Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-ASTRAZENECA-2013SE76740occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10172378Date Received15/05/2014transmissiondate12/12/2014serious2Date Last Updated15/05/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age889Unit of Onset AgemonthsWeight81.6SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionTerminal insomniaOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionNauseaOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionSleep disorderOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionAbdominal discomfortOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionAbdominal discomfortOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductZOLADEXdrugauthorizationnumb020578drugstructuredosagenumb10.8drugstructuredosageunit003drugdosageformIMPLANTdrugadministrationroute058drugindicationPROSTATE CANCERdrugstartdateformat102drugstartdate07/10/2013actiondrug4

openFDA Info on Medication

Application NumberNDA019726, NDA020578Brand NameZOLADEXGeneric NameGOSERELIN ACETATEManufacturersTerSera Therapeutics LLCproduct_ndc70720-950, 70720-951Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsGOSERELIN ACETATERXCUI105641, 310592, 211544, 314008spl_id9d516046-20e4-44b2-bb48-ff0778f56dca, 0e4036b4-e4a4-4dc9-891c-dc11802c6ea7spl_set_id294b168b-6e5f-4db9-bf70-d599271458b3, e4cb3c20-2738-400a-b522-3f36f71fe6c5Package NDC70720-950-36, 70720-951-30UNII6YUU2PV0U8

2)

drugcharacterization1medicinalproductLISINOPRILdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationHYPERTENSIONactiondrug4

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

3)

drugcharacterization2medicinalproductAVADARTdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationBENIGN PROSTATIC HYPERPLASIA

4)

drugcharacterization2medicinalproductFLOMAXdrugstructuredosagenumb.4drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationBENIGN PROSTATIC HYPERPLASIA

openFDA Info on Medication

Application NumberNDA020579Brand NameFLOMAXGeneric NameTAMSULOSIN HYDROCHLORIDEManufacturersBoehringer Ingelheim Pharmaceuticals, Inc., sanofi-aventis U.S. LLCproduct_ndc0597-0058, 0024-5837Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTAMSULOSIN HYDROCHLORIDERXCUI863669, 863671spl_id0bb39eda-fe6f-e454-727f-1ba3cbf9cf4d, db1b29b8-fb5c-42ff-a093-cc5001e6ad6fspl_set_idc00d5f7b-dad7-4479-aae2-fea7c0db40ed, 6771ad8e-ac92-4aec-b484-5d8350a353f8Package NDC0597-0058-01, 0024-5837-01UNII11SV1951MR

5)

drugcharacterization2medicinalproductTRAZADONEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationSLEEP DISORDER

6)

drugcharacterization2medicinalproductTRAZADONEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationANXIETY

7)

drugcharacterization2medicinalproductTRAZADONEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationDEPRESSION

8)

drugcharacterization2medicinalproductWHEY PROTEIN POWDERdrugdosagetext1 SCOOP DAILYdrugadministrationroute048drugindicationSUPPLEMENTATION THERAPY

9)

drugcharacterization2medicinalproductMAGNESIUM CARBINATEdrugstructuredosagenumb375drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationCONSTIPATION

10)

drugcharacterization2medicinalproductCALCIUM CIIRATEdrugstructuredosagenumb420drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationMINERAL SUPPLEMENTATION

11)

drugcharacterization2medicinalproductCALCIUM CIIRATEdrugstructuredosagenumb420drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationMUSCLE SPASMS

12)

drugcharacterization2medicinalproductASPIRINdrugstructuredosagenumb81drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048

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

13)

drugcharacterization2medicinalproductMELATONINdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationSLEEP DISORDER

openFDA Info on Medication

Brand NameMELATONIN, MELATONIN CORDGeneric NameMELATONINManufacturersBioActive Nutritional, Inc., Deseret Biologicals, Inc., Energique, Inc.product_ndc43857-0086, 43742-0205, 44911-0194, 43742-0771Product TypeHUMAN OTC DRUGRouteORALActive IngredientsMELATONINspl_id e189499d-9da3-43fc-8a0b-9d5dd0923b11, a02d2040-67c7-40d6-8725-f774db2408c4, 51e3 ... spl_set_id cd82eb5d-a44a-4512-ad65-0fffae70d1d0, bb074765-ca7c-4c30-bd6f-b2292f0abb96, 9a59 ... Package NDC43857-0086-1, 43742-0205-1, 44911-0194-1, 43742-0771-1UNIIJL5DK93RCL

14)

drugcharacterization2medicinalproductZOLOFT

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

15)

drugcharacterization2medicinalproductPEPCID

openFDA Info on Medication

Application NumberNDA019527, ANDA075805Brand NamePEPCIDGeneric NameFAMOTIDINEManufacturersSalix Pharmaceuticals, Inc, Bausch Health Americas Inc.product_ndc65649-211, 0187-4420, 0187-4440Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFAMOTIDINERXCUI206873, 310274, 104094, 104095, 284245, 310273spl_id9e8f6a6d-4f04-4201-8d8e-802f08125adc, 117ab388-f0c2-4d9b-9cd0-1b7c478a665cspl_set_id4f1a0b58-f7c8-485e-a317-432e1c374d2f, a06502d9-7903-4f37-833e-e5763d502defPackage NDC65649-211-24, 0187-4420-30, 0187-4420-10, 0187-4440-30, 0187-4440-10NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]UNII5QZO15J2Z8

16)

drugcharacterization2medicinalproductDOMPERIDONE

17)

drugcharacterization2medicinalproductLIBRIUM

Report Duplicate

duplicatesourceASTRAZENECAduplicatenumbUS-ASTRAZENECA-2013SE76740