FDA 1932a VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS,

Form Approved: OMB No. 0910-0284
Expiration Date: 7/31/2023

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Veterinary Medicine

(See mailer page for Burden Statement)

VETERINARY ADVERSE DRUG REACTION, LACK OF
EFFECTIVENESS, OR PRODUCT DEFECT REPORT
(For VOLUNTARY Reporting)

NOTE: This report is authorized by 21 U.S.C 352 (a) and (f). While you are not required to report, your cooperation is needed to
assure comprehensive and timely assessment of product labeling.
Submission Type

Individual Case Safety Report Number (FDA Assigned Number)

Follow-up

Initial
Report Type (Check all that apply)

Product Problem

Adverse Event

Date of this Report (mm/dd/yyyy)
Day

Month

Product Use Error

Date of Initial Report (If this report is a follow-up) (mm/dd/yyyy)
Year

Month

Day

Year

Sender Information
First Name

Last Name

Street Address
City

State or Province

Postal/ZIP Code

Country

Telephone Number

Telephone Number (Other)

Fax Number

Email Address

Sender Category

Veterinarian

Animal Owner

Other Health Care Professional
Sender Previously Reported to the Manufacturer?

Yes

Physician

Patient

Other

Unknown

No

If Yes, provide the Manufacturer’s Case Number:
No Identity Disclosure

If you do NOT want your identity disclosed to the manufacturer, mark this box.

Preferred Method of Contact

Telephone

First Name

Email

Health Care Professional Information (If different from Sender Information)
Last Name

Street Address
City

State or Province

Postal/ZIP Code

Country

Telephone Number

Telephone Number (Other)

Fax Number

Email Address

FORM FDA 1932a (4/21)

Page 1

PSC Publishing Services (301) 443-6740

EF

Owner Information (If different from Sender Information)

First Name

Last Name

Street Address
City

State or Province

Postal/ZIP Code

Country

Telephone Number

Telephone Number (Other)

Fax Number

Email Address

Suspected Product Informatiom
Name of Suspected Product

Is this a Compounded Product?
Yes

Uncertain

No

Diagnosis and/or Reason for Use of the Product

Dosage Form (Chewable, liquid, tablet, topical, injection, etc.)

Strength of Active Ingredient(s)
Item Ingredient

Strength

1
2
3
Date of First Exposure (mm/dd/yyyy)
Month

Day

Date of Last Exposure (mm/dd/yyyy)
Month

Year

Day

Year

Duration of Product Use

Product Use Information for Suspected Product
Dose Administered
Interval of Administration (Frequency)
Route of Administration
Product Administered By
Lot Number

Owner

Veterinarian/Veterinary Staff

Other

Expiration Date (mm/dd/yyyy)
Month

FORM FDA 1932a (4/21)

Page 2

Day

Year

Manufacturer or Compounding Pharmacy/Compounder Information
Name of Manufacturer or Compounding Pharmacy/Compounder of Suspected Product
Street Address
City

State or Province

Postal/ZIP Code

Country

Telephone Number

Telephone Number (Other)

Fax Number

Email Address

Adverse Event Information
Veterinarian’s Level of Suspicion that Product Caused the Adverse Event
High

Medium

Low

Unknown

Treatment of Adverse Event (Describe briefly)

Did Adverse Event Reappear After Reintroduction of the Product?

Did Adverse Event Abate After Stopping the Product?
Yes
Outcome

No

Not Applicable

Recovered

Died

Yes

No

Not Applicable

Other

Species and Related Information
Budgerigar

Cat

Cattle

Cockatiel

Cockatoo

Dog

Ferret

Fish

Goat

Guinea Pig

Horse

Human

Parrot

Pig

Rabbit

Sheep

Other (Specify):

Breed

Gender

Age:

Male

Female

Male Neutered

Female Neutered

Weight:

Overall Health Status When Suspected Product Given
Excellent

Good

FORM FDA 1932a (4/21)

Fair

Poor

Critical

Page 3

Number of Animals Treated:
Number of Animals Affected:

Adverse Event Occurrence
Date of Onset of Adverse Event (mm/dd/yyyy)

Month

Day

Length of Time Between First Exposure to
Suspected Product(s) and Onset of Adverse Event

Year

Length of Time Between Last Administration of
Suspected Product(s) and Onset of Adverse Event

When the Adverse Event Occurred, Treatment with Suspected Product
Had already been completed

Was discontinued

Was discontinued and replaced with another product

Was discontinued and reintroduced later

Was continued at an altered dose

Other (Specify):

Document Information
Attached Document Name (Filename if Electronic)
Attached Document Description
Attached Document Name (Filename if Electronic)
Attached Document Description
Attached Document Name (Filename if Electronic)
Attached Document Description

Concurrent Clinical Problem(s)
Were There Concurrent Clinical Problems?
Yes

No

Do not know

None

List Concurrent Clinical Problem(s).

Concurrent Product Information (Excluding Treatment of Current Event)
Please provide name(s), dose(s), interval(s), date(s) of treatment(s), and other relevant information to describe other products
that the patient was taking at the time of the event. Either copy this section as needed (you may fill out this section in other
copies of this form) or provide comments in the long narrative section that follows this one.
Were Concurrent Products Given?
Yes

No

Do not know

None

List Names of Concurrent Products Administered.

Date of First Exposure (mm/dd/yyyy)
Month

Day

Date of Last Exposure (mm/dd/yyyy)
Year

Month

Duration of Product Use

FORM FDA 1932a (4/21)

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Day

Year

Adverse Event/Product Problem/Event Use Error (Long Narrative)

Describe the Adverse Event/Product Problem/Event Use Error.

FORM FDA 1932a (4/21)

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INSTRUCTIONS
GENERAL INSTRUCTIONS
• Please either type or print all entries in a font no smaller than 8 point. If filling in the form by hand, please use
black ink.
• Please complete all sections that apply.
• For narrative entries, attach additional pages as needed.
• If attaching additional pages, please do the following:
– Identify all attached pages as Page # of # (e.g., Page 1 of 4);
– Indicate the appropriate section and block number next to the narrative continuation; and
– Include the phrase continued at the end of each field that has additional information continued onto
another page.
Individual Case Safety Report Number: This number will be assigned by the Food and Drug Administration
(FDA).
Submission Type: Choose a Submission Type. If this is the first time you have sent FDA information about
this, choose “Initial” report. If this is additional information for a previously submitted report, choose “Follow-up”
report.
Report Type: Choose a Report Type by checking all that apply. If you are reporting something that has
affected an animal or a human, including lack of effectiveness, choose “Adverse Event.” If you are reporting
something associated with a product (such as crumbled tablets or peculiar appearance), choose “Product
Problem.” If you are reporting something associated with a product that could have or has led to a medication
error (such as look-alike/sound-alike drug names, similar product appearance, or error prone packaging or
labeling), choose "Product Use Error".
Date of this Report and Date of Initial Report: Enter dates as mm/dd/yyyy. If exact dates are unknown,
provide the best estimate.
Sender Information: Provide the contact information for the person who is filling out this form.
Sender Category: Choose the appropriate Sender Category.
Manufacturer’s Case Number: Fill in the case number, if applicable or known. If you previously reported to
the manufacturer, you can contact the manufacturer for the Manufacturer’s Case Number.
Health Care Professional Information: Please provide the name, mailing address, phone number, and e-mail
address of the veterinarian or other health care professional who can be contacted to provide information, if
such follow-up is necessary.
If the health care professional is also the sender, there is no need to repeat the information.
Owner’s Name: Please provide the owner’s name, mailing address, and phone number. If the owner is also
the sender, there is no need to repeat the information.
The owner’s information is held in strict confidence by FDA and protected to the fullest extent of the law. The
FDA will not disclose the reporter’s identity in response to a request from the public, pursuant to the
Freedom of Information Act.
Name of Suspected Product: Provide the brand name of the product.
FORM FDA 1932a (4/21)

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Is this a Compounded Product?: Check the appropriate box.
Diagnosis and/or Reason for Use: Provide the reason or indication for which the product was prescribed or
used in the animal.
Dosage Form: Provide the dosage form (e.g., chewable tablet, liquid, tablet, topical, injection, etc.).
Strength of Active Ingredient(s): If available, provide the amount in each tablet or capsule, the concentration
of an injectable, etc. (such as "20 mg", "100 mg/ml", etc.)
Date(s) of First and Last Exposure: Enter the date(s) the product was started and stopped. If actual dates
are unknown, enter the approximate time period the product was used in the Duration of Product Use box
(e.g., 2 weeks during the summer of 2006). If the product was used less than 1 day, enter the same date in
the Date of First Exposure and Date of Last Exposure boxes.
Dose Administered, Interval of Administration (Frequency), and Route of Administration: Describe how
the product was administered (e.g., 250 mg), frequency of administration (e.g., every 12 hours for 5 days), and
how it was administered (e.g., orally, injection, etc.). Describe how the product was administered, even if it
differs from what was prescribed.
Product Administered By: Please check the appropriate box. If given by a member of the veterinarian’s staff,
please identify (e.g., technician, assistant) in the narrative section at the end of the form. If given by someone
other than the owner (e.g., pet sitter, trainer), choose “Owner” but identify in the narrative section.
Lot Number and Expiration Date: Please provide the lot number and expiration date from the product, if
available.
Name of Manufacturer or Compounding Pharmacy/Compounder of Suspected Product: Provide the
name of the manufacturer or if applicable, the name of the compounding pharmacy/compounder.
Treatment of Adverse Event: If the adverse event was treated, describe the treatment given.
Did Adverse Event Abate after Stopping the Product? Choose “Yes” if the adverse event lessened or went
away when the product was stopped or the dose was decreased. Choose “Not Applicable” if the product was
not stopped or decreased.
Outcome: Choose an outcome for the adverse event. If “Other” is chosen, describe this outcome in the
narrative section at the end of the form (e.g., the dog lived but never recovered fully, since it was left with a
permanent elevation of liver enzymes).
Species: Choose a box for species (e.g., cat, dog, ferret, horse, human, other, etc.). If “Other” is chosen,
identify the species in the space provided; if more space is needed, use the narrative section at the end of the
form.
Breed: Enter the breed (e.g., Yorkie, Mixed Breed, Lab mix, Siamese/Persian mix). Note: This category is not
applicable if the patient is human.
Age: Provide the patient’s age at the time of the adverse event, including a time descriptor (e.g., 8 years).
Provide the best estimate if exact age is unknown.
Weight: Provide the patient’s weight in pounds (lb). Make a best estimate if exact weight is unknown.
Overall Health Status: Check the box that best describes the patient’s overall state of health when drug/
product was first given.
Number of Animals Treated: If more than one animal was treated with the same drug/product at the same
time, please tell us how many were treated (e.g., two kittens received Drug X).
FORM FDA 1932a (4/21)

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Number of Animals Affected: If more than one animal had an adverse event after the treatment, please tell
us how many. If more than one animal had an adverse event, and the reaction was not the same, please
submit a separate report for each animal (e.g., two kittens received Drug X, a de-worming medication. One
vomited and wouldn’t eat for several days, whereas the other had a seizure).
Date of Onset: Provide the date when the adverse event first started.
Length of Time Between Exposure to Suspected Product and Onset of Adverse Event: Enter the length
of time from the first day the product was given to the onset of the adverse event (e.g., 3 days).
Length of Time Between Last Administration of Suspected Product(s) and Onset of Adverse Event:
Enter the length of time from the last dose of the product to the onset of the adverse event (e.g., 3 hours).
When the Reaction Occurred, Treatment with Suspected Product: Check the appropriate box that applies
to the reported adverse event. If “Other” is chosen, identify in the space provided; if more space is needed, use
the narrative section at the end of the form.
Attached Document Name: If attaching any supporting documents, such as letters, medical records, or
photos, provide the name of the file here.
Examples:
• Documents for Princess.doc.
• Spreadsheet of Princess’s laboratory results.xls
• Photographs of Princess before and after treatment.jpg
• Newspaper article about the product.pdf
If you mail your report, these attachments should accompany the paper Form FDA 1932a.
Attached Document Description: If attaching any supporting documents, provide the description of the
contents (e.g., medical records, lab tests, photograph, newspaper article, etc.).
Concurrent Clinical Problem(s): Provide information on other known health problems of the patient at
the time of exposure to the product (e.g., chronic allergic dermatitis, intermittent vomiting, allergic reaction
following vaccination). Check “None” if there are no known concurrent problems.
Concurrent Product Information: Please provide names, doses, and dates of treatments for products that
the patient was taking at the time of the event. Do include over-the-counter products, such as supplements,
vitamins, and homeopathic preparations. Do not include products used to treat the event. Check “None” if
nothing else was being given at the time of the adverse event.
Adverse Event/Product Defect/Product Use Error (Long Narrative): Use this space to describe the event,
possible contributing factors, and outcome. Include a description of what happened and a summary of all
available clinical information.

FORM FDA 1932a (4/21)

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THANK YOU FOR SHARING YOUR CONCERN ABOUT ANIMAL DRUG EFFECTS.

Confidentiality: The owner’s identity is held in strict confidence by FDA and protected to the fullest
extent of the law. The reporter’s identity, including the identity of self-reporter, may be shared with the
manufacturer unless requested otherwise. However, FDA will not disclose the reporter’s identity in
response to a request from the public, pursuant to the Freedom of Information Act.

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