Adverse Event Report

Report

reporttype2receiptdateformat102companynumbUS-ABBVIE-14P-163-1218697-00occurcountryUSVersion of Safety Report ID3receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10062974Date Received07/04/2014transmissiondate20/03/2018serious1Date Last Updated17/12/2017

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Weight77.18SexFemale

Reaction

1)

reactionmeddraversionpt20.1ReactionTremorOutcomeUnknown

2)

reactionmeddraversionpt20.1ReactionBasal cell carcinomaOutcomeRecovered/resolved

3)

reactionmeddraversionpt20.1ReactionRheumatoid arthritisOutcomeRecovering/resolving

4)

reactionmeddraversionpt20.1ReactionDysstasiaOutcomeRecovered/resolved

5)

reactionmeddraversionpt20.1ReactionPrecancerous skin lesionOutcomeRecovered/resolved

6)

reactionmeddraversionpt20.1ReactionBack painOutcomeUnknown

7)

reactionmeddraversionpt20.1ReactionDrug ineffectiveOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt20.1ReactionSquamous cell carcinomaOutcomeRecovered/resolved

9)

reactionmeddraversionpt20.1ReactionSurgical failureOutcomeRecovered/resolved

10)

reactionmeddraversionpt20.1ReactionImpaired healingOutcomeRecovered/resolved

11)

reactionmeddraversionpt20.1ReactionHypersensitivityOutcomeUnknown

12)

reactionmeddraversionpt20.1ReactionThyroid cancerOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCIMZIAdrugbatchnumbUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat610drugstartdate/12/2013drugenddateformat610drugenddate/02/2014actiondrug1drugadditional1

activesubstance

activesubstancenameCERTOLIZUMAB PEGOL

openFDA Info on Medication

Application NumberBLA125160Brand NameCIMZIAGeneric NameCERTOLIZUMAB PEGOLManufacturersUCB, Inc.product_ndc50474-700, 50474-710Product TypeHUMAN PRESCRIPTION DRUGRXCUI795081, 795085, 849597, 849599spl_ida40abf29-c224-1ae7-e053-2a95a90a2f58spl_set_idb4c2c9dc-a0bb-4d64-a667-a67ebe88392dPackage NDC50474-700-62, 50474-700-61, 50474-710-79, 50474-710-80, 50474-710-81NUIN0000175610, N0000175451Established Pharmacologic ClassTumor Necrosis Factor Blocker [EPC]Mechanism of ActionTumor Necrosis Factor Receptor Blocking Activity [MoA]UNIIUMD07X179ERouteSUBCUTANEOUSActive IngredientsCERTOLIZUMAB PEGOL

2)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1011624,UNKNOWNdrugauthorizationnumb125057drugdosageformSOLUTION FOR INJECTION IN PRE-FILLED PENdrugadministrationroute058drugindicationPSORIATIC ARTHROPATHYdrugstartdateformat610drugstartdate/02/2014actiondrug1drugadditional1

activesubstance

activesubstancenameADALIMUMAB

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)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1011624,UNKNOWNdrugauthorizationnumb125057drugindicationPSORIASISactiondrug1drugadditional1

activesubstance

activesubstancenameADALIMUMAB

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- ...

4)

drugcharacterization2medicinalproductHYDROCHLOROTHIAZIDE.drugadministrationroute065drugindicationHYPERTENSION

activesubstance

activesubstancenameHYDROCHLOROTHIAZIDE

openFDA Info on Medication

Application Number ANDA040780, ANDA203018, ANDA040412, ANDA085182, ANDA203561, ANDA078164, ANDA0870 ... Brand NameHYDROCHLOROTHIAZIDEGeneric NameHYDROCHLOROTHIAZIDEManufacturers Aurobindo Pharma Limited, ScieGen Pharmaceuticals, Inc., Solco Healthcare U.S., ... product_ndc 65862-133, 65862-134, 50228-111, 50228-112, 43547-397, 43547-398, 23155-008, 231 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCHLOROTHIAZIDERXCUI197770, 310798, 199903, 429503spl_id 9d73930e-75b8-4a7b-9d12-2049f593ca9d, 5c6f4c6a-cc43-4f4d-bc16-688310c98c72, d8ce ... spl_set_id 01f1f478-5493-439f-9b99-f4f82023781c, 02e96a51-1d56-460c-8c20-3d6f37e0ce46, 60c9 ... Package NDC 65862-133-01, 65862-133-99, 65862-134-01, 65862-134-99, 50228-111-30, 50228-111- ... NUIN0000175359, N0000175419, M0471776Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide Diuretic [EPC]Chemical StructureThiazides [CS]UNII0J48LPH2TH

5)

drugcharacterization2medicinalproductAMBIENdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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_id6c172483-d1e2-4203-8dab-7f8a780a02ad, e932d227-dc7a-405f-855b-4994aabb85f4spl_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

6)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1011624,UNKNOWNdrugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformSOLUTION FOR INJECTION IN PRE-FILLED PENdrugadministrationroute058drugindicationRHEUMATOID ARTHRITISdrugstartdateformat602drugstartdate//2010drugenddateformat602drugenddate//2013actiondrug1drugadditional1

activesubstance

activesubstancenameADALIMUMAB

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- ...

7)

drugcharacterization2medicinalproductNORVASCdrugadministrationroute065drugindicationHYPERTENSION

activesubstance

activesubstancenameAMLODIPINE BESYLATE

openFDA Info on Medication

Application NumberNDA019787Brand NameNORVASCGeneric NameAMLODIPINE BESYLATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0069-1520, 0069-1530, 0069-1540Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BESYLATERXCUI197361, 212542, 212549, 212575, 308135, 308136spl_id3f5ca9a3-9076-49ab-b247-669c337f3364spl_set_idabd6a2ca-40c2-485c-bc53-db1c652505edPackage NDC 0069-1520-68, 0069-1530-68, 0069-1530-41, 0069-1530-72, 0069-1540-68, 0069-1540- ... UNII864V2Q084H

8)

drugcharacterization2medicinalproductFOLIC ACID.drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameFOLIC ACID

openFDA Info on Medication

Application Number ANDA040796, ANDA204418, ANDA202437, ANDA091145, ANDA211064, ANDA202522, ANDA0407 ... Brand NameFOLIC ACID, VENEXA, VITREXYL, VITRANOLGeneric NameFOLIC ACIDManufacturers Leading Pharma, LLC, Marlex Pharmaceuticals Inc, PureTek Corporation, Cadila Pha ... product_ndc 69315-127, 10135-182, 59088-176, 71209-007, 58657-150, 11534-165, 58657-151, 731 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSActive Ingredients FOLIC ACID, .ALPHA.-TOCOPHEROL ACETATE, DL-, MAGNESIUM OXIDE, CHROMIUM NICOTINAT ... RXCUI310410, 237786spl_id 92322e52-3179-4738-8c8a-14fef62311d4, ba726c8a-bfad-11f7-e053-2995a90a239e, ba13 ... spl_set_id 1ba8c407-9613-4319-ac40-0a429cb0f3f4, 35cd5498-0af8-4bcc-a755-bf30f37b091a, ba13 ... Package NDC 69315-127-01, 69315-127-10, 10135-182-01, 10135-182-10, 59088-176-54, 71209-007- ... UNII 935E97BOY8, WR1WPI7EW8, 3A3U0GI71G, A150AY412V, 68Y4CF58BV, 81AH48963U, H6241UJ2 ... NUIM0022797, N0000175952, N0000193618, M0001797, M0022794, N0000175951Chemical StructureVitamin D [CS], Ascorbic Acid [CS], Vitamin B 12 [CS]Established Pharmacologic ClassVitamin D [EPC], Vitamin C [EPC], Vitamin B12 [EPC]

9)

drugcharacterization1medicinalproductMETHOTREXATE.drugbatchnumbUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat610drugstartdate/02/2014actiondrug6

activesubstance

activesubstancenameMETHOTREXATE

openFDA Info on Medication

Application Number NDA011719, ANDA040385, ANDA040263, ANDA040632, ANDA201529, ANDA201530, NDA008085 ... Brand NameMETHOTREXATE, TREXALL, RASUVO, XATMEP, REDITREX, OTREXUPGeneric NameMETHOTREXATE, METHOTREXATE SODIUMManufacturers Hospira, Inc., Teva Women's Health, Inc., Fresenius Kabi USA, LLC, Hikma Pharmac ... product_ndc 61703-350, 51285-366, 51285-367, 51285-368, 51285-369, 63323-123, 0143-9830, 674 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRA-ARTERIAL, INTRAMUSCULAR, INTRAVENOUS, ORAL, INTRATHECAL, SUBCUTANEOUSActive IngredientsMETHOTREXATE SODIUM, METHOTREXATERXCUI 1946772, 105586, 283510, 283511, 283671, 284592, 284593, 284594, 284595, 311625, ... spl_id 60bbb387-0ce5-4c7e-a917-5bc4b4685616, 78d0abc0-9ade-4302-ada0-72fd6d67eff9, 46c4 ... spl_set_id 0d63ba29-b692-41b4-87e8-351265c8273f, 0e30eaef-5a09-4104-8a11-c32933eadeab, e942 ... Package NDC 61703-350-37, 61703-350-38, 61703-350-09, 61703-350-10, 51285-366-01, 51285-367- ... UNII3IG1E710ZN, YL5FZ2Y5U1NUIN0000175584, N0000000111Established Pharmacologic ClassFolate Analog Metabolic Inhibitor [EPC]Mechanism of ActionFolic Acid Metabolism Inhibitors [MoA]

10)

drugcharacterization2medicinalproductZOLOFTdrugadministrationroute065drugindicationDEPRESSION

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

11)

drugcharacterization2medicinalproductNEXIUMdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMRXCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, ... spl_id416c365d-7271-4804-9285-643858cf578b, ac4ba22b-f431-4ab4-b239-0e220ad804ddspl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43H

summary

narrativeincludeclinicalCASE EVENT DATE: 2012

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14P-163-1218697-00