4%69 reports
IGA Animal mortality greater than expected41.8%41 reports
Fish body deformity31.6%31 reports
Moribund24.5%24 reports
IGA Animal morbidity greater than expected17.3%17 reports
Death by euthanasia[the animal was euthanized]14.3%14 reports
Genotypic test failure (IGA)2%2 reports
Partial lack of efficacy[the product worked less well than expected]2%2 reports
Product Defect, General[a product quality report, not a sign in an animal]2%2 reports
Containment system or component failure (IGA)1%1 reports
Fish malformation1%1 reports
Fungal skin infection NOS[NOS: not otherwise specified]1%1 reports
Unrelated death1%1 reports

The list shows 13 of 13 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

Fish99%97

The share is of all 98 reports that name opafp-ghc2 rdna construct. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog0 reports

No chart: no month has 5 or more reports.

Cat0 reports

No chart: no month has 5 or more reports.

Horse0 reports

No chart: no month has 5 or more reports.

Other or not given28 reports

No chart: no month has 5 or more reports.

The month is the month in which FDA received the report. Each chart has its own scale. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.

Reports by year

Dog
Cat
Horse
Other or not given

Reports that name opafp-ghc2 rdna construct, by the year in which FDA received them and by species
Year	Other or not given	All species
2024	1	1
2023	10	10
2022	13	13
2021	11	11
2020	15	15
2019	11	11
2018	7	7
2017	16	16
2016	14	14

2024 has the reports that FDA received through Apr 2024. Download the years (CSV)

What the reports record

Outcome at the time of the report

Recovered/Normal0%0
Recovered with Sequela[recovered, with a lasting effect]0%0
Ongoing4.1%4
Died70.4%69
Euthanized42.9%42
Outcome Unknown0%0

An outcome in a report is not proof that the drug caused it. The person who sends the report gives the outcome. Each share is of the 98 reports that name opafp-ghc2 rdna construct.

A report about more than one animal can have more than one outcome.

Kind of report

Safety issue96.9%95
Lack of expected effectiveness0%0
Both safety and lack of expected effectiveness0%0
Manufacturing or product defect2%2
Other1%1

97 reports say if the event was serious. 93.8% of them have the serious flag. The person who sends the report sets the flag.

Show age, weight, breed

Age of the animal

Under 1 year82.7%81
1 to 3 years11.2%11
4 to 7 years3.1%3
8 to 11 years0%0
12 years and over0%0
Age not given3.1%3

Weight of the animal

Under 5 kg (11 lb)34.7%34
5 to 9.9 kg (11 to 22 lb)0%0
10 to 24.9 kg (22 to 55 lb)0%0
25 to 44.9 kg (55 to 99 lb)0%0
45 kg and over (99 lb and over)0%0
Weight not given65.3%64

Breed, where the report gives one breed

Atlantic Salmon (Salmo salar)99%97

A breed with many animals has many reports.

Each bar is on a scale of 0 to 100%.

Approved animal drugs with this active ingredient (FDA Green Book)

This section is reference data. It has no report count.

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.

Brand names

AquAdvantage Salmon

What the Green Book records give

Applications with an approval in force: 1
Approved species: Fish
Sale: OTC (over the counter)
Earliest approval date in the records: 19 Nov 2015

The species, dose forms and routes are the words of the Green Book records for all the applications together. One product can have fewer. The label of a product gives its approved use.

Applications in the Green Book of 2 Nov 2026, pioneer applications (NADA) first
Brand name	Active ingredients	Sponsor	Approved species	Application
AquAdvantage Salmon	opAFP-GHc2 rDNA construct	Aqua Bounty Canada Inc.	Not in the list of major species	NADA 141-454

Next in the A to Z list

All drugs by active ingredient. Brand names A to Z

FDA pages for this drug

How to Report Animal Drug and Device Side Effects and Product ProblemsThe FDA page that tells an owner or a veterinarian how to send a report.
Green Book record of NADA 141-454The FDA record of the application for AquAdvantage Salmon.
Animal Drugs @ FDAThe search page of the Green Book, the FDA list of approved animal drugs.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Pet Drug Reports. opAFP-GHc2 rDNA construct: adverse event reports that FDA received. https://petdrugreports.com/drug/opafp-ghc2-rdna-construct/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of 30 Oct 2026. Reports received through 26 Jun 2026.

Where the data come from

The counts come from the openFDA Animal and Veterinary adverse event files, export of 30 Oct 2026. The files have the reports that the FDA Center for Veterinary Medicine received through 26 Jun 2026. The files mask brand and manufacturer names. The site counts a drug by the active ingredients that each record gives, and gives no count to a brand, an application or a company. Ingredient names and the lists of approved products follow the FDA Green Book of 2 Nov 2026. The site does not use the application number that a record has.

The site does not publish report text, lot numbers or details of a reporter. FDA's record is the authority. See how the site counts reports, the data sources and the corrections page.

Questions about these reports

Which brand are these reports about?: The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand. The Green Book section of this page lists the brand names with this active ingredient.
Do the reports show that the drug caused the signs?: No. FDA states this about the data.
When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event.
The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
How many reports did FDA receive in the latest 12 months?: FDA received no reports in the 12 months to June 2026. It received no reports in the 12 months before. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.
What kinds of report are in the count?: Of the 98 reports received from April 2016 to April 2024, 96.9% are about a safety issue only. 2% are about a defect of the product or its package.