Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID11007410primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/08/2015reporttype1serious2receivedateformat102Date Received09/04/2015receiptdateformat102Date Last Updated25/05/2015fulfillexpeditecriteria2companynumbUS-JNJFOC-20130501019duplicate1

Report Duplicate

duplicatesourceJANSSENduplicatenumbUS-JNJFOC-20130501019

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age65Unit of Onset Ageyearspatientagegroup6Weight88.45SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionNasopharyngitisOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionPyrexiaOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionFlushingOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionEnergy increasedOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionDrug ineffectiveOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt18.0ReactionMalaiseOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductREMICADEdrugbatchnumbUNKNOWNdrugstructuredosagenumb5drugstructuredosageunit032drugdosageformLYOPHILIZED POWDERdrugadministrationroute042drugindicationCROHN^S DISEASEactiondrug1drugrecurreadministration3

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)

drugcharacterization1medicinalproductREMICADEdrugbatchnumbUNKNOWNdrugauthorizationnumb103772drugstructuredosagenumb5drugstructuredosageunit032drugdosageformLYOPHILIZED POWDERdrugadministrationroute042drugindicationCROHN^S DISEASEdrugstartdateformat610drugstartdate/01/2013actiondrug1drugrecurreadministration3

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)

drugcharacterization2medicinalproductSOLU-MEDROLdrugdosageformINJECTIONdrugadministrationroute065drugindicationPREMEDICATION

activesubstance

activesubstancenameMETHYLPREDNISOLONE SODIUM SUCCINATE

openFDA Info on Medication

Application NumberNDA011856Brand NameSOLU-MEDROLGeneric NameMETHYLPREDNISOLONE SODIUM SUCCINATEManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0047, 0009-0758, 0009-0698, 0009-0796, 0009-0039, 0009-0003, 0009-0018, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUSActive IngredientsMETHYLPREDNISOLONE SODIUM SUCCINATERXCUI 207191, 207193, 311659, 314099, 1357886, 1357888, 1743704, 1743707, 1743720, 174 ... spl_id289fe43b-bdde-422c-ac63-65795a6af311, 411c816c-a44b-4366-bfb1-b89fd9c6cbddspl_set_idcd99be87-c8d9-48d6-a8e5-e081052e3f19, 7271310c-7764-4812-aa30-a5e90987c7a9Package NDC 0009-0758-01, 0009-0698-01, 0009-0796-01, 0009-0039-30, 0009-0039-28, 0009-0039- ... UNIILEC9GKY20K

4)

drugcharacterization2medicinalproductLUVOXdrugdosageformUNKNOWNdrugadministrationroute065

activesubstance

activesubstancenameFLUVOXAMINE MALEATE

5)

drugcharacterization2medicinalproductLIALDAdrugdosageformUNSPECIFIEDdrugadministrationroute065

activesubstance

activesubstancenameMESALAMINE

openFDA Info on Medication

Application NumberNDA022000Brand NameLIALDAGeneric NameMESALAMINEManufacturersTakeda Pharmaceuticals America, Inc.product_ndc54092-476Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMESALAMINERXCUI686429, 686433spl_id289ae435-4dc4-452d-bd50-f781057f1045spl_set_id3098a080-be86-4265-9818-7fc4beab77b7Package NDC54092-476-08, 54092-476-01, 54092-476-12, 54092-476-02NUIN0000175781, M0000971Established Pharmacologic ClassAminosalicylate [EPC]Chemical StructureAminosalicylic Acids [CS]UNII4Q81I59GXC

6)

drugcharacterization2medicinalproductVITAMIN B12drugdosageformINJECTIONdrugadministrationroute065

activesubstance

activesubstancenameCYANOCOBALAMIN

7)

drugcharacterization2medicinalproductVALIUMdrugdosageformUNSPECIFIEDdrugadministrationroute065

activesubstance

activesubstancenameDIAZEPAM

openFDA Info on Medication

Application NumberNDA013263Brand NameVALIUMGeneric NameDIAZEPAMManufacturersRoche Laboratories Inc., Waylis Therapuetics LLCproduct_ndc0140-0004, 0140-0005, 0140-0006, 80725-004, 80725-005, 80725-006Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIAZEPAMRXCUI104699, 104700, 104701, 197589, 197590, 197591spl_idc0054f7c-9c38-4ac8-ae8f-5e6427e1fd14, dc250376-39ef-2207-e053-2a95a90a4901spl_set_id554baee5-b171-4452-a50a-41a0946f956c, 260e2041-2bb3-482f-850e-b5d47a7bdbe6Package NDC 0140-0004-01, 0140-0005-01, 0140-0005-14, 0140-0006-01, 0140-0006-14, 80725-004- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

8)

drugcharacterization2medicinalproductPRILOSECdrugdosageformUNSPECIFIEDdrugadministrationroute065

activesubstance

activesubstancenameOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022056Brand NamePRILOSECGeneric NameOMEPRAZOLE MAGNESIUMManufacturersCovis Pharma US, Incproduct_ndc70515-610, 70515-625Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE MAGNESIUMRXCUI797058, 797061, 797063, 797065spl_idba93d1bb-75ca-407c-b2e0-9aa66d8eed84spl_set_idb6761f84-53ac-4745-a8c8-1e5427d7e179Package NDC70515-625-01, 70515-610-01UNII426QFE7XLK

9)

drugcharacterization2medicinalproductZYRTECdrugdosageformUNSPECIFIEDdrugadministrationroute065

activesubstance

activesubstancenameCETIRIZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022429, NDA021621Brand NameZYRTECGeneric NameCETIRIZINE HYDROCHLORIDEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-779, 50580-753Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCETIRIZINE HYDROCHLORIDERXCUI1014675, 1020023, 1014674, 1020022spl_idcea20e63-c9ab-38c7-e053-2995a90adebe, dfe981c1-d2ce-2fbc-e053-2995a90ab14fspl_set_id605adf29-734f-451a-8ff3-74be7b5814a6, dc613bd5-70fd-1d9b-e053-2995a90a41cdPackage NDC50580-779-12, 50580-779-25, 50580-779-40, 50580-779-65, 50580-753-24UNII64O047KTOA

10)

drugcharacterization2medicinalproductPRAVASTATINdrugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationBLOOD CHOLESTEROL INCREASED

activesubstance

activesubstancenamePRAVASTATIN\PRAVASTATIN SODIUM

11)

drugcharacterization2medicinalproductNORPRAMINdrugdosageformUNSPECIFIEDdrugadministrationroute065

activesubstance

activesubstancenameDESIPRAMINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA014399Brand NameNORPRAMINGeneric NameDESIPRAMINE HYDROCHLORIDEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-007, 30698-011, 30698-015, 30698-019, 30698-020, 30698-021Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDESIPRAMINE HYDROCHLORIDERXCUI 1099288, 1099290, 1099292, 1099294, 1099296, 1099298, 1099300, 1099302, 1099304, ... spl_idc9efec15-3ade-4070-acd3-dc36254d030dspl_set_id70b562ea-9f21-4e4a-b3ed-0590b2892f6aPackage NDC 30698-007-01, 30698-011-01, 30698-015-01, 30698-019-01, 30698-020-01, 30698-021- ... UNII1Y58DO4MY1

12)

drugcharacterization2medicinalproductLUNESTAdrugdosageformUNSPECIFIEDdrugadministrationroute065

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

13)

drugcharacterization2medicinalproductMULTIVITAMINSdrugdosageformUNSPECIFIEDdrugadministrationroute065

activesubstance

activesubstancenameVITAMINS

14)

drugcharacterization2medicinalproductTENORMINdrugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationHYPERTENSION

activesubstance

activesubstancenameATENOLOL

openFDA Info on Medication

Application NumberNDA018240Brand NameTENORMINGeneric NameATENOLOLManufacturersAlmatica Pharma LLCproduct_ndc52427-429, 52427-430, 52427-431Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATENOLOLRXCUI150750, 152414, 197379, 197380, 197381, 201322spl_id1b1cbfbf-b6bc-d1f8-d245-c6c68cda33f3spl_set_id746db603-a6e1-4dc3-c2d8-92314419098cPackage NDC52427-429-90, 52427-430-90, 52427-431-90NUIN0000000161, N0000175556Mechanism of ActionAdrenergic beta-Antagonists [MoA]Established Pharmacologic Classbeta-Adrenergic Blocker [EPC]UNII50VV3VW0TI

15)

drugcharacterization2medicinalproductSINGULAIRdrugdosageformUNSPECIFIEDdrugadministrationroute065

activesubstance

activesubstancenameMONTELUKAST SODIUM

openFDA Info on Medication

Application NumberNDA020830, NDA021409, NDA020829Brand NameSINGULAIRGeneric NameMONTELUKAST SODIUMManufacturersOrganon LLCproduct_ndc78206-170, 78206-171, 78206-173, 78206-172Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406spl_id679860ff-4c1d-432d-856a-90d4eea82ea0spl_set_id482dcc92-b47f-4ea6-854a-f5ac2aea7842Package NDC78206-171-01, 78206-170-01, 78206-173-01, 78206-172-01, 78206-172-02UNIIU1O3J18SFL

summary

narrativeincludeclinicalCASE EVENT DATE: 201212