Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10750298primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/08/2015reporttype2serious1seriousnessother1receivedateformat102Date Received29/01/2015receiptdateformat102Date Last Updated14/04/2015fulfillexpeditecriteria1companynumbUS-ELI_LILLY_AND_COMPANY-US201501006306duplicate1

Report Duplicate

duplicatesourceELI LILLY AND COduplicatenumbUS-ELI_LILLY_AND_COMPANY-US201501006306

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionDrug withdrawal syndromeOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionEmotional disorderOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.0ReactionSuicidal ideationOutcomeRecovered/resolved

4)

reactionmeddraversionpt18.0ReactionVisual impairmentOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionCryingOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductDULOXETINE HYDROCHLORIDE.drugbatchnumbC259975Adrugauthorizationnumb021427drugdosagetextUNK UNK, UNKNOWNdrugdosageformCAPSULEdrugadministrationroute065drugindicationFIBROMYALGIAdrugstartdateformat602drugstartdate//2007drugenddateformat610drugenddate/07/2014

activesubstance

activesubstancenameDULOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA090723, ANDA090778, NDA021427, ANDA207219, ANDA203088, ANDA202045, ANDA20481 ... Brand NameDULOXETINE, CYMBALTA, DULOXETINE HYDROCHLORIDE, DULOXETINE DELAYED-RELEASEGeneric NameDULOXETINE HYDROCHLORIDE, DULOXETIN HYDROCHLORIDE, DULOXETINEManufacturers MARKSANS PHARMA LIMITED, BluePoint, Aurobindo Pharma Limited, Eli Lilly and Comp ... product_ndc 25000-608, 25000-609, 25000-610, 68001-413, 68001-414, 68001-415, 59651-279, 596 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDULOXETINE HYDROCHLORIDERXCUI596926, 596930, 596934, 596928, 596932, 615186, 616402spl_id 922e6be8-2bd2-464c-8bf5-a208c9201cb1, d0faf0c2-6a7c-b57f-e053-2a95a90a4c8a, fff1 ... spl_set_id 3686cde5-f76d-4d16-aa5d-caceb8408f8c, c9492555-6061-47bf-923e-26d4d5528453, 3adf ... Package NDC 25000-608-06, 25000-609-03, 25000-609-07, 25000-610-03, 25000-610-07, 68001-413- ... UNII9044SC542W

2)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNK, UNKNOWNdrugadministrationroute065actiondrug5

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

3)

drugcharacterization2medicinalproductREQUIPdrugdosagetextUNK, UNKNOWNdrugadministrationroute065actiondrug5

activesubstance

activesubstancenameROPINIROLE HYDROCHLORIDE

4)

drugcharacterization2medicinalproductPOTASSIUMdrugdosagetextUNK, UNKNOWNdrugadministrationroute065actiondrug5

activesubstance

activesubstancenamePOTASSIUM

5)

drugcharacterization2medicinalproductLISINOPRIL.drugdosagetextUNK, UNKNOWNdrugadministrationroute065actiondrug5

activesubstance

activesubstancenameLISINOPRIL

openFDA Info on Medication

Application Number ANDA076063, ANDA077321, ANDA077622, NDA208401, ANDA078402, ANDA208920, ANDA21204 ... Brand NameLISINOPRIL, QBRELIS, ZESTRILGeneric NameLISINOPRILManufacturers Hikma Pharmaceuticals USA Inc., International Laboratories, LLC, Rising Pharma H ... product_ndc 0143-9713, 0143-9715, 0143-9714, 54458-872, 54458-877, 54458-874, 54458-873, 165 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 311354, 314076, 314077, 197884, 205326, 311353, 1806884, 1806890, 104375, 104376 ... spl_id 533f6e0f-04a0-4ef7-81b8-0a7be07ddd1a, b685bb45-44a6-4afc-bb3e-940bce536bda, c031 ... spl_set_id b70933da-55b2-4025-a00e-63ce3e6b7fdf, 6eef83b4-ce4c-462b-bcfa-eefa525e682d, c031 ... Package NDC 0143-9715-01, 0143-9715-10, 0143-9715-99, 0143-9714-01, 0143-9714-10, 0143-9714- ... UNIIE7199S1YWR

6)

drugcharacterization2medicinalproductULTRAMdrugdosagetextUNK, UNKNOWNdrugadministrationroute065actiondrug5

activesubstance

activesubstancenameTRAMADOL HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020281Brand NameULTRAMGeneric NameTRAMADOL HYDROCHLORIDEManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-659Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTRAMADOL HYDROCHLORIDERXCUI835603, 835605spl_id573482f4-b6a3-11ec-b822-b84b65fc2800spl_set_id45f59e6f-1794-40a4-8f8b-3a9415924468Package NDC50458-659-60UNII9N7R477WCK

7)

drugcharacterization2medicinalproductVITAMIN D /00107901/drugdosagetextUNK, UNKNOWNdrugadministrationroute065actiondrug5

activesubstance

activesubstancenameERGOCALCIFEROL

8)

drugcharacterization2medicinalproductALDACTONEdrugdosagetextUNK, UNKNOWNdrugadministrationroute065actiondrug5

activesubstance

activesubstancenameSPIRONOLACTONE

openFDA Info on Medication

Application NumberNDA012151Brand NameALDACTONEGeneric NameSPIRONOLACTONEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0025-1001, 0025-1041, 0025-1031Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSPIRONOLACTONERXCUI198222, 198223, 200817, 200820, 200825, 313096spl_idd74a21f3-ea37-4c3d-8647-6880d1f7437cspl_set_id0fed2822-3a03-4b64-9857-c682fcd462bcPackage NDC0025-1001-31, 0025-1041-31, 0025-1031-31NUIN0000175557, N0000011310Established Pharmacologic ClassAldosterone Antagonist [EPC]Mechanism of ActionAldosterone Antagonists [MoA]UNII27O7W4T232

9)

drugcharacterization2medicinalproductPREVACIDdrugdosagetextUNK, UNKNOWNdrugadministrationroute065actiondrug5

activesubstance

activesubstancenameLANSOPRAZOLE

openFDA Info on Medication

Application NumberNDA020406, NDA022327Brand NamePREVACID, PREVACID 24 HRGeneric NameLANSOPRAZOLEManufacturers Takeda Pharmaceuticals America, Inc., GlaxoSmithKline Consumer Healthcare Holdin ... product_ndc64764-046, 64764-541, 64764-543, 64764-544, 0067-6286Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsLANSOPRAZOLERXCUI206205, 206206, 311277, 351260, 351261, 596843, 596918, 866152spl_idcb972f0e-170e-4c9b-bc44-caa4b584ba4a, 7f6cc3d5-6355-48cb-b50a-958b1e96aa90spl_set_id71ba78cb-7e46-43eb-9425-fa130f537f84, fd4629d5-b876-4ae9-bb32-c3560ad416a9Package NDC 64764-541-30, 64764-541-19, 64764-541-11, 64764-541-05, 64764-046-13, 64764-046- ... NUIN0000175525, N0000000147, N0000009724Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA]Physiologic/Pharmacodynamic EffectInhibition Gastric Acid Secretion [PE]UNII0K5C5T2QPG

10)

drugcharacterization2medicinalproductETODOLAC.drugdosagetextUNK, UNKNOWNdrugadministrationroute065actiondrug5

activesubstance

activesubstancenameETODOLAC

openFDA Info on Medication

Application Number ANDA210704, ANDA076174, ANDA091134, ANDA075665, ANDA075419, ANDA076004, ANDA0749 ... Brand NameETODOLACGeneric NameETODOLACManufacturers Bayshore Pharmaceuticals, LLC, Taro Pharmaceuticals U.S.A., Inc., Zydus Pharmace ... product_ndc 76385-118, 76385-119, 51672-4051, 51672-4052, 51672-4053, 68382-271, 68382-272, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsETODOLACRXCUI197686, 199390, 310245, 310247, 359500, 197684, 197685spl_id 6b94a010-3486-4742-b3b5-01fc5914ff3e, 213bd46b-ab03-40e1-8361-65b406cebc5b, 7a7c ... spl_set_id 18215cb7-c833-4a98-a61d-4bedf518a380, 2c5b44b4-78d5-43b2-827d-d2763b6672b3, 7ef7 ... Package NDC 76385-118-01, 76385-119-01, 51672-4051-6, 51672-4051-4, 51672-4051-1, 51672-4051 ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNII2M36281008

11)

drugcharacterization2medicinalproductHYDROCODONEdrugdosagetextUNK, UNKNOWNdrugadministrationroute065actiondrug5

activesubstance

activesubstancenameHYDROCODONE

12)

drugcharacterization2medicinalproductENALAPRILdrugdosagetextUNK, UNKNOWNdrugadministrationroute065actiondrug5

activesubstance

activesubstancenameENALAPRIL

openFDA Info on Medication

Application NumberNDA208686Brand NameENALAPRIL MALEATEGeneric NameENALAPRILManufacturersAmneal Pharmaceuticals NY LLCproduct_ndc69238-2141Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsENALAPRIL MALEATERXCUI1435624spl_id2fc6aecb-bdb7-48f2-bcbc-903477686536spl_set_id7efed863-919d-458e-99e1-ce0cec95537aPackage NDC69238-2141-7UNII9O25354EPJ

summary

narrativeincludeclinicalCASE EVENT DATE: 201407