Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10097333serious1Date Last Updated23/04/2014receiptdateformat102companynumbUS-GILEAD-2014-0099614occurcountryUSseriousnessother1duplicate1Date Received23/04/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionMuscle twitchingOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionConfusional stateOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionIrritabilityOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductSOVALDIdrugauthorizationnumb204671drugdosagetextUNKdrugdosageformTABLETdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat610drugstartdate/02/2014actiondrug5

openFDA Info on Medication

Application NumberNDA204671, NDA212480Brand NameSOVALDIGeneric NameSOFOSBUVIRManufacturersGilead Sciences, Inc.product_ndc61958-1501, 61958-1503, 61958-1504, 61958-1505Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSOFOSBUVIRRXCUI1484916, 1484922, 2203891, 2203893, 2203993, 2203999, 2204090, 2204092spl_idb6ff385d-224a-0bad-e053-2995a90adcd4spl_set_id80beab2c-396e-4a37-a4dc-40fdb62859cfPackage NDC61958-1501-1, 61958-1503-1, 61958-1504-1, 61958-1505-1NUIN0000191493, N0000191258, N0000175459Established Pharmacologic ClassHepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]Mechanism of ActionRNA Replicase Inhibitors [MoA]UNIIWJ6CA3ZU8B

2)

drugcharacterization2medicinalproductRIBAVIRINdrugrecurreadministration3

openFDA Info on Medication

Application NumberNDA018859, ANDA077094, ANDA207366, ANDA077224, ANDA079111, ANDA079117, NDA021546Brand NameVIRAZOLE, RIBAVIRIN, REBETOLGeneric NameRIBAVIRINManufacturers Bausch Health US, LLC, Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) In ... product_ndc 0187-0007, 65841-046, 65841-603, 65841-632, 65841-129, 68382-046, 68382-127, 683 ... Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION), ORALActive IngredientsRIBAVIRINRXCUI207406, 312818, 248109, 597718, 597722, 790286, 312817, 248112, 352007, 544400spl_id 73a3e060-c827-40d8-925c-2d02b9313070, 1596fe48-b374-4c0c-b2ae-1ceb802ca2ba, b46a ... spl_set_id adf16e64-345f-469a-b987-3fbdd17e0ac2, 666e8b22-f519-460b-a774-88a621d56139, 0899 ... Package NDC 0187-0007-14, 0187-0007-01, 65841-046-03, 65841-046-28, 65841-046-10, 65841-046- ... NUIN0000175459, N0000175466Established Pharmacologic ClassNucleoside Analog Antiviral [EPC]UNII49717AWG6K

3)

drugcharacterization2medicinalproductPEGINTERFERON ALFAdrugrecurreadministration3

4)

drugcharacterization2medicinalproductLITHIUMdrugrecurreadministration3

openFDA Info on Medication

Application NumberNDA018421Brand NameLITHIUMGeneric NameLITHIUM, LITHIUM BROMATUMManufacturersWest-Ward Pharmaceuticals Corp, Marco Pharma International LLC.product_ndc 0054-3527, 0054-8528, 0054-4527, 0054-8526, 0054-2526, 0054-8527, 0054-2527, 005 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsLITHIUM CITRATE, LITHIUM BROMIDERXCUI197889, 197890, 197893, 311355, 756059spl_id8e25764e-8fda-438d-a778-411c43074aa7, b5ad884d-209d-cc5d-e053-2a95a90a0339spl_set_id7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e, f4a1d451-33ad-4df3-ae68-58cfbfccfa89Package NDC 0054-8528-25, 0054-4527-25, 0054-4527-31, 0054-8526-25, 0054-2526-25, 0054-8527- ... UNII5Z6E9K79YV, 2BMD2GNA4V, 864G646I84

5)

drugcharacterization2medicinalproductDOXEPINdrugrecurreadministration3

openFDA Info on Medication

Application NumberANDA201951Brand NameDOXEPINGeneric NameDOXEPINManufacturersActavis Pharma, Inc.product_ndc0228-3315, 0228-3316Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDOXEPIN HYDROCHLORIDERXCUI966787, 966793spl_idaeefed70-09dc-4efa-809e-b80fe14656a6spl_set_idc42333f8-1add-4f33-9458-6fe4436874a1Package NDC0228-3315-03, 0228-3316-03UNII3U9A0FE9N5

6)

drugcharacterization2medicinalproductMETFORMINdrugrecurreadministration3

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

7)

drugcharacterization2medicinalproductAMLODIPINEdrugrecurreadministration3

openFDA Info on Medication

Application NumberNDA211340Brand NameKATERZIAGeneric NameAMLODIPINEManufacturersAzurity Pharmaceuticals, Inc.product_ndc52652-5001Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BENZOATERXCUI2184120, 2184126spl_id33926064-be3f-4380-b051-ac4136524317spl_set_iddf673a4d-acb8-444c-a472-c87ab8cbd366Package NDC52652-5001-1UNIIXD75TQ8A2P

8)

drugcharacterization2medicinalproductGLYBURIDEdrugrecurreadministration3

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

9)

drugcharacterization2medicinalproductLISINOPRILdrugrecurreadministration3

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

10)

drugcharacterization2medicinalproductLABETALOLdrugrecurreadministration3

openFDA Info on Medication

Application NumberANDA075215Brand NameLABETALOL HYDROCHLORIDEGeneric NameLABETALOLManufacturersMarlex Pharmaceuticals Incproduct_ndc10135-711, 10135-712, 10135-713Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLABETALOLRXCUI896758, 896762, 896766spl_idaeff3fe6-3caa-437a-a4a4-8cd92da704a3spl_set_id28c91727-e5a8-48b3-a4df-d7bec8feda40Package NDC 10135-711-01, 10135-711-05, 10135-712-01, 10135-712-05, 10135-713-01, 10135-713- ... NUIN0000000161, N0000175556Mechanism of ActionAdrenergic beta-Antagonists [MoA]Established Pharmacologic Classbeta-Adrenergic Blocker [EPC]UNIIR5H8897N95

11)

drugcharacterization2medicinalproductSERTRALINEdrugrecurreadministration3

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

12)

drugcharacterization2medicinalproductLANTUSdrugrecurreadministration3

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

Report Duplicate

duplicatesourceGILEADduplicatenumbUS-GILEAD-2014-0099614

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use