U.S. Department of Health and Human Services
Food and Drug Administration
MEDWATCH
FORM FDA 3500 (2/19)
The FDA Safety Information and
Adverse Event Reporting Program
For VOLUNTARY reporting of
adverse events, product problems
and product use/medication errors
Form Approved: OMB No. 0910-0291, Expires: 11-30-2021
See PRA statement on reverse.
FDA Use only
Note: For date prompts of “dd-mmm-yyyy” please use 2-digit day, 3-letter month abbreviation, and 4-digit year; for example, 01-Jul-2018
A. PATIENT INFORMATION
B. ADVERSE EVENT, PRODUCT PROBLEM
C. PRODUCT AVAILABILITY
D. SUSPECT PRODUCTS
#1
#2
Dose or Amount
Frequency
Route
#1 Start
#1 Stop
Is therapy still on-going?
#2 Start
#2 Stop
Is therapy still on-going?
#1
#2
#1
#2
#1
#2
E. SUSPECT MEDICAL DEVICE
F. OTHER (CONCOMITANT) MEDICAL PRODUCTS
G. REPORTER (See confidentiality section on back)
Last Name:
First Name:
Address:
City:
State/Province/Region:
ZIP/Postal Code:
Last Name:
Country:
Phone #:
Email: