Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11184150primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/08/2015reporttype1serious2receivedateformat102Date Received12/06/2015receiptdateformat102Date Last Updated12/06/2015fulfillexpeditecriteria2companynumbUS-PFIZER INC-2015194295duplicate1

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2015194295

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age71Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionDrug hypersensitivityOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductIBUPROFEN.drugauthorizationnumb018989drugdosagetextUNKactiondrug5

activesubstance

activesubstancenameIBUPROFEN

openFDA Info on Medication

Application Number ANDA077349, ANDA074937, ANDA075139, ANDA078682, ANDA079174, NDA019012, ANDA20231 ... Brand Name CAREONE IBUPROFEN, HEALTH MART CHILDRENS IBUPROFEN, IBUPROFEN, WELBY CHILDRENS I ... Generic Name IBUPROFEN, IBUPROFEN 200MG, IBUPROFEN CAPSULES 200 MG, IBUPROFEN ORAL, IBUPFROFE ... Manufacturers American Sales Company, Strategic Sourcing Services LLC, CVS Pharmacy, Rite Aid ... product_ndc 41520-495, 62011-0214, 59779-392, 11822-3307, 50804-199, 64024-003, 55910-847, 2 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsIBUPROFEN, IBUPROFEN SODIUMRXCUI 310965, 197803, 310964, 201126, 204442, 310963, 731536, 197805, 197806, 197807, ... spl_id 0647c7c2-b153-4d8c-b72b-f63d43c41853, 397d86de-d7a7-4087-a017-f714b1c1dd5a, a2fe ... spl_set_id 03cdff8a-8890-440d-82b5-54ce809f88cc, 1d81eea7-0104-4b3d-842c-c763e290581c, 29b2 ... Package NDC 41520-495-71, 41520-495-78, 62011-0214-1, 59779-392-14, 59779-392-08, 59779-392- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, RM1CE97Z4N

2)

drugcharacterization1medicinalproductDAYPROdrugauthorizationnumb018841drugdosagetextUNKdrugdosageformTABLETactiondrug5

activesubstance

activesubstancenameOXAPROZIN

openFDA Info on Medication

Application NumberNDA018841Brand NameDAYPROGeneric NameOXAPROZINManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0025-1381Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXAPROZINRXCUI207243, 312132spl_id1d508849-28b8-4a9c-b850-fa47e2481fd5spl_set_idea1de47e-3101-4414-817c-0a098af8988cPackage NDC0025-1381-31, 0025-1381-34, 0025-1381-51NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIMHJ80W9LRB

3)

drugcharacterization1medicinalproductNORFLEXdrugdosagetextUNKactiondrug5

activesubstance

activesubstancenameORPHENADRINE CITRATE

4)

drugcharacterization1medicinalproductVALIUMdrugdosagetextUNKactiondrug5

activesubstance

activesubstancenameDIAZEPAM

openFDA Info on Medication

Application NumberNDA013263Brand NameVALIUMGeneric NameDIAZEPAMManufacturersRoche Laboratories Inc., Waylis Therapuetics LLCproduct_ndc0140-0004, 0140-0005, 0140-0006, 80725-004, 80725-005, 80725-006Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIAZEPAMRXCUI104699, 104700, 104701, 197589, 197590, 197591spl_idc0054f7c-9c38-4ac8-ae8f-5e6427e1fd14, dc250376-39ef-2207-e053-2a95a90a4901spl_set_id554baee5-b171-4452-a50a-41a0946f956c, 260e2041-2bb3-482f-850e-b5d47a7bdbe6Package NDC 0140-0004-01, 0140-0005-01, 0140-0005-14, 0140-0006-01, 0140-0006-14, 80725-004- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

5)

drugcharacterization1medicinalproductLEVAQUINdrugdosagetextUNKactiondrug5

activesubstance

activesubstancenameLEVOFLOXACIN

6)

drugcharacterization1medicinalproductXANAXdrugauthorizationnumb018276drugdosagetextUNKactiondrug5

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0094, 0009-0029, 0009-0055, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_idf364e489-b47b-4283-a7fe-d5b15f77447e, bf933d5a-53e2-4454-a040-cacc061bca92spl_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

7)

drugcharacterization1medicinalproductAMBIENdrugdosagetextUNKactiondrug5

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

8)

drugcharacterization1medicinalproductLUNESTAdrugdosagetextUNKactiondrug5

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