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PDS - FDA MedWatch
Adverse Drug Reaction (ADR) Reporting Form
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* Indicates required question
PATIENT INFORMATION
Name
*
Your answer
Age
*
Your answer
Gender
*
Male
Female
Address (if available)
Your answer
Contact number (if available)
Your answer
Hospital/facility seen or admitted
*
Your answer
DETAILS OF ADVERSE REACTION
Date of onset
*
MM
/
DD
/
YYYY
Duration
*
Your answer
Do you consider the reaction to be serious?
*
Yes
No
If you answered "yes" to the previous question, please indicate the reason:
Patient died due to reaction
Involved or prolonged in-patient hospitalization
Life threatening
Involved persistent or significant disability
Congenital anomaly in the newborn
Other:
Can this be due to Medication Error?
*
Yes
No
SUSPECTED DRUG PRODUCT
Generic name
*
Your answer
Brand name
Your answer
Daily dose
*
Your answer
Route
*
Your answer
Reason/s for using the product (Indication)
*
Your answer
Date started
*
MM
/
DD
/
YYYY
Date stopped (if applicable)
MM
/
DD
/
YYYY
Reporter's Details
Name
*
Your answer
Contact number
*
Your answer
Email address
*
Your answer
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