Adverse drug reaction form English Type of reportInitialFollow-upReport sourceHCPRelativePatientliteratureOtherPatientName / initialsGenderMaleFemaleOtherPregnantYesNoMonthAgeWeightHeightCountrySuspected productDrug Name *Dosage FormAction TakenDrug stoppedDose IncreasedDose reducedNot ChangedUnknownDaily 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-seriousThis Reaction mentioned in the PIL and SPCYesNoThe 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):YesNoOtherSubmit
