Adverse Event Report

Report

reporttype2Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10016638serious1Date Last Updated03/06/2014receiptdateformat102companynumbUS-ABBVIE-14P-163-1209734-00occurcountryUSseriousnessother1duplicate1Date Received17/03/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification5

Patient

Onset Age62Unit of Onset AgeyearsWeight47.22SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionVolvulusOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionNauseaOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionVomitingOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionDiarrhoeaOutcomeRecovered/resolved

5)

reactionmeddraversionpt17.0ReactionFatigueOutcomeRecovering/resolving

6)

reactionmeddraversionpt17.0ReactionBlood calcium decreasedOutcomeRecovered/resolved

7)

reactionmeddraversionpt17.0ReactionBlood magnesium decreasedOutcomeRecovered/resolved

8)

reactionmeddraversionpt17.0ReactionBlood potassium decreasedOutcomeRecovered/resolved

9)

reactionmeddraversionpt17.0ReactionHypophagiaOutcomeRecovered/resolved

10)

reactionmeddraversionpt17.0ReactionAdhesionOutcomeRecovered/resolved

11)

reactionmeddraversionpt17.0ReactionProcedural painOutcomeRecovered/resolved

12)

reactionmeddraversionpt17.0ReactionAbdominal adhesionsOutcomeRecovered/resolved

13)

reactionmeddraversionpt17.0ReactionWeight increasedOutcomeUnknown

14)

reactionmeddraversionpt17.0ReactionIncreased appetiteOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1006259,1009150drugauthorizationnumb125057drugstructuredosagenumb160drugstructuredosageunit003drugdosageformSolution for injection in pre-filled pendrugindicationCROHN^S DISEASEdrugstartdateformat102drugstartdate25/06/2013drugenddateformat102drugenddate25/06/2013actiondrug4

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- ...

2)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1006259,1009150drugauthorizationnumb125057drugstructuredosagenumb80drugstructuredosageunit003drugdosagetextLOADING DOSEactiondrug4

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)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1006259,1009150drugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803actiondrug4

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)

drugcharacterization2medicinalproductPENTASAdrugindicationCROHN^S DISEASE

openFDA Info on Medication

Application NumberNDA020049Brand NamePENTASAGeneric NameMESALAMINEManufacturersTakeda Pharmaceuticals America, Inc.product_ndc54092-189, 54092-191Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMESALAMINERXCUI206791, 314092, 476362, 580286spl_idc69ba849-555c-4b23-8010-e32ab00dee21spl_set_ide39d9a3d-5d3a-4bb6-aab1-fdbb2a598606Package NDC54092-189-81, 54092-191-08, 54092-191-12NUIN0000175781, M0000971Established Pharmacologic ClassAminosalicylate [EPC]Chemical StructureAminosalicylic Acids [CS]UNII4Q81I59GXC

5)

drugcharacterization2medicinalproductPREDNISONEdrugindicationCROHN^S DISEASE

openFDA Info on Medication

Application Number NDA202020, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA040584, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., GeneYork Pharmaceuticals Group LLC, Mylan Pharma ... product_ndc 75987-020, 75987-021, 75987-022, 71329-106, 0378-0640, 0378-0641, 0378-0642, 060 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id be29c86d-242b-42a7-9488-ecf6f76426cd, 4384c1d1-059b-4689-9f3d-1078de814ce8, 88a6 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, be50449f-3aa8-46b7-9246-2dbd5f04f2b1, fec0 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

6)

drugcharacterization2medicinalproductREQUIPdrugindicationRESTLESS LEGS SYNDROME

7)

drugcharacterization2medicinalproductZOLOFTdrugindicationDEPRESSION

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

8)

drugcharacterization2medicinalproductTRAZODONEdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

9)

drugcharacterization2medicinalproductLEVOTHYROXINEdrugindicationHYPOTHYROIDISM

openFDA Info on Medication

Brand NameLEVOTHYROXINEGeneric NameLEVOTHYROXINEManufacturersDeseret Biologicals, Inc.product_ndc43742-0955Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLEVOTHYROXINEspl_id7c431149-4f46-4c4f-a5bb-c1b1fb705283spl_set_id1a467f8b-2611-4936-af2b-098e4791d6aePackage NDC43742-0955-1NUIN0000175945, M0021504Established Pharmacologic Classl-Thyroxine [EPC]Chemical StructureThyroxine [CS]UNIIQ51BO43MG4

10)

drugcharacterization2medicinalproductVITAMIN B12drugindicationVITAMIN SUPPLEMENTATION

11)

drugcharacterization2medicinalproductLOMITILdrugindicationDIARRHOEA

12)

drugcharacterization2medicinalproductVITAMIN D3drugindicationVITAMIN SUPPLEMENTATION

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturersStrides Pharma Science Limitedproduct_ndc64380-737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36Package NDC64380-737-06, 64380-737-25NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

13)

drugcharacterization2medicinalproductFOLIC ACIDdrugindicationVITAMIN SUPPLEMENTATION

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]

14)

drugcharacterization2medicinalproductBENADRYLdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Numberpart341Brand NameCHILDRENS ALLERGY RELIEF, BENADRYLGeneric NameBENADRYL, DIPHENHYDRAMINE HYDROCHLORIDEManufacturers Rite Aid Corporation, Johnson & Johnson Consumer Inc., McNeil Consumer Healthcar ... product_ndc11822-0025, 50580-370, 50580-226Product TypeHUMAN OTC DRUGRouteORALActive IngredientsDIPHENHYDRAMINE HYDROCHLORIDERXCUI1049906, 1049630, 1049632spl_id fecb0ac3-0ede-4e4a-91c3-b6322f055b5c, ecd53790-6b06-46a1-a4ed-dd69293aa1c5, b09d ... spl_set_id 50434eaf-650c-4416-a357-d174f86d729f, 2884d2dc-2d4a-4ca6-ab73-688a80b428eb, 702f ... Package NDC 11822-0025-4, 50580-370-01, 50580-226-50, 50580-226-51, 50580-226-53, 50580-226- ... UNIITC2D6JAD40

15)

drugcharacterization2medicinalproductPRILOSECdrugindicationGASTROOESOPHAGEAL REFLUX DISEASE

openFDA Info on Medication

Application NumberNDA022056Brand NamePRILOSECGeneric NameOMEPRAZOLE MAGNESIUMManufacturersCovis Pharmaproduct_ndc70515-610, 70515-625Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE MAGNESIUMRXCUI797058, 797061, 797063, 797065spl_id1bd73b0f-b2c2-4409-94ce-1955c6ab119bspl_set_idb6761f84-53ac-4745-a8c8-1e5427d7e179Package NDC70515-625-01, 70515-610-01UNII426QFE7XLK

16)

drugcharacterization2medicinalproductANTIBIOTICSdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat610drugstartdate/02/2014drugenddateformat610drugenddate/02/2014

17)

drugcharacterization2medicinalproductMAGNESIUMdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Brand NameMAGNESIUM METALLICUMGeneric NameMAGNESIUMManufacturersWashington Homeopathic Productsproduct_ndc71919-432, 68428-981Product TypeHUMAN OTC DRUGRouteORALActive IngredientsMAGNESIUMspl_id7e576a9a-5338-06b5-e053-2a91aa0a87b5, f66824cf-f8b0-4a71-b798-821343c5a77bspl_set_idce81f9c8-da78-43dd-a255-46978ec47d9c, 458aa1da-e975-4e11-a0c0-5ce352046ae1Package NDC 71919-432-07, 71919-432-08, 71919-432-09, 71919-432-10, 68428-981-03, 68428-981- ... UNIII38ZP9992A

18)

drugcharacterization2medicinalproductPOTASSIUMdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14P-163-1209734-00

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use