Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10682415primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate29/05/2015reporttype1serious1seriousnesshospitalization1seriousnessother1receivedateformat102Date Received30/12/2014receiptdateformat102Date Last Updated30/12/2014fulfillexpeditecriteria2companynumbUS-TEVA-472939USAduplicate1

Report Duplicate

duplicatesourceTEVAduplicatenumbUS-TEVA-472939USA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age67Unit of Onset AgeyearsWeight83.54SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionParanoiaOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionAnxietyOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionSuicidal ideationOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionDelusionOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionDepressionOutcomeUnknown

6)

reactionmeddraversionpt18.0ReactionPanic attackOutcomeUnknown

7)

reactionmeddraversionpt18.0ReactionConfusional stateOutcomeUnknown

8)

reactionmeddraversionpt18.0ReactionInsomniaOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugstartdateformat102drugstartdate20/02/2014drugenddateformat102drugenddate21/02/2014actiondrug1

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

2)

drugcharacterization2medicinalproductATORVASTATIN

activesubstance

activesubstancenameATORVASTATIN

openFDA Info on Medication

3)

drugcharacterization2medicinalproductFISH OIL

activesubstance

activesubstancenameFISH OIL

openFDA Info on Medication

Application NumberNDA210589Brand NameOMEGAVENGeneric NameFISH OILManufacturersFresenius Kabi USA, LLCproduct_ndc63323-205Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsFISH OILRXCUI2053499, 2053504, 2053513, 2053514spl_idc4f460d5-da90-4b9b-aff1-df3176a43d47spl_set_id5d9d0b24-e139-48bf-ab2d-536fb59cf8e0Package NDC63323-205-21, 63323-205-50, 63323-205-31, 63323-205-00UNIIXGF7L72M0F

4)

drugcharacterization2medicinalproductFLOMAX

activesubstance

activesubstancenameTAMSULOSIN HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020579Brand NameFLOMAXGeneric NameTAMSULOSIN HYDROCHLORIDEManufacturerssanofi-aventis U.S. LLCproduct_ndc0024-5837Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTAMSULOSIN HYDROCHLORIDERXCUI863669, 863671spl_iddb1b29b8-fb5c-42ff-a093-cc5001e6ad6fspl_set_id6771ad8e-ac92-4aec-b484-5d8350a353f8Package NDC0024-5837-01UNII11SV1951MR

5)

drugcharacterization1medicinalproductTRAZODONEdrugauthorizationnumb071523drugstructuredosagenumb50drugstructuredosageunit003drugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate21/02/2014actiondrug4

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

openFDA Info on Medication

6)

drugcharacterization1medicinalproductLUNESTAdrugstructuredosagenumb2drugstructuredosageunit003drugindicationINSOMNIAdrugstartdateformat102drugstartdate12/02/2014drugenddateformat102drugenddate19/02/2014actiondrug1

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

7)

drugcharacterization2medicinalproductLISINOPRIL.

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20140305