Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-MALLINCKRODT-T201303425occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10132614Date Received28/04/2014transmissiondate12/12/2014serious2Date Last Updated28/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Weight92.52SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionLiver function test abnormalOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionSpinal osteoarthritisOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionBack painOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionArthralgiaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductHYDROCODONE/ACETAMINOPHENdrugbatchnumbNOT REPORTEDdrugauthorizationnumb089160drugdosagetext10/325MGdrugdosageformTABLETdrugadministrationroute048drugindicationPAINdrugenddateformat610drugenddate/05/2013drugrecurreadministration3

2)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumbUNKNOWNdrugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, 1 IN 2 WK, INJECTIONdrugdosageformSOLUTION FOR INJECTIONdrugindicationRHEUMATOID ARTHRITISdrugstartdateformat610drugstartdate/01/2013drugenddateformat610drugenddate/04/2013drugrecurreadministration3

openFDA Info on Medication

Application NumberBLA125057Brand NameHUMIRAGeneric NameADALIMUMABManufacturersAbbVie Inc.product_ndc 0074-0067, 0074-3799, 0074-6347, 0074-4339, 0074-9374, 0074-0243, 0074-0554, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 351290, 352334, 727703, 727705, 763564, 763565, 797544, 825169, 825170, 1551887, ... spl_id7a967019-f452-7b99-ba3d-e9b3ac703363spl_set_id608d4f0d-b19f-46d3-749a-7159aa5f933dPackage NDC 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-6347-02, 0074-4339- ...

3)

drugcharacterization1medicinalproductARAVAdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2000drugenddateformat610drugenddate/04/2013drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA020905Brand NameARAVAGeneric NameLEFLUNOMIDEManufacturerssanofi-aventis U.S. LLCproduct_ndc0088-2160, 0088-2161, 0088-2162Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEFLUNOMIDERXCUI205284, 205285, 205286, 213377, 213379, 213380spl_idf52c3d5c-6d99-402a-a658-915601216318spl_set_id320f63f2-fac3-4aee-aff8-85724e00ef52Package NDC0088-2160-30, 0088-2161-30, 0088-2162-33NUIN0000175713Established Pharmacologic ClassAntirheumatic Agent [EPC]UNIIG162GK9U4W

4)

drugcharacterization1medicinalproductLIPITORdrugbatchnumbUNKNOWNdrugindicationBLOOD CHOLESTEROL INCREASEDdrugrecurreadministration3

openFDA Info on Medication

Application NumberNDA020702Brand NameLIPITORGeneric NameATORVASTATIN CALCIUMManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0155, 0071-0156, 0071-0157, 0071-0158Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATORVASTATIN CALCIUM TRIHYDRATERXCUI259255, 262095, 617310, 617311, 617312, 617314, 617318, 617320spl_id0ba214c6-250e-42a0-aea8-5e44aba04882spl_set_idc6e131fe-e7df-4876-83f7-9156fc4e8228Package NDC 0071-0155-23, 0071-0155-40, 0071-0155-10, 0071-0155-97, 0071-0156-23, 0071-0156- ... UNII48A5M73Z4Q

5)

drugcharacterization1medicinalproductATENOLOLdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, 2 IN 1 DdrugindicationHYPERTENSIONdrugenddateformat610drugenddate/05/2013drugrecurreadministration3

openFDA Info on Medication

Application Number NDA018240, ANDA078512, ANDA213136, ANDA077443, ANDA076900, ANDA074052, ANDA07302 ... Brand NameTENORMIN, ATENOLOLGeneric NameATENOLOLManufacturers Almatica Pharma LLC, Aurobindo Pharma Limited, Unichem Pharmaceuticals (USA), In ... product_ndc 52427-429, 52427-430, 52427-431, 65862-168, 65862-169, 65862-170, 29300-410, 293 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATENOLOLRXCUI150750, 152414, 197379, 197380, 197381, 201322spl_id 70291313-c4f6-7c2a-cd07-04fd6a07b634, 2f8a6d3c-fbcd-4b11-aa14-d0522fa7600e, d850 ... spl_set_id 746db603-a6e1-4dc3-c2d8-92314419098c, 1b8a4689-3916-4f4b-b54a-bbb4e322d79b, 35d9 ... Package NDC 52427-429-90, 52427-430-90, 52427-431-90, 65862-168-01, 65862-168-99, 65862-169- ... NUIN0000000161, N0000175556Mechanism of ActionAdrenergic beta-Antagonists [MoA]Established Pharmacologic Classbeta-Adrenergic Blocker [EPC]UNII50VV3VW0TI

6)

drugcharacterization1medicinalproductATENOLOLdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, 1 IN 1 DdrugindicationHYPERTENSIONdrugstartdateformat610drugstartdate/05/2013drugrecurreadministration3

openFDA Info on Medication

Application Number NDA018240, ANDA078512, ANDA213136, ANDA077443, ANDA076900, ANDA074052, ANDA07302 ... Brand NameTENORMIN, ATENOLOLGeneric NameATENOLOLManufacturers Almatica Pharma LLC, Aurobindo Pharma Limited, Unichem Pharmaceuticals (USA), In ... product_ndc 52427-429, 52427-430, 52427-431, 65862-168, 65862-169, 65862-170, 29300-410, 293 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATENOLOLRXCUI150750, 152414, 197379, 197380, 197381, 201322spl_id 70291313-c4f6-7c2a-cd07-04fd6a07b634, 2f8a6d3c-fbcd-4b11-aa14-d0522fa7600e, d850 ... spl_set_id 746db603-a6e1-4dc3-c2d8-92314419098c, 1b8a4689-3916-4f4b-b54a-bbb4e322d79b, 35d9 ... Package NDC 52427-429-90, 52427-430-90, 52427-431-90, 65862-168-01, 65862-168-99, 65862-169- ... NUIN0000000161, N0000175556Mechanism of ActionAdrenergic beta-Antagonists [MoA]Established Pharmacologic Classbeta-Adrenergic Blocker [EPC]UNII50VV3VW0TI

7)

drugcharacterization2medicinalproductACIPHEXdrugindicationGASTROOESOPHAGEAL REFLUX DISEASEdrugrecurreadministration3

openFDA Info on Medication

Application NumberNDA204736, NDA020973Brand NameACIPHEX SPRINKLE, ACIPHEXGeneric NameRABEPRAZOLE SODIUMManufacturersAytu Therapeutics, LLC, Eisai Inc.product_ndc23594-205, 23594-210, 62856-243Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRABEPRAZOLE SODIUMRXCUI1437489, 1437492, 1483318, 1483319, 854868, 854870spl_idb60f61f6-6afd-0dd0-e053-2995a90a7c7a, e1d76276-cc45-4db5-9b2d-b48011930ab7spl_set_idced27556-e0d6-4fad-8a0e-8ac763f81f33, 5d103551-978f-472a-9c62-51e6e4dea068Package NDC23594-205-01, 23594-210-01, 62856-243-41, 62856-243-30, 62856-243-90UNII3L36P16U4R

8)

drugcharacterization2medicinalproductLISINOPRILdrugindicationHYPERTENSIONdrugrecurreadministration3

openFDA Info on Medication

Application Number ANDA076063, ANDA077321, NDA208401, ANDA078402, ANDA212041, ANDA076180, ANDA07616 ... Brand NameLISINOPRIL, QBRELIS, PRINIVIL, ZESTRILGeneric NameLISINOPRILManufacturers Hikma Pharmaceuticals USA Inc., International Laboratories, LLC, Azurity Pharmac ... product_ndc 0143-9713, 0143-9715, 0143-9714, 54458-872, 54458-877, 54458-874, 54458-873, 526 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 311354, 314076, 314077, 197884, 1806884, 1806890, 205326, 311353, 206764, 206765 ... spl_id 533f6e0f-04a0-4ef7-81b8-0a7be07ddd1a, b685bb45-44a6-4afc-bb3e-940bce536bda, 2fdc ... spl_set_id b70933da-55b2-4025-a00e-63ce3e6b7fdf, 6eef83b4-ce4c-462b-bcfa-eefa525e682d, 9f6e ... Package NDC 0143-9715-01, 0143-9715-10, 0143-9715-99, 0143-9714-01, 0143-9714-10, 0143-9714- ... UNIIE7199S1YWR

9)

drugcharacterization2medicinalproductZOLOFTdrugindicationANXIETYdrugrecurreadministration3

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

10)

drugcharacterization2medicinalproductASAdrugindicationPROPHYLAXISdrugrecurreadministration3

Report Duplicate

duplicatesourceMALLINCKRODTduplicatenumbUS-MALLINCKRODT-T201303425