Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-SANOFI-AVENTIS-2013SA085991occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10187665Date Received22/05/2014transmissiondate12/12/2014serious2Date Last Updated22/05/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age66Unit of Onset AgeyearsWeight113.39SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionLocalised infectionOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionHaemorrhageOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionBlood glucose increasedOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionIncorrect product storageOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductLANTUS SOLOSTARdrugbatchnumb3F316Adrugauthorizationnumb021081drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextDOSE:34 UNIT(S)drugdosageformSOLUTION FOR INJECTIONdrugadministrationroute051drugindicationTYPE 2 DIABETES MELLITUSdrugstartdateformat610drugstartdate/01/2012actiondrug4

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

2)

drugcharacterization1medicinalproductVICTOZAdrugbatchnumbUNKNOWNdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextDOSE:1.8 UNIT(S)drugadministrationroute065drugindicationDIABETES MELLITUSactiondrug5

openFDA Info on Medication

Application NumberNDA022341Brand NameVICTOZAGeneric NameLIRAGLUTIDEManufacturersNovo Nordiskproduct_ndc0169-4060Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsLIRAGLUTIDERXCUI897122, 897126spl_id15c86a89-8747-40bc-8339-287e8785bba9spl_set_id5a9ef4ea-c76a-4d34-a604-27c5b505f5a4Package NDC 0169-4060-13, 0169-4060-12, 0169-4060-90, 0169-4060-97, 0169-4060-98, 0169-4060- ... NUIN0000178480, M0160181, N0000020058Established Pharmacologic ClassGLP-1 Receptor Agonist [EPC]Chemical StructureGlucagon-Like Peptide 1 [CS]Mechanism of ActionGlucagon-like Peptide-1 (GLP-1) Agonists [MoA]UNII839I73S42A

3)

drugcharacterization2medicinalproductSOLOSTAR

4)

drugcharacterization2medicinalproductANTITHROMBOTIC AGENTS

5)

drugcharacterization2medicinalproductDILTIAZEMdrugstructuredosagenumb240drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065drugindicationBLOOD PRESSURE

6)

drugcharacterization2medicinalproductCLONIDINEdrugstructuredosagenumb.02drugstructuredosageunit003drugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065drugindicationBLOOD PRESSURE

openFDA Info on Medication

Application Number ANDA076166, ANDA209675, ANDA210052, NDA018891, ANDA203167, ANDA090873, ANDA07909 ... Brand NameCLONIDINE, CLONIDINE HYDROCHLORIDE, CATAPRES-TTS, CLONIDINE TRANSDERMAL SYSTEMGeneric NameCLONIDINEManufacturers Mylan Pharmaceuticals Inc., Ingenus Pharmaceuticals, LLC, Amneal Pharmaceuticals ... product_ndc 0378-0871, 0378-0872, 0378-0873, 50742-247, 69238-1426, 0597-0031, 0597-0032, 05 ... Product TypeHUMAN PRESCRIPTION DRUGRouteTRANSDERMAL, ORAL, EPIDURALActive IngredientsCLONIDINE, CLONIDINE HYDROCHLORIDERXCUI998671, 998675, 998679, 1013930, 998673, 998677, 998681, 884221, 884225spl_id e08c98d5-41af-4ba3-b186-af56a940ff3b, c48928af-0077-4c1b-b428-8c00237c3aa0, cec4 ... spl_set_id 7adfc439-e6d0-4593-87dd-0eef36d33c6d, 99485427-a120-4fc7-bb61-25857d1900ec, accb ... Package NDC 0378-0871-16, 0378-0871-99, 0378-0872-16, 0378-0872-99, 0378-0873-16, 0378-0873- ... NUIN0000009918, N0000175554Mechanism of ActionAdrenergic alpha2-Agonists [MoA]Established Pharmacologic ClassCentral alpha-2 Adrenergic Agonist [EPC]UNIIMN3L5RMN02, W76I6XXF06

7)

drugcharacterization2medicinalproductSPIRONOLACTONEdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065drugindicationBLOOD PRESSURE

openFDA Info on Medication

Application Number ANDA091426, ANDA040750, ANDA203512, ANDA203253, NDA012151, ANDA089424, ANDA20593 ... Brand NameSPIRONOLACTONE, ALDACTONEGeneric NameSPIRONOLACTONEManufacturers Amneal Pharmaceuticals LLC, Oxford Pharmaceuticals, LLC, Accord Healthcare, Inc. ... product_ndc 65162-511, 65162-514, 65162-515, 69584-852, 69584-853, 69584-854, 16729-225, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSPIRONOLACTONERXCUI198222, 198223, 313096, 200817, 200820, 200825spl_id 5c663162-67fb-4890-977c-70db2561d387, db73b6cc-b152-4ec1-8566-f4ead6f9ae6d, 9590 ... spl_set_id fb66327e-8261-46ae-b39a-4fa79d520844, 852684dc-e1c6-4caa-bccb-10ac90bbb3bb, 8a96 ... Package NDC 65162-511-03, 65162-511-06, 65162-511-09, 65162-511-10, 65162-511-11, 65162-511- ... NUIN0000175557, N0000011310Established Pharmacologic ClassAldosterone Antagonist [EPC]Mechanism of ActionAldosterone Antagonists [MoA]UNII27O7W4T232

8)

drugcharacterization2medicinalproductLIPITORdrugstructuredosagenumb80drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065drugindicationBLOOD PRESSURE

openFDA Info on Medication

Application NumberNDA020702Brand NameLIPITORGeneric NameATORVASTATIN CALCIUMManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0155, 0071-0156, 0071-0157, 0071-0158Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATORVASTATIN CALCIUM TRIHYDRATERXCUI259255, 262095, 617310, 617311, 617312, 617314, 617318, 617320spl_id0ba214c6-250e-42a0-aea8-5e44aba04882spl_set_idc6e131fe-e7df-4876-83f7-9156fc4e8228Package NDC 0071-0155-23, 0071-0155-40, 0071-0155-10, 0071-0155-97, 0071-0156-23, 0071-0156- ... UNII48A5M73Z4Q

9)

drugcharacterization2medicinalproductASPIRINdrugstructuredosagenumb81drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065drugindicationBLOOD PRESSURE

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

10)

drugcharacterization2medicinalproductGLYCERYL TRINITRATEdrugstructuredosagenumb.4drugstructuredosageunit003drugadministrationroute065drugindicationBLOOD PRESSURE

openFDA Info on Medication

Brand NameGLONOINUMGeneric NameGLYCERYL TRINITRATEManufacturersSeroyal USAproduct_ndc62106-5945Product TypeHUMAN OTC DRUGRouteORALActive IngredientsNITROGLYCERINspl_id9a6689a3-638e-2b1f-e053-2995a90a64b0spl_set_id1b7cb5e7-e1f7-093d-e054-00144ff8d46cPackage NDC62106-5945-4NUIN0000175415, M0014874, N0000009909Established Pharmacologic ClassNitrate Vasodilator [EPC]Chemical StructureNitrates [CS]Physiologic/Pharmacodynamic EffectVasodilation [PE]UNIIG59M7S0WS3

11)

drugcharacterization2medicinalproductISOSORBIDE MONONITRATEdrugstructuredosagenumb90drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext60 AND 30 MG IN MORNINGdrugadministrationroute065drugindicationBLOOD PRESSURE

openFDA Info on Medication

Application Number NDA020215, ANDA200270, ANDA200495, ANDA075395, ANDA075155, ANDA210918, ANDA07503 ... Brand NameMONOKET, ISOSORBIDE MONONITRATEGeneric NameISOSORBIDE MONONITRATEManufacturers Lannett Company, Inc., Torrent Pharmaceuticals Limited, Zydus Pharmaceuticals (U ... product_ndc 62175-361, 62175-362, 13668-104, 13668-105, 13668-106, 68382-650, 68382-651, 683 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOSORBIDE MONONITRATERXCUI206854, 206856, 311192, 311197, 311196, 317110, 353538spl_id bd2457f5-22de-4e07-829c-1eadb77e0e9e, 91901717-443c-4ee4-9bae-76c6fdb67bdf, f811 ... spl_set_id d8f4202c-5103-40dc-9309-dcf72da02d0d, 0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c, 897a ... Package NDC 62175-361-01, 62175-362-01, 13668-104-05, 13668-104-40, 13668-104-10, 13668-104- ... NUIN0000175415, M0014874, N0000009909Established Pharmacologic ClassNitrate Vasodilator [EPC]Chemical StructureNitrates [CS]Physiologic/Pharmacodynamic EffectVasodilation [PE]UNIILX1OH63030

12)

drugcharacterization2medicinalproductOMEPRAZOLEdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065drugindicationGASTROOESOPHAGEAL REFLUX DISEASE

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

13)

drugcharacterization2medicinalproductFUROSEMIDEdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 PILLS MORNINGdrugadministrationroute065drugindicationFLUID IMBALANCE

openFDA Info on Medication

Application Number ANDA077293, ANDA207552, ANDA213902, NDA016273, ANDA070655, ANDA212174, ANDA07043 ... Brand Name TOXYCOLOGY MEDICATED COLLECTION SYSTEM, FUROSEMIDE, LASIX, DIASCREEN 12-PANEL ME ... Generic NameFUROSEMIDEManufacturers IT3 Medical LLC, Amneal Pharmaceuticals LLC, Gland Pharma Limited, Validus Pharm ... product_ndc 70529-549, 70121-1076, 70121-1163, 70121-1164, 68083-432, 68083-433, 68083-434, ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 310429, 1038558, 1719286, 1719290, 1719291, 197732, 200801, 200809, 205732, 3139 ... spl_id 67969d0e-ce2a-4634-b46a-968c898b61ee, c22d0330-1b76-420a-a84b-8ea59f8733a7, e7bd ... spl_set_id a78407a8-3d3e-4eb5-9e3f-b32a1b8015e4, d5b9f12e-d1e9-42de-90f2-c9ba33a86457, 6447 ... Package NDC 70529-549-01, 70529-061-08, 68345-883-50, 70121-1163-1, 70121-1163-5, 70121-1164 ... RouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsFUROSEMIDENUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

14)

drugcharacterization2medicinalproductCENTRUMdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 PILL MORNINGdrugadministrationroute065drugindicationVITAMIN SUPPLEMENTATION

15)

drugcharacterization2medicinalproductSERTRALINEdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextDOSE - 100 MG (1 AND 1/2) AT NIGHTdrugadministrationroute065drugindicationDEPRESSION

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

16)

drugcharacterization2medicinalproductTRAZODONEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 PILL AT NIGHTdrugadministrationroute065drugindicationSLEEP DISORDER

17)

drugcharacterization2medicinalproductGABAPENTINdrugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 PILL FOUR TIMES A DAYdrugadministrationroute065drugindicationNEUROPATHY PERIPHERAL

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

18)

drugcharacterization2medicinalproductSALBUTAMOL SULFATEdrugdosagetextFORM - INHALERdrugadministrationroute065drugindicationRESPIRATORY DISORDER

19)

drugcharacterization2medicinalproductHYDROCODONE W/APAPdrugdosagetextDOSE 10-500drugdosageformTABLETdrugadministrationroute065drugindicationARTHRITIS

20)

drugcharacterization2medicinalproductLORCETdrugdosagetextDOSE - 10-500drugdosageformTABLETdrugadministrationroute065drugindicationPAIN

21)

drugcharacterization2medicinalproductCARVEDILOLdrugstructuredosagenumb6.25drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065drugindicationBLOOD PRESSURE

openFDA Info on Medication

Application Number ANDA076373, ANDA078384, ANDA077316, ANDA077614, NDA020297, ANDA078332, ANDA07822 ... Brand NameCARVEDILOL, COREGGeneric NameCARVEDILOLManufacturers Teva Pharmaceuticals USA, Inc., Bayshore Pharmaceuticals LLC, Mylan Pharmaceutic ... product_ndc 0093-0051, 0093-0135, 0093-7295, 0093-7296, 76385-110, 76385-111, 76385-112, 763 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCARVEDILOLRXCUI200031, 200032, 200033, 686924, 212388, 212389, 212390, 686926spl_id a369c0d5-8f93-4b0d-a5a0-8125af1309f7, 8df8b35d-dade-43e2-9f28-d47a452efb36, d19e ... spl_set_id 68c275e8-992a-4520-8065-ab6d615d89cc, 33dfcf29-19d6-46ba-b8ed-d59d2226ad07, e502 ... Package NDC 0093-0051-01, 0093-0051-05, 0093-0135-01, 0093-0135-05, 0093-7295-01, 0093-7295- ... NUIN0000000099, N0000009923, N0000009924, N0000175553, N0000175556Mechanism of Action Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenerg ... Established Pharmacologic Classalpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]UNII0K47UL67F2

22)

drugcharacterization2medicinalproductVITAMIN Ddrugstructuredosagenumb2000drugstructuredosageunit025drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065drugindicationOSTEOPOROSIS

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturersStrides Pharma Science Limitedproduct_ndc64380-737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36Package NDC64380-737-06, 64380-737-25NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

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duplicatesourceAVENTISduplicatenumbUS-SANOFI-AVENTIS-2013SA085991