Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID13225152primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate28/04/2017reporttype1serious2receivedateformat102Date Received13/02/2017receiptdateformat102Date Last Updated13/02/2017fulfillexpeditecriteria2companynumbUS-ASTRAZENECA-2017SE12741duplicate1

Report Duplicate

duplicatesourceASTRAZENECAduplicatenumbUS-ASTRAZENECA-2017SE12741

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age22040Unit of Onset AgedaysWeight59SexMale

Reaction

1)

reactionmeddraversionpt19.1ReactionAbnormal faecesOutcomeUnknown

2)

reactionmeddraversionpt19.1ReactionNervousnessOutcomeUnknown

3)

reactionmeddraversionpt19.1ReactionDrug screen positiveOutcomeUnknown

4)

reactionmeddraversionpt19.1ReactionMemory impairmentOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductAMBIEN

activesubstance

activesubstancenameZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberNDA021774, NDA019908Brand NameAMBIEN CR, AMBIENGeneric NameZOLPIDEM TARTRATEManufacturerssanofi-aventis U.S. LLCproduct_ndc0024-5501, 0024-5521, 0024-5401, 0024-5421Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854880, 854882, 854894, 854896, 854873, 854875, 854876, 854878spl_id8138a0a9-168c-46d2-b13e-e7e84f27eaee, c8f05d12-bc35-43cb-8b65-588bec02c73dspl_set_id404c858c-89ac-4c9d-8a96-8702a28e6e76, c36cadf4-65a4-4466-b409-c82020b42452Package NDC 0024-5501-31, 0024-5501-10, 0024-5521-31, 0024-5521-50, 0024-5521-10, 0024-5401- ... UNIIWY6W63843K

2)

drugcharacterization2medicinalproductMETOPROLOL TARTRATE.drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationCARDIAC DISORDER

activesubstance

activesubstancenameMETOPROLOL TARTRATE

openFDA Info on Medication

Application Number ANDA204205, ANDA077761, ANDA078085, ANDA077739, ANDA078950, ANDA074644, ANDA0766 ... Brand NameMETOPROLOL TARTRATE, METOPROLOL, LOPRESSORGeneric NameMETOPROLOL TARTRATE, METOROPROLOL TARTRATE, METOPROLOLManufacturers Almaject, Inc., Hikma Pharmaceuticals USA Inc., Hospira, Inc., FOSUN PHARMA USA ... product_ndc 72611-740, 0143-9660, 0143-9873, 0409-2016, 72266-122, 57237-100, 57237-101, 572 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsMETOPROLOL TARTRATERXCUI866508, 866511, 866514, 866924, 1606347, 1606349, 866513, 866516spl_id 9918066c-3783-f604-32f1-745887f1e767, 5e67823e-d4f6-4495-ae17-12b075244380, 0dad ... spl_set_id f0370951-ab26-d4d1-b857-57518f3c4175, c7ec36bb-bc6f-42de-9974-a50ac13e9410, f65e ... Package NDC 72611-740-01, 72611-740-10, 0143-9873-10, 0143-9873-25, 0143-9660-01, 0143-9660- ... UNIIW5S57Y3A5L

3)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugdosagetext3.0MG AS REQUIREDdrugadministrationroute048drugindicationSLEEP DISORDER

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

4)

drugcharacterization2medicinalproductFENTANYL TRANSDERMAL SYSTEMdrugstructuredosagenumb100drugstructuredosageunit004drugindicationPAIN

activesubstance

activesubstancenameFENTANYL

openFDA Info on Medication

5)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationDEPRESSION

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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 f8a443ce-38d2-4184-ac36-7954fbae84d3, f35de481-61af-428e-abb4-a267238b3959, 7d81 ... 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

6)

drugcharacterization2medicinalproductWARFARIN

activesubstance

activesubstancenameWARFARIN

openFDA Info on Medication

Application NumberANDA090935, ANDA202202Brand NameWARFARIN SODIUMGeneric NameWARFARINManufacturersExelan Pharmaceuticals Inc., Amneal Pharmaceuticals LLCproduct_ndc 76282-327, 76282-328, 76282-329, 76282-330, 76282-331, 76282-332, 76282-333, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsWARFARIN SODIUMRXCUI855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 855344spl_id45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5, 02a5640e-a453-4463-976c-34d448423071spl_set_idc0cc4511-e656-4b6d-96cd-e02e76173b9d, 558b7a0d-5490-4c1b-802e-3ab3f1efe760Package NDC 76282-327-01, 76282-327-10, 76282-328-01, 76282-328-10, 76282-329-01, 76282-329- ... UNII6153CWM0CL

7)

drugcharacterization2medicinalproductOXYMORPHONEdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10.0MG AS REQUIREDdrugadministrationroute048drugindicationPAINdrugstartdateformat602drugstartdate//2016

activesubstance

activesubstancenameOXYMORPHONE

8)

drugcharacterization2medicinalproductDIAZEPAM.drugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10.0MG AS REQUIREDdrugadministrationroute048drugindicationMUSCLE SPASMSdrugstartdateformat602drugstartdate//2012

activesubstance

activesubstancenameDIAZEPAM

openFDA Info on Medication

Application Number ANDA072079, NDA020124, ANDA210363, NDA020648, NDA211635, NDA013263, ANDA071583, ... Brand NameDIAZEPAM, DIASTAT, VALTOCO, VALIUMGeneric NameDIAZEPAMManufacturers Hospira, Inc., Meridian Medical Technologies LLC, Dash Pharmaceuticals LLC, Baus ... product_ndc 0409-1273, 11704-600, 69339-136, 66490-650, 68682-650, 68682-652, 68682-655, 722 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, RECTAL, NASAL, ORALActive IngredientsDIAZEPAMRXCUI 1807459, 1807452, 2120550, 801957, 801958, 801961, 801966, 2272613, 2272619, 227 ... spl_id 14233fc1-606a-4e78-8da4-df9eedb1c793, 512dee3e-2c4c-4436-b92b-67113989cca5, 5b08 ... spl_set_id 41044928-dd1f-40bf-1fa6-709dff559124, fa352464-14c8-49e9-b8b7-5a968b1cfa93, 6b8d ... Package NDC 0409-1273-03, 0409-1273-32, 11704-600-01, 69339-136-02, 69339-136-32, 69339-136- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

9)

drugcharacterization2medicinalproductBUPROPION.drugstructuredosagenumb150drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationDEPRESSION

activesubstance

activesubstancenameBUPROPION

openFDA Info on Medication

Application NumberANDA202304, ANDA201567Brand NameBUPROPIONGeneric NameBUPROPION HYDROCHLORIDE, BUPROPIONManufacturers Solco Healthcare US LLC, Zydus Pharmaceuticals (USA) Inc., Cadila Healthcare Lim ... product_ndc43547-288, 43547-289, 43547-290, 68382-353, 68382-354, 65841-780, 65841-836Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUPROPION HYDROCHLORIDERXCUI993503, 993518, 993536, 993541, 993557spl_id 1e71f995-cdb3-43e5-a181-1121c54df18d, 87110421-ed0b-479f-9f4b-2f421e8ebe6c, b789 ... spl_set_id 39b2d509-1281-4464-9cf1-a94bbc18b84b, 8d937ca3-3351-40f1-8192-348ba0c68162, 78d3 ... Package NDC 43547-288-06, 43547-288-09, 43547-288-10, 43547-288-50, 43547-289-06, 43547-289- ... UNIIZG7E5POY8O

10)

drugcharacterization2medicinalproductXARELTOdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationBLOOD DISORDERdrugstartdateformat602drugstartdate//2016

activesubstance

activesubstancenameRIVAROXABAN

openFDA Info on Medication

Application NumberNDA215859, NDA022406Brand NameXARELTOGeneric NameRIVAROXABANManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-575, 50458-577, 50458-580, 50458-578, 50458-579, 50458-584Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRIVAROXABANRXCUI 1114198, 1114202, 1232082, 1232084, 1232086, 1232088, 1549682, 1549683, 2059015, ... spl_idabfa2b94-8108-11eb-814c-12fffb2ca371spl_set_id10db92f9-2300-4a80-836b-673e1ae91610Package NDC 50458-577-60, 50458-577-18, 50458-577-14, 50458-577-01, 50458-577-10, 50458-580- ... NUIN0000175635, N0000175637Mechanism of ActionFactor Xa Inhibitors [MoA]Established Pharmacologic ClassFactor Xa Inhibitor [EPC]UNII9NDF7JZ4M3

11)

drugcharacterization2medicinalproductMODAFENILdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationSOMNOLENCE

12)

drugcharacterization2medicinalproductANDRODERM PATCHdrugstructuredosagenumb4drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationBLOOD TESTOSTERONE DECREASED

13)

drugcharacterization1medicinalproductMOVANTIKdrugbatchnumbFAAFdrugauthorizationnumb204760drugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb9900drugcumulativedosageunit003drugdosageformTABLETdrugadministrationroute048drugindicationCONSTIPATIONdrugstartdateformat610drugstartdate/09/2015actiondrug4

activesubstance

activesubstancenameNALOXEGOL OXALATE

openFDA Info on Medication

Application NumberNDA204760Brand NameMOVANTIKGeneric NameNALOXEGOL OXALATEManufacturersRedHill Biopharma Ltd, AstraZeneca Pharmaceuticals LPproduct_ndc57841-1300, 57841-1301, 0310-1969, 0310-1970Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNALOXEGOL OXALATERXCUI1551782, 1551917, 1551923, 1601373spl_id553fc1b8-3efa-4fd9-8faa-b52deaa0e97f, ffc5b181-ff54-4ad6-b6d5-793ac052041fspl_set_id300a6474-ebcd-4404-8040-48fdcfcc1635, f49c6978-ca7b-4a66-919b-757f8f92ef64Package NDC 57841-1300-1, 57841-1300-2, 57841-1300-3, 57841-1300-4, 57841-1301-1, 57841-1301 ... UNII65I14TNM33

14)

drugcharacterization2medicinalproductHYDROMORPHONE

activesubstance

activesubstancenameHYDROMORPHONE

summary

narrativeincludeclinicalCASE EVENT DATE: 20161013