Adverse Event Report

Report

reporttype2receiptdateformat102companynumbUS-ALEXION-A201401145occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10062144Date Received07/04/2014transmissiondate12/12/2014serious2Date Last Updated07/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

SexUnknown

Reaction

1)

reactionmeddraversionpt17.0ReactionHyperplasiaOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionPain in extremityOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionHeadacheOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionAbdominal painOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductSOLIRISdrugauthorizationnumb125166drugstructuredosagenumb900drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosagetext900 MG, Q2WdrugdosageformCONCENTRATE FOR SOLUTION FOR INFUSIONdrugadministrationroute042drugindicationPAROXYSMAL NOCTURNAL HAEMOGLOBINURIAdrugstartdateformat102drugstartdate06/03/2008actiondrug4

openFDA Info on Medication

Application NumberBLA125166Brand NameSOLIRISGeneric NameECULIZUMABManufacturersAlexion Pharmaceuticals Inc.product_ndc25682-001Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsECULIZUMABRXCUI700384, 700387spl_id1677eecc-45b6-46eb-bd25-a1b0c8ae268espl_set_idebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722Package NDC25682-001-01NUIN0000175575, N0000175974Established Pharmacologic ClassComplement Inhibitor [EPC]Mechanism of ActionComplement Inhibitors [MoA]UNIIA3ULP0F556

2)

drugcharacterization2medicinalproductADDERALLdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, TIDdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/01/2009

openFDA Info on Medication

Application NumberANDA040422, NDA021303Brand NameADDERALL, ADDERALL XRGeneric Name DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, ... ManufacturersTeva Pharmaceuticals USA, Inc., Takeda Pharmaceuticals America, Inc.product_ndc 57844-105, 57844-117, 57844-110, 57844-112, 57844-115, 57844-120, 57844-130, 540 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive Ingredients DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMI ... RXCUI 541363, 541365, 541878, 541879, 541892, 541894, 577957, 577960, 577961, 577962, ... spl_ide9cd0754-917c-4545-8963-e0b5b8fe544a, 05c01190-093d-41b3-8fe6-4ad8d6e2aee3spl_set_idf22635fe-821d-4cde-aa12-419f8b53db81, aff45863-ffe1-4d4f-8acf-c7081512a6c0Package NDC 57844-105-01, 57844-117-01, 57844-110-01, 57844-112-01, 57844-115-01, 57844-120- ... UNII6DPV8NK46S, G83415V073, O1ZPV620O4, JJ768O327N

3)

drugcharacterization2medicinalproductHYDROCODONEdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition801drugdosagetext10/325MG, PRNdrugadministrationroute065drugindicationPAINdrugstartdateformat102drugstartdate01/01/2009

4)

drugcharacterization2medicinalproductMETHADONEdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, QDdrugadministrationroute065drugindicationPAINdrugstartdateformat102drugstartdate01/01/2009

openFDA Info on Medication

Application NumberANDA204166Brand NameMETHADONE HYDROCHLORIDEGeneric NameMETHADONEManufacturersVistaPharm, Inc.product_ndc66689-836Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETHADONE HYDROCHLORIDERXCUI864706spl_id00594a6e-2875-4640-95cc-e8bcff7541bcspl_set_id4a44bde6-c348-4316-b0e0-c24b407cb823Package NDC66689-836-99UNII229809935B

5)

drugcharacterization2medicinalproductXANAXdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, TIDdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/01/2009

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia and Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_iddfdda989-af0a-4c14-871c-b26b7b6da50e, d95506a3-aba6-47f4-83c4-443a4cce678bspl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

6)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, BIDdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/01/2009

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

7)

drugcharacterization2medicinalproductTESTOSTERONEdrugdosagetextUNKdrugadministrationroute058drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/01/2013

openFDA Info on Medication

Application Number NDA022309, ANDA205781, ANDA204268, ANDA210835, ANDA076737, ANDA208620, ANDA07674 ... Brand Name ANDROGEL, TESTOSTERONE, VOGELXO, TESTIM, ANDRODERM, FORTESTA, TESTOSTERONE 12.5 ... Generic Name TESTOSTERONE, AVENA SATIVA, BARYTA CARBONICA, CARDUUS MAR, DAMIANA, HAMAMELIS VI ... Manufacturers AbbVie Inc., Zydus Pharmaceuticals USA Inc, Perrigo New York Inc, Xiromed, LLC, ... product_ndc 0051-8462, 68382-362, 45802-281, 45802-754, 45802-366, 70700-112, 0591-2921, 059 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteTRANSDERMAL, TOPICAL, ORAL, SUBCUTANEOUS, NASALActive Ingredients TESTOSTERONE, AVENA SATIVA FLOWERING TOP, BARIUM CARBONATE, MILK THISTLE, TURNER ... RXCUI 1597075, 1597076, 1597120, 1597121, 1597126, 1597127, 1596780, 1597123, 1597129, ... spl_id 82f7abad-fc55-fb9a-dd1a-a7078ed950b1, 52cc0e06-8081-21e1-e3f6-cebcda7bc3f8, 51e4 ... spl_set_id 8677ba5b-8374-46cb-854c-403972e9ddf3, 13c89fbb-f8e7-1f70-ef5a-468b90efb933, 54fc ... Package NDC 0051-8462-33, 0051-8462-12, 0051-8462-31, 0051-8462-01, 0051-8462-30, 68382-362- ... NUIN0000175824, N0000000146, M0001109Established Pharmacologic ClassAndrogen [EPC]Mechanism of ActionAndrogen Receptor Agonists [MoA]Chemical StructureAndrostanes [CS]UNII 3XMK78S47O, MA9CQJ3F7F, 6P669D8HQ8, U946SH95EE, RQ2CFA7WWJ, T7S323PKJS, 6EC706HI ...

8)

drugcharacterization2medicinalproductFOLIC ACIDdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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)

drugcharacterization2medicinalproductMULTIVITAMIN /00097801/drugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

Report Duplicate

duplicatesourceALEXIONduplicatenumbUS-ALEXION-A201401145