Suspected Adverse Drug Reaction Reporting Form for Healthcare Professionals

for

A. Patient Information





MaleFemaleOther

B. Suspected Adverse Reaction




C. Suspected Medication(s)

Sr. Name
(brand and/or generic name)
Manufacturer
(if known)
Batch No. /
Lot No.
(if known)
Exp. Date
(if known)
Dose used Route used Frequency Therapy dates
(if known, give duration)
Reason for use or prescribed for
Date started Date stopped
 1.
 2.
 3.
 4.

Dose reducedDrug discontinuedContinued in same dose

1.YesNoUnknownNAReduced dose

2.YesNoUnknownNAReduced dose
3.YesNoUnknownNAReduced dose
4.YesNoUnknownNAReduced dose

1.YesNoUnknownNAIf reintroduced, dose

2.YesNoUnknownNAIf reintroduced, dose
3.YesNoUnknownNAIf reintroduced, dose
4.YesNoUnknownNAIf reintroduced, dose



YesNo

If 'Yes',

DeathCongenital AnomalyLife ThreateningPersistent or SignificantHospitalization - Initial or ProlongedDisability or IncapacityRequired intervention to prevent permanent impairment / damageOther

FatalRecoveringUnknownContinuingRecoveredOther

D. Reporter









NOTE: PLEASE DO NOT LEAVE ANY FIELD BLANK. STRIKE OUT WHERE INFORMATION IS ‘NOT AVAILABLE’ OR ‘NOT APPLICABLE’

Confidentiality: The patient’s identity is held in strict confidence and protected to the fullest extent. The pharmacovigilance staff at INTAS is not expected to and will not disclose the reporter’s identity in response to a request from the public. Submission of a report does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the reaction.