Adverse Event Report

Report

reporttype2Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10147354serious1Date Last Updated16/05/2014receiptdateformat102companynumbUS-MYLANLABS-2014S1009671occurcountryUSseriousnessother1duplicate1Date Received01/05/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age16Unit of Onset AgeyearsWeight78SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionSuicidal ideationOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionSuicidal behaviourOutcomeRecovering/resolving

3)

reactionmeddraversionpt17.0ReactionDepressionOutcomeRecovering/resolving

4)

reactionmeddraversionpt17.0ReactionSocial problemOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductAMNESTEEM CAPSULESdrugauthorizationnumb075945drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute048drugindicationACNEdrugenddateformat610drugenddate/03/2014actiondrug1

2)

drugcharacterization1medicinalproductABSORICAdrugauthorizationnumb075945drugdosageformCAPSULEdrugindicationACNEdrugstartdateformat610drugstartdate/11/2013actiondrug1

openFDA Info on Medication

Application NumberNDA021951Brand NameABSORICAGeneric NameISOTRETINOINManufacturersSun Pharmaceutical Industries, Inc.product_ndc 10631-115, 10631-116, 10631-117, 10631-118, 10631-133, 10631-134, 10631-002, 106 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI 197843, 197844, 197845, 403930, 1299203, 1300006, 1300014, 1300016, 1547561, 154 ... spl_ida8d4793a-5043-40e1-b623-35812733499fspl_set_id3ef0cff8-19c1-4441-b780-fca6c7ee1615Package NDC 10631-115-69, 10631-115-31, 10631-116-69, 10631-116-31, 10631-117-69, 10631-117- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

3)

drugcharacterization1medicinalproductABSORICAdrugauthorizationnumb075945drugdosageformCAPSULEdrugindicationACNEdrugstartdateformat610drugstartdate/11/2013actiondrug1

openFDA Info on Medication

Application NumberNDA021951Brand NameABSORICAGeneric NameISOTRETINOINManufacturersSun Pharmaceutical Industries, Inc.product_ndc 10631-115, 10631-116, 10631-117, 10631-118, 10631-133, 10631-134, 10631-002, 106 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI 197843, 197844, 197845, 403930, 1299203, 1300006, 1300014, 1300016, 1547561, 154 ... spl_ida8d4793a-5043-40e1-b623-35812733499fspl_set_id3ef0cff8-19c1-4441-b780-fca6c7ee1615Package NDC 10631-115-69, 10631-115-31, 10631-116-69, 10631-116-31, 10631-117-69, 10631-117- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

4)

drugcharacterization2medicinalproductVYVANSEdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804

openFDA Info on Medication

Application NumberNDA021977, NDA208510Brand NameVYVANSEGeneric NameLISDEXAMFETAMINE DIMESYLATEManufacturersShire LLCproduct_ndc 59417-101, 59417-102, 59417-103, 59417-104, 59417-105, 59417-106, 59417-107, 594 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISDEXAMFETAMINE DIMESYLATERXCUI 854830, 854832, 854834, 854836, 854838, 854840, 854842, 854844, 854846, 854848, ... spl_idd2aa8390-b739-4621-abff-bd18bf342f65spl_set_id704e4378-ca83-445c-8b45-3cfa51c1ecadPackage NDC 59417-101-10, 59417-102-10, 59417-103-10, 59417-104-10, 59417-105-10, 59417-106- ... UNIISJT761GEGS

Report Duplicate

duplicatesourceMYLANduplicatenumbUS-MYLANLABS-2014S1009671

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use