The adverse drug reaction MUST pertain to an identifiable patient. Fill in as much details as are possible - the patient particulars, nature of event and the names of suspect drug(s) are the minimum necessary.
REPORTER'S IDENTITY WILL REMAIN CONFIDENTIAL
What to report: Report all reactions to recently introduced drugs and / or uncommon or severe reactions to older drugs. Also report reactions to vaccines and all suspected drug interactions resulting in ADRs.
A reaction is to be regarded as SERIOUS if it is fatal, life-threatening, permanently or significantly disabling or incapacitating, requires or prolongs hospitalization or requires intervention to prevent one of the above consequences. Events that are in the nature of birth defects are also serious.