Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10166782serious1Date Last Updated12/05/2014receiptdateformat102companynumbUS-NOVOPROD-409185occurcountryUSduplicate1Date Received12/05/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age60Unit of Onset AgeyearsWeight82SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionSyncopeOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionPyrexiaOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionAnaemiaOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionDizzinessOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionDehydrationOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductNOVOLOGdrugbatchnumbUNKNOWNdrugauthorizationnumb020986drugdosagetextPER SLIDING SCALEdrugdosageformSOLUTION FOR INJECTIONdrugadministrationroute058drugindicationTYPE 2 DIABETES MELLITUSactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberBLA020986Brand NameNOVOLOGGeneric NameINSULIN ASPARTManufacturersNovo Nordiskproduct_ndc0169-3303, 0169-7501, 0169-6339, 0169-6338, 0169-2001Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, SUBCUTANEOUSActive IngredientsINSULIN ASPARTRXCUI311040, 351926, 1653196, 1653198, 1653202, 1653204spl_id952147fd-80b2-481b-bc17-e94ac49f1bb1spl_set_id3a1e73a2-3009-40d0-876c-b4cb2be56fc5Package NDC 0169-7501-11, 0169-7501-90, 0169-3303-12, 0169-3303-91, 0169-3303-90, 0169-6339- ... NUIM0011417, N0000175453Chemical StructureInsulin [CS]Established Pharmacologic ClassInsulin Analog [EPC]UNII059QF0KO0R, D933668QVX

2)

drugcharacterization1medicinalproductGEMCITABINEdrugbatchnumbUNKNOWNdrugdosagetext750 MG/M2drugadministrationroute042drugindicationPANCREATIC CARCINOMAdrugstartdateformat102drugstartdate17/07/2013actiondrug4

openFDA Info on Medication

Application Number ANDA212129, ANDA210991, NDA208313, NDA200795, ANDA079183, ANDA090799, ANDA202485 ... Brand NameGEMCITABINE, INFUGEMGeneric NameGEMCITABINE HYDROCHLORIDE, GEMCITABINEManufacturers Meitheal Pharmaceuticals Inc., Armas Pharmaceuticals Inc., Sun Pharmaceutical In ... product_ndc 71288-117, 72485-223, 62756-008, 62756-073, 62756-102, 62756-219, 62756-321, 627 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsGEMCITABINE HYDROCHLORIDERXCUI 1720960, 1720975, 2058858, 2058863, 2058866, 2058867, 2058880, 2058881, 2058882, ... spl_id b6847fe9-1c9e-44d8-e053-2a95a90ab16f, 470dbc2b-c18a-403d-b815-3c6e296a7f41, 88ff ... spl_set_id 73ae04d8-38f9-4d3d-b0c2-71d22af1fc86, 518b9c2e-fdbe-46de-9859-02314c220d58, 4e7e ... Package NDC 71288-117-06, 71288-117-28, 71288-117-54, 72485-223-20, 62756-073-60, 62756-008- ... UNIIU347PV74IL

3)

drugcharacterization1medicinalproductABRAXANE /01116001/drugbatchnumbUNKNOWNdrugdosagetext100 MG/M2drugadministrationroute042drugindicationPANCREATIC CARCINOMAdrugstartdateformat102drugstartdate17/07/2013actiondrug4

4)

drugcharacterization1medicinalproductCHEMOTHERAPEUTICSdrugbatchnumbUNKNOWNdrugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb18900drugcumulativedosageunit003drugdosagetext300 MG, QDdrugadministrationroute048drugindicationPANCREATIC CARCINOMAdrugstartdateformat102drugstartdate18/07/2013drugenddateformat102drugenddate19/09/2013actiondrug1drugrecurreadministration3

5)

drugcharacterization1medicinalproductCHEMOTHERAPEUTICSdrugbatchnumbUNKNOWNdrugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb18900drugcumulativedosageunit003drugdosagetext300 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate24/09/2013actiondrug1drugrecurreadministration3

6)

drugcharacterization1medicinalproductLANTUSdrugbatchnumbUNKNOWNdrugstructuredosagenumb23drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext23 U, QDdrugadministrationroute058drugindicationTYPE 2 DIABETES MELLITUSactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberBLA021081Brand NameLANTUSGeneric NameINSULIN GLARGINEManufacturerssanofi-aventis U.S. LLCproduct_ndc0088-2220, 0088-2219, 0088-5021, 0088-5020Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsINSULIN GLARGINERXCUI285018, 311041, 847230, 847232spl_id0a57f187-f101-4268-851f-7f20c7f708f9, 4e455ace-94f4-4fa3-85eb-0152e5a06239spl_set_idd5e07a0c-7e14-4756-9152-9fea485d654a, 6328c99d-d75f-43ef-b19e-7e71f91e57f6Package NDC 0088-2220-33, 0088-2220-34, 0088-2219-00, 0088-2219-01, 0088-2219-05, 0088-5021- ... NUIN0000004931, N0000175453Chemical StructureInsulin [Chemical/Ingredient]Established Pharmacologic ClassInsulin Analog [EPC]UNII2ZM8CX04RZ

7)

drugcharacterization2medicinalproductPOLYETHYLENE GLYCOLdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA091077Brand NameEASYLAX, OSMOTIC LAXATIVEGeneric NamePOLYETHYLENE GLYCOLManufacturersMarc Glassman, Inc., Lidl US, LLCproduct_ndc68998-465, 71141-140Product TypeHUMAN OTC DRUGRouteTOPICAL, ORALActive IngredientsPOLYETHYLENE GLYCOL 3350spl_idd1c545f2-a116-48cd-b04d-500a3c996012, aa19a516-b9bd-4e92-96ec-041031193c01spl_set_idc22fd883-7d17-43c6-8bae-5b669064db5d, a61acdee-7371-4ac1-8285-8b4fd023e42bPackage NDC68998-465-83, 71141-140-32NUIN0000010288, N0000175811, N0000009871Mechanism of ActionOsmotic Activity [MoA]Established Pharmacologic ClassOsmotic Laxative [EPC]Physiologic/Pharmacodynamic EffectStimulation Large Intestine Fluid/Electrolyte Secretion [PE]UNIIG2M7P15E5PRXCUI876193

8)

drugcharacterization2medicinalproductCOLACEdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Numberpart334Brand NameCOLACEGeneric NameDOCUSATE SODIUM, DOCUSATE SODIUM - SENNOSIDESManufacturersAvrio Health L.P.product_ndc67618-101, 67618-110, 67618-111Product TypeHUMAN OTC DRUGRouteORALActive IngredientsDOCUSATE SODIUM, SENNOSIDESRXCUI1115005, 1247756, 998740, 1872920, 1247759, 1247761spl_id 008f0cb3-8a9a-42f6-b985-a3dbc0deabc0, 7ec009a7-4793-524b-5e6d-202f324d81fd, f8b2 ... spl_set_id 7793fced-e8ee-44e2-b212-dd2a59a5f462, 9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b, a159 ... Package NDC 67618-101-10, 67618-101-30, 67618-101-60, 67618-101-52, 67618-110-10, 67618-110- ... UNIIF05Q2T2JA0, 3FYP5M0IJX

9)

drugcharacterization2medicinalproductCREONdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberBLA020725Brand NameCREONGeneric NamePANCRELIPASEManufacturersAbbVie Inc.product_ndc0032-1203, 0032-1206, 0032-1212, 0032-1224, 0032-3016Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPANCRELIPASE AMYLASE, PANCRELIPASE LIPASE, PANCRELIPASE PROTEASERXCUI 855495, 855499, 855503, 863829, 863836, 863841, 1113042, 1113046, 1373325, 13733 ... spl_id3dd173f8-17c2-a84f-82ac-099909ba9ef0spl_set_id073201aa-556d-4a70-918e-84e9616fd88dPackage NDC 0032-1206-07, 0032-1206-01, 0032-1206-56, 0032-1212-07, 0032-1212-01, 0032-1212- ... UNII8MYC33932O, 3560D81V50, YOJ58O116E

10)

drugcharacterization2medicinalproductMORPHINEdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Brand NameOPIUM TINCTURE DEODORIZEDGeneric NameMORPHINEManufacturersEdenbridge Pharmaceuticals, LLCproduct_ndc42799-217Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMORPHINERXCUI830196spl_id5b376952-010f-adfc-e053-2a91aa0ae464spl_set_ide2a5697a-cc41-4cf1-b3a8-59b0268740d7Package NDC42799-217-01, 42799-217-02NUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]UNII76I7G6D29C

11)

drugcharacterization2medicinalproductREGLAN /00041901/drugbatchnumbUNKNOWNdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

12)

drugcharacterization2medicinalproductMEGACEdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

13)

drugcharacterization2medicinalproductSERTRALINEdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

14)

drugcharacterization2medicinalproductCALCITROL /00508501/drugbatchnumbUNKNOWNdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

15)

drugcharacterization2medicinalproductONDANSETRONdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA206846, ANDA079224, ANDA090648, ANDA078776, ANDA077851, ANDA076972, ANDA0769 ... Brand NameONDANSETRON, ZUPLENZ, ONDANSETRON HYDROCHLORIDEGeneric NameONDANSETRON, ONDANSETRON HYDROCHLORIDE, ONDANSETRON TABLETSManufacturers Accord Healthcare, Inc., Heritage Pharmaceuticals, NorthStar Rx LLC, Eywa Pharma ... product_ndc 16729-298, 23155-547, 23155-549, 16714-671, 71930-017, 71930-018, 45963-538, 459 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsONDANSETRON, ONDANSETRON HYDROCHLORIDERXCUI 283504, 1740467, 312085, 198052, 312086, 998028, 998032, 998033, 998035, 104894, ... spl_id 58fbdc1b-69f5-58f3-e053-2991aa0a1a04, 4503b017-b020-41e2-b0e1-6602dc7e28f2, f821 ... spl_set_id 35e0d160-813f-41d7-a382-d2cab6485d9c, b746d4db-43e6-4219-9e6b-f53e59581305, ac3d ... Package NDC 16729-298-05, 23155-547-31, 23155-547-41, 23155-547-42, 23155-549-31, 16714-671- ... NUIN0000175817, N0000175818Mechanism of ActionSerotonin 3 Receptor Antagonists [MoA]Established Pharmacologic ClassSerotonin-3 Receptor Antagonist [EPC]UNII4AF302ESOS, NMH84OZK2B

Report Duplicate

duplicatesourceNOVO NORDISKduplicatenumbUS-NOVOPROD-409185

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use