Report

reporttype1receiptdateformat102companynumbUS-INCYTE CORPORATION-2012IN000665occurcountryUSVersion of Safety Report ID2receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10008880Date Received12/03/2014transmissiondate02/10/2014serious2Date Last Updated12/03/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age71Unit of Onset AgeyearsWeight78.46SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionPruritus generalisedOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionTherapeutic response unexpectedOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionRashOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionPyrexiaOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionHot flushOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionNight sweatsOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt17.0ReactionCoughOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt17.0ReactionStomatitisOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt17.0ReactionNauseaOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt17.0ReactionVomitingOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt17.0ReactionDry skinOutcomeUnknown

12)

reactionmeddraversionpt17.0ReactionConstipationOutcomeNot recovered/not resolved

13)

reactionmeddraversionpt17.0ReactionDiarrhoeaOutcomeNot recovered/not resolved

14)

reactionmeddraversionpt17.0ReactionInsomniaOutcomeUnknown

15)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeUnknown

16)

reactionmeddraversionpt17.0ReactionHypoaesthesiaOutcomeNot recovered/not resolved

17)

reactionmeddraversionpt17.0ReactionParaesthesiaOutcomeNot recovered/not resolved

18)

reactionmeddraversionpt17.0ReactionWeight increasedOutcomeNot recovered/not resolved

19)

reactionmeddraversionpt17.0ReactionAnaemiaOutcomeNot recovered/not resolved

20)

reactionmeddraversionpt17.0ReactionHeadacheOutcomeNot recovered/not resolved

21)

reactionmeddraversionpt17.0ReactionPlatelet count decreasedOutcomeRecovered/resolved

22)

reactionmeddraversionpt17.0ReactionContusionOutcomeUnknown

23)

reactionmeddraversionpt17.0ReactionDysphagiaOutcomeUnknown

24)

reactionmeddraversionpt17.0ReactionDepression

Drug

1)

drugcharacterization1medicinalproductJAKAFIdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, BIDdrugdosageformTABLETdrugadministrationroute048drugindicationMYELOFIBROSISdrugstartdateformat102drugstartdate19/01/2012drugenddateformat102drugenddate13/02/2012actiondrug2

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Application NumberNDA202192Brand NameJAKAFIGeneric NameRUXOLITINIBManufacturersIncyte Corporationproduct_ndc50881-005, 50881-010, 50881-015, 50881-020, 50881-025Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRUXOLITINIBRXCUI 1193331, 1193337, 1193339, 1193341, 1193343, 1193345, 1193347, 1193349, 1193351, ... spl_id1cf98918-4377-4b1b-8b2f-1ae23681d1d2spl_set_idf1c82580-87ae-11e0-bc84-0002a5d5c51bPackage NDC 50881-005-60, 50881-010-01, 50881-010-60, 50881-015-60, 50881-020-60, 50881-025- ... NUIN0000175605, N0000175076Established Pharmacologic ClassKinase Inhibitor [EPC]Mechanism of ActionProtein Kinase Inhibitors [MoA]UNII82S8X8XX8H

2)

drugcharacterization1medicinalproductJAKAFIdrugstructuredosagenumb15drugstructuredosageunit003drugdosagetext15 MG, BIDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate14/02/2012drugenddateformat102drugenddate30/04/2012actiondrug2

openFDA Info on Medication

3)

drugcharacterization1medicinalproductJAKAFIdrugstructuredosagenumb15drugstructuredosageunit003drugdosagetext15 MG, QD IN THE MORNINGdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate01/05/2012drugenddateformat102drugenddate15/05/2012actiondrug2

openFDA Info on Medication

4)

drugcharacterization1medicinalproductJAKAFIdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, QD IN THE EVENINGdrugdosageformTABLETdrugstartdateformat102drugstartdate01/05/2012drugenddateformat102drugenddate15/05/2012actiondrug2

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5)

drugcharacterization1medicinalproductJAKAFIdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, BIDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate16/05/2012actiondrug2

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6)

drugcharacterization2medicinalproductXYZAL

openFDA Info on Medication

Application NumberNDA022064, NDA022157Brand NameXYZALGeneric NameLEVOCETIRIZINE DIHYDROCHLORIDEManufacturersSanofi-Aventis U.S. LLCproduct_ndc0024-5803, 0024-5804Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOCETIRIZINE DIHYDROCHLORIDERXCUI855168, 855170, 855172, 855174spl_ide96c760a-8427-4e90-a3fd-5bc091016a3aspl_set_ida6ca9f62-c065-4eda-bf95-97165cdd5fecPackage NDC0024-5803-90, 0024-5804-05UNIISOD6A38AGA

7)

drugcharacterization2medicinalproductATARAX

8)

drugcharacterization2medicinalproductAMITRIPTYLINE

9)

drugcharacterization2medicinalproductCETAPHIL

openFDA Info on Medication

Application Numberpart352Brand NameCETAPHILGeneric NameOCTOCRYLENE, AVOBENZONEManufacturersGalderma Laboratories, L.P.product_ndc0299-3928Product TypeHUMAN OTC DRUGRouteTOPICALActive IngredientsOCTOCRYLENE, AVOBENZONEspl_idc2a0ae50-a8b1-4ccd-b8b0-4b35234c4168spl_set_id2a6bc3f2-4e52-252b-d051-94be1ee0cc00Package NDC0299-3928-04UNII5A68WGF6WM, G63QQF2NOX

10)

drugcharacterization2medicinalproductTRIAMCINOLONEdrugadministrationroute061

11)

drugcharacterization2medicinalproductARANESPdrugindicationANAEMIA

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Application NumberBLA103951Brand NameARANESPGeneric NameDARBEPOETIN ALFAManufacturersAmgen Incproduct_ndc 55513-002, 55513-098, 55513-006, 55513-110, 55513-003, 55513-004, 55513-005, 555 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, SUBCUTANEOUSActive IngredientsDARBEPOETIN ALFARXCUI 349273, 349274, 349275, 349276, 351247, 352044, 352045, 352046, 352047, 352262, ... spl_id6492444c-b5d3-49d5-847c-8690c9ce28fdspl_set_id0fd36cb9-c4f6-4167-93c9-8530865db3f9Package NDC 55513-098-01, 55513-098-04, 55513-006-01, 55513-110-01, 55513-002-01, 55513-002- ... NUIN0000175665, M0007726, N0000009319Established Pharmacologic ClassErythropoiesis-stimulating Agent [EPC]Chemical StructureErythropoietin [CS]Physiologic/Pharmacodynamic EffectIncreased Erythroid Cell Production [PE]UNII15UQ94PT4P

12)

drugcharacterization2medicinalproductINSULINdrugdosagetext40 UNITS AM; 30 UNITS PM

13)

drugcharacterization2medicinalproductBENADRYLdrugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MG, 2 DF AS DIRECTEDdrugadministrationroute048

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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

14)

drugcharacterization2medicinalproductCHLORHEXIDINE GLUCONATEdrugstructuredosagenumb15drugstructuredosageunit012drugdosagetext15 ML, SWISH AND SPIT AS DIRECTEDdrugdosageformLiquiddrugadministrationroute048

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Application Number ANDA077789, NDA019125, NDA019258, NDA019422, ANDA074522, ANDA076434, NDA017768, ... Brand Name CHLORHEXIDINE GLUCONATE, ANTISEPTIC SKIN CLEANSER, SCRUB, SCRUB-STAT, FOAM SAFE, ... Generic NameCHLORHEXIDINE GLUCONATE, ANTISEPTIC SKIN CLEANSERManufacturers Xttrium Laboratories, Inc., AVA, Inc., Medline Industries, Inc., Pharmaceutical ... product_ndc 0116-2001, 0116-1061, 42939-124, 0116-0301, 53329-994, 0121-0893, 66467-2560, 52 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORAL, TOPICAL, PERIODONTAL, BUCCALActive IngredientsCHLORHEXIDINE GLUCONATERXCUI 834127, 211365, 1245230, 1437966, 834167, 1233682, 2289028, 1661076, 1869723, 21 ... spl_id b8a2140b-3edc-2bd8-e053-2a95a90aab17, 6e62eb50-ebab-361e-e053-2991aa0aba6f, 9dc5 ... spl_set_id 34d15e72-8770-49dc-a514-d44ae4468a1e, 6e62eb50-ebaa-361e-e053-2991aa0aba6f, 9dc6 ... Package NDC 0116-2001-16, 0116-2001-04, 0116-2001-15, 0116-2001-05, 0116-2001-06, 0116-2001- ... UNIIMOR84MUD8E

15)

drugcharacterization2medicinalproductCOZAARdrugstructuredosagenumb15drugstructuredosageunit003drugdosagetext15 MG, BIDdrugadministrationroute048

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Application NumberNDA020386Brand NameCOZAARGeneric NameLOSARTAN POTASSIUMManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0951, 0006-0952, 0006-0960Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLOSARTAN POTASSIUMRXCUI979480, 979482, 979485, 979487, 979492, 979494spl_id28c07f10-b266-4479-9e82-e217a34910b0spl_set_id5ac32c20-169d-475a-fc8a-934f758d6ab0Package NDC0006-0951-54, 0006-0952-31, 0006-0952-54, 0006-0960-31, 0006-0960-54UNII3ST302B24A

16)

drugcharacterization2medicinalproductFISH OILdrugstructuredosagenumb1000drugstructuredosageunit003drugdosagetext1000 MG, BID (1 AM; 1 PM)drugadministrationroute050

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Application NumberNDA210589Brand NameOMEGAVENGeneric NameFISH OILManufacturersFresenius Kabi USA, LLCproduct_ndc63323-205Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsFISH OILRXCUI2053499, 2053504, 2053513, 2053514spl_idc4f460d5-da90-4b9b-aff1-df3176a43d47spl_set_id5d9d0b24-e139-48bf-ab2d-536fb59cf8e0Package NDC63323-205-21, 63323-205-50, 63323-205-31, 63323-205-00UNIIXGF7L72M0F

17)

drugcharacterization2medicinalproductLISINOPRILdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, QDdrugadministrationroute048

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Application Number ANDA076063, ANDA077321, NDA208401, ANDA078402, ANDA212041, ANDA076180, ANDA07616 ... Brand NameLISINOPRIL, QBRELIS, PRINIVIL, ZESTRILGeneric NameLISINOPRILManufacturers Hikma Pharmaceuticals USA Inc., International Laboratories, LLC, Azurity Pharmac ... product_ndc 0143-9713, 0143-9715, 0143-9714, 54458-872, 54458-877, 54458-874, 54458-873, 526 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 311354, 314076, 314077, 197884, 1806884, 1806890, 205326, 311353, 206764, 206765 ... spl_id 533f6e0f-04a0-4ef7-81b8-0a7be07ddd1a, b685bb45-44a6-4afc-bb3e-940bce536bda, 2fdc ... spl_set_id b70933da-55b2-4025-a00e-63ce3e6b7fdf, 6eef83b4-ce4c-462b-bcfa-eefa525e682d, 9f6e ... Package NDC 0143-9715-01, 0143-9715-10, 0143-9715-99, 0143-9714-01, 0143-9714-10, 0143-9714- ... UNIIE7199S1YWR

18)

drugcharacterization2medicinalproductNORCOdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 DF, QID, PRNdrugadministrationroute048drugindicationPAIN

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Application NumberANDA040099, ANDA040148Brand NameNORCOGeneric NameHYDROCODONE BITARTRATE AND ACETAMINOPHENManufacturersAllergan, Inc.product_ndc0023-6002, 0023-6021, 0023-6022Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCODONE BITARTRATE, ACETAMINOPHENRXCUI856999, 857001, 857002, 857004, 857005, 857007spl_id801535a8-4c58-4a32-9c8f-df02584b8d13spl_set_id66a328bc-055f-4107-8b81-f6f939bea0a7Package NDC0023-6002-01, 0023-6021-01, 0023-6021-05, 0023-6022-01, 0023-6022-05UNIINO70W886KK, 362O9ITL9D

19)

drugcharacterization2medicinalproductOMEPRAZOLEdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, QDdrugadministrationroute048

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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

20)

drugcharacterization2medicinalproductPRAVASTATIN SODIUMdrugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, QDdrugadministrationroute048

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Application Number ANDA209869, ANDA207068, ANDA076056, ANDA077793, ANDA076714, ANDA077917, ANDA2033 ... Brand NamePRAVASTATIN SODIUM, PRAVACHOLGeneric NamePRAVASTATIN SODIUMManufacturers BIOCON PHARMA INC.,, Accord Healthcare Inc., Teva Pharmaceuticals USA, Inc., Dr. ... product_ndc 70377-045, 70377-046, 70377-047, 70377-048, 16729-008, 16729-009, 16729-010, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPRAVASTATIN SODIUMRXCUI904458, 904467, 904475, 904481, 904469, 904477spl_id 35751ea8-7d0f-5334-0e36-df438b2b9202, 96d49c2d-3263-3692-e053-2995a90ac8f4, c288 ... spl_set_id 9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb, 6c011348-a236-47d3-bbef-3e0b956dd080, 99e0 ... Package NDC 70377-045-11, 70377-045-12, 70377-045-14, 70377-046-11, 70377-046-12, 70377-046- ... UNII3M8608UQ61

21)

drugcharacterization2medicinalproductTOPROL XLdrugstructuredosagenumb200drugstructuredosageunit003drugdosagetext200 MG, QDdrugadministrationroute048

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Application NumberNDA019962Brand NameTOPROL XLGeneric NameMETOPROLOL SUCCINATEManufacturersAstraZeneca Pharmaceuticals LP, Aralez Pharmaceuticals US Inc.product_ndc 0186-1088, 0186-1090, 0186-1092, 0186-1094, 70347-025, 70347-050, 70347-100, 703 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOPROLOL SUCCINATERXCUI866412, 866414, 866419, 866421, 866427, 866429, 866436, 866438spl_id03b2ba2e-c4b7-449d-8e07-9c0e08171f66, 259b9a5f-b63a-44a0-8d05-1bb38cfc85bdspl_set_id4a5762c6-d7a2-4e4c-10b7-8832b36fa5f4, 991fe00b-498b-400e-9e5b-921cb07d9b2cPackage NDC 0186-1088-05, 0186-1088-39, 0186-1088-30, 0186-1088-35, 0186-1090-05, 0186-1090- ... UNIITH25PD4CCB

22)

drugcharacterization2medicinalproductTRAMADOLdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, PRN

23)

drugcharacterization2medicinalproductVITAMIN D3drugstructuredosagenumb1000drugstructuredosageunit025drugdosagetext1000 IU, QDdrugadministrationroute048

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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

24)

drugcharacterization2medicinalproductZOLOFTdrugdosagetext100 MG IN A.M.; 50 MG IN P.M.drugadministrationroute048

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

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Adverse Event Report

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Drug

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