Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10041016serious1Date Last Updated11/04/2014receiptdateformat102companynumbUS-INCYTE CORPORATION-2014IN000722occurcountryUSduplicate1Date Received27/03/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification2

Patient

Onset Age83Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionAnaemiaOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionThrombocytopeniaOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionNeutropeniaOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionPyrexiaOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionChillsOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionOral painOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionEating disorderOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionFluid intake reducedOutcomeUnknown

9)

reactionmeddraversionpt17.0ReactionNauseaOutcomeUnknown

10)

reactionmeddraversionpt17.0ReactionVomitingOutcomeUnknown

11)

reactionmeddraversionpt17.0ReactionUrinary tract infectionOutcomeRecovered/resolved

12)

reactionmeddraversionpt17.0ReactionSomnolenceOutcomeUnknown

13)

reactionmeddraversionpt17.0ReactionAstheniaOutcomeNot recovered/not resolved

14)

reactionmeddraversionpt17.0ReactionConfusional stateOutcomeRecovering/resolving

15)

reactionmeddraversionpt17.0ReactionDehydrationOutcomeUnknown

16)

reactionmeddraversionpt17.0ReactionMental status changesOutcomeRecovering/resolving

17)

reactionmeddraversionpt17.0ReactionHyponatraemiaOutcomeUnknown

18)

reactionmeddraversionpt17.0ReactionHypokalaemiaOutcomeUnknown

19)

reactionmeddraversionpt17.0ReactionLeukopeniaOutcomeUnknown

20)

reactionmeddraversionpt17.0ReactionOral candidiasisOutcomeUnknown

21)

reactionmeddraversionpt17.0ReactionDyspnoeaOutcomeNot recovered/not resolved

22)

reactionmeddraversionpt17.0ReactionEar painOutcomeNot recovered/not resolved

23)

reactionmeddraversionpt17.0ReactionDecreased appetiteOutcomeNot recovered/not resolved

24)

reactionmeddraversionpt17.0ReactionEustachian tube dysfunctionOutcomeUnknown

25)

reactionmeddraversionpt17.0ReactionHeadacheOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductHYDROCHLOROTHIAZIDEdrugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MG, QDdrugadministrationroute065

openFDA Info on Medication

Application Number ANDA040780, ANDA203018, ANDA040412, ANDA085182, ANDA203561, ANDA078164, ANDA0870 ... Brand NameHYDROCHLOROTHIAZIDEGeneric NameHYDROCHLOROTHIAZIDEManufacturers Aurobindo Pharma Limited, ScieGen Pharmaceuticals, Inc., Solco Healthcare U.S., ... product_ndc 65862-133, 65862-134, 50228-111, 50228-112, 43547-397, 43547-398, 23155-008, 231 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCHLOROTHIAZIDERXCUI197770, 310798, 199903, 429503spl_id 9d73930e-75b8-4a7b-9d12-2049f593ca9d, 5c6f4c6a-cc43-4f4d-bc16-688310c98c72, d8ce ... spl_set_id 01f1f478-5493-439f-9b99-f4f82023781c, 02e96a51-1d56-460c-8c20-3d6f37e0ce46, 60c9 ... Package NDC 65862-133-01, 65862-133-99, 65862-134-01, 65862-134-99, 50228-111-30, 50228-111- ... NUIN0000175359, N0000175419, M0471776Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide Diuretic [EPC]Chemical StructureThiazides [CS]UNII0J48LPH2TH

2)

drugcharacterization2medicinalproductMOTRIN

openFDA Info on Medication

Application NumberNDA020603, ANDA079113Brand NameMOTRIN INFANTS, MOTRIN PMGeneric NameIBUPROFEN, IBUPROFEN AND DIPHENHYDRAMINE CITRATEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-198, 50580-563Product TypeHUMAN OTC DRUGRouteORALActive IngredientsIBUPROFEN, DIPHENHYDRAMINE CITRATERXCUI204442, 854762, 895664, 895666spl_id3cdbe8dc-eb86-4c5f-8e5c-8bdd8a81b593, 6f68d6ba-ca5c-46d2-9b6e-f096cce12929spl_set_idc57f6ded-c0bd-45ae-823a-4c02ce334d98, 55403f19-58ae-450b-8a7b-0bc544088f20Package NDC 50580-198-50, 50580-198-51, 50580-198-52, 50580-563-20, 50580-563-40, 50580-563- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, 4OD433S209

3)

drugcharacterization2medicinalproductMUCINEXdrugdosagetextAS DIRECTED TWICE DAILYdrugadministrationroute065

openFDA Info on Medication

Application NumberNDA021282, part341Brand NameMUCINEX, MUCINEX MAXIMUM STRENGTH, MUCINEX FAST-MAX SEVERE COLDGeneric Name GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHEN ... ManufacturersRB Health (US) LLCproduct_ndc63824-008, 63824-023, 63824-020Product TypeHUMAN OTC DRUGRouteORALActive Ingredients GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCH ... RXCUI636522, 891301, 310621, 891297, 1116572spl_id a41a03f3-908a-4f4d-a456-d5e3696f6f01, 28208539-5a7e-4abe-8eea-02323da52933, 4dca ... spl_set_id dd379cdd-90ab-42e0-ad89-f50d3220f611, 47f5323c-ee3a-400d-b133-31d9c286fafd, bee0 ... Package NDC 63824-008-36, 63824-008-32, 63824-008-34, 63824-008-69, 63824-008-27, 63824-008- ... UNII495W7451VQ, 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ

4)

drugcharacterization2medicinalproductTYLENOL ARTHRITISdrugstructuredosagenumb650drugstructuredosageunit003drugdosagetext650 MG, 2 TABLETS EVERY 12 HOURSdrugdosageformTABLET

5)

drugcharacterization2medicinalproductVITAMIN C /00008001/drugstructuredosagenumb500drugstructuredosageunit003drugdosagetext500 MG, QDdrugdosageformTABLETdrugadministrationroute065

6)

drugcharacterization2medicinalproductAMBIENdrugstructuredosagenumb5drugstructuredosageunit003drugdosagetext5 MG, 1/2 TO 1 TABLET DAILY AT BEDTIMEdrugadministrationroute065

openFDA Info on Medication

Application NumberNDA021774, NDA019908Brand NameAMBIEN CR, AMBIENGeneric NameZOLPIDEM TARTRATEManufacturersSanofi-Aventis U.S. LLCproduct_ndc0024-5501, 0024-5521, 0024-5401, 0024-5421Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854880, 854882, 854894, 854896, 854873, 854875, 854876, 854878spl_id6c172483-d1e2-4203-8dab-7f8a780a02ad, e932d227-dc7a-405f-855b-4994aabb85f4spl_set_id404c858c-89ac-4c9d-8a96-8702a28e6e76, c36cadf4-65a4-4466-b409-c82020b42452Package NDC 0024-5501-31, 0024-5501-10, 0024-5521-31, 0024-5521-50, 0024-5521-10, 0024-5401- ... UNIIWY6W63843K

7)

drugcharacterization2medicinalproductSERTRALINE

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)

drugcharacterization2medicinalproductHYDROCORTISONE

openFDA Info on Medication

Application Number part348, ANDA088799, ANDA040351, ANDA089682, ANDA080706, NDA213876, ANDA040646, ... Brand Name HARRIS TEETER ANTI-ITCH WITH ALOE, DG HEALTH HYDROCORTISONE, PROCTOSOL-HC, GOOD ... Generic Name HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, ANTI-ITCH, HYDROCORTI ... Manufacturers Harris Teeter, Dolgencorp, LLC, Sun Pharmaceutical Industries, Inc., Amerisource ... product_ndc 72036-407, 55910-646, 10631-407, 24385-276, 67091-280, 69396-069, 61010-4402, 70 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteTOPICAL, ORAL, RECTALActive IngredientsHYDROCORTISONE, HYDROCORTISONE ACETATERXCUI 106258, 103403, 310891, 1540356, 203105, 197785, 1790684, 206352, 1043063, 19870 ... spl_id 2b90d9a3-ebb1-4aee-8a9c-6601618b7738, 27dc9e09-fc4f-4b66-a303-177725f3a513, 297a ... spl_set_id 1755c97e-87a3-43c7-ab61-3e971a7b3135, 27dc9e09-fc4f-4b66-a303-177725f3a513, 5652 ... Package NDC 72036-407-28, 55910-646-25, 10631-407-01, 24385-276-03, 67091-280-28, 69396-069- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIWI4X0X7BPJ, 3X7931PO74

9)

drugcharacterization2medicinalproductMULTIVITAMIN /00097801/

10)

drugcharacterization2medicinalproductPROBIOTIC

11)

drugcharacterization2medicinalproductVIDAZAdrugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100 MG, FOR 5 DAYS A WEEK FOR 2 WEEKS EVERY 5 WEEKS

openFDA Info on Medication

Application NumberNDA050794Brand NameVIDAZAGeneric NameAZACITIDINEManufacturersCelgene Corporationproduct_ndc59572-102Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, SUBCUTANEOUSActive IngredientsAZACITIDINERXCUI485246, 545206spl_id59a04f93-6da3-4ad2-8996-14488e8d91dbspl_set_id3495a71a-cc04-4776-851f-f185956f32afPackage NDC59572-102-01NUIN0000000233, N0000175595Mechanism of ActionNucleic Acid Synthesis Inhibitors [MoA]Established Pharmacologic ClassNucleoside Metabolic Inhibitor [EPC]UNIIM801H13NRU

12)

drugcharacterization1medicinalproductJAKAFIdrugbatchnumbNOT AVAILABLEdrugauthorizationnumb202192drugstructuredosagenumb15drugstructuredosageunit003drugdosagetext15 MG, BIDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate14/06/2013drugenddateformat602drugenddate//2014actiondrug1drugrecurreadministration3

openFDA Info on Medication

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

13)

drugcharacterization2medicinalproductMETOPROLOLdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, QD

openFDA Info on Medication

Application NumberANDA078950, ANDA091045, ANDA202871Brand NameMETOPROLOL, METOPROLOL TARTRATEGeneric NameMETOPROLOL TARTRATE, METOPROLOLManufacturers Baxter Healthcare Corporation, Fresenius Kabi USA, LLC, Alembic Pharmaceuticals ... product_ndc 36000-033, 63323-660, 62332-112, 62332-113, 62332-114, 46708-290, 46708-291, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsMETOPROLOL TARTRATERXCUI866508, 866511, 866514, 866924spl_id 202a1ff0-38f7-4bf2-ade7-6ede8fa64486, 94a4f468-def9-95b9-e053-2995a90a3428, bd31 ... spl_set_id 09566368-f91d-43a3-b683-30c844fb125a, be1c686e-37a5-4a53-945b-68a6ead35134, 2483 ... Package NDC 36000-033-10, 63323-660-05, 62332-112-30, 62332-112-31, 62332-112-91, 62332-113- ... UNIIW5S57Y3A5L

14)

drugcharacterization2medicinalproductLISINOPRIL

openFDA Info on Medication

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

15)

drugcharacterization2medicinalproductSYNTHROIDdrugdosagetext100 MCG, QD

openFDA Info on Medication

Application NumberNDA021402Brand NameSYNTHROIDGeneric NameLEVOTHYROXINE SODIUMManufacturersAbbVie Inc.product_ndc 0074-3727, 0074-7149, 0074-4341, 0074-4552, 0074-5182, 0074-6624, 0074-6594, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, ... spl_iddb21fc0c-4a2d-9922-39bd-8128e429bebcspl_set_id1e11ad30-1041-4520-10b0-8f9d30d30fccPackage NDC 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341- ... UNII9J765S329G

16)

drugcharacterization2medicinalproductTYLENOL /00020001/

17)

drugcharacterization2medicinalproductOCUVITE /01053801/

18)

drugcharacterization2medicinalproductGLUCOTROL

openFDA Info on Medication

Application NumberNDA020329, NDA017783Brand NameGLUCOTROL XL, GLUCOTROLGeneric NameGLIPIZIDEManufacturersRoerigproduct_ndc 0049-0170, 0049-1620, 0049-1550, 0049-1560, 0049-0174, 0049-0178, 0049-4110, 004 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGLIPIZIDERXCUI310489, 314006, 315107, 865568, 865571, 865573, 205828, 205830, 310488, 310490spl_id60be542a-179a-42f1-bc4b-ee13cfde5e64, f8829f3b-71ed-4cf3-a503-e53ecd168670spl_set_ideed99b60-d043-4249-9b2a-f05e46fb588d, b4f55916-91a2-4171-a361-919e7cb329b0Package NDC 0049-1620-30, 0049-1550-66, 0049-1550-73, 0049-1560-66, 0049-1560-73, 0049-0170- ... NUIN0000175608, M0020795Established Pharmacologic ClassSulfonylurea [EPC]Chemical StructureSulfonylurea Compounds [CS]UNIIX7WDT95N5C

19)

drugcharacterization2medicinalproductCLARITIN /00413701/drugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, QDdrugadministrationroute065

20)

drugcharacterization2medicinalproductTAGAMET /00397401/

21)

drugcharacterization2medicinalproductBENADRYL /00000402/drugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MG, Q 6 HOURS, PRN

22)

drugcharacterization2medicinalproductGLUCOSAMINEdrugstructuredosagenumb2000drugstructuredosageunit003drugdosagetext2000 MG, QDdrugadministrationroute065

Report Duplicate

duplicatesourceINCYTEduplicatenumbUS-INCYTE CORPORATION-2014IN000722

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use