Adverse Event Report

Report

reporttype1receiptdateformat102Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10166861Date Received09/05/2014seriousnesshospitalization1transmissiondate12/12/2014serious1Date Last Updated09/05/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age60Unit of Onset AgeyearsWeight80.83SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionChest pain

2)

reactionmeddraversionpt17.0ReactionPalpitations

3)

reactionmeddraversionpt17.0ReactionPain

4)

reactionmeddraversionpt17.0ReactionHypotension

5)

reactionmeddraversionpt17.0ReactionFlushing

6)

reactionmeddraversionpt17.0ReactionAsthenia

7)

reactionmeddraversionpt17.0ReactionDizziness

8)

reactionmeddraversionpt17.0ReactionMyocardial infarction

Drug

1)

drugcharacterization1medicinalproductCETUXIMABdrugstructuredosagenumb250drugstructuredosageunit009drugindicationHEAD AND NECK CANCERdrugstartdateformat102drugstartdate01/05/2014drugenddateformat102drugenddate01/05/2014

openFDA Info on Medication

Application NumberBLA125084Brand NameERBITUXGeneric NameCETUXIMABManufacturersImClone LLCproduct_ndc66733-948, 66733-958Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsCETUXIMABRXCUI1657658, 1657660, 1657663, 1657664spl_idbeffacf4-9b93-40c0-a27f-35d51de020bespl_set_id8bc6397e-4bd8-4d37-a007-a327e4da34d9Package NDC66733-948-23, 66733-958-23NUIN0000175664, N0000020010Established Pharmacologic ClassEpidermal Growth Factor Receptor Antagonist [EPC]Mechanism of ActionHER1 Antagonists [MoA]UNIIPQX0D8J21J

2)

drugcharacterization1medicinalproductCETUXIMABdrugstructuredosagenumb250drugstructuredosageunit009drugindicationMETASTASISdrugstartdateformat102drugstartdate01/05/2014drugenddateformat102drugenddate01/05/2014

openFDA Info on Medication

Application NumberBLA125084Brand NameERBITUXGeneric NameCETUXIMABManufacturersImClone LLCproduct_ndc66733-948, 66733-958Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsCETUXIMABRXCUI1657658, 1657660, 1657663, 1657664spl_idbeffacf4-9b93-40c0-a27f-35d51de020bespl_set_id8bc6397e-4bd8-4d37-a007-a327e4da34d9Package NDC66733-948-23, 66733-958-23NUIN0000175664, N0000020010Established Pharmacologic ClassEpidermal Growth Factor Receptor Antagonist [EPC]Mechanism of ActionHER1 Antagonists [MoA]UNIIPQX0D8J21J

3)

drugcharacterization1medicinalproductPAZOPANIBdrugstructuredosagenumb600drugstructuredosageunit003drugindicationHEAD AND NECK CANCERdrugstartdateformat102drugstartdate01/05/2014drugenddateformat102drugenddate07/05/2014drugadditional2

4)

drugcharacterization1medicinalproductPAZOPANIBdrugstructuredosagenumb600drugstructuredosageunit003drugindicationMETASTASISdrugstartdateformat102drugstartdate01/05/2014drugenddateformat102drugenddate07/05/2014drugadditional2

5)

drugcharacterization2medicinalproductABILIFY

openFDA Info on Medication

Application NumberNDA021436Brand NameABILIFYGeneric NameARIPIPRAZOLEManufacturersOtsuka America Pharmaceutical, Inc.product_ndc 59148-006, 59148-007, 59148-008, 59148-009, 59148-010, 59148-011, 59148-013, 591 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsARIPIPRAZOLERXCUI 349490, 349545, 349547, 349553, 352307, 352308, 352309, 352310, 402131, 404602, ... spl_id85ae6d7d-eb0f-44b1-bb1f-b58d196124a4spl_set_idc040bd1d-45b7-49f2-93ea-aed7220b30acPackage NDC 59148-006-13, 59148-006-92, 59148-007-13, 59148-007-35, 59148-007-94, 59148-008- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNII82VFR53I78

6)

drugcharacterization2medicinalproductASPIRIN

openFDA Info on Medication

Application Numberpart343Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN 81MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 0363-0587, 70000-0218, 70000-0170, 6 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 198471, 825180, 198464 ... spl_id a1833a99-76cc-47fb-80fb-3a6507a2db3e, acc2acbd-b310-e26a-e053-2a95a90a1874, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

7)

drugcharacterization2medicinalproductCYMBALTA

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_idb742d0a5-e67d-49ed-ba95-afe068f1d228spl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

8)

drugcharacterization2medicinalproductHYDROCHLOROTHIAZIDE

openFDA Info on Medication

Application Number ANDA040780, ANDA203018, ANDA040412, ANDA085182, ANDA203561, ANDA078164, ANDA0870 ... Brand NameHYDROCHLOROTHIAZIDEGeneric NameHYDROCHLOROTHIAZIDEManufacturers Aurobindo Pharma Limited, ScieGen Pharmaceuticals, Inc., Solco Healthcare U.S., ... product_ndc 65862-133, 65862-134, 50228-111, 50228-112, 43547-397, 43547-398, 23155-008, 231 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCHLOROTHIAZIDERXCUI197770, 310798, 199903, 429503spl_id 9d73930e-75b8-4a7b-9d12-2049f593ca9d, 5c6f4c6a-cc43-4f4d-bc16-688310c98c72, d8ce ... spl_set_id 01f1f478-5493-439f-9b99-f4f82023781c, 02e96a51-1d56-460c-8c20-3d6f37e0ce46, 60c9 ... Package NDC 65862-133-01, 65862-133-99, 65862-134-01, 65862-134-99, 50228-111-30, 50228-111- ... NUIN0000175359, N0000175419, M0471776Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide Diuretic [EPC]Chemical StructureThiazides [CS]UNII0J48LPH2TH

9)

drugcharacterization2medicinalproductMELOXICAM

openFDA Info on Medication

Application Number ANDA077921, ANDA077944, NDA207233, ANDA077918, NDA020938, ANDA077928, ANDA077929 ... Brand NameMELOXICAM, VIVLODEX, MOBIC, QMIIZ ODT, ANJESOGeneric NameMELOXICAMManufacturers Zydus Pharmaceuticals (USA) Inc., Lupin Pharmaceuticals, Inc., Egalet US Inc., C ... product_ndc 68382-050, 68382-051, 68180-501, 68180-502, 69344-205, 69344-206, 61442-126, 614 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsMELOXICAMRXCUI 152695, 311486, 1722349, 1722355, 1722357, 1722359, 152697, 152698, 2118581, 211 ... spl_id 4e28c8e0-2747-4d30-a179-a20748cd9cde, 912f162d-d846-4561-af48-2e08a45c323b, ed7a ... spl_set_id 6c015f72-5ce3-4f56-8237-776fc2165b0c, 06a401f0-4380-4081-86ed-a309a25abf6b, 1177 ... Package NDC 68382-050-16, 68382-050-01, 68382-050-05, 68382-050-40, 68382-050-30, 68382-050- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIVG2QF83CGL

10)

drugcharacterization2medicinalproductMIRALAX

openFDA Info on Medication

Application NumberNDA022015Brand NameMIRALAXGeneric NamePOLYETHYLENE GLYCOL 3350ManufacturersBayer HealthCare LLC.product_ndc11523-4357, 11523-7268, 11523-7234, 11523-7341Product TypeHUMAN OTC DRUGRouteORALActive IngredientsPOLYETHYLENE GLYCOL 3350RXCUI876193, 876195spl_idb1cc7dea-6153-4b82-e053-2995a90a62a7spl_set_idd69ce3d4-7ca4-4fe3-b49e-6655e48d6963Package NDC 11523-7268-3, 11523-7268-8, 11523-7268-7, 11523-7268-4, 11523-7268-9, 11523-7234 ... NUIN0000010288, N0000175811, N0000009871Mechanism of ActionOsmotic Activity [MoA]Established Pharmacologic ClassOsmotic Laxative [EPC]Physiologic/Pharmacodynamic EffectStimulation Large Intestine Fluid/Electrolyte Secretion [PE]UNIIG2M7P15E5P

11)

drugcharacterization2medicinalproductPOTASSIUM

12)

drugcharacterization2medicinalproductSERTRALINE

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

13)

drugcharacterization2medicinalproductVITAMINS

14)

drugcharacterization2medicinalproductSTOOL SOFTENER

openFDA Info on Medication

Application Numberpart334Brand Name STOOL SOFTENER WITH LAXATIVE, STOOL SOFTENER, STOOL SOFTENER EXTRA STRENGTH, STO ... Generic Name DOCUSATE SODIUM AND SENNOSIDES, DOCUSATE SODIUM, DOCUSATE CALCIUM, MARC GLASSMAN ... Manufacturers AmerisourceBergen (Good Neighbor Pharmacy) 46122, CVS PHARMACY, INC., CVS Pharma ... product_ndc 46122-567, 69842-169, 69842-483, 68016-408, 0363-2570, 55301-655, 46122-451, 683 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsDOCUSATE SODIUM, SENNOSIDES, DOCUSATE CALCIUMRXCUI998740, 1115005, 1245376, 1245468, 1791612spl_id 0a092a40-e3dc-4509-a613-6fed0ae94255, 468f2bab-b388-4bfc-af88-abacdd46a129, 7b62 ... spl_set_id 0cf2f610-bff4-48b8-b640-2c3c708a47a8, 9665721c-40bf-4674-8430-399c70bdca47, 14b0 ... Package NDC 46122-567-78, 69842-169-48, 69842-483-10, 68016-408-01, 68016-408-25, 68016-408- ... UNIIF05Q2T2JA0, 3FYP5M0IJX, 6K7YS503HC