Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID12219928primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate26/05/2016reporttype1serious1seriousnesshospitalization1seriousnessother1receivedateformat102Date Received30/03/2016receiptdateformat102Date Last Updated30/03/2016fulfillexpeditecriteria1companynumbUS-DEXPHARM-20160463duplicate1

Report Duplicate

duplicatesourceDEXCELduplicatenumbUS-DEXPHARM-20160463

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age62Unit of Onset Ageyearspatientagegroup5Weight102.06SexFemale

Reaction

1)

reactionmeddraversionpt19.0ReactionAcute kidney injuryOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductOMEPRAZOLE.drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugenddateformat610drugenddate/02/2016actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA206877, ANDA075757, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, EQUALINE OMEPRAZOLE DELAYED RELEASE, KIRKLAND ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Supervalu Inc, Costco Wholesale Company, INNOVUS PHARMACEUTI ... product_ndc 46122-281, 41163-614, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 621 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, bd28c8a0-73e5-4c81-bc0e-b2c1504a88c3, 8c9d ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 16bf0c57-0376-48b3-90e5-502d61d1b6eb, 48a4 ... Package NDC 46122-281-04, 46122-281-74, 41163-614-01, 63981-915-55, 57483-740-01, 57483-740- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

2)

drugcharacterization1medicinalproductVALSARTAN AND HYDROCHLOROTHIAZIDEdrugdosagetext320/25 MGdrugindicationBLOOD PRESSURE MEASUREMENTdrugstartdateformat102drugstartdate14/12/2015drugenddateformat102drugenddate14/01/2016actiondrug1

activesubstance

activesubstancenameHYDROCHLOROTHIAZIDE\VALSARTAN

openFDA Info on Medication

Application Number NDA020818, ANDA201662, ANDA203145, ANDA206083, ANDA203000, ANDA078946, ANDA07802 ... Brand NameDIOVAN HCT, VALSARTAN AND HYDROCHLOROTHIAZIDEGeneric NameVALSARTAN AND HYDROCHLOROTHIAZIDEManufacturers Novartis Pharmaceuticals Corporation, Alembic Pharmaceuticals Limited, Macleods ... product_ndc 0078-0314, 0078-0315, 0078-0383, 0078-0471, 0078-0472, 46708-453, 46708-454, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCHLOROTHIAZIDE, VALSARTANRXCUI200284, 200285, 349353, 636042, 636045, 809014, 809018, 809022, 809026, 809030spl_id 3f1a38fe-d886-46d1-9a62-fb96b0dcc29f, 0ffeaac5-a682-41db-a49d-9151dd995b16, 9a77 ... spl_set_id d76a0419-05ee-437e-884c-65807aea9569, 3b80f726-9e1e-4d44-ad4f-afd10e26292f, 771a ... Package NDC 0078-0314-34, 0078-0315-34, 0078-0315-61, 0078-0315-15, 0078-0383-34, 0078-0383- ... NUIN0000000070, N0000175561, N0000175359, N0000175419, M0471776Mechanism of ActionAngiotensin 2 Receptor Antagonists [MoA]Established Pharmacologic ClassAngiotensin 2 Receptor Blocker [EPC], Thiazide Diuretic [EPC]Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Chemical StructureThiazides [CS]UNII80M03YXJ7I, 0J48LPH2TH

3)

drugcharacterization2medicinalproductPNEUMO VAXdrugstartdateformat102drugstartdate05/01/2016

4)

drugcharacterization2medicinalproductAGGRENOXdrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext25-200 MGdrugindicationCOAGULOPATHY

activesubstance

activesubstancenameASPIRIN\DIPYRIDAMOLE

5)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugdosagetextAT BEDTIMEdrugindicationSLEEP DISORDER

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

6)

drugcharacterization2medicinalproductFLEXERILdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetextAT BEDTIMEdrugindicationMUSCLE RELAXANT THERAPY

activesubstance

activesubstancenameCYCLOBENZAPRINE HYDROCHLORIDE

7)

drugcharacterization1medicinalproductMS CONTINdrugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationBACK PAIN

activesubstance

activesubstancenameMORPHINE SULFATE

openFDA Info on Medication

Application NumberNDA019516Brand NameMS CONTINGeneric NameMORPHINE SULFATEManufacturersRhodes Pharmaceuticals L.P.product_ndc42858-515, 42858-631, 42858-760, 42858-799, 42858-900Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMORPHINE SULFATERXCUI891874, 891881, 891888, 891893, 892560, 892574, 892646, 892648, 892660, 894813spl_id426c7771-4aee-4e4d-b3c0-6cefb0f7e154spl_set_idc354b3bf-86c0-4bb8-8b1f-be2164942698Package NDC42858-515-01, 42858-631-01, 42858-760-01, 42858-799-01, 42858-900-01UNIIX3P646A2J0

8)

drugcharacterization1medicinalproductGABAPENTIN.drugbatchnumbGESB1508drugstructuredosagenumb300drugstructuredosageunit003drugindicationNERVE INJURYdrugstartdateformat102drugstartdate18/11/2015drugenddateformat102drugenddate04/01/2016actiondrug1

activesubstance

activesubstancenameGABAPENTIN

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, 59afc809-201f-4cf8-95f6-67ae52c0a327, 4553 ... 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