Adverse drug reaction form ICSR report NoDate of reportLinked to ICSR NoInitial report noType of reportInitialFollow-upReport sourceHCPRelativePatientliteratureOtherPatientName / initialsGenderMaleFemaleOtherPregnantYesNoMonthAgeWeightHeightCountrySuspected productDrug Name *Dosage FormAction TakenDrug stoppedDose IncreasedDose reducedUnknownDaily DoseRoute of AdministrationStrengthIndicationBatch numberSuspected reaction and outcome of the reactionDescription of the adverse event *Reaction OnsetReaction resolve dateDrug intake starting dateDrug intake stopping dateSeriousnessSerious (Fatal, Life threatening, Disability, hospitalization, prolongation of hospit.)Non-serious This Reaction mentioned in the PIL and SPCThe patientRecoveredNo ImprovementImprovedUnknownReporterName/initialOffice addressPhone numberEmailConcomitant Drug(s) and history:Concomitant Drug(s) and dates of administration :History (diagnostic, allergic) and other diseases:Causality assessment:Event subsided after stopping the drug (De-challenge):YesNoOtherEvent reappear after reintroducing the drug (Re-challenge):YesNoPharmacovigilance departmentNeeded to be reported to HAYesNoReporting due date to HA:CommentsDuplicate report:YesNoSubmit
