Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11437620primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious2receivedateformat102Date Received21/08/2015receiptdateformat102Date Last Updated21/08/2015fulfillexpeditecriteria2companynumbUS-ELI_LILLY_AND_COMPANY-US200705007505duplicate1

Report Duplicate

duplicatesourceELI LILLY AND COduplicatenumbUS-ELI_LILLY_AND_COMPANY-US200705007505

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age43Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionNervousnessOutcomeUnknown

2)

reactionmeddraversionpt18.1ReactionVisual impairmentOutcomeUnknown

3)

reactionmeddraversionpt18.1ReactionDiarrhoeaOutcomeUnknown

4)

reactionmeddraversionpt18.1ReactionBlood pressure increasedOutcomeUnknown

5)

reactionmeddraversionpt18.1ReactionNauseaOutcomeUnknown

6)

reactionmeddraversionpt18.1ReactionFeeling abnormalOutcomeUnknown

7)

reactionmeddraversionpt18.1ReactionHeadacheOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductMULTIVITAMINactiondrug4

activesubstance

activesubstancenameVITAMINS

2)

drugcharacterization2medicinalproductNEXIUMdrugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, UNKactiondrug4

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMRXCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, ... spl_id84c822de-ebe2-4a39-9944-7e38e1961dde, 24d37125-c3cf-48e0-9e50-75cbc818e7c1spl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43H

3)

drugcharacterization2medicinalproductLEXAPROdrugdosagetextUNK MG, UNKdrugindicationANXIETYactiondrug1

activesubstance

activesubstancenameESCITALOPRAM OXALATE

openFDA Info on Medication

Application NumberNDA021323Brand NameLEXAPROGeneric NameESCITALOPRAMManufacturersAllergan, Inc.product_ndc0456-2005, 0456-2010, 0456-2020, 0456-2101Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESCITALOPRAM OXALATERXCUI349332, 351249, 351250, 351285, 352272, 352273, 404408, 404420spl_idd6a08762-d20a-47c9-b92e-b5dde195489cspl_set_id13bb8267-1cab-43e5-acae-55a4d957630aPackage NDC 0456-2005-01, 0456-2010-01, 0456-2010-11, 0456-2010-63, 0456-2020-01, 0456-2020- ... UNII5U85DBW7LO

4)

drugcharacterization2medicinalproductMAXZIDEdrugindicationBLOOD PRESSURE MEASUREMENTactiondrug5

activesubstance

activesubstancenameHYDROCHLOROTHIAZIDE\TRIAMTERENE

openFDA Info on Medication

Application NumberNDA019129Brand NameMAXZIDE, MAXZIDE-25Generic NameMAXZIDEManufacturersMylan Pharmaceuticals Inc.product_ndc0378-0460, 0378-0464Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCHLOROTHIAZIDE, TRIAMTERENERXCUI93252, 93253, 310812, 310818spl_id0e54ebec-df86-4205-9434-315913b56a94spl_set_ide92eda49-861e-4c79-b446-ec1213151d92Package NDC0378-0464-01, 0378-0460-01NUIN0000008859, N0000175359, N0000175418, N0000175419, M0471776Physiologic/Pharmacodynamic EffectDecreased Renal K+ Excretion [PE], Increased Diuresis [PE]Established Pharmacologic ClassPotassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC]Chemical StructureThiazides [CS]UNIIWS821Z52LQ, 0J48LPH2TH

5)

drugcharacterization2medicinalproductPERCOCETdrugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK MG, 4/Dactiondrug4

activesubstance

activesubstancenameACETAMINOPHEN\OXYCODONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA040330Brand NamePERCOCETGeneric NameOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENManufacturersEndo Pharmaceuticals Inc.product_ndc63481-623, 63481-627, 63481-628, 63481-629Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsACETAMINOPHEN, OXYCODONE HYDROCHLORIDERXCUI1049214, 1049221, 1049225, 1049625, 1049635, 1049637, 1049640, 1049642spl_id8a04ce2f-d576-469f-91bc-5ed75e27e47espl_set_id4dd36cf5-8f73-404a-8b1d-3bd53bd90c25Package NDC63481-627-70, 63481-623-70, 63481-623-85, 63481-628-70, 63481-629-70UNIIC1ENJ2TE6C, 362O9ITL9D

6)

drugcharacterization2medicinalproductPOTASSIUMdrugstructuredosagenumb20drugstructuredosageunit029drugdosagetext20 MEQ, UNKactiondrug4

activesubstance

activesubstancenamePOTASSIUM

7)

drugcharacterization2medicinalproductCONCERTAdrugstructuredosagenumb54drugstructuredosageunit003drugdosagetext54 MG, UNKactiondrug4

activesubstance

activesubstancenameMETHYLPHENIDATE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021121Brand NameCONCERTAGeneric NameMETHYLPHENIDATE HYDROCHLORIDEManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-585, 50458-588, 50458-586, 50458-587Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETHYLPHENIDATE HYDROCHLORIDERXCUI1091155, 1091157, 1091170, 1091172, 1091185, 1091187, 1091210, 1091212spl_ide07a69ac-3422-4eac-8a0e-bd720a91d991spl_set_id1a88218c-5b18-4220-8f56-526de1a276cdPackage NDC50458-585-01, 50458-588-01, 50458-586-01, 50458-587-01UNII4B3SC438HI

8)

drugcharacterization1medicinalproductCYMBALTAdrugbatchnumbA297158drugauthorizationnumb38838drugstructuredosagenumb60drugstructuredosageunit003drugdosagetext60 MG, UNKdrugdosageformCAPSULEdrugindicationANXIETYactiondrug4

activesubstance

activesubstancenameDULOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021427Brand NameCYMBALTAGeneric NameDULOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3235, 0002-3240, 0002-3270Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDULOXETINE HYDROCHLORIDERXCUI596926, 596928, 596930, 596932, 596934, 615186spl_id892f05de-dd11-4ae3-9a85-ce9cfcbeaaccspl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

9)

drugcharacterization2medicinalproductSYNTHROIDactiondrug4

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM

openFDA Info on Medication

Application NumberNDA021402Brand NameSYNTHROIDGeneric NameLEVOTHYROXINE SODIUMManufacturersAbbVie Inc.product_ndc 0074-3727, 0074-7149, 0074-4341, 0074-4552, 0074-5182, 0074-6624, 0074-6594, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, ... spl_ided6f6960-2439-4bb0-bb7f-c7d05e4d37a5spl_set_id1e11ad30-1041-4520-10b0-8f9d30d30fccPackage NDC 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341- ... UNII9J765S329G

10)

drugcharacterization2medicinalproductGUAIFENESIN.drugindicationSINUSITISactiondrug4

activesubstance

activesubstancenameGUAIFENESIN

openFDA Info on Medication

Application Number part341, ANDA207342, ANDA209215, ANDA213420, ANDA210453, NDA021282, ANDA091009, ... Brand Name SIMPEX GUAIFENESIN, MUCUS RELIEF, GOOD NEIGHBOR PHARMACY TABTUSSIN, MUCUS RELIEF ... Generic NameGUAIFENESINManufacturers Simpex Pharma Pvt. Ltd, Strategic Sourcing Services LLC, AmerisourceBergen Drug ... product_ndc 76457-004, 70677-0049, 46122-057, 55301-532, 10956-002, 41520-731, 68163-743, 05 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDERXCUI 359601, 636522, 310604, 213160, 310621, 197741, 198687, 310625, 891301, 1112205, ... spl_id 7d870204-c1ad-fa24-e053-2a91aa0a2be6, 9148996d-3708-4b7f-a08c-f5abdf2ab624, 31a9 ... spl_set_id 1594f9d6-0c48-42bf-b76b-d621f215179a, 2200cd7d-3611-4413-9ce3-91fdac9c76c2, 3cab ... Package NDC 76457-004-00, 70677-0049-1, 46122-057-62, 55301-532-11, 10956-002-60, 41520-731- ... NUIN0000193956, N0000008867, N0000009560Established Pharmacologic ClassExpectorant [EPC]Physiologic/Pharmacodynamic Effect Decreased Respiratory Secretion Viscosity [PE], Increased Respiratory Secretions ... UNII495W7451VQ, 9D2RTI9KYH

11)

drugcharacterization2medicinalproductPHENYLEPHRINEdrugindicationSINUSITISactiondrug4

activesubstance

activesubstancenamePHENYLEPHRINE\PHENYLEPHRINE HYDROCHLORIDE

openFDA Info on Medication

Application Numberpart341Brand NameNORTH SINUS DECONGESTANT, SINUS DECONGESTANT, XPECT DECONGESTANTGeneric NamePHENYLEPHRINEManufacturersHoneywell Safety Products USA, Inc, Cintas Corporationproduct_ndc0498-3330, 0498-3331, 42961-205Product TypeHUMAN OTC DRUGRouteORALActive IngredientsPHENYLEPHRINE HYDROCHLORIDERXCUI1299145spl_idd2ba32dd-deb9-3da8-e053-2a95a90aae78, 046f772b-67c1-4363-aaf5-cb6868d8f48aspl_set_id3314b12f-78a0-47d7-91b9-56289179bfe2, 11077704-936c-4e1a-b9d9-8d4cc2ec1b94Package NDC 0498-3330-10, 0498-3330-25, 0498-3330-50, 0498-3331-10, 0498-3331-25, 0498-3331- ... UNII04JA59TNSJ

12)

drugcharacterization2medicinalproductSOMAdrugstructuredosagenumb350drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext350 MG, 2/Dactiondrug4

activesubstance

activesubstancenameCARISOPRODOL

openFDA Info on Medication

Application NumberNDA011792Brand NameSOMAGeneric NameCARISOPRODOLManufacturersMeda Pharmaceuticalsproduct_ndc0037-2001, 0037-2250Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCARISOPRODOLRXCUI197446, 213695, 730794, 730918spl_idf1040579-1917-4488-9df8-ca3424ebd03bspl_set_id6297cf20-830a-11dc-94c8-0002a5d5c51bPackage NDC0037-2250-10, 0037-2250-30, 0037-2001-01NUIN0000175730, N0000175737Physiologic/Pharmacodynamic EffectCentrally-mediated Muscle Relaxation [PE]Established Pharmacologic ClassMuscle Relaxant [EPC]UNII21925K482H

13)

drugcharacterization2medicinalproductDEMEROLdrugstructuredosagenumb75drugstructuredosageunit003drugdosagetext75 MG, UNKdrugindicationPAINactiondrug4

activesubstance

activesubstancenameMEPERIDINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021171, NDA005010Brand NameDEMEROLGeneric NameMEPERIDINE HYDROCHLORIDEManufacturersHospira, Inc., Validus Pharmaceuticals LLCproduct_ndc 0409-1176, 0409-1178, 0409-1179, 0409-1180, 0409-1181, 0409-1201, 0409-1362, 040 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, ORALActive IngredientsMEPERIDINE HYDROCHLORIDEspl_ida2ee3fbb-43db-474a-9963-f1f7b4545ed9, 8b04c129-63c0-422c-88a7-265d1fb6d579spl_set_idb31d1308-28c3-43f4-e0a6-2f3ed76b8975, 5cb2674c-a70d-4022-9188-3f711cccff5ePackage NDC 0409-1176-03, 0409-1176-30, 0409-1178-03, 0409-1178-30, 0409-1179-03, 0409-1179- ... UNIIN8E7F7Q170RXCUI861455, 861467, 861517, 861525

14)

drugcharacterization2medicinalproductPROPANOLOLdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, 3/Dactiondrug4

activesubstance

activesubstancenamePROPRANOLOL HYDROCHLORIDE

15)

drugcharacterization2medicinalproductPHENERGANdrugdosagetextUNK MG, AS NEEDEDdrugindicationNAUSEAactiondrug4

activesubstance

activesubstancenamePROMETHAZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA083312Brand NamePHENERGANGeneric NamePROMETHAZINE HYDROCHLORIDEManufacturersWest-Ward Pharmaceuticals Corp., Hikma Pharmaceuticals USA Inc.product_ndc0641-6082, 0641-6083, 0641-6084, 0641-6085Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUSActive IngredientsPROMETHAZINE HYDROCHLORIDERXCUI992460, 992462, 992858, 992876spl_ided9c544d-8e03-45cb-8509-b71b630d764d, bc2d8f01-1268-4bb2-8db9-793866d32782spl_set_id6f7e47cc-f823-4336-8107-f980e3049617, 481866da-a712-48a5-853f-8e84aacaab6dPackage NDC 0641-6082-01, 0641-6082-25, 0641-6083-01, 0641-6083-25, 0641-6084-01, 0641-6084- ... UNIIR61ZEH7I1I

16)

drugcharacterization2medicinalproductZYRTECdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKactiondrug4

activesubstance

activesubstancenameCETIRIZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022429, NDA021621Brand NameZYRTECGeneric NameCETIRIZINE HYDROCHLORIDEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-779, 50580-753Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCETIRIZINE HYDROCHLORIDERXCUI1014675, 1020023, 1014674, 1020022spl_idcea20e63-c9ab-38c7-e053-2995a90adebe, dfe981c1-d2ce-2fbc-e053-2995a90ab14fspl_set_id605adf29-734f-451a-8ff3-74be7b5814a6, dc613bd5-70fd-1d9b-e053-2995a90a41cdPackage NDC50580-779-12, 50580-779-25, 50580-779-40, 50580-779-65, 50580-753-24UNII64O047KTOA

17)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugdosagetext3 MG, UNKactiondrug4

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

18)

drugcharacterization2medicinalproductLYRICAdrugstructuredosagenumb75drugstructuredosageunit003drugdosagetext75 MG, UNKdrugindicationPAIN IN EXTREMITYactiondrug4

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

Application NumberNDA021446, NDA022488Brand NameLYRICAGeneric NamePREGABALINManufacturersParke-Davis Div of Pfizer Inc, U.S. Pharmaceuticalsproduct_ndc 0071-1012, 0071-1013, 0071-1014, 0071-1015, 0071-1016, 0071-1017, 0071-1019, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 607018, 607020, ... spl_idb9b1285a-2cb3-4789-8b0e-8d5e1b253534, bfdec19d-6a54-449c-95b4-908d28e5369aspl_set_id60185c88-ecfd-46f9-adb9-b97c6b00a553, ce1a4b9d-3127-4416-8bf2-fee5899fc0baPackage NDC 0071-1012-68, 0071-1013-41, 0071-1013-68, 0071-1014-41, 0071-1014-68, 0071-1015- ... UNII55JG375S6M

summary

narrativeincludeclinicalCASE EVENT DATE: 200705