Adverse Event Report

Report

reporttype2Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10151809serious1Date Last Updated05/05/2014receiptdateformat102companynumbUS-BRISTOL-MYERS SQUIBB COMPANY-20643896occurcountryUSduplicate1Date Received05/05/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age56Unit of Onset AgeyearsWeight54.87SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionSyncopeOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionHypokalaemiaOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionAscitesOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionDiarrhoeaOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionAbdominal painOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductIPILIMUMABdrugstructuredosagenumb4drugstructuredosageunit007drugdosageformINJECTIONdrugindicationPANCREATIC CARCINOMAdrugstartdateformat102drugstartdate29/08/2013actiondrug1

openFDA Info on Medication

Application NumberBLA125377Brand NameYERVOYGeneric NameIPILIMUMABManufacturersE.R. Squibb & Sons, L.L.C.product_ndc0003-2327, 0003-2328Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsIPILIMUMABRXCUI1657005, 1657007, 1657012, 1657013spl_idcd43a9b1-a191-43e7-95f0-d43124af5aa7spl_set_id2265ef30-253e-11df-8a39-0800200c9a66Package NDC0003-2327-11, 0003-2328-22NUIN0000182635, N0000182634, N0000182157Established Pharmacologic ClassCTLA-4-directed Blocking Antibody [EPC]Mechanism of ActionCTLA-4-directed Antibody Interactions [MoA]Physiologic/Pharmacodynamic EffectIncreased T Lymphocyte Activation [PE]UNII6T8C155666

2)

drugcharacterization1medicinalproductGEMCITABINEdrugstructuredosagenumb234drugstructuredosageunit009drugindicationPANCREATIC CARCINOMAdrugstartdateformat102drugstartdate29/08/2013actiondrug1

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)

drugcharacterization2medicinalproductIBUPROFENdrugstartdateformat102drugstartdate08/03/2013

openFDA Info on Medication

Application Number ANDA077349, ANDA206568, ANDA074937, ANDA091355, ANDA075139, ANDA078682, ANDA0791 ... Brand Name CAREONE IBUPROFEN, IBUPROFEN, HEALTH MART CHILDRENS IBUPROFEN, IBUPROFEN MINIS, ... Generic Name IBUPROFEN, IBUPROFEN TABLETS, IBUPROFEN 200MG, IBUPROFEN ORAL, IBUPFROFEN, IBUPR ... Manufacturers American Sales Company, Family Dollar (FAMILY WELLNESS), Strategic Sourcing Serv ... product_ndc 41520-495, 55319-745, 62011-0214, 49738-510, 59779-392, 11822-3307, 50804-199, 7 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsIBUPROFEN, IBUPROFEN SODIUMRXCUI 310965, 310964, 197803, 204442, 310963, 731536, 197805, 197806, 197807, 206905, ... spl_id 0647c7c2-b153-4d8c-b72b-f63d43c41853, 720dc13b-5778-44fa-a4d2-e35db0b2d589, 397d ... spl_set_id 03cdff8a-8890-440d-82b5-54ce809f88cc, 135f910d-a5cd-46e9-9436-015170cc7e38, 1d81 ... Package NDC 41520-495-71, 41520-495-78, 55319-745-30, 55319-745-80, 55319-745-16, 62011-0214 ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, RM1CE97Z4N

4)

drugcharacterization2medicinalproductCLONAZEPAMdrugstartdateformat102drugstartdate11/03/2013

openFDA Info on Medication

Application Number ANDA077171, ANDA074569, ANDA074869, ANDA077194, ANDA077147, ANDA074979, ANDA2110 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Par Pharmaceutical, Inc., Teva Pharmaceuticals USA, Inc., Actavis Pharma, Inc., ... product_ndc 49884-306, 49884-307, 49884-308, 49884-309, 49884-310, 0093-0832, 0093-3212, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_id a95f8799-0bb3-41d6-aa27-8a291127ad54, 90dc0b61-37a3-4e54-bde3-7e4c3f7dae98, 9b58 ... spl_set_id 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069b1a0-7c06-4252-b44e-e2eef065d9b8, a58f ... Package NDC 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02, 0093-0832- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

5)

drugcharacterization2medicinalproductDOCUSATE SODIUM + SENNAdrugstartdateformat102drugstartdate08/03/2013

6)

drugcharacterization2medicinalproductGABAPENTINdrugstartdateformat102drugstartdate11/02/2013

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 6e41ce47-a6cc-4c34-84f1-305747df38c2, 5fc4 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

7)

drugcharacterization2medicinalproductMORPHINEdrugstartdateformat102drugstartdate11/02/2013

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

8)

drugcharacterization2medicinalproductLORAZEPAMdrugstartdateformat102drugstartdate11/02/2013

openFDA Info on Medication

Application Number ANDA076150, NDA018140, ANDA203572, ANDA074282, ANDA072755, ANDA090260, ANDA07502 ... Brand NameLORAZEPAM, ATIVANGeneric NameLORAZEPAMManufacturers International Medication Systems, Limited, West-Ward Pharmaceuticals Corp., Auro ... product_ndc 76329-8261, 0641-6207, 13107-083, 13107-084, 13107-085, 0409-6778, 0054-3532, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsLORAZEPAMRXCUI 238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 763028, 763029 ... spl_id decb713d-bc45-4bf5-8f61-c0e2f23051b0, eb500b8e-b94e-4900-bc8a-8217fc718704, e1fa ... spl_set_id 7dda070d-7809-46c4-8592-eb4e4c509707, b79b38ee-c29d-4099-964f-000031f47f5a, 5b85 ... Package NDC 76329-8261-1, 0641-6207-01, 0641-6207-25, 13107-083-10, 13107-083-01, 13107-083- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

9)

drugcharacterization2medicinalproductOMEPRAZOLEdrugstartdateformat102drugstartdate14/04/2013

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA075757, ANDA206877, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, AC ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., OHM ... product_ndc 46122-281, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 62175-136, 078 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, 8c9d9c38-9da6-4f99-9f08-26ec4693fa55, ce5c ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c ... Package NDC 46122-281-04, 46122-281-74, 63981-915-55, 57483-740-01, 57483-740-42, 51660-029- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

10)

drugcharacterization2medicinalproductPOLYETHYLENE GLYCOLdrugstartdateformat102drugstartdate11/03/2013

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

11)

drugcharacterization2medicinalproductPOTASSIUM CHLORIDEdrugstartdateformat102drugstartdate08/03/2013

openFDA Info on Medication

Brand Name KALI MURIATICUM, POTASSIUM CHLORIDE, SORE THROAT 911, KLOR-CON M, POTASSIUM CHLO ... Generic NamePOTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASEManufacturers Hyland's, Camber Pharmaceuticals, Inc., Epic Pharma, LLC, DelCorean, LLC, Actavi ... product_ndc 54973-5224, 31722-133, 31722-134, 31722-135, 42806-094, 35484-204, 62037-559, 62 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, TOPICAL, INTRAVENOUS, PARENTERAL, SUBLINGUALActive IngredientsPOTASSIUM CHLORIDE, POTASSIUM CATIONspl_id 603fa445-ab7d-3929-e053-2a91aa0afb47, 4dca93f2-d9a9-4ecb-89d2-f67b819f82dc, ebba ... spl_set_id 2e8a4762-d28d-4b64-892f-913e04d18d2d, b1e827aa-b2fb-4fa5-984d-ddd94338ff53, 1373 ... Package NDC 54973-5224-1, 54973-5224-2, 31722-133-01, 31722-133-05, 31722-133-10, 31722-134- ... UNII660YQ98I10, 295O53K152Application Number ANDA214422, ANDA210200, ANDA077419, ANDA209922, ANDA209786, NDA018279, ANDA08020 ... RXCUI 403888, 1801294, 1801298, 1867544, 312504, 315183, 312515, 314182, 198116, 31252 ... NUIM0026737, N0000175600, N0000175811, N0000009371, N0000009726, N0000010288Chemical StructurePotassium Compounds [CS]Established Pharmacologic ClassPotassium Salt [EPC], Osmotic Laxative [EPC]Physiologic/Pharmacodynamic Effect Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Elect ... Mechanism of ActionOsmotic Activity [MoA]

12)

drugcharacterization2medicinalproductPROCHLORPERAZINEdrugstartdateformat102drugstartdate11/02/2013

openFDA Info on Medication

Application NumberANDA040058, ANDA040246Brand NamePROCHLORPERAZINE, COMPROGeneric NamePROCHLORPERAZINEManufacturersCosette Pharmaceuticals, Inc., Paddock Laboratories, LLCproduct_ndc0713-0135, 0574-7226Product TypeHUMAN PRESCRIPTION DRUGRouteRECTALActive IngredientsPROCHLORPERAZINERXCUI198159, 284254spl_idca1e6e40-c2e6-46a6-ad10-6a881d91e1e3, 9fece974-eb12-49e0-8975-97b0b9a1b27cspl_set_id9595346e-76e5-e155-341b-ffaaafb885ab, ea381bc5-0957-4c91-826a-0ff680cebaccPackage NDC0713-0135-12, 0713-0135-10, 0574-7226-12NUIN0000175746, M0016525Established Pharmacologic ClassPhenothiazine [EPC]Chemical StructurePhenothiazines [CS]UNIIYHP6YLT61T

13)

drugcharacterization2medicinalproductSERTRALINEdrugstartdateformat102drugstartdate08/03/2014

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)

drugcharacterization2medicinalproductTRAZODONE HCLdrugstartdateformat102drugstartdate08/03/2013

Report Duplicate

duplicatesourceBRISTOL MYERS SQUIBBduplicatenumbUS-BRISTOL-MYERS SQUIBB COMPANY-20643896

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use