Adverse Event Report

Report

Version of Safety Report ID3Safety Report ID10261020primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate26/03/2015reporttype1serious2receivedateformat102Date Received26/06/2014receiptdateformat102Date Last Updated29/07/2014fulfillexpeditecriteria2companynumbUS-PFIZER INC-2014167443duplicate1

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014167443

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age32Unit of Onset AgeyearsWeight81.63SexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionFatigueOutcomeUnknown

2)

reactionmeddraversionpt17.1ReactionFibromyalgiaOutcomeUnknown

3)

reactionmeddraversionpt17.1ReactionIntentional product misuseOutcomeUnknown

4)

reactionmeddraversionpt17.1ReactionMyalgiaOutcomeUnknown

5)

reactionmeddraversionpt17.1ReactionInsomniaOutcomeUnknown

6)

reactionmeddraversionpt17.1ReactionAmnesiaOutcomeUnknown

7)

reactionmeddraversionpt17.1ReactionMuscle spasmsOutcomeUnknown

8)

reactionmeddraversionpt17.1ReactionPainOutcomeUnknown

9)

reactionmeddraversionpt17.1ReactionMemory impairmentOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductLYRICAdrugauthorizationnumb021446drugstructuredosagenumb75drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext75 MG, 2X/DAY (EVERY 12 HOURS)drugdosageformCAPSULE, HARDdrugadministrationroute048drugstartdateformat610drugstartdate/06/2014drugenddateformat102drugenddate14/06/2014

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

Application NumberNDA021446, NDA022488Brand NameLYRICAGeneric NamePREGABALINManufacturersParke-Davis Div of Pfizer Inc, U.S. Pharmaceuticalsproduct_ndc 0071-1012, 0071-1013, 0071-1014, 0071-1015, 0071-1016, 0071-1017, 0071-1019, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 607018, 607020, ... spl_idb9b1285a-2cb3-4789-8b0e-8d5e1b253534, bfdec19d-6a54-449c-95b4-908d28e5369aspl_set_id60185c88-ecfd-46f9-adb9-b97c6b00a553, ce1a4b9d-3127-4416-8bf2-fee5899fc0baPackage NDC 0071-1012-68, 0071-1013-41, 0071-1013-68, 0071-1014-41, 0071-1014-68, 0071-1015- ... UNII55JG375S6M

2)

drugcharacterization2medicinalproductXANAXdrugdosagetextUNK

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

3)

drugcharacterization1medicinalproductLYRICAdrugauthorizationnumb021446drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, 1X/DAYdrugdosageformCAPSULE, HARDdrugadministrationroute048drugindicationFIBROMYALGIAdrugenddateformat610drugenddate/06/2014

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

Application NumberNDA021446, NDA022488Brand NameLYRICAGeneric NamePREGABALINManufacturersParke-Davis Div of Pfizer Inc, U.S. Pharmaceuticalsproduct_ndc 0071-1012, 0071-1013, 0071-1014, 0071-1015, 0071-1016, 0071-1017, 0071-1019, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 607018, 607020, ... spl_idb9b1285a-2cb3-4789-8b0e-8d5e1b253534, bfdec19d-6a54-449c-95b4-908d28e5369aspl_set_id60185c88-ecfd-46f9-adb9-b97c6b00a553, ce1a4b9d-3127-4416-8bf2-fee5899fc0baPackage NDC 0071-1012-68, 0071-1013-41, 0071-1013-68, 0071-1014-41, 0071-1014-68, 0071-1015- ... UNII55JG375S6M

4)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNK

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

summary

narrativeincludeclinicalCASE EVENT DATE: 201406