Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11866583primarysourcecountryJPoccurcountryJPtransmissiondateformat102transmissiondate05/03/2016reporttype1serious1seriousnesshospitalization1receivedateformat102Date Received24/12/2015receiptdateformat102Date Last Updated24/12/2015fulfillexpeditecriteria1companynumbJP-ROCHE-1682773duplicate1

Report Duplicate

duplicatesourceROCHEduplicatenumbJP-ROCHE-1682773

Primary Source

reportercountryJPqualification2

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age65Unit of Onset AgeyearsWeight36SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionNasopharyngitisOutcomeUnknown

2)

reactionmeddraversionpt18.1ReactionAcute kidney injuryOutcomeUnknown

3)

reactionmeddraversionpt18.1ReactionHypercalcaemiaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductEDIROLdrugstructuredosagenumb.75drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute048drugindicationOSTEOPOROSISdrugstartdateformat610drugstartdate/06/2012actiondrug1

activesubstance

activesubstancenameELDECALCITOL

2)

drugcharacterization2medicinalproductURSOdrugdosagetextDOSAGE IS UNCERTAIN.drugadministrationroute048

activesubstance

activesubstancenameURSODIOL

3)

drugcharacterization2medicinalproductALLOPURINOL.drugdosagetextDOSAGE IS UNCERTAIN.drugadministrationroute048

activesubstance

activesubstancenameALLOPURINOL

openFDA Info on Medication

Application Number NDA020298, ANDA203154, ANDA212363, ANDA071450, ANDA204467, NDA018832, NDA018877, ... Brand NameALOPRIM, ALLOPURINOL, ZYLOPRIMGeneric NameALLOPURINOLManufacturers Mylan Institutional LLC, Accord Healthcare Inc., Gland Pharma Limited, Sun Pharm ... product_ndc 67457-978, 16729-134, 16729-135, 68083-380, 53489-156, 53489-157, 23155-693, 231 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsALLOPURINOL SODIUM, ALLOPURINOLRXCUI252931, 261265, 197319, 197320, 213995, 213998spl_id 2acff21e-7d8f-4b03-b7b7-9400f54f66ac, d10d00c1-a0d9-6fd8-e053-2a95a90a588a, 6a0e ... spl_set_id 018525b1-e37d-4ff2-9dc3-36b3d90ac3e0, 682dd8b8-fc6e-47c5-95b7-82d7ad96b750, 4839 ... Package NDC 67457-978-50, 16729-134-10, 16729-134-01, 16729-134-16, 16729-134-17, 16729-135- ... UNII428673RC2Z, 63CZ7GJN5INUIN0000175698, N0000000206Established Pharmacologic ClassXanthine Oxidase Inhibitor [EPC]Mechanism of ActionXanthine Oxidase Inhibitors [MoA]

4)

drugcharacterization2medicinalproductBIOFERMINdrugdosagetextDOSAGE IS UNCERTAIN.drugadministrationroute048

activesubstance

activesubstancenameBACILLUS SUBTILIS\LACTOBACILLUS ACIDOPHILUS\STREPTOCOCCUS FAECAIS

5)

drugcharacterization2medicinalproductLUNESTAdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextAMOUNT OF 1 ONCE ADMINISTRATION: 2 (UNIT UNCERTAINTY)drugadministrationroute048

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

6)

drugcharacterization2medicinalproductDEXALTINdrugdosagetextDOSAGE IS UNCERTAIN.drugadministrationroute048

activesubstance

activesubstancenameDEXAMETHASONE

7)

drugcharacterization2medicinalproductGASTERdrugdosagetextDOSAGE IS UNCERTAIN.drugadministrationroute048

activesubstance

activesubstancenameFAMOTIDINE

8)

drugcharacterization2medicinalproductCRESTORdrugdosagetextDOSAGE IS UNCERTAIN.drugadministrationroute048

activesubstance

activesubstancenameROSUVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA021366Brand NameCRESTORGeneric NameROSUVASTATIN CALCIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0310-7560, 0310-7570, 0310-7580, 0310-7590, 0310-0751, 0310-0755, 0310-0752, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsROSUVASTATIN CALCIUMRXCUI859419, 859421, 859424, 859426, 859747, 859749, 859751, 859753spl_id08039402-2a60-4599-83b5-1c63b85ead70, d9298e4d-e35f-4ba4-9fdf-1a8d0358707fspl_set_id325a5d0e-9a72-4015-9fcd-1655fb504cee, bb0f3b5e-4bc6-41c9-66b9-6257e2513512Package NDC 0310-7560-90, 0310-7570-90, 0310-7580-90, 0310-7590-30, 0310-0755-90, 0310-0751- ... UNII83MVU38M7Q

9)

drugcharacterization2medicinalproductOZEX (JAPAN)drugdosagetextDOSAGE IS UNCERTAIN.drugadministrationroute048

activesubstance

activesubstancenameTOSUFLOXACIN TOSYLATE

10)

drugcharacterization2medicinalproductDEPASdrugdosagetextDOSAGE IS UNCERTAIN.drugadministrationroute048

activesubstance

activesubstancenameETIZOLAM

11)

drugcharacterization2medicinalproductSULPIRIDEdrugdosagetextDOSAGE IS UNCERTAIN.drugadministrationroute048

activesubstance

activesubstancenameSULPIRIDE

12)

drugcharacterization1medicinalproductBONVIVAdrugauthorizationnumb021858drugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition802drugdosageformSOLUTION FOR INJECTIONdrugadministrationroute042drugindicationOSTEOPOROSISdrugstartdateformat610drugstartdate/06/2015actiondrug1

activesubstance

activesubstancenameIBANDRONATE SODIUM

13)

drugcharacterization2medicinalproductKREMEZINdrugdosagetextDOSAGE IS UNCERTAIN.drugadministrationroute048

activesubstance

activesubstancenameACTIVATED CHARCOAL

summary

narrativeincludeclinicalCASE EVENT DATE: 2015