Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10048141serious1Date Last Updated03/06/2014receiptdateformat102companynumbIT-PFIZER INC-2014089588occurcountryITduplicate1Date Received31/03/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryIT

Primary Source

reportercountryITqualification3

Patient

Onset Age47Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionChest painOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionDyspnoeaOutcomeRecovering/resolving

3)

reactionmeddraversionpt17.0ReactionDepressed level of consciousnessOutcomeRecovering/resolving

4)

reactionmeddraversionpt17.0ReactionPain in extremityOutcomeRecovering/resolving

5)

reactionmeddraversionpt17.0ReactionLoss of consciousnessOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductQUARKdrugauthorizationnumb019901drugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, DAILYdrugdosageformTABLETdrugadministrationroute048drugindicationHYPERTENSIONdrugstartdateformat102drugstartdate01/11/2011drugenddateformat102drugenddate03/03/2014actiondrug2

2)

drugcharacterization2medicinalproductSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA077206, NDA020990, NDA019839, ANDA078861, ANDA077864, ANDA077106, ANDA076934 ... Brand NameSERTRALINE HYDROCHLORIDE, SERTRALINE, ZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturers Aurobindo Pharma Limited, Greenstone LLC, Rising Pharmaceuticals, Inc., Hikma Ph ... product_ndc 65862-011, 65862-012, 65862-013, 59762-0067, 59762-4960, 59762-4900, 59762-4910, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941, 861064, 208149, 208161, 212233, 861066spl_id 80aac5d8-bb02-46f5-a8ca-5fc9f934541c, 1ef7897d-60bb-4685-820f-21c78a097642, 96aa ... spl_set_id 39a85db1-9e59-4ab0-9e18-36757f019faa, 1a58062b-e635-431a-908d-2651c6a4a21c, af2c ... Package NDC 65862-011-30, 65862-011-50, 65862-011-60, 65862-011-90, 65862-011-01, 65862-011- ... UNIIUTI8907Y6X

3)

drugcharacterization2medicinalproductCARDIOASPIRIN

4)

drugcharacterization2medicinalproductPLAVIX

openFDA Info on Medication

Application NumberNDA020839Brand NamePLAVIXGeneric NameCLOPIDOGRELManufacturerssanofi-aventis U.S. LLC, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnershipproduct_ndc0024-1171, 0024-1332, 63653-1171, 63653-1332Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLOPIDOGREL BISULFATERXCUI213169, 309362, 749196, 749198spl_idcb770afe-b6de-469f-9d9c-3db134394d4d, 12eb3088-f30b-4bb5-aee0-113114b5a08cspl_set_idde8b0b67-eb25-4684-83b5-7ad785314227, 01b14603-8f29-4fa3-8d7e-9d523f802e0bPackage NDC 0024-1171-90, 0024-1332-30, 63653-1171-6, 63653-1171-1, 63653-1171-3, 63653-1171 ... UNII08I79HTP27

5)

drugcharacterization2medicinalproductXANAX

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia and Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_iddfdda989-af0a-4c14-871c-b26b7b6da50e, d95506a3-aba6-47f4-83c4-443a4cce678bspl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

Report Duplicate

duplicatesourcePFIZERduplicatenumbIT-PFIZER INC-2014089588

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use