Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10410314primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate26/03/2015reporttype2serious1seriousnesshospitalization1receivedateformat102Date Received26/08/2014receiptdateformat102Date Last Updated26/08/2014fulfillexpeditecriteria1companynumbUS-JNJFOC-20140821245duplicate1

Report Duplicate

duplicatesourceJANSSENduplicatenumbUS-JNJFOC-20140821245

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

patientagegroup5Weight81.65SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionHepatic enzyme abnormalOutcomeUnknown

2)

reactionmeddraversionpt17.1ReactionNauseaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.1ReactionPancreatitis relapsingOutcomeUnknown

4)

reactionmeddraversionpt17.1ReactionMuscle spasmsOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.1ReactionHeadacheOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.1ReactionFatigueOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt17.1ReactionInfusion related reactionOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductREMICADEdrugstructuredosagenumb400drugstructuredosageunit003drugdosageformLyophilized Powderdrugadministrationroute042drugindicationPROCTITISactiondrug1drugrecurreadministration2

activesubstance

activesubstancenameINFLIXIMAB

openFDA Info on Medication

Application NumberBLA103772Brand NameREMICADEGeneric NameINFLIXIMABManufacturersJanssen Biotech, Inc.product_ndc57894-030Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsINFLIXIMABRXCUI213361, 310994spl_idd9c13b29-5863-427e-878d-23ae57012d85spl_set_ida0a046c1-056d-45a9-bfd9-13b47c24f257Package NDC57894-030-01NUIN0000175610, N0000175451Established Pharmacologic ClassTumor Necrosis Factor Blocker [EPC]Mechanism of ActionTumor Necrosis Factor Receptor Blocking Activity [MoA]UNIIB72HH48FLU

2)

drugcharacterization1medicinalproductREMICADEdrugauthorizationnumb103772drugstructuredosagenumb400drugstructuredosageunit003drugdosageformLyophilized Powderdrugadministrationroute042drugindicationCOLITIS ULCERATIVEactiondrug1drugrecurreadministration2

activesubstance

activesubstancenameINFLIXIMAB

openFDA Info on Medication

Application NumberBLA103772Brand NameREMICADEGeneric NameINFLIXIMABManufacturersJanssen Biotech, Inc.product_ndc57894-030Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsINFLIXIMABRXCUI213361, 310994spl_idd9c13b29-5863-427e-878d-23ae57012d85spl_set_ida0a046c1-056d-45a9-bfd9-13b47c24f257Package NDC57894-030-01NUIN0000175610, N0000175451Established Pharmacologic ClassTumor Necrosis Factor Blocker [EPC]Mechanism of ActionTumor Necrosis Factor Receptor Blocking Activity [MoA]UNIIB72HH48FLU

3)

drugcharacterization2medicinalproductZANTACdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationDYSPEPSIAdrugstartdateformat602drugstartdate//2013

activesubstance

activesubstancenameRANITIDINE HYDROCHLORIDE

4)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugenddateformat602drugenddate//2014

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

5)

drugcharacterization2medicinalproductNEXIUMdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationDYSPEPSIAdrugstartdateformat602drugstartdate//2013

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMRXCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, ... spl_id84c822de-ebe2-4a39-9944-7e38e1961dde, 24d37125-c3cf-48e0-9e50-75cbc818e7c1spl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43H

6)

drugcharacterization2medicinalproductCYMBALTAdrugdosageformCAPSULEdrugadministrationroute048drugindicationANXIETYdrugenddateformat602drugenddate//2014

activesubstance

activesubstancenameDULOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021427Brand NameCYMBALTAGeneric NameDULOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3235, 0002-3240, 0002-3270Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDULOXETINE HYDROCHLORIDERXCUI596926, 596928, 596930, 596932, 596934, 615186spl_id892f05de-dd11-4ae3-9a85-ce9cfcbeaaccspl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

7)

drugcharacterization1medicinalproductREMICADEdrugstructuredosagenumb400drugstructuredosageunit003drugdosageformLyophilized Powderdrugadministrationroute042drugindicationCOLITIS ULCERATIVEdrugstartdateformat102drugstartdate14/08/2014actiondrug1drugrecurreadministration2

activesubstance

activesubstancenameINFLIXIMAB

openFDA Info on Medication

Application NumberBLA103772Brand NameREMICADEGeneric NameINFLIXIMABManufacturersJanssen Biotech, Inc.product_ndc57894-030Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsINFLIXIMABRXCUI213361, 310994spl_idd9c13b29-5863-427e-878d-23ae57012d85spl_set_ida0a046c1-056d-45a9-bfd9-13b47c24f257Package NDC57894-030-01NUIN0000175610, N0000175451Established Pharmacologic ClassTumor Necrosis Factor Blocker [EPC]Mechanism of ActionTumor Necrosis Factor Receptor Blocking Activity [MoA]UNIIB72HH48FLU

8)

drugcharacterization2medicinalproductZANTACdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationGASTRITISdrugstartdateformat602drugstartdate//2013

activesubstance

activesubstancenameRANITIDINE HYDROCHLORIDE

9)

drugcharacterization2medicinalproductNEXIUMdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationGASTROOESOPHAGEAL REFLUX DISEASEdrugstartdateformat602drugstartdate//2013

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMRXCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, ... spl_id84c822de-ebe2-4a39-9944-7e38e1961dde, 24d37125-c3cf-48e0-9e50-75cbc818e7c1spl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43H

10)

drugcharacterization2medicinalproductLYRICAdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute048drugindicationFIBROMYALGIA

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

Application NumberNDA021446, NDA022488Brand NameLYRICAGeneric NamePREGABALINManufacturersParke-Davis Div of Pfizer Inc, U.S. Pharmaceuticalsproduct_ndc 0071-1012, 0071-1013, 0071-1014, 0071-1015, 0071-1016, 0071-1017, 0071-1019, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 607018, 607020, ... spl_idb9b1285a-2cb3-4789-8b0e-8d5e1b253534, bfdec19d-6a54-449c-95b4-908d28e5369aspl_set_id60185c88-ecfd-46f9-adb9-b97c6b00a553, ce1a4b9d-3127-4416-8bf2-fee5899fc0baPackage NDC 0071-1012-68, 0071-1013-41, 0071-1013-68, 0071-1014-41, 0071-1014-68, 0071-1015- ... UNII55JG375S6M

11)

drugcharacterization2medicinalproductZANTACdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationGASTROOESOPHAGEAL REFLUX DISEASEdrugstartdateformat602drugstartdate//2013

activesubstance

activesubstancenameRANITIDINE HYDROCHLORIDE

12)

drugcharacterization1medicinalproductREMICADEdrugstructuredosagenumb400drugstructuredosageunit003drugdosageformLyophilized Powderdrugadministrationroute042drugindicationPROCTITISdrugstartdateformat102drugstartdate14/08/2014actiondrug1drugrecurreadministration2

activesubstance

activesubstancenameINFLIXIMAB

openFDA Info on Medication

Application NumberBLA103772Brand NameREMICADEGeneric NameINFLIXIMABManufacturersJanssen Biotech, Inc.product_ndc57894-030Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsINFLIXIMABRXCUI213361, 310994spl_idd9c13b29-5863-427e-878d-23ae57012d85spl_set_ida0a046c1-056d-45a9-bfd9-13b47c24f257Package NDC57894-030-01NUIN0000175610, N0000175451Established Pharmacologic ClassTumor Necrosis Factor Blocker [EPC]Mechanism of ActionTumor Necrosis Factor Receptor Blocking Activity [MoA]UNIIB72HH48FLU

13)

drugcharacterization2medicinalproductXANAXdrugstructuredosagenumb.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationANXIETYdrugenddateformat602drugenddate//2014

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0094, 0009-0029, 0009-0055, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_idf364e489-b47b-4283-a7fe-d5b15f77447e, bf933d5a-53e2-4454-a040-cacc061bca92spl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

14)

drugcharacterization2medicinalproductTRAZODONEdrugstructuredosagenumb250drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat602drugstartdate//2011

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

openFDA Info on Medication

15)

drugcharacterization1medicinalproductMETHOTREXATEdrugbatchnumbUNKNOWNdrugstructuredosagenumb17.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosageformTABLETdrugadministrationroute048drugindicationARTHRITISdrugstartdateformat602drugstartdate//2012actiondrug4

activesubstance

activesubstancenameMETHOTREXATE

openFDA Info on Medication

Application Number NDA011719, ANDA040385, ANDA040263, ANDA209787, ANDA040632, ANDA201749, ANDA08123 ... Brand NameMETHOTREXATE, TREXALL, RASUVO, XATMEP, REDITREX, OTREXUPGeneric NameMETHOTREXATE, METHOTREXATE SODIUMManufacturers Hospira, Inc., Teva Women's Health, Inc., Fresenius Kabi USA, LLC, Alvogen Inc., ... product_ndc 61703-350, 61703-408, 51285-366, 51285-367, 51285-368, 51285-369, 63323-123, 477 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRATHECAL, ORAL, INTRA-ARTERIALActive IngredientsMETHOTREXATE SODIUM, METHOTREXATERXCUI 1655956, 1946772, 105586, 283510, 283511, 283671, 284592, 284593, 284594, 284595 ... spl_id e7f451fd-9103-459a-8a81-115f1fc1077c, 17840925-09d5-493f-90ba-f2082d625a86, d2bf ... spl_set_id 0d63ba29-b692-41b4-87e8-351265c8273f, 0e30eaef-5a09-4104-8a11-c32933eadeab, e942 ... Package NDC 61703-350-37, 61703-350-38, 61703-408-41, 61703-350-09, 61703-350-10, 61703-408- ... UNII3IG1E710ZN, YL5FZ2Y5U1NUIN0000175584, N0000000111Established Pharmacologic ClassFolate Analog Metabolic Inhibitor [EPC]Mechanism of ActionFolic Acid Metabolism Inhibitors [MoA]

16)

drugcharacterization2medicinalproductNEXIUMdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationGASTRITISdrugstartdateformat602drugstartdate//2013

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMRXCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, ... spl_id84c822de-ebe2-4a39-9944-7e38e1961dde, 24d37125-c3cf-48e0-9e50-75cbc818e7c1spl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43H

summary

narrativeincludeclinicalCASE EVENT DATE: 2013