Adverse Event Report

Report

reporttype2Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID11108865serious1Date Last Updated02/07/2015receiptdateformat102companynumbUS-ALEXION-A201501603occurcountryUSduplicate1Date Received13/05/2015seriousnesshospitalization1transmissiondate25/11/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age20Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionChronic kidney diseaseOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductNIFEDIPINE.drugstructuredosagenumb90drugstructuredosageunit003drugdosagetext90 MG, UNKdrugadministrationroute048drugindicationHYPERTENSIONdrugenddateformat102drugenddate17/12/2014

activesubstance

activesubstancenameNIFEDIPINE

openFDA Info on Medication

Application Number ANDA075269, ANDA210184, ANDA212016, ANDA075289, ANDA202644, ANDA074045, ANDA2031 ... Brand NameNIFEDIPINE, PROCARDIA XL, PROCARDIAGeneric NameNIFEDIPINEManufacturers Oceanside Pharmaceuticals, Cadila Healthcare Limited, Elite pharmaceutical Techn ... product_ndc 68682-105, 70771-1365, 70771-1366, 70771-1367, 72214-503, 68682-106, 68682-108, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNIFEDIPINERXCUI 198034, 198035, 198036, 1812015, 1812011, 1812013, 198032, 198033, 207772, 20777 ... spl_id 64ad6e32-2e35-4042-ad92-cd44e38b32fc, cdd27f39-5dcc-4792-bd9d-f9450ae318aa, 279a ... spl_set_id cb051508-60f3-4b89-9da0-5261024bd7f4, 925e2ea9-f51a-4b89-ab5d-ce590b6c4d85, 1c02 ... Package NDC 68682-105-10, 68682-105-30, 70771-1365-9, 70771-1365-1, 70771-1365-7, 70771-1365 ... NUIN0000000069, N0000175421, M0006414Mechanism of ActionCalcium Channel Antagonists [MoA]Established Pharmacologic ClassDihydropyridine Calcium Channel Blocker [EPC]Chemical StructureDihydropyridines [CS]UNIII9ZF7L6G2L

2)

drugcharacterization2medicinalproductRENVELAdrugstructuredosagenumb800drugstructuredosageunit003drugdosagetext800 MG, UNKdrugadministrationroute048drugindicationRENAL TRANSPLANTdrugenddateformat102drugenddate17/12/2014

activesubstance

activesubstancenameSEVELAMER CARBONATE

openFDA Info on Medication

Application NumberNDA022127, NDA022318Brand NameRENVELAGeneric NameSEVELAMER CARBONATEManufacturersGenzyme Corporationproduct_ndc58468-0130, 58468-0131, 58468-0132Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSEVELAMER CARBONATERXCUI749206, 749210, 861370, 861373, 861375, 861377spl_id1dc91d65-9867-4e1c-b780-cfff471f3757spl_set_ide6328460-a57b-450b-a48c-6dcd4b476360Package NDC 58468-0130-1, 58468-0130-2, 58468-0131-1, 58468-0131-2, 58468-0131-3, 58468-0131 ... UNII9YCX42I8IU

3)

drugcharacterization2medicinalproductATIVANdrugstructuredosagenumb.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition801drugdosagetext0.5 MG, Q12HRS PRNdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application NumberNDA017794, NDA018140Brand NameATIVANGeneric NameLORAZEPAMManufacturersBausch Health US LLC, West-Ward Pharmaceuticals Corp.product_ndc0187-0063, 0187-0064, 0187-0065, 0641-6000, 0641-6001, 0641-6003, 0641-6002Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsLORAZEPAMspl_idb87ffa4d-6634-4d66-a907-3eba6911444c, 30a1b292-640f-477d-b193-f564e84d0436spl_set_id89057c93-8155-4040-acec-64e877bd2b4c, 5fc0e987-61c9-40c4-b0d5-fcea07c8733ePackage NDC 0187-0063-01, 0187-0063-50, 0187-0063-10, 0187-0064-01, 0187-0064-50, 0187-0064- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769LRXCUI206819, 206820, 238100, 238101, 1665188, 1665190, 1665326, 1665327

4)

drugcharacterization2medicinalproductEPOGENdrugdosagetextUNKdrugadministrationroute058drugindicationRENAL TRANSPLANTdrugenddateformat102drugenddate17/12/2014

activesubstance

activesubstancenameERYTHROPOIETIN

openFDA Info on Medication

Application NumberBLA103234Brand NameEPOGENGeneric NameEPOETIN ALFAManufacturersAmgen Incproduct_ndc55513-126, 55513-267, 55513-148, 55513-144, 55513-283, 55513-478Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, SUBCUTANEOUSActive IngredientsERYTHROPOIETINRXCUI 205912, 205917, 205921, 205923, 212218, 239998, 239999, 240000, 240377, 241999, ... spl_idcaa3eb25-7790-4904-b1fa-2fe3469c784cspl_set_id1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5Package NDC 55513-126-01, 55513-126-10, 55513-267-01, 55513-267-10, 55513-148-01, 55513-148- ... NUIN0000175665, M0007726, N0000009319Established Pharmacologic ClassErythropoiesis-stimulating Agent [EPC]Chemical StructureErythropoietin [CS]Physiologic/Pharmacodynamic EffectIncreased Erythroid Cell Production [PE]UNII64FS3BFH5W

5)

drugcharacterization2medicinalproductVENOFERdrugdosagetextUNKdrugadministrationroute042drugindicationMINERAL SUPPLEMENTATIONdrugenddateformat102drugenddate17/12/2014

activesubstance

activesubstancenameIRON SUCROSE

openFDA Info on Medication

Application NumberNDA021135Brand NameVENOFERGeneric NameIRON SUCROSEManufacturersFresenius Medical Care Holdings, Inc., American Regent, Inc.product_ndc49230-530, 49230-534, 0517-2310, 0517-2325, 0517-2340Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsIRON SUCROSERXCUI1741267, 1741268, 1741270, 1741271, 1741261, 1741263spl_id 60feb53c-6515-42f7-9ea1-8914713097f8, 3e5dd5d5-cf59-4dcc-a077-e7b9bbbd2847, 9968 ... spl_set_id f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040, 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a, b998 ... Package NDC 49230-530-01, 49230-530-10, 49230-530-25, 49230-534-01, 49230-534-10, 49230-534- ... NUIM0011718, N0000177913Chemical StructureIron [CS]Established Pharmacologic ClassParenteral Iron Replacement [EPC]UNIIFZ7NYF5N8L

6)

drugcharacterization2medicinalproductPEPCIDdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb12drugintervaldosagedefinition805drugdosagetext20 MG, Q12Hdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameFAMOTIDINE

openFDA Info on Medication

Application NumberNDA019527, ANDA075805Brand NamePEPCIDGeneric NameFAMOTIDINEManufacturersSalix Pharmaceuticals, Inc, Bausch Health Americas Inc.product_ndc65649-211, 0187-4420, 0187-4440Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFAMOTIDINERXCUI206873, 310274, 104094, 104095, 284245, 310273spl_id9e8f6a6d-4f04-4201-8d8e-802f08125adc, 117ab388-f0c2-4d9b-9cd0-1b7c478a665cspl_set_id4f1a0b58-f7c8-485e-a317-432e1c374d2f, a06502d9-7903-4f37-833e-e5763d502defPackage NDC65649-211-24, 0187-4420-30, 0187-4420-10, 0187-4440-30, 0187-4440-10NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]UNII5QZO15J2Z8

7)

drugcharacterization2medicinalproductFIBERCONdrugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 TAB, TIDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameCALCIUM POLYCARBOPHIL

openFDA Info on Medication

Application Numberpart334Brand NameFIBERCONGeneric NameCALCIUM POLYCARBOPHILManufacturersWyeth Pharmaceutical Division of Wyeth Holdings LLCproduct_ndc0005-2500Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCALCIUM POLYCARBOPHILRXCUI210665, 308934spl_id8476c4ce-d8cd-4cdf-9482-3e6b193bec03spl_set_id80e507f2-d9bd-bc7b-2249-f5bfc8ac1845Package NDC0005-2500-02, 0005-2500-33, 0005-2500-23UNII8F049NKY49

8)

drugcharacterization2medicinalproductGENTAMYCIN /00047101/drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK, QDdrugadministrationroute061drugindicationPROPHYLAXIS

activesubstance

activesubstancenameGENTAMICIN

9)

drugcharacterization2medicinalproductNYSTATIN.drugstructuredosagenumb1drugstructuredosageunit012drugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 ML, QIDdrugadministrationroute048drugindicationPROPHYLAXIS

activesubstance

activesubstancenameNYSTATIN

openFDA Info on Medication

Application Number ANDA203621, ANDA064142, ANDA211838, ANDA062124, ANDA062838, ANDA065148, ANDA0651 ... Brand NameNYSTATIN, NYAMYC, NYSTOPGeneric NameNYSTATIN, NYSTATIN ORAL SUSPENSION, NYSTATIN OINTMENT, NYSTATIN CREAMManufacturers Pharmaceutical Associates, Inc., VistaPharm, Inc., Torrent Pharmaceuticals Limit ... product_ndc 0121-0810, 0121-4810, 66689-037, 13668-534, 0168-0007, 53489-400, 80432-003, 083 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, TOPICALActive IngredientsNYSTATINRXCUI312055, 884308, 312059, 584414, 646456, 543546, 261178spl_id a9034435-e353-7bf6-e053-2995a90a4867, 91e9fe62-a1e7-46e6-8357-cdc2a93cc62f, bede ... spl_set_id 31e3da10-5a7b-4bc5-8a4f-3e786b64c13a, 41034d7b-33a1-4d6d-b425-9cfefff8d518, 4949 ... Package NDC 0121-0810-02, 0121-0810-16, 0121-4810-05, 0121-4810-40, 0121-4810-00, 0121-4810- ... NUIN0000175498, M0017172Established Pharmacologic ClassPolyene Antifungal [EPC]Chemical StructurePolyenes [CS]UNIIBDF1O1C72E

10)

drugcharacterization2medicinalproductZESTRILdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKdrugadministrationroute048drugindicationHYPERTENSIONdrugenddateformat102drugenddate17/12/2014

activesubstance

activesubstancenameLISINOPRIL

openFDA Info on Medication

Application NumberNDA019777Brand NameZESTRILGeneric NameLISINOPRILManufacturersAlmatica Pharma LLCproduct_ndc52427-438, 52427-439, 52427-440, 52427-441, 52427-442, 52427-443Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 104375, 104376, 104377, 104378, 197884, 205326, 206771, 213482, 311353, 311354, ... spl_id9d575dfd-e478-8637-357c-b1bb89a4678aspl_set_ida95727ae-2bf1-e675-4a36-71043a8af3b8Package NDC 52427-438-90, 52427-439-90, 52427-440-90, 52427-441-90, 52427-442-90, 52427-443- ... UNIIE7199S1YWR

11)

drugcharacterization2medicinalproductCOREGdrugstructuredosagenumb12.5drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext12.5 MG, BIDdrugadministrationroute048drugindicationBLOOD PRESSURE MEASUREMENT

activesubstance

activesubstancenameCARVEDILOL

openFDA Info on Medication

Application NumberNDA022012, NDA020297Brand NameCOREG CR, COREGGeneric NameCARVEDILOL PHOSPHATE, CARVEDILOLManufacturersGlaxoSmithKline LLCproduct_ndc 0007-3370, 0007-3371, 0007-3372, 0007-3373, 0007-3383, 0007-3385, 0007-3387, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCARVEDILOL PHOSPHATE, CARVEDILOLRXCUI 860510, 860512, 860516, 860518, 860522, 860524, 860532, 860534, 200031, 200032, ... spl_idfa474dd1-fddd-4f3b-9ac6-338b160458ee, d1eb3353-1a6e-4fa8-ae95-7a3e94ee1da8spl_set_id06400a4c-42b4-440a-92b4-1f47f98ac7ba, c57982f2-c7da-488a-7ea9-b9609439ac68Package NDC 0007-3370-13, 0007-3371-13, 0007-3372-13, 0007-3373-13, 0007-3373-61, 0007-3383- ... UNIIEQT531S367, 0K47UL67F2NUIN0000000099, N0000009923, N0000009924, N0000175553, N0000175556Mechanism of Action Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenerg ... Established Pharmacologic Classalpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]

12)

drugcharacterization2medicinalproductDAPSONE.drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, QDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameDAPSONE

openFDA Info on Medication

Application Number NDA207154, ANDA206505, ANDA086841, ANDA086842, ANDA204074, ANDA209506, ANDA21019 ... Brand NameDAPSONE, ACZONE, ACZONE 7.5Generic NameDAPSONEManufacturers Taro Pharmaceuticals U.S.A., Inc., Almirall, LLC, Novitium Pharma LLC, Seton Pha ... product_ndc 51672-5307, 16110-526, 70954-135, 70954-136, 13925-504, 13925-505, 69543-150, 69 ... Product TypeHUMAN PRESCRIPTION DRUGRouteTOPICAL, ORALActive IngredientsDAPSONERXCUI1741905, 1741907, 197557, 197558, 607295, 701858spl_id 64935595-1b17-44b1-831c-2bbbe5aaa520, fe7553ec-43ac-4528-81a9-1921282b0741, 57a4 ... spl_set_id ec99b115-d163-4145-8c76-cb1a008305a4, 22058b7d-a578-4eaa-a476-ac982337f02a, 57a4 ... Package NDC 51672-5307-3, 51672-5307-8, 16110-526-30, 16110-526-60, 16110-526-90, 70954-135- ... NUIN0000175881, M0020791Established Pharmacologic ClassSulfone [EPC]Chemical StructureSulfones [CS]UNII8W5C518302

13)

drugcharacterization2medicinalproductDSSdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb12drugintervaldosagedefinition805drugdosagetext200 MG, Q12Hdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameDOCUSATE SODIUM

14)

drugcharacterization1medicinalproductECULIZUMABdrugauthorizationnumb125166drugstructuredosagenumb1200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosagetext1200 MG, Q2WdrugdosageformCONCENTRATE FOR SOLUTION FOR INFUSIONdrugadministrationroute042drugstartdateformat102drugstartdate06/05/2013actiondrug4

activesubstance

activesubstancenameECULIZUMAB

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

15)

drugcharacterization2medicinalproductVITAMIN D3drugdosagetext1000 UT, UNKdrugadministrationroute048drugindicationSUPPLEMENTATION THERAPYdrugenddateformat102drugenddate17/12/2014

activesubstance

activesubstancenameCHOLECALCIFEROL

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

16)

drugcharacterization1medicinalproductECULIZUMABdrugauthorizationnumb125166drugstructuredosagenumb900drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext900 MG, QWdrugdosageformCONCENTRATE FOR SOLUTION FOR INFUSIONdrugadministrationroute042drugindicationHAEMOLYTIC URAEMIC SYNDROMEdrugstartdateformat102drugstartdate08/04/2013drugenddateformat102drugenddate29/04/2013actiondrug4

activesubstance

activesubstancenameECULIZUMAB

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

17)

drugcharacterization2medicinalproductASPIRIN /00002701/drugstructuredosagenumb81drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext81 MG, QDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameASPIRIN

18)

drugcharacterization2medicinalproductDIPHENHYDRAMINE.drugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition801drugdosagetext25 MG, Q6HRS PRNdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameDIPHENHYDRAMINE

openFDA Info on Medication

Application Numberpart341, ANDA205723, ANDA040466Brand NameNIGHTIME SLEEP AID, DIPHENHYDRAMINEGeneric NameDIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HCLManufacturers Velocity Pharma, AAA Pharmaceutical, Inc., Safetec of America, Inc., Micro Labs ... product_ndc76168-065, 57344-090, 61010-4409, 42571-169, 42571-337, 68196-929, 63323-664Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsDIPHENHYDRAMINE HYDROCHLORIDERXCUI1020477, 1049630, 1049909, 1723740spl_id 6cbc010f-0449-cb45-e053-2a91aa0a1ec6, 94e265d8-7fba-2ee9-e053-2a95a90a4993, 8909 ... spl_set_id 9c44e54f-d8bc-4451-8382-40d2e8e03b42, 76724432-ff3c-404f-ba1f-5af68e3ab8c4, ef6b ... Package NDC 76168-065-37, 57344-090-02, 57344-090-03, 61010-4409-0, 61010-4409-1, 61010-4409 ... UNIITC2D6JAD40

19)

drugcharacterization2medicinalproductLEVORA /00022701/drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 TAB, QDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

20)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, QHSdrugadministrationroute048drugindicationDEPRESSION

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20141211

Report Duplicate

duplicatesourceALEXIONduplicatenumbUS-ALEXION-A201501603

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use