Adverse Event Report

Report

reporttype2Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10077921serious1Date Last Updated10/11/2015receiptdateformat102companynumbUS-ROCHE-1381402occurcountryUSseriousnessother1duplicate1Date Received15/04/2014transmissiondate04/03/2016primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age62Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionUrticariaOutcomeUnknown

2)

reactionmeddraversionpt18.1ReactionRashOutcomeUnknown

3)

reactionmeddraversionpt18.1ReactionHerpes zosterOutcomeUnknown

4)

reactionmeddraversionpt18.1ReactionCerebrovascular accidentOutcomeUnknown

5)

reactionmeddraversionpt18.1ReactionBlindness unilateralOutcomeUnknown

6)

reactionmeddraversionpt18.1ReactionPruritusOutcomeUnknown

7)

reactionmeddraversionpt18.1ReactionArterial occlusive diseaseOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductMETFORMINdrugstructuredosagenumb1000drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb12drugintervaldosagedefinition805drugdosagetextIN THE MORNING, AT NIGHTdrugadministrationroute065drugindicationDIABETES 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)

drugcharacterization2medicinalproductNITROGLYCERIN.drugstructuredosagenumb.4drugstructuredosageunit003drugdosagetextWHEN NEEDEDdrugadministrationroute065

activesubstance

activesubstancenameNITROGLYCERIN

openFDA Info on Medication

Brand Name GLONOINUM, NITROGLYCERIN, NITROGLYCERIN IN DEXTROSE, GLONOINUM KIT REFILL, HEADA ... Generic NameNITROGLYCERINManufacturers Boiron, Rouses Point Pharm, Baxter Healthcare Company, Washington Homeopathic Pr ... product_ndc 0220-2282, 43478-410, 0338-1047, 0338-1049, 0338-1051, 68428-100, 43598-435, 435 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, SUBLINGUAL, INTRAVENOUS, TRANSDERMAL, RECTAL, TOPICALActive IngredientsNITROGLYCERINspl_id 85a1163a-fe46-e31a-e053-2991aa0a6466, 905b7ddc-f00a-4303-9a62-8e4933bffc82, 5fb3 ... spl_set_id 85a1163a-fe45-e31a-e053-2991aa0a6466, 3214ddac-e068-4306-8500-0fa90c8c5842, 457a ... Package NDC 0220-2282-41, 43478-410-07, 43478-410-03, 0338-1047-02, 0338-1049-02, 0338-1051- ... NUIN0000175415, M0014874, N0000009909Established Pharmacologic ClassNitrate Vasodilator [EPC]Chemical StructureNitrates [CS]Physiologic/Pharmacodynamic EffectVasodilation [PE]UNIIG59M7S0WS3Application Number NDA021780, NDA019970, ANDA208191, NDA020145, NDA021134, ANDA206391, NDA208424, A ... RXCUI 705129, 312004, 1868494, 1868562, 198038, 198039, 198040, 486146, 486148, 486152 ...

3)

drugcharacterization2medicinalproductVITAMIN D3drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext50,000 UNITSdrugadministrationroute065

activesubstance

activesubstancenameCHOLECALCIFEROL

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

4)

drugcharacterization2medicinalproductCRESTORdrugstructuredosagenumb20drugstructuredosageunit003drugadministrationroute065

activesubstance

activesubstancenameROSUVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA021366Brand NameCRESTORGeneric NameROSUVASTATIN CALCIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0310-0751, 0310-0755, 0310-0752, 0310-0754Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsROSUVASTATIN CALCIUMRXCUI859419, 859421, 859424, 859426, 859747, 859749, 859751, 859753spl_id0abd2d1e-ee9a-4738-ad7e-610a2caa24abspl_set_idbb0f3b5e-4bc6-41c9-66b9-6257e2513512Package NDC 0310-0755-90, 0310-0751-90, 0310-0751-39, 0310-0752-90, 0310-0752-39, 0310-0754- ... UNII83MVU38M7Q

5)

drugcharacterization2medicinalproductLEVOTHYROXINE.drugstructuredosagenumb125drugstructuredosageunit004drugadministrationroute065drugindicationTHYROID DISORDER

activesubstance

activesubstancenameLEVOTHYROXINE

openFDA Info on Medication

Brand NameLEVOTHYROXINEGeneric NameLEVOTHYROXINEManufacturersDeseret Biologicals, Inc.product_ndc43742-0955Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLEVOTHYROXINEspl_id7c431149-4f46-4c4f-a5bb-c1b1fb705283spl_set_id1a467f8b-2611-4936-af2b-098e4791d6aePackage NDC43742-0955-1NUIN0000175945, M0021504Established Pharmacologic Classl-Thyroxine [EPC]Chemical StructureThyroxine [CS]UNIIQ51BO43MG4

6)

drugcharacterization2medicinalproductLISINOPRIL AND HYDROCHLOROTHIAZIDEdrugseparatedosagenumb1drugintervaldosageunitnumb12drugintervaldosagedefinition805drugdosagetextDOSE:20/25 MG?ONE IN THE MORNING, ONE AT NIGHTdrugadministrationroute065

activesubstance

activesubstancenameHYDROCHLOROTHIAZIDE\LISINOPRIL

openFDA Info on Medication

Application Number ANDA076265, ANDA204058, ANDA077606, ANDA077912, ANDA076194, NDA019888, ANDA07626 ... Brand Name LISINOPRIL WITH HYDROCHLOROTHIAZIDE, LISINOPRIL AND HYDROCHLOROTHIAZIDE, ZESTORE ... Generic NameLISINOPRIL AND HYDROCHLOROTHIAZIDE, LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSManufacturers Hikma Pharmaceuticals USA Inc., Exelan Pharmaceuticals, Inc., Aurobindo Pharma L ... product_ndc 0143-1262, 0143-1263, 0143-1264, 76282-446, 76282-447, 76282-448, 65862-043, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCHLOROTHIAZIDE, LISINOPRILRXCUI197885, 197886, 197887, 823971, 823982, 823986spl_id 203e1723-341b-49e7-a9d1-7a58155846be, aaf7ecb6-22c4-42dc-81c5-8f657e6a15b6, afc2 ... spl_set_id 6573671e-3386-43d0-8f7c-bb8456bdfcbd, c40b15ec-6083-4778-bca8-3e895e5694e1, d721 ... Package NDC 0143-1262-01, 0143-1262-10, 0143-1263-01, 0143-1263-10, 0143-1264-01, 0143-1264- ... NUIN0000175359, N0000175419, M0471776Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide Diuretic [EPC]Chemical StructureThiazides [CS]UNIIE7199S1YWR, 0J48LPH2TH

7)

drugcharacterization2medicinalproductASPIRIN.drugstructuredosagenumb325drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065

activesubstance

activesubstancenameASPIRIN

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

8)

drugcharacterization1medicinalproductLUCENTISdrugauthorizationnumb125156drugdosageformSOLUTION FOR INJECTIONdrugadministrationroute050drugindicationRETINAL VASCULAR DISORDERdrugstartdateformat602drugstartdate//2013actiondrug5

activesubstance

activesubstancenameRANIBIZUMAB

openFDA Info on Medication

Application NumberBLA125156Brand NameLUCENTISGeneric NameRANIBIZUMABManufacturersGenentech, Inc.product_ndc50242-080, 50242-082Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVITREALActive IngredientsRANIBIZUMABRXCUI643193, 644301, 1306074, 1306076, 1864423, 1864425, 2045501, 2045502spl_idd9d384c9-63ec-44a5-8e41-23975ba171cespl_set_idde4e66cc-ca05-4dc9-8262-e00e9b41c36dPackage NDC 50242-080-01, 50242-080-03, 50242-080-02, 50242-080-86, 50242-080-88, 50242-082- ... NUIN0000193542, N0000193543Mechanism of ActionVascular Endothelial Growth Factor Inhibitors [MoA]Established Pharmacologic ClassVascular Endothelial Growth Factor Inhibitor [EPC]UNIIZL1R02VT79

9)

drugcharacterization2medicinalproductCRESTORdrugstructuredosagenumb40drugstructuredosageunit003drugadministrationroute065

activesubstance

activesubstancenameROSUVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA021366Brand NameCRESTORGeneric NameROSUVASTATIN CALCIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0310-0751, 0310-0755, 0310-0752, 0310-0754Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsROSUVASTATIN CALCIUMRXCUI859419, 859421, 859424, 859426, 859747, 859749, 859751, 859753spl_id0abd2d1e-ee9a-4738-ad7e-610a2caa24abspl_set_idbb0f3b5e-4bc6-41c9-66b9-6257e2513512Package NDC 0310-0755-90, 0310-0751-90, 0310-0751-39, 0310-0752-90, 0310-0752-39, 0310-0754- ... UNII83MVU38M7Q

10)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextEVERY EVENINGdrugadministrationroute065

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

11)

drugcharacterization1medicinalproductLUCENTISdrugauthorizationnumb125156drugindicationDIABETIC RETINAL OEDEMAactiondrug5

activesubstance

activesubstancenameRANIBIZUMAB

openFDA Info on Medication

Application NumberBLA125156Brand NameLUCENTISGeneric NameRANIBIZUMABManufacturersGenentech, Inc.product_ndc50242-080, 50242-082Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVITREALActive IngredientsRANIBIZUMABRXCUI643193, 644301, 1306074, 1306076, 1864423, 1864425, 2045501, 2045502spl_idd9d384c9-63ec-44a5-8e41-23975ba171cespl_set_idde4e66cc-ca05-4dc9-8262-e00e9b41c36dPackage NDC 50242-080-01, 50242-080-03, 50242-080-02, 50242-080-86, 50242-080-88, 50242-082- ... NUIN0000193542, N0000193543Mechanism of ActionVascular Endothelial Growth Factor Inhibitors [MoA]Established Pharmacologic ClassVascular Endothelial Growth Factor Inhibitor [EPC]UNIIZL1R02VT79

12)

drugcharacterization2medicinalproductSIMVASTATIN.drugstructuredosagenumb40drugstructuredosageunit003drugadministrationroute065

activesubstance

activesubstancenameSIMVASTATIN

openFDA Info on Medication

Application Number NDA206679, ANDA078155, ANDA077691, ANDA078103, ANDA090383, ANDA078034, ANDA07783 ... Brand NameFLOLIPID, SIMVASTATIN, ZOCORGeneric NameSIMVASTATINManufacturers Salerno Pharmaceuticals Co., Accord Healthcare, Inc., NorthStar Rx LLC, Lupin Ph ... product_ndc 29273-401, 29273-402, 16729-004, 16729-156, 16729-005, 16729-006, 16729-007, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSIMVASTATINRXCUI 1790679, 1944262, 1944264, 1944266, 198211, 200345, 312961, 312962, 314231, 1044 ... spl_id 37ec6157-4088-4638-8eba-74a6aa1238d3, a467e8e1-fe36-61f4-e053-2a95a90a3c3c, 81d3 ... spl_set_id 6ee17d10-6eb1-452a-99e8-02381368b3fe, 871251c0-36a1-4a32-9eab-ff6c1e925ca9, 0376 ... Package NDC 29273-401-04, 29273-402-04, 16729-156-10, 16729-156-15, 16729-156-17, 16729-004- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNIIAGG2FN16EV

13)

drugcharacterization2medicinalproductINVOKANAdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextSAMPLESdrugadministrationroute065

activesubstance

activesubstancenameCANAGLIFLOZIN

openFDA Info on Medication

Application NumberNDA204042Brand NameINVOKANAGeneric NameCANAGLIFLOZINManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-140, 50458-141Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCANAGLIFLOZINRXCUI1373463, 1373469, 1373471, 1373473spl_idc3d5d49d-4af6-4317-8ffc-2e17bae018b9spl_set_idb9057d3b-b104-4f09-8a61-c61ef9d4a3f3Package NDC 50458-140-30, 50458-140-90, 50458-140-50, 50458-140-10, 50458-140-01, 50458-141- ... UNII0SAC974Z85

14)

drugcharacterization2medicinalproductLANTUS

activesubstance

activesubstancenameINSULIN GLARGINE

openFDA Info on Medication

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

summary

narrativeincludeclinicalCASE EVENT DATE: 201309

Report Duplicate

duplicatesourceROCHEduplicatenumbUS-ROCHE-1381402

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use