Adverse Event Report

Report

reporttype2Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10013999serious1Date Last Updated17/03/2014receiptdateformat102companynumbUS-JNJFOC-20130610697occurcountryUSseriousnessother1duplicate1Date Received17/03/2014transmissiondate02/10/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age65Unit of Onset AgeyearsWeight106.14SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionBone neoplasmOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionProstatic specific antigen increasedOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionDrug ineffectiveOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductZYTIGAdrugbatchnumbNGNMdrugauthorizationnumb202379drugstructuredosagenumb1000drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationPROSTATE CANCERdrugstartdateformat102drugstartdate16/03/2013drugenddateformat102drugenddate01/03/2014actiondrug1drugrecurreadministration2

openFDA Info on Medication

Application NumberNDA202379Brand NameZYTIGAGeneric NameABIRATERONE ACETATEManufacturersJanssen Biotech, Inc.product_ndc57894-150, 57894-195Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsABIRATERONE ACETATERXCUI1100075, 1100079, 1918042, 1918044spl_id9c65c57b-4e84-4332-b446-5f792aa13deaspl_set_id4e338e89-3cf2-48eb-b6e2-a06c608c6513Package NDC57894-150-12, 57894-150-25, 57894-195-06, 57894-195-15UNIIEM5OCB9YJ6

2)

drugcharacterization2medicinalproductPREDNISONEdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate02/03/2014

openFDA Info on Medication

Application Number NDA202020, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA040584, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., GeneYork Pharmaceuticals Group LLC, Mylan Pharma ... product_ndc 75987-020, 75987-021, 75987-022, 71329-106, 0378-0640, 0378-0641, 0378-0642, 060 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id be29c86d-242b-42a7-9488-ecf6f76426cd, 4384c1d1-059b-4689-9f3d-1078de814ce8, 88a6 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, be50449f-3aa8-46b7-9246-2dbd5f04f2b1, fec0 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

3)

drugcharacterization2medicinalproductPREDNISONEdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate16/03/2013drugenddateformat102drugenddate01/03/2014

openFDA Info on Medication

Application Number NDA202020, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA040584, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., GeneYork Pharmaceuticals Group LLC, Mylan Pharma ... product_ndc 75987-020, 75987-021, 75987-022, 71329-106, 0378-0640, 0378-0641, 0378-0642, 060 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id be29c86d-242b-42a7-9488-ecf6f76426cd, 4384c1d1-059b-4689-9f3d-1078de814ce8, 88a6 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, be50449f-3aa8-46b7-9246-2dbd5f04f2b1, fec0 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

4)

drugcharacterization2medicinalproductFUROSEMIDEdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationBLOOD PRESSURE

openFDA Info on Medication

Application Number ANDA077293, ANDA207552, ANDA213902, NDA016273, ANDA070655, ANDA212174, ANDA07043 ... Brand Name TOXYCOLOGY MEDICATED COLLECTION SYSTEM, FUROSEMIDE, LASIX, DIASCREEN 12-PANEL ME ... Generic NameFUROSEMIDEManufacturers IT3 Medical LLC, Amneal Pharmaceuticals LLC, Gland Pharma Limited, Validus Pharm ... product_ndc 70529-549, 70121-1076, 70121-1163, 70121-1164, 68083-432, 68083-433, 68083-434, ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 310429, 1038558, 1719286, 1719290, 1719291, 197732, 200801, 200809, 205732, 3139 ... spl_id 67969d0e-ce2a-4634-b46a-968c898b61ee, c22d0330-1b76-420a-a84b-8ea59f8733a7, e7bd ... spl_set_id a78407a8-3d3e-4eb5-9e3f-b32a1b8015e4, d5b9f12e-d1e9-42de-90f2-c9ba33a86457, 6447 ... Package NDC 70529-549-01, 70529-061-08, 68345-883-50, 70121-1163-1, 70121-1163-5, 70121-1164 ... RouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsFUROSEMIDENUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

5)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationDEPRESSIONdrugstartdateformat602drugstartdate//2005

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

6)

drugcharacterization2medicinalproductLOSARTANdrugstructuredosagenumb100drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048drugindicationBLOOD PRESSURE

7)

drugcharacterization2medicinalproductFENOFIBRIC ACIDdrugstructuredosagenumb135drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPLETdrugadministrationroute048drugindicationBLOOD TRIGLYCERIDES

openFDA Info on Medication

Application Number NDA022224, NDA022418, ANDA200750, ANDA211626, ANDA210469, ANDA208705, ANDA201573 ... Brand NameFENOFIBRIC ACID, FIBRICOR, FENOFIBRIC ACID DELAYED-RELEASE, TRILIPIXGeneric NameFENOFIBRIC ACIDManufacturers Amneal Pharmaceuticals of New York LLC, Palmetto Pharmaceuticals, Inc, Athena Bi ... product_ndc 0115-1554, 0115-1459, 0115-1460, 0115-1555, 68134-601, 68134-602, 71511-501, 715 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFENOFIBRIC ACID, CHOLINE FENOFIBRATERXCUI828373, 828379, 860880, 860886, 860884, 860888, 828377, 828381spl_id 0758938f-2318-5305-df79-2f1852f308d1, 000114da-959d-4159-bd00-22d9b7faad4d, 99c9 ... spl_set_id 369b3e55-2c05-d879-fe7e-91296c529ae9, bb559b34-79b1-45a6-a148-38639115cd49, 454a ... Package NDC 0115-1459-10, 0115-1460-10, 0115-1554-10, 0115-1555-10, 68134-601-30, 68134-602- ... NUIN0000175596Established Pharmacologic ClassPeroxisome Proliferator Receptor alpha Agonist [EPC]UNIIBGF9MN2HU1, 4BMH7IZT98

8)

drugcharacterization2medicinalproductOXYCONTINdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationPAIN

openFDA Info on Medication

Application NumberNDA022272Brand NameOXYCONTINGeneric NameOXYCODONE HYDROCHLORIDEManufacturersPurdue Pharma LPproduct_ndc59011-410, 59011-480, 59011-415, 59011-420, 59011-430, 59011-440, 59011-460Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDERXCUI 1049504, 1049545, 1049565, 1049576, 1049586, 1049595, 1049601, 1860127, 1860129, ... spl_id21ec1aed-af99-6d71-bc44-4755651ecd9espl_set_idbfdfe235-d717-4855-a3c8-a13d26dadedePackage NDC 59011-480-20, 59011-480-10, 59011-410-10, 59011-410-20, 59011-415-10, 59011-415- ... UNIIC1ENJ2TE6C

9)

drugcharacterization2medicinalproductTYLENOLdrugstructuredosagenumb625drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationARTHRITIS

openFDA Info on Medication

Application Numberpart341, part343Brand Name TYLENOL COLD PLUS HEAD CONGESTION SEVERE, TYLENOL REGULAR STRENGTH, TYLENOL EXTR ... Generic NameACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHENManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc 50580-566, 50580-495, 50580-458, 50580-487, 50580-496, 50580-451, 50580-600, 505 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDERXCUI1243679, 209387, 313782, 198436, 1738139, 198440, 209459spl_id bf686cc3-17be-4bb9-bd87-f8f50b65d874, 068c419e-d1f7-46d9-bdd0-05aa4039a374, c138 ... spl_set_id ce43e5c2-fe96-4462-882c-d7479318b33d, de5c6654-56c5-40d3-a286-f04ed47ac7c8, 01f4 ... Package NDC 50580-566-25, 50580-495-01, 50580-458-11, 50580-458-50, 50580-458-10, 50580-487- ... UNII362O9ITL9D, 495W7451VQ, 04JA59TNSJ

10)

drugcharacterization2medicinalproductASPIRINdrugstructuredosagenumb81drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

openFDA Info on Medication

Application Numberpart343Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN 81MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 0363-0587, 70000-0218, 70000-0170, 6 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 198471, 825180, 198464 ... spl_id a1833a99-76cc-47fb-80fb-3a6507a2db3e, acc2acbd-b310-e26a-e053-2a95a90a1874, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

Report Duplicate

duplicatesourceJANSSENduplicatenumbUS-JNJFOC-20130610697

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use