Balsam Peru Oil + Castor Oil + Trypsin (Trypzyme Aerosol, Granulex V): adverse event reports that FDA received

Name: Balsam Peru Oil + Castor Oil + Trypsin: adverse event reports that FDA received, by year and species
Creator: Pet Drug Reports
License: https://creativecommons.org/publicdomain/zero/1.0/

Combination of 3 active ingredients

The names in brackets are brand names with these active ingredients.

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 31 Mar 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 August 1988 to May 2010, FDA received 21 adverse event reports that name this drug. Its active ingredients are balsam peru oil, castor oil and trypsin. Of the 21 reports, 7 (33.3%) are about dogs. 3 reports are about people who were exposed to the drug (14.3%).

In January to March 2026, FDA received no reports that name this drug. The sign that appears in the largest number of the 21 reports is "Accidental exposure". A report is not proof that a drug caused a sign.

This page has fewer than 50 reports. The site keeps the page for its links and keeps it out of search engines.

Since the last update of the FDA data

No update is on record. The record starts when FDA adds the reports of April to June 2026.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 0 reports that name balsam peru oil + castor oil + trypsin: 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 21 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.

Accidental exposure[exposure that was not intended]28.6%6 reports
No sign[no clinical sign was reported]14.3%3 reports
Unclassifiable adverse event[event that fits no dictionary term]14.3%3 reports
Containers, Damaged[a product quality report, not a sign in an animal]9.5%2 reports
Anorexia[not eating]4.8%1 reports
Applicator, Abnormal[a product quality report, not a sign in an animal]4.8%1 reports
Balance problem4.8%1 reports
Bronchitis4.8%1 reports
Confused4.8%1 reports
Conjunctivitis4.8%1 reports
Corneal oedema4.8%1 reports
Corneal ulcer4.8%1 reports
Cough4.8%1 reports
Death4.8%1 reports

Show the next 16 signs

Depression[dull, quiet or withdrawn]4.8%1 reports
Dermatitis[inflamed skin]4.8%1 reports
Dispenser, Abnormal[a product quality report, not a sign in an animal]4.8%1 reports
Electrolyte disorder4.8%1 reports
Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]4.8%1 reports
Elevated creatine-kinase (CK)[a muscle enzyme above the normal range]4.8%1 reports
Elevated fibrinogen level4.8%1 reports
Elevated serum alkaline phosphatase (ALP)[a liver and bone enzyme above the normal range]4.8%1 reports
Eye disorder NOS (for photophobia see 'neurological')4.8%1 reports
Eye irritation4.8%1 reports
Eye pain4.8%1 reports
Eye redness4.8%1 reports
Eyelid inflammation4.8%1 reports
Facial oedema[swollen face]4.8%1 reports
Hyperkalaemia[high blood potassium]4.8%1 reports
Hypoproteinaemia[low blood protein]4.8%1 reports

The list shows 30 of 52 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

Dog33.3%7
Human exposure14.3%3
Horse9.5%2
Cat4.8%1

The share is of all 21 reports that name balsam peru oil + castor oil + trypsin. The other reports give a different species or no species.

Reports for each month, Apr 2021 to Mar 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 given0 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 balsam peru oil + castor oil + trypsin, by the year in which FDA received them and by species
Year	Dog	Cat	Horse	Other or not given	All species
2010	2	0	0	0	2
2009	2	0	0	1	3
2007	0	0	0	1	1
2006	1	0	0	1	2
2005	1	1	0	1	3
2004	1	0	1	0	2
2003	0	0	0	1	1
2002	0	0	0	1	1
2001	0	0	0	3	3
2000	0	0	0	1	1
1999	0	0	0	1	1
1988	0	0	1	0	1

2010 has the reports that FDA received through May 2010. 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
Ongoing4.8%1
Died4.8%1
Euthanized0%0
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 21 reports that name balsam peru oil + castor oil + trypsin.

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

Kind of report

Safety issue61.9%13
Lack of expected effectiveness0%0
Both safety and lack of expected effectiveness0%0
Manufacturing or product defect38.1%8
Other0%0

Show age, weight, breed and route

Age of the animal

Under 1 year9.5%2
1 to 3 years14.3%3
4 to 7 years9.5%2
8 to 11 years4.8%1
12 years and over4.8%1
Age not given57.1%12

Weight of the animal

Under 5 kg (11 lb)0%0
5 to 9.9 kg (11 to 22 lb)0%0
10 to 24.9 kg (22 to 55 lb)19%4
25 to 44.9 kg (55 to 99 lb)14.3%3
45 kg and over (99 lb and over)4.8%1
Weight not given61.9%13

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

Oral19%4
Topical19%4
Intraocular4.8%1
Other4.8%1
Respiratory (Inhalation)4.8%1

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

Approved animal drugs with these active ingredients (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

Trypzyme Aerosol
Granulex V

What the Green Book records give

Applications with an approval in force: 2
Approved species: Unspecified
Dose forms: Aerosol
Routes: Topical
Sale: OTC (over the counter)

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 1 Oct 2026, pioneer applications (NADA) first
Brand name	Active ingredients	Sponsor	Approved species	Application
Trypzyme Aerosol	Balsam Peru Oil, Castor Oil, Trypsin	Farnam Companies, Inc.	Not in the list of major species	NADA 031-555
Granulex V	Balsam Peru Oil, Castor Oil, Trypsin	Cronus Pharma Specialities India Private Ltd.	Not in the list of major species	NADA 039-583

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 031-555The FDA record of the application for Trypzyme Aerosol.
Green Book record of NADA 039-583The FDA record of the application for Granulex V.
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. Balsam Peru Oil + Castor Oil + Trypsin: adverse event reports that FDA received. https://petdrugreports.com/drug/balsam-peru-oil-castor-oil-trypsin/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of 28 Sep 2026. Reports received through 31 Mar 2026.

Where the data come from

The counts come from the openFDA Animal and Veterinary adverse event files, export of 28 Sep 2026. The files have the reports that the FDA Center for Veterinary Medicine received through 31 Mar 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 1 Oct 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 these active ingredients.
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 March 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 21 reports received from August 1988 to May 2010, 61.9% are about a safety issue only. 38.1% are about a defect of the product or its package.