Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10807812primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/07/2015reporttype2serious2receivedateformat102Date Received17/02/2015receiptdateformat102Date Last Updated17/02/2015fulfillexpeditecriteria2companynumbUS-ABBVIE-14K-163-1253858-00duplicate1

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14K-163-1253858-00

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age57Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionDiarrhoeaOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionAlopeciaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.0ReactionHeadacheOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.0ReactionDrug ineffectiveOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt18.0ReactionMalaiseOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt18.0ReactionTooth abscessOutcomeUnknown

7)

reactionmeddraversionpt18.0ReactionNasal congestionOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt18.0ReactionDefaecation urgencyOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt18.0ReactionHair texture abnormalOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt18.0ReactionInfluenza like illnessOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt18.0ReactionChest painOutcomeRecovered/resolved

12)

reactionmeddraversionpt18.0ReactionTooth infectionOutcomeUnknown

13)

reactionmeddraversionpt18.0ReactionMusculoskeletal painOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1011625drugauthorizationnumb125057drugstructuredosagenumb160drugstructuredosageunit003drugdosageformSOLUTION FOR INJECTION IN PRE-FILLED PENdrugindicationCROHN^S DISEASEdrugstartdateformat102drugstartdate25/04/2014drugenddateformat102drugenddate25/04/2014actiondrug1

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_id1b259c93-37f5-4845-92ff-224dacfe1d50spl_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)

drugcharacterization1medicinalproductBIAXINdrugbatchnumbUNKNOWNdrugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationTOOTH INFECTIONdrugstartdateformat102drugstartdate12/06/2014drugenddateformat102drugenddate15/06/2014actiondrug1

activesubstance

activesubstancenameCLARITHROMYCIN

3)

drugcharacterization2medicinalproductZOFRANdrugstructuredosagenumb8drugstructuredosageunit003drugindicationNAUSEA

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

4)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1011625drugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformSOLUTION FOR INJECTION IN PRE-FILLED PENdrugenddateformat102drugenddate20/06/2014actiondrug1

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_id1b259c93-37f5-4845-92ff-224dacfe1d50spl_set_id608d4f0d-b19f-46d3-749a-7159aa5f933dPackage NDC 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-6347-02, 0074-4339- ...

5)

drugcharacterization2medicinalproductPHENERGANdrugstructuredosagenumb25drugstructuredosageunit003drugdosagetextONE EVERY EIGHT HOURS, USUALY TAKE ONE MAYBE 2 A DAYdrugdosageformTABLETdrugindicationNAUSEA

activesubstance

activesubstancenamePROMETHAZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA083312Brand NamePHENERGANGeneric NamePROMETHAZINE HYDROCHLORIDEManufacturersWest-Ward Pharmaceuticals Corp., Hikma Pharmaceuticals USA Inc.product_ndc0641-6082, 0641-6083, 0641-6084, 0641-6085Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUSActive IngredientsPROMETHAZINE HYDROCHLORIDERXCUI992460, 992462, 992858, 992876spl_ided9c544d-8e03-45cb-8509-b71b630d764d, bc2d8f01-1268-4bb2-8db9-793866d32782spl_set_id6f7e47cc-f823-4336-8107-f980e3049617, 481866da-a712-48a5-853f-8e84aacaab6dPackage NDC 0641-6082-01, 0641-6082-25, 0641-6083-01, 0641-6083-25, 0641-6084-01, 0641-6084- ... UNIIR61ZEH7I1I

6)

drugcharacterization2medicinalproductASPIRIN.drugstructuredosagenumb81drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextEVERY NIGHTdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameASPIRIN

openFDA Info on Medication

Application Numberpart343, NDA203697Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN TABLET 325MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 36800-545, 0363-0587, 70000-0218, 63 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 260847, 198471, 825180 ... spl_id 70f66f99-a450-4ab6-a3b9-c5d9207e0a79, da59962f-0c77-5c08-e053-2a95a90aaee7, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

7)

drugcharacterization2medicinalproductPERCOCETdrugdosagetext10/325: ONE EVERY DAY, USUALLY TAKE ONE OR TWO PER DAYdrugindicationPAIN

activesubstance

activesubstancenameACETAMINOPHEN\OXYCODONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA040330Brand NamePERCOCETGeneric NameOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENManufacturersEndo Pharmaceuticals Inc.product_ndc63481-623, 63481-627, 63481-628, 63481-629Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsACETAMINOPHEN, OXYCODONE HYDROCHLORIDERXCUI1049214, 1049221, 1049225, 1049625, 1049635, 1049637, 1049640, 1049642spl_id8a04ce2f-d576-469f-91bc-5ed75e27e47espl_set_id4dd36cf5-8f73-404a-8b1d-3bd53bd90c25Package NDC63481-627-70, 63481-623-70, 63481-623-85, 63481-628-70, 63481-629-70UNIIC1ENJ2TE6C, 362O9ITL9D

8)

drugcharacterization1medicinalproductAMOXICILLIN.drugbatchnumbUNKNOWNdrugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextFOR 6 DAYdrugindicationTOOTH INFECTIONdrugstartdateformat610drugstartdate/06/2014drugenddateformat102drugenddate22/06/2014actiondrug4

activesubstance

activesubstancenameAMOXICILLIN

openFDA Info on Medication

Application Number ANDA065255, ANDA065056, ANDA065271, ANDA065256, ANDA064013, ANDA061926, ANDA0619 ... Brand NameAMOXICILLINGeneric NameAMOXICILLINManufacturers Hikma Pharmaceuticals USA Inc., Teva Pharmaceuticals USA, Inc., NorthStar Rx LLC ... product_ndc 0143-9285, 0093-2263, 0093-2264, 16714-298, 16714-299, 57237-028, 57237-029, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMOXICILLINRXCUI308194, 308192, 308182, 308191, 239191, 308177, 598025, 308189, 313850, 313797spl_id 11f42795-cdea-4c98-a921-2c54e40370ba, 7b44bb9c-2d87-4260-81f1-fea8539749a5, 832f ... spl_set_id c8591c2a-92ef-4432-b19a-bb46063047ee, 20c86622-85b7-4827-a317-57aee79dfe57, 843f ... Package NDC 0143-9285-01, 0143-9285-20, 0093-2263-01, 0093-2264-01, 16714-298-01, 16714-298- ... UNII804826J2HU

9)

drugcharacterization2medicinalproductLORAZEPAM.drugstructuredosagenumb.5drugstructuredosageunit003drugdosagetextTWICE A DAYdrugindicationANXIETY

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application Number ANDA076150, NDA018140, ANDA203572, ANDA074282, ANDA072755, ANDA090260, ANDA07502 ... Brand NameLORAZEPAM, LOREEV XR, ATIVANGeneric NameLORAZEPAMManufacturers International Medication Systems, Limited, Hikma Pharmaceuticals USA Inc., Aurol ... product_ndc 76329-8261, 0641-6207, 13107-083, 13107-084, 13107-085, 0409-6778, 0054-3532, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsLORAZEPAMRXCUI 238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 2569564, 25695 ... spl_id 8b30da4f-e5a1-4e8a-9971-b5c687508d81, 4f2988b1-2854-4051-962f-07cc925608ab, 66ed ... spl_set_id 7dda070d-7809-46c4-8592-eb4e4c509707, b79b38ee-c29d-4099-964f-000031f47f5a, 5b85 ... Package NDC 76329-8261-1, 0641-6207-01, 0641-6207-25, 13107-083-11, 13107-083-01, 13107-083- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

10)

drugcharacterization2medicinalproductZANTACdrugstructuredosagenumb150drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextONE IN MORNING AND ONE IN THE EVENINGdrugdosageformTABLETdrugindicationGASTROOESOPHAGEAL REFLUX DISEASE

activesubstance

activesubstancenameRANITIDINE HYDROCHLORIDE

11)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition802drugindicationINSOMNIA

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

12)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1011625drugauthorizationnumb125057drugstructuredosagenumb80drugstructuredosageunit003drugdosageformSOLUTION FOR INJECTION IN PRE-FILLED PENdrugstartdateformat102drugstartdate09/05/2014drugenddateformat102drugenddate09/05/2014actiondrug1

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_id1b259c93-37f5-4845-92ff-224dacfe1d50spl_set_id608d4f0d-b19f-46d3-749a-7159aa5f933dPackage NDC 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-6347-02, 0074-4339- ...

13)

drugcharacterization1medicinalproductTYLENOLdrugbatchnumbUNKNOWNdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameACETAMINOPHEN

openFDA Info on Medication

Application Numberpart341, part343Brand Name TYLENOL COLD PLUS HEAD CONGESTION SEVERE, TYLENOL REGULAR STRENGTH, TYLENOL EXTR ... Generic NameACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHENManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc 50580-566, 50580-495, 50580-458, 50580-487, 50580-496, 50580-451, 50580-600, 505 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDERXCUI1243679, 209387, 313782, 198436, 1738139, 198440, 209459spl_id da433eb1-9a1d-276e-e053-2a95a90a7794, dfd72ee1-40ac-6983-e053-2995a90a4d94, da40 ... spl_set_id ce43e5c2-fe96-4462-882c-d7479318b33d, de5c6654-56c5-40d3-a286-f04ed47ac7c8, 01f4 ... Package NDC 50580-566-25, 50580-495-01, 50580-458-11, 50580-458-50, 50580-458-10, 50580-487- ... NUIN0000193956, N0000008867, N0000009560Established Pharmacologic ClassExpectorant [EPC]Physiologic/Pharmacodynamic Effect Decreased Respiratory Secretion Viscosity [PE], Increased Respiratory Secretions ... UNII362O9ITL9D, 495W7451VQ, 04JA59TNSJ

14)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1011625drugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformSOLUTION FOR INJECTION IN PRE-FILLED PENactiondrug1

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_id1b259c93-37f5-4845-92ff-224dacfe1d50spl_set_id608d4f0d-b19f-46d3-749a-7159aa5f933dPackage NDC 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-6347-02, 0074-4339- ...

15)

drugcharacterization2medicinalproductATACANDdrugstructuredosagenumb4drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextTWO IN MORNING + ONE IN THE EVENINGdrugindicationHYPERTENSION

activesubstance

activesubstancenameCANDESARTAN CILEXETIL

openFDA Info on Medication

Application NumberNDA020838Brand NameATACANDGeneric NameCANDESARTAN CILEXETILManufacturersANI Pharmaceuticals, Inc.product_ndc62559-640, 62559-641, 62559-642, 62559-643Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCANDESARTAN CILEXETILRXCUI153822, 153823, 577776, 577785, 577787, 639537, 639539, 639543spl_id690e8be9-d5c7-457b-a24e-9f5479d63562spl_set_id94a59260-d2b6-464a-b5b9-bbc599e57e10Package NDC 62559-640-30, 62559-641-30, 62559-642-30, 62559-642-90, 62559-643-30, 62559-643- ... UNIIR85M2X0D68

summary

narrativeincludeclinicalCASE EVENT DATE: 2014