Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10189724serious1Date Last Updated17/05/2018receiptdateformat102companynumbUS-SA-2014SA039292occurcountryUSduplicate1Date Received22/05/2014seriousnesshospitalization1transmissiondate11/07/2018primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age56Unit of Onset Ageyearspatientagegroup5SexFemale

Reaction

1)

reactionmeddraversionpt21.0ReactionProduct use issueOutcomeUnknown

2)

reactionmeddraversionpt21.0ReactionLaryngeal ulcerationOutcomeUnknown

3)

reactionmeddraversionpt21.0ReactionDevice issueOutcomeUnknown

4)

reactionmeddraversionpt21.0ReactionBlood glucose increasedOutcomeUnknown

5)

reactionmeddraversionpt21.0ReactionInfectionOutcomeUnknown

6)

reactionmeddraversionpt21.0ReactionMalaiseOutcomeUnknown

7)

reactionmeddraversionpt21.0ReactionDisorganised speechOutcomeUnknown

8)

reactionmeddraversionpt21.0ReactionAphthous ulcerOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductMETFORMINdrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextSTRENGTH: 1000 MGdrugadministrationroute065drugindicationDIABETES MELLITUS

activesubstance

activesubstancenameMETFORMIN HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA200690, ANDA209674, ANDA209313Brand NameMETFORMIN HYDROCHLORIDE, METFORMINGeneric NameMETFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MGManufacturers Mylan Pharmaceuticals Inc., Ingenus Pharmaceuticals, LLC, Granules Pharmaceutica ... product_ndc0378-6001, 0378-6002, 50742-633, 50742-634, 70010-491, 70010-492Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETFORMIN HYDROCHLORIDERXCUI1807894, 1807917, 860975, 860981spl_id b1d71739-26c3-43d3-9088-60bef3689e74, d7e2ad60-7a17-4c65-b836-e56644be754d, a353 ... spl_set_id 7e41818c-60e9-4bcf-9586-7bb8d33d5e89, 49a0b5c2-ebaf-4c4c-905f-dfd1962ac647, 6d6e ... Package NDC 0378-6002-91, 0378-6001-91, 50742-633-60, 50742-633-90, 50742-633-10, 50742-634- ... UNII786Z46389E

2)

drugcharacterization2medicinalproductTENORMINdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065drugindicationBLOOD PRESSURE MEASUREMENT

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_id70291313-c4f6-7c2a-cd07-04fd6a07b634spl_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

3)

drugcharacterization2medicinalproductMETHADONEdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065

activesubstance

activesubstancenameMETHADONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA204166Brand NameMETHADONE HYDROCHLORIDEGeneric NameMETHADONEManufacturersVistaPharm, Inc.product_ndc66689-836Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETHADONE HYDROCHLORIDERXCUI864706spl_id00594a6e-2875-4640-95cc-e8bcff7541bcspl_set_id4a44bde6-c348-4316-b0e0-c24b407cb823Package NDC66689-836-99UNII229809935B

4)

drugcharacterization2medicinalproductGABAPENTIN.drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextSTRENGTH: 800 MGdrugadministrationroute065drugindicationNEUROPATHY PERIPHERAL

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, 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

5)

drugcharacterization2medicinalproductLISINOPRIL.drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065drugindicationBLOOD PRESSURE MEASUREMENT

activesubstance

activesubstancenameLISINOPRIL

openFDA Info on Medication

Application Number ANDA076063, ANDA077321, NDA208401, ANDA078402, ANDA212041, ANDA076180, ANDA07616 ... Brand NameLISINOPRIL, QBRELIS, PRINIVIL, ZESTRILGeneric NameLISINOPRILManufacturers Hikma Pharmaceuticals USA Inc., International Laboratories, LLC, Azurity Pharmac ... product_ndc 0143-9713, 0143-9715, 0143-9714, 54458-872, 54458-877, 54458-874, 54458-873, 526 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 311354, 314076, 314077, 197884, 1806884, 1806890, 205326, 311353, 206764, 206765 ... spl_id 533f6e0f-04a0-4ef7-81b8-0a7be07ddd1a, b685bb45-44a6-4afc-bb3e-940bce536bda, 2fdc ... spl_set_id b70933da-55b2-4025-a00e-63ce3e6b7fdf, 6eef83b4-ce4c-462b-bcfa-eefa525e682d, 9f6e ... Package NDC 0143-9715-01, 0143-9715-10, 0143-9715-99, 0143-9714-01, 0143-9714-10, 0143-9714- ... UNIIE7199S1YWR

6)

drugcharacterization2medicinalproductNOVOLOGdrugdosagetextDOSE: SLIDING SCALEdrugadministrationroute065drugindicationDIABETES MELLITUS

activesubstance

activesubstancenameINSULIN ASPART

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

7)

drugcharacterization2medicinalproductKLONOPINdrugdosagetextSTRENGTH: 1MGdrugadministrationroute065drugindicationANXIETY

activesubstance

activesubstancenameCLONAZEPAM

openFDA Info on Medication

Application NumberNDA017533Brand NameKLONOPINGeneric NameCLONAZEPAMManufacturersGenentech, Inc.product_ndc0004-0058, 0004-0068, 0004-0098Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI197527, 197528, 197529, 206157, 206159, 206160spl_id7a882463-5215-477c-bc1c-2cce0801bf4bspl_set_id542f22e8-dad2-47a8-93b6-30936715d73bPackage NDC0004-0068-01, 0004-0058-01, 0004-0098-01NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

8)

drugcharacterization2medicinalproductPANTOPRAZOLEdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065

activesubstance

activesubstancenamePANTOPRAZOLE

openFDA Info on Medication

Application NumberANDA205119, ANDA077619Brand NamePANTOPRAZOLE SODIUM, PANTOPRAZOLEGeneric NamePANTOPRAZOLEManufacturersAmneal Pharmaceuticals LLC, Dr.Reddy's Laboratories Limitedproduct_ndc65162-636, 65162-637, 55111-332, 55111-333Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPANTOPRAZOLE SODIUMRXCUI251872, 314200spl_id5c7a8fef-13ea-42c4-9e13-d8bc23c8f8a4, 02f0a994-cbaa-6f9b-56bd-48e9952540ecspl_set_idf3ded82a-cf0d-4844-944a-75f9f9215ff0, 564709e8-358f-c185-4ecb-b3849c3fe59cPackage NDC 65162-636-03, 65162-636-09, 65162-637-03, 65162-637-09, 65162-637-11, 65162-637- ... UNII6871619Q5X

9)

drugcharacterization2medicinalproductLEVEMIRdrugadministrationroute065

activesubstance

activesubstancenameINSULIN DETEMIR

openFDA Info on Medication

Application NumberBLA021536Brand NameLEVEMIRGeneric NameINSULIN DETEMIRManufacturersNovo Nordiskproduct_ndc0169-3687, 0169-6438Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsINSULIN DETEMIRRXCUI484322, 616238, 847239, 847241spl_ideb3d65cd-c44f-440c-b2d1-db2e766581c4spl_set_idd38d65c1-25bf-401d-9c7e-a2c3222da8afPackage NDC0169-3687-12, 0169-6438-10, 0169-6438-90, 0169-6438-97, 0169-6438-98NUIN0000004931, N0000175453Chemical StructureInsulin [Chemical/Ingredient]Established Pharmacologic ClassInsulin Analog [EPC]UNII4FT78T86XV

10)

drugcharacterization2medicinalproductGLYBURIDE.drugadministrationroute065drugindicationDIABETES MELLITUS

activesubstance

activesubstancenameGLYBURIDE

openFDA Info on Medication

Application Number ANDA074388, ANDA203581, ANDA206749, ANDA206079, NDA017532, ANDA206483, ANDA20337 ... Brand NameGLYBURIDE, GLYNASEGeneric NameGLYBURIDEManufacturers Teva Pharmaceuticals USA, Inc., TruPharma, LLC, Cadila Healthcare Limited, Amnea ... product_ndc 0093-8342, 0093-8343, 0093-8344, 52817-120, 52817-121, 52817-122, 65841-832, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGLYBURIDERXCUI197737, 310534, 310537, 310536, 310539, 314000, 881407, 881409, 881411spl_id c91816e6-19e7-48f8-bde4-018c74d47375, b7928c2d-1e2e-a219-e053-2995a90aedee, db3b ... spl_set_id a56f100f-0f42-4188-81ab-04644b824040, 2dfddffe-ca77-6cb0-e054-00144ff8d46c, 5d0e ... Package NDC 0093-8342-01, 0093-8343-01, 0093-8343-05, 0093-8343-10, 0093-8343-98, 0093-8344- ... NUIN0000175608, M0020795Established Pharmacologic ClassSulfonylurea [EPC]Chemical StructureSulfonylurea Compounds [CS]UNIISX6K58TVWC

11)

drugcharacterization2medicinalproductHUMALOGdrugadministrationroute065

activesubstance

activesubstancenameINSULIN LISPRO

openFDA Info on Medication

Application NumberBLA021017, BLA020563, BLA205747, BLA021018Brand Name HUMALOG MIX75/25, HUMALOG MIX75/25 KWIKPEN, HUMALOG KWIKPEN, HUMALOG, HUMALOG J ... Generic NameINSULIN LISPROManufacturersEli Lilly and Companyproduct_ndc 0002-7511, 0002-8797, 0002-8799, 0002-7510, 0002-7516, 0002-7712, 0002-7714, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUS, INTRAVENOUSActive IngredientsINSULIN LISPRORXCUI 259111, 752388, 847252, 847254, 242120, 865098, 1652239, 1652242, 1652639, 16526 ... spl_id b2994f24-d275-417a-a5a1-0997652e9091, 4d586487-399b-43f6-9050-dd1a1a270bcf, eceb ... spl_set_id c73da51a-1899-45ad-b6cf-9c52c36a25dd, c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f, b34c ... Package NDC 0002-7511-01, 0002-7511-99, 0002-8797-01, 0002-8797-59, 0002-8797-99, 0002-8797- ... NUIN0000004931, N0000175453Chemical StructureInsulin [Chemical/Ingredient]Established Pharmacologic ClassInsulin Analog [EPC]UNIIGFX7QIS1II

12)

drugcharacterization2medicinalproductHUMULIN R

activesubstance

activesubstancenameINSULIN HUMAN

openFDA Info on Medication

Application NumberBLA018780Brand NameHUMULIN RGeneric NameINSULIN HUMANManufacturersEli Lilly and Companyproduct_ndc0002-8215Product TypeHUMAN OTC DRUGRoutePARENTERALActive IngredientsINSULIN HUMANRXCUI311034, 311036spl_idd2e3e7a4-7ef8-4b3c-a025-dbd2c4d5dd27spl_set_idb519bd83-038c-4ec5-a231-a51ec5cc291fPackage NDC0002-8215-01, 0002-8215-17, 0002-8215-99NUIM0011417, N0000175944Chemical StructureInsulin [CS]Established Pharmacologic ClassInsulin [EPC]UNII1Y17CTI5SR

13)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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)

drugcharacterization2medicinalproductFENOFIBRATE.drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065

activesubstance

activesubstancenameFENOFIBRATE

openFDA Info on Medication

Application Number ANDA211080, ANDA202676, ANDA209950, ANDA207378, ANDA211122, ANDA210606, ANDA2051 ... Brand NameFENOFIBRATE, FENOFIBRATE FILM COATED, ANTARA, TRICOR, FENOGLIDE, LIPOFENGeneric NameFENOFIBRATEManufacturers Solco Healthcare US, LLC, Mylan Pharmaceuticals Inc., Amneal Pharmaceuticals NY ... product_ndc 43547-430, 43547-431, 0378-8628, 0378-8629, 0378-8630, 69238-1262, 69238-1263, 1 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFENOFIBRATERXCUI 477560, 477562, 200311, 310288, 310289, 349287, 351133, 483425, 483427, 1442163, ... spl_id 165e6912-1ca0-4fad-8c3c-97a927d0d249, dc10b5a1-7266-4333-b516-df25f7b643df, 0be7 ... spl_set_id 085109a6-f006-44f0-a170-980d8899a365, 66d2c555-2880-4ac6-80f8-69a00f1fbc4c, 7e79 ... Package NDC 43547-430-09, 43547-430-50, 43547-431-09, 43547-431-50, 0378-8628-77, 0378-8629- ... NUIN0000175596, N0000175375, M0199111Established Pharmacologic ClassPeroxisome Proliferator Receptor alpha Agonist [EPC]Mechanism of ActionPeroxisome Proliferator-activated Receptor alpha Agonists [MoA]Chemical StructurePPAR alpha [CS]UNIIU202363UOS

15)

drugcharacterization1medicinalproductLANTUS SOLOSTARdrugbatchnumb3F472Adrugauthorizationnumb021081drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextDOSE:50 UNIT(S)drugdosageformSOLUTION FOR INJECTIONdrugadministrationroute051drugindicationTYPE 2 DIABETES MELLITUSactiondrug4

activesubstance

activesubstancenameINSULIN GLARGINE

openFDA Info on Medication

Application NumberBLA021081Brand NameLANTUS SOLOSTARGeneric NameINSULIN GLARGINEManufacturerssanofi-aventis U.S. LLCproduct_ndc0088-2219, 0088-2220, 0088-5020, 0088-5021Product 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

16)

drugcharacterization1medicinalproductSOLOSTARdrugbatchnumb3F472Adrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationTYPE 2 DIABETES MELLITUSactiondrug4

activesubstance

activesubstancenameDEVICE

Report Duplicate

duplicatesourceAVENTISduplicatenumbUS-SA-2014SA039292

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use