DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

The FDA Safety Information and 

Adverse Event Reporting Program

Form FDA 3500

Form Approved: OMB No. 0910-0291, Expires: 06-30-2025

See PRA statement on page 6.

FDA USE ONLY

Triage unit 

sequence # 

FDA Rec. Date

For VOLUNTARY reporting of adverse events, product problems and product use/medication errors

Note: For date prompts of “dd-mmm-yyyy” please use 2-digit day, 3-letter month abbreviation, and 4-digit year; for example, 01-Jan-1900.

A. PATIENT INFORMATION

1. Patient Identifier (In confidence) 2. Age

Year(s)

Month(s)

Week(s)

Day(s)

or Date of Birth (e.g., 01-Jan-1900)

3a. Sex: Enter the patient’s sex at birth

(the sex that a person has or was 

assigned to at birth).

Male

Female

Undifferentiated 

Decline to answer

3b. Gender: Enter the patient’s current gender (how the patient thinks of themself).

Cisgender man/boy 

(gender corresponds with birth sex)

Cisgender woman/girl 

(gender corresponds with birth sex)

Transgender man/trans man/ 

female-to-male (FTM)

Transgender woman/trans woman/ 

male-to-female (MTF)

Other gender category; please specify: 

Decline to answer 

4. Weight

lb

kg

5. Ethnicity (Check one)

Hispanic/Latino

Not Hispanic/Latino

6. Race (check all that apply)

American Indian/Alaska Native

Asian

Black or African American

Native Hawaiian/ 

Other Pacific Islander

White

B. ADVERSE EVENT, PRODUCT PROBLEM

1. Type of Report (check all that apply)

Adverse Event

Product Use/Medication Error

Product Problem (e.g., defects/malfunctions)

Problem with Different Manufacturer of Same Medicine

2. Outcome Attributed to Adverse Event (check all that apply)

Death – Date of death (e.g., 01-Jan-1900): 

Life-threatening

Hospitalization (initial or prolonged)

Other Serious or Important 

Medical Events

Required Intervention to Prevent 

Permanent Impairment/Damage

Disability or Permanent Damage

Congenital Anomaly/Birth Defects

3. Date of Event (e.g., 01-Jan-1900) 4. Date of this Report (e.g., 01-Jan-1900)

5. Describe Event, Problem or Product Use/Medication Error Characters Remaining (max. 4,000):

(field continues on next page)

Submission of a report does not constitute an admission that medical personnel or the product caused or contributed to the event. 

* Please see instructions

Form FDA-3500 (11/22) Page 1 of 6 PSC Publishing Services (301) 443-6740 EF
6. Relevant Test/Laboratory Data Date (e.g., 01-Jan-1900) Relevant Test/Laboratory Data Date (e.g., 01-Jan-1900)

Additional comments Characters Remaining (max. 2,000):

7. Other Relevant History, Including Preexisting Medical Conditions (e.g., allergies, pregnancy, tobacco product use, liver/kidney 

problems, etc.) Characters Remaining (max. 2,000):

Form FDA-3500 (11/22) Page 2 of 6 (continued on next page)
C. PRODUCT AVAILABILITY

1. Product Available for Evaluation? (Do not send product to FDA)

 Yes No Returned to Manufacturer on (e.g., 01-Jan-1900)

2. Do you have a picture of the product? 

(Check if you are including a picture) Yes

D. SUSPECT PRODUCTS

SUSPECT PRODUCT #1

This report involves: Cosmetic Dietary supplement Food/medical food Other

1. Name, Strength, Manufacturer/Compounder (from product label).

Product Name Strength Unit

NDC # or Unique ID Manufacturer/ Compounder Name Lot #

2. Dose or Amount

Unit

Frequency

Other Frequency

Route 

Other Route 

3. Treament Dates/Therapy Dates (give best estimate of length of treatment (start/stop) or date of dose reduction.)

Therapy started on 

(e.g., 01-Jan-1900)

Therapy stopped on 

(e.g., 01-Jan-1900)

Dose reduced on 

(e.g., 01-Jan-1900)

OR Duration Unit

Is therapy still on-going? Yes No

4. Diagnosis for use (indication) 5. Product Type (check all that apply)

 OTC

 Compounded

 Generic

 Biosimilar

6. Expiration Date (e.g., 01-Jan-1900)

7. Event Abated after use Stopped or Dose Reduced?

 Yes No Doesn’t apply

8. Event Reappeared after Reintroduction?

 Yes No Doesn’t apply

SUSPECT PRODUCT #2

This report involves: Cosmetic Dietary supplement Food/medical food Other

1. Name, Strength, Manufacturer/Compounder (from product label).

Product Name Strength Unit

NDC # or Unique ID Manufacturer/ Compounder Name Lot #

2. Dose or Amount

Unit

Frequency

Other Frequency

Route 

Other Route 

3. Treament Dates/Therapy Dates (give best estimate of length of treatment (start/stop) or date of dose reduction.)

Therapy started on 

(e.g., 01-Jan-1900)

Therapy stopped on 

(e.g., 01-Jan-1900)

Dose reduced on 

(e.g., 01-Jan-1900)

OR Duration Unit

Is therapy still on-going? Yes No

4. Diagnosis for use (indication) 5. Product Type (check all that apply)

 OTC

 Compounded

 Generic

 Biosimilar

6. Expiration Date (e.g., 01-Jan-1900)

7. Event Abated after use Stopped or Dose Reduced?

 Yes No Doesn’t apply

8. Event Reappeared after Reintroduction?

 Yes No Doesn’t apply

Form FDA-3500 (11/22) Page 3 of 6 (continued on next page)
E. SUSPECT MEDICAL DEVICE

1. Brand Name 2a. Common Device Name 2b. Procode

3. Manufacurer Name, City and State

4. Model # Lot # Catalog #

Expiration Date (e.g., 01-Jan-1900) Serial #

Unique Device Identifier (UDI) #

5. Operator of device

 Health Professional Patient/Consumer Other

6a. If Implanted, Give Date (e.g., 01-Jan-1900) 6b. If Explanted, Give Date (e.g., 01-Jan-1900)

7a. Is this a single-use device 

that was reprocessed and 

reused on a patient?

 Yes No

7b. If Yes to Item 7a, Enter Name, Address of Reprocessor 8. Was this device ever serviced

by a third-party servicer?

 Yes No Unknown

F. OTHER (CONCOMITANT) MEDICAL PRODUCTS

1. Product names and therapy dates (Exclude treatment of event)

Product Name Therapy Start Date (e.g., 01-Jan-1900) Therapy End Date (e.g., 01-Jan-1900)

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

Form FDA-3500 (11/22) Page 4 of 6 (continued on next page)
G. REPORTER (See confidentiality section on next page)

1. Name and Address

Last Name First Name

Address

City State/Province/Region ZIP/Postal Code

Country

Phone # Email

2. Health Professional?

 Yes No

3. Occupation 4. Also Reported to:

 Manufacturer/Compounder

 User Facility

 Distributor/Importer

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

ADVICE ABOUT VOLUNTARY REPORTING

Detailed instructions available at: 

https://www.fda.gov/safety/medwatch-forms-fda-safety-reporting/instructions-completing-form-fda-3500

Report adverse events, product problems or product 

use errors with:

• Medications(drugs or biologics)

• Medical devices (including diabetes glucose-test kit, 

hearing aids, breast pumps, and many more)

• Combination products(medication & medical devices)

• Blood transfusions, gene therapies, and human cells 

and tissue transplants (for example, tendons, bone, 

and corneas)

• Special nutritional products(dietary supplements, 

medical foods, infant formulas)

• Cosmetics (such as moisturizers, makeup, shampoos 

and conditioners, face and body washes, deodorants, 

nail care products, hair dyes and relaxers, and 

tattoos)

• Food (including beverages and ingredients added to 

foods)

Report product problems – quality, performance or 

safety concerns such as:

• Suspected counterfeit product

• Suspected contamination

• Questionable stability

• Defective components

• Poor packaging or labeling

• Therapeutic failures (product didn’t work)

Report SERIOUS adverse events. An event is serious 

when the patient outcome is:

• Death

• Life-threatening

• Hospitalization (initial or prolonged)

• Disability or permanent damage

• Congenital anomaly/birth defect

• Required intervention to prevent permanent 

impairment or damage

• Other serious (important medical events)

Report even if:

• You’re not certain the product caused the event

• You don’t have all the details

• Just fill in the sections that apply to your report

How to report:

• Use section D for all products except medical devices

• Attach additional pages if needed

• Use a separate form for each patient

• Report either to FDA or the manufacturer (or both)

How to submit report: 

• To report by phone, call toll-free: 1-800-FDA (332)- 

1088

• To fax report: 1-800-FDA (332)-0178

• To report online: www.fda.gov/medwatch/report.htm

If your report involves a serious adverse event with a 

device and it occurred in a facility outside a doctor’s 

office, that facility may be legally required to report to 

FDA and/or the manufacturer. Please notify the person 

in that facility who would handle such reporting.

Where to submit adverse events related to the following 

products:

• If your report involves an animal drug, device, pet 

food and livestock feed problems, go to 

http://www.fda.gov/vetproductreporting

• If your report involves a health problem or a product 

problem with a tobacco product, go to 

https://www.safetyreporting.hhs.gov or call 

1-877-287-1373 to report. 

• If your report involves an adverse event with a 

vaccine, go to http://vaers.hhs.gov to report or call 

1-800-822-7967.

Form FDA-3500 (11/22) Page 5 of 6
Confidentiality:

The patient’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 a self-reporter, 

may be shared with the manufacturer unless requested 

otherwise.

The information in this box applies only to requirements 

of the Paperwork Reduction Act of 1995

The burden time for this collection of information has 

been estimated to average 40 minutes per response, 

including the time to review instructions, search existing 

data sources, gather and maintain the data needed, and 

complete and review the collection of information. 

Send comments regarding this burden estimate or any 

other aspect of this collection of information, including 

suggestions for reducing this burden to:

Department of Health and Human Services 

Food and Drug Administration 

Office of Chief Information Officer 

Office of Chief Information Officer 

Paperwork Reduction Act (PRA) Staff 

PRAStaff@fda.hhs.gov

Please DO NOT RETURN this form to the PRA Staff 

e-mail above.

OMB statement:

“An agency may not conduct or sponsor, and a person is 

not required to respond to, a collection of information 

unless it displays a currently valid OMB control number.”

U.S. DEPARTMENT OF HEALTH 

AND HUMAN SERVICES

Form FDA-3500 (11/22) Page 6 of 6