Adverse Event Report

Report

reporttype2Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10053894serious1Date Last Updated02/04/2014receiptdateformat102companynumbCO-ABBVIE-14P-036-1219642-00occurcountryCOduplicate1Date Received02/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryCO

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification5

Patient

Onset Age51Unit of Onset AgeyearsWeight65SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionCardiac disorderOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionPneumoniaOutcomeRecovering/resolving

3)

reactionmeddraversionpt17.0ReactionUrinary tract infectionOutcomeRecovering/resolving

4)

reactionmeddraversionpt17.0ReactionOedema peripheralOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumbUNKNOWNdrugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformSolution for injection in pre-filled syringedrugadministrationroute058drugindicationRHEUMATOID ARTHRITISdrugstartdateformat102drugstartdate14/05/2013drugenddateformat102drugenddate28/02/2014actiondrug1

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)

drugcharacterization2medicinalproductCLONAZEPAMdrugdosagetext10 DROOPS PER DAYdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA077171, ANDA074569, ANDA074869, ANDA077194, ANDA077147, ANDA074979, ANDA2110 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Par Pharmaceutical, Inc., Teva Pharmaceuticals USA, Inc., Actavis Pharma, Inc., ... product_ndc 49884-306, 49884-307, 49884-308, 49884-309, 49884-310, 0093-0832, 0093-3212, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_id a95f8799-0bb3-41d6-aa27-8a291127ad54, 90dc0b61-37a3-4e54-bde3-7e4c3f7dae98, 9b58 ... spl_set_id 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069b1a0-7c06-4252-b44e-e2eef065d9b8, a58f ... Package NDC 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02, 0093-0832- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

3)

drugcharacterization2medicinalproductOMEPRAZOLEdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA075757, ANDA206877, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, AC ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., OHM ... product_ndc 46122-281, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 62175-136, 078 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, 8c9d9c38-9da6-4f99-9f08-26ec4693fa55, ce5c ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c ... Package NDC 46122-281-04, 46122-281-74, 63981-915-55, 57483-740-01, 57483-740-42, 51660-029- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

4)

drugcharacterization2medicinalproductOXYBUTYNINdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA202332, NDA021351, NDA202211Brand NameOXYBUTYNIN, OXYTROL, OXYTROL FOR WOMENGeneric NameOXYBUTYNINManufacturersZydus Pharmaceuticals (USA) Inc., Cadila Healthcare Limited, Allergan, Inc.product_ndc 68382-255, 68382-256, 68382-257, 70771-1086, 70771-1087, 70771-1088, 0023-6153, ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORAL, TRANSDERMALActive IngredientsOXYBUTYNIN CHLORIDE, OXYBUTYNINRXCUI863619, 863628, 863636, 403799, 404448spl_id abd28f4e-f15d-401c-8541-96bb308bf94c, 38ac4e71-8edf-4dd1-ba35-8e84006d4b48, 603f ... spl_set_id c042bf06-79a3-4dc7-ae05-3ef3cfae9d44, f405a774-bd91-4513-b7c7-c44f0596d988, 20de ... Package NDC 68382-255-06, 68382-255-14, 68382-255-16, 68382-255-01, 68382-255-05, 68382-255- ... UNIIL9F3D9RENQ, K9P6MC7092NUIN0000175700, N0000000125Established Pharmacologic ClassCholinergic Muscarinic Antagonist [EPC]Mechanism of ActionCholinergic Muscarinic Antagonists [MoA]

5)

drugcharacterization2medicinalproductVALPROIC ACIDdrugdosagetext3 TABLET PER DAYdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA207611, ANDA077960, ANDA073484, ANDA073229, ANDA074060, ANDA070868, ANDA0753 ... Brand NameVALPROIC ACID, VALPROICGeneric NameVALPROIC ACIDManufacturers Eywa Pharma Inc, Lannett Company, Inc., Bionpharma Inc., Upsher-Smith Laboratori ... product_ndc 71930-057, 0527-5250, 69452-150, 0832-0310, 50383-792, 63739-253, 60432-621, 059 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVALPROIC ACIDRXCUI1099681, 1099687spl_id 06a8321c-d852-4000-9c8d-01cddb9fe6d1, c72bdbdd-4aac-46ad-95a7-4d79690e9031, b7b0 ... spl_set_id dcce9cbd-ab6d-4ddf-b638-74e336ebc3d8, 027c77dd-3051-4beb-b132-f73d6c165529, ceb5 ... Package NDC 71930-057-12, 0527-5250-70, 69452-150-20, 0832-0310-11, 50383-792-16, 50383-792- ... NUIN0000175753, N0000008486, N0000175751Established Pharmacologic ClassAnti-epileptic Agent [EPC], Mood Stabilizer [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII614OI1Z5WI

6)

drugcharacterization2medicinalproductPREDNISOLONEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA040401, ANDA080354, ANDA202179, ANDA040775Brand NamePREDNISOLONE, MILLIPRED, PREDNISOLONE SODIUM PHOSPHATEGeneric NamePREDNISOLONEManufacturers Hi-Tech Pharmacal Co., Inc., Aytu Therapeutics, Mylan Pharmaceuticals Inc., Lann ... product_ndc50383-042, 23594-505, 0378-4710, 0378-4715, 0378-4730, 0527-5406Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISOLONE, PREDNISOLONE SODIUM PHOSPHATERXCUI 283077, 198142, 808118, 1005830, 1005831, 1013114, 1235042, 643123, 643125, 6431 ... spl_id c4cdae5e-103f-47b3-90b9-8797c544136e, 53c7d3cf-3691-4150-b720-d592931737db, 13ad ... spl_set_id 6b201232-4a52-487c-b963-a98539469e5d, 863ad743-eec0-46f0-beba-c1556384c636, f658 ... Package NDC 50383-042-48, 50383-042-24, 23594-505-01, 23594-505-50, 23594-505-02, 23594-505- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII9PHQ9Y1OLM, IV021NXA9J

7)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

8)

drugcharacterization2medicinalproductRISPERIDONEdrugdosagetext3 TABLET PER DAYdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA077328, ANDA202386, ANDA076904, NDA020588, ANDA078116, ANDA079088, ANDA07851 ... Brand NameRISPERIDONE, PERSERIS, RISPERDAL, RISPERDAL M-TAB, RISPERDAL CONSTAGeneric NameRISPERIDONEManufacturers Dr. Reddy's Laboratories Limited, Lannett Company, Inc., Hikma Pharmaceuticals U ... product_ndc 55111-207, 55111-208, 55111-209, 55111-470, 55111-471, 54838-563, 0054-0063, 504 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, SUBCUTANEOUSActive IngredientsRISPERIDONERXCUI 401953, 401954, 403825, 616698, 616705, 199387, 312828, 312829, 312830, 312831, ... spl_id 9293825e-f154-ffc9-20b0-5846d813b7ec, 95f6336f-cac0-40b5-a7ad-29df965445a1, af95 ... spl_set_id c00809e1-e632-f246-97d9-73e1f9804587, 1219dff4-0320-4530-b1ad-b6ecdac376cf, cd74 ... Package NDC 55111-207-81, 55111-207-78, 55111-207-79, 55111-208-81, 55111-208-78, 55111-208- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIL6UH7ZF8HC

9)

drugcharacterization2medicinalproductPOLYETHYLENEGLYCOLdrugdosagetext1 PACKET PER DAYdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

10)

drugcharacterization2medicinalproductCOLCHICINEdrugdosagetext2 TABLET PER DAYdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number NDA210942, ANDA211250, NDA022352, ANDA204711, NDA204820, ANDA204461, ANDA209876, ... Brand NameGLOPERBA, COLCHICINE, MITIGARE, COLCRYSGeneric NameCOLCHICINEManufacturers Avion Pharmaceuticals, LLC, Ascend Laboratories, LLC, Prasco Laboratories, Amnea ... product_ndc 75854-801, 67877-589, 66993-165, 65162-710, 59467-318, 0591-2562, 0254-2008, 435 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCOLCHICINE, COLCHICEINERXCUI2118892, 2180558, 197541, 1550940, 1550946, 858071spl_id b85547d8-fce6-323d-e053-2995a90a4e7e, 1c0075d8-6ecc-40f1-ae48-09f69f18ae2e, c890 ... spl_set_id 8f9ba661-b7aa-11fc-e053-2995a90a0bd1, a4284783-fea6-4af2-9a8d-79c929176c05, 153f ... Package NDC 75854-801-01, 67877-589-30, 67877-589-60, 67877-589-01, 67877-589-86, 67877-589- ... NUIN0000182141, N0000000239Mechanism of ActionCytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Interactions [MoA]UNIISML2Y3J35T, HJ30158L57

11)

drugcharacterization2medicinalproductLEVETIRACETAMdrugstructuredosagenumb500drugstructuredosageunit003drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA202869, ANDA090515, ANDA078904, NDA021872, ANDA091399, ANDA078858, ANDA07810 ... Brand Name LEVETIRACETAM, KEPPRA, LEVETIRACETAM LEVETIRACETAM, ROWEEPRA, LEVETIRACETAM EXTE ... Generic NameLEVETIRACETAM, LEVETIRACETAM INJECTIONManufacturers Hospira, Inc., NorthStar RxLLC, Dr. Reddy's Laboratories Limited, UCB, Inc., Lup ... product_ndc 0409-1886, 16714-035, 55111-248, 50474-002, 68180-117, 68180-118, 13668-014, 136 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORAL, INTRAVASCULARActive IngredientsLEVETIRACETAMRXCUI 647121, 311289, 387003, 647123, 807832, 846378, 311288, 311290, 403884, 1875868, ... spl_id 3570b20d-b176-4f93-8e99-e7d71de7786b, 3884cb76-822b-400d-9b24-49c286c9b6f7, 1b3a ... spl_set_id 56de8d14-7860-4b3a-944c-a5c8f34a0935, 3884cb76-822b-400d-9b24-49c286c9b6f7, 1f3c ... Package NDC 0409-1886-15, 0409-1886-05, 16714-035-01, 16714-035-02, 55111-248-30, 55111-248- ... NUIN0000008486Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII44YRR34555

Report Duplicate

duplicatesourceABBVIEduplicatenumbCO-ABBVIE-14P-036-1219642-00

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use