Adverse Event Report

Report

reporttype1Version of Safety Report ID10receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10157307serious1Date Last Updated28/06/2019seriousnesslifethreatening1receiptdateformat102companynumbUS-DSJP-DSU-2014-00120occurcountryUSseriousnessother1duplicate1Date Received07/05/2014seriousnesshospitalization1transmissiondate11/07/2019primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Reaction

1)

reactionmeddraversionpt22.0ReactionRenal cystOutcomeUnknown

2)

reactionmeddraversionpt22.0ReactionDecubitus ulcerOutcomeRecovering/resolving

3)

reactionmeddraversionpt22.0ReactionInsomniaOutcomeRecovering/resolving

4)

reactionmeddraversionpt22.0ReactionGastric polypsOutcomeRecovered/resolved

5)

reactionmeddraversionpt22.0ReactionArthropathyOutcomeUnknown

6)

reactionmeddraversionpt22.0ReactionNeuropathy peripheralOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt22.0ReactionChronic kidney diseaseOutcomeRecovering/resolving

8)

reactionmeddraversionpt22.0ReactionDepressionOutcomeRecovering/resolving

9)

reactionmeddraversionpt22.0ReactionFallOutcomeUnknown

10)

reactionmeddraversionpt22.0ReactionBacteraemiaOutcomeRecovering/resolving

11)

reactionmeddraversionpt22.0ReactionSeptic embolusOutcomeRecovering/resolving

12)

reactionmeddraversionpt22.0ReactionUrinary tract infectionOutcomeRecovered/resolved

13)

reactionmeddraversionpt22.0ReactionCytomegalovirus colitisOutcomeRecovering/resolving

14)

reactionmeddraversionpt22.0ReactionLarge intestinal ulcerOutcomeRecovering/resolving

15)

reactionmeddraversionpt22.0ReactionGastrooesophageal reflux diseaseOutcomeRecovering/resolving

16)

reactionmeddraversionpt22.0ReactionHiatus herniaOutcomeUnknown

17)

reactionmeddraversionpt22.0ReactionIritisOutcomeRecovering/resolving

18)

reactionmeddraversionpt22.0ReactionGeneralised oedemaOutcomeUnknown

19)

reactionmeddraversionpt22.0ReactionGastrointestinal bacterial overgrowthOutcomeUnknown

20)

reactionmeddraversionpt22.0ReactionAcute kidney injuryOutcomeRecovered/resolved

21)

reactionmeddraversionpt22.0ReactionSprue-like enteropathyOutcomeRecovering/resolving

22)

reactionmeddraversionpt22.0ReactionDiabetes mellitusOutcomeUnknown

23)

reactionmeddraversionpt22.0ReactionAlopeciaOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, QDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

2)

drugcharacterization1medicinalproductAZORdrugauthorizationnumb022100drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10/20 MG, QDdrugdosageformTABLETdrugadministrationroute048drugindicationHYPERTENSIONdrugstartdateformat610drugstartdate/01/2008drugenddateformat610drugenddate/05/2010actiondrug1drugadditional1

activesubstance

activesubstancenameAMLODIPINE BESYLATE\OLMESARTAN MEDOXOMIL

openFDA Info on Medication

Application NumberNDA022100Brand NameAZORGeneric NameAMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMILManufacturersDaiichi Sankyo Inc.product_ndc65597-110, 65597-111, 65597-112, 65597-113Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BESYLATE, OLMESARTAN MEDOXOMILRXCUI730861, 730866, 730869, 730872, 744624, 744628, 744632, 744636spl_idb69a20a4-4b6b-46f4-8a44-8c628108d6adspl_set_idf48911e0-705f-11dc-afc9-0002a5d5c51bPackage NDC 65597-110-10, 65597-110-07, 65597-110-11, 65597-110-30, 65597-110-90, 65597-111- ... UNII864V2Q084H, 6M97XTV3HD

3)

drugcharacterization1medicinalproductBENICARdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, SINGLEdrugdosageformTABLETdrugadministrationroute048drugindicationHYPERTENSIONdrugenddateformat102drugenddate24/06/2010actiondrug1drugadditional1

activesubstance

activesubstancenameOLMESARTAN MEDOXOMIL

openFDA Info on Medication

Application NumberNDA021286Brand NameBENICARGeneric NameOLMESARTAN MEDOXOMILManufacturersDaiichi Sankyo Inc.product_ndc65597-101, 65597-103, 65597-104Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOLMESARTAN MEDOXOMILRXCUI349373, 349401, 349405, 352199, 352200, 352201spl_id656da9a1-3db2-4667-97dd-37eb061a037espl_set_id33770d80-754f-11de-8dba-0002a5d5c51bPackage NDC 65597-101-30, 65597-103-03, 65597-103-06, 65597-103-10, 65597-103-30, 65597-103- ... UNII6M97XTV3HD

4)

drugcharacterization1medicinalproductAZORdrugauthorizationnumb022100drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10/40 MG, QDdrugdosageformTABLETdrugstartdateformat610drugstartdate/05/2010drugenddateformat102drugenddate30/07/2010actiondrug1drugadditional1

activesubstance

activesubstancenameAMLODIPINE BESYLATE\OLMESARTAN MEDOXOMIL

openFDA Info on Medication

Application NumberNDA022100Brand NameAZORGeneric NameAMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMILManufacturersDaiichi Sankyo Inc.product_ndc65597-110, 65597-111, 65597-112, 65597-113Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BESYLATE, OLMESARTAN MEDOXOMILRXCUI730861, 730866, 730869, 730872, 744624, 744628, 744632, 744636spl_idb69a20a4-4b6b-46f4-8a44-8c628108d6adspl_set_idf48911e0-705f-11dc-afc9-0002a5d5c51bPackage NDC 65597-110-10, 65597-110-07, 65597-110-11, 65597-110-30, 65597-110-90, 65597-111- ... UNII864V2Q084H, 6M97XTV3HD

5)

drugcharacterization2medicinalproductCENTRUM SILVER /01292501/drugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameMINERALS\VITAMINS

6)

drugcharacterization2medicinalproductVIAGRAdrugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100 MG, UNKdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameSILDENAFIL CITRATE

openFDA Info on Medication

Application NumberNDA020895Brand NameVIAGRAGeneric NameSILDENAFIL CITRATEManufacturersU.S. Pharmaceuticals, Pfizer Laboratories Div Pfizer Incproduct_ndc63539-421, 63539-422, 0069-4200, 0069-4210, 0069-4220Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSILDENAFIL CITRATERXCUI213270, 213271, 312950, 314229, 213269, 314228spl_id44077f94-92ff-4cd3-ae7d-3913bd41d97a, 825327ae-a572-4b15-b9dd-1221249a7ac8spl_set_id442a09ee-e7de-4d53-a32e-07c7530cdede, 0b0be196-0c62-461c-94f4-9a35339b4501Package NDC 63539-421-97, 63539-422-02, 63539-422-03, 0069-4200-30, 0069-4210-30, 0069-4210- ... UNIIBW9B0ZE037

summary

narrativeincludeclinicalCASE EVENT DATE: 2008

Report Duplicate

duplicatesourceDAIICHIduplicatenumbUS-DSJP-DSU-2014-00120

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use