Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11328723primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious2receivedateformat102Date Received31/07/2015receiptdateformat102Date Last Updated31/07/2015fulfillexpeditecriteria2companynumbUS-PFIZER INC-2015245760duplicate1

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2015245760

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age56Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionBack painOutcomeUnknown

2)

reactionmeddraversionpt18.1ReactionAllodyniaOutcomeUnknown

3)

reactionmeddraversionpt18.1ReactionCondition aggravatedOutcomeUnknown

4)

reactionmeddraversionpt18.1ReactionPain in extremityOutcomeUnknown

5)

reactionmeddraversionpt18.1ReactionBurning sensationOutcomeUnknown

6)

reactionmeddraversionpt18.1ReactionMusculoskeletal chest painOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductLYRICAdrugauthorizationnumb021446drugindicationPAINactiondrug5

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)

drugcharacterization1medicinalproductLIDODERMdrugstructuredosagenumb5drugstructuredosageunit030drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 %, 2X/DAY (12 HOURS A DAY)actiondrug5

activesubstance

activesubstancenameLIDOCAINE

openFDA Info on Medication

Application NumberNDA020612Brand NameLIDODERMGeneric NameLIDOCAINEManufacturersEndo Pharmaceuticals, Inc.product_ndc63481-687Product TypeHUMAN PRESCRIPTION DRUGRouteCUTANEOUSActive IngredientsLIDOCAINERXCUI1011705, 1745091spl_id9c6118a9-8702-4025-e053-2995a90a50adspl_set_idf1c40164-4626-4290-9012-c00e33420a33Package NDC63481-687-01, 63481-687-06NUIN0000175682, M0000897, N0000175426, N0000175976Established Pharmacologic ClassAmide Local Anesthetic [EPC], Antiarrhythmic [EPC]Chemical StructureAmides [CS]Physiologic/Pharmacodynamic EffectLocal Anesthesia [PE]UNII98PI200987

3)

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

4)

drugcharacterization2medicinalproductMS CONTINdrugstructuredosagenumb15drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext15 MG, 2X/DAYdrugdosageformTABLETdrugadministrationroute048

activesubstance

activesubstancenameMORPHINE SULFATE

openFDA Info on Medication

Application NumberNDA019516Brand NameMS CONTINGeneric NameMORPHINE SULFATEManufacturersRhodes Pharmaceuticals L.P.product_ndc42858-515, 42858-631, 42858-760, 42858-799, 42858-900Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMORPHINE SULFATERXCUI891874, 891881, 891888, 891893, 892560, 892574, 892646, 892648, 892660, 894813spl_id426c7771-4aee-4e4d-b3c0-6cefb0f7e154spl_set_idc354b3bf-86c0-4bb8-8b1f-be2164942698Package NDC42858-515-01, 42858-631-01, 42858-760-01, 42858-799-01, 42858-900-01UNIIX3P646A2J0

5)

drugcharacterization1medicinalproductLYRICAdrugauthorizationnumb021446drugstructuredosagenumb75drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext75 MG, 2X/DAYdrugadministrationroute048drugindicationNEUROPATHY PERIPHERALactiondrug5

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