Adverse Event Report

Report

Version of Safety Report ID3Safety Report ID10648402primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate04/03/2016reporttype1serious1seriousnesshospitalization1seriousnessother1receivedateformat102Date Received12/12/2014receiptdateformat102Date Last Updated12/11/2015fulfillexpeditecriteria2companynumbUS-JNJFOC-20141207261duplicate1

Report Duplicate

duplicatesourcePHARMACYCLICSduplicatenumbUS-JNJFOC-20141207261

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age65Unit of Onset Ageyearspatientagegroup5SexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionAnaemiaOutcomeUnknown

2)

reactionmeddraversionpt18.1ReactionAtrial fibrillationOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.1ReactionConfusional stateOutcomeUnknown

4)

reactionmeddraversionpt18.1ReactionPericardial effusionOutcomeRecovered/resolved

5)

reactionmeddraversionpt18.1ReactionOropharyngeal painOutcomeUnknown

6)

reactionmeddraversionpt18.1ReactionPleural effusionOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt18.1ReactionBalance disorderOutcomeUnknown

8)

reactionmeddraversionpt18.1ReactionCardiomegalyOutcomeUnknown

9)

reactionmeddraversionpt18.1ReactionCardiac failure congestiveOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductIMBRUVICAdrugbatchnumbL0406499B1drugauthorizationnumb205552drugstructuredosagenumb280drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute048drugindicationWALDENSTROM^S MACROGLOBULINAEMIAdrugstartdateformat610drugstartdate/05/2015actiondrug1drugrecurreadministration2

activesubstance

activesubstancenameIBRUTINIB

openFDA Info on Medication

Application NumberNDA205552, NDA210563Brand NameIMBRUVICAGeneric NameIBRUTINIBManufacturersPharmacyclics LLCproduct_ndc57962-007, 57962-070, 57962-014, 57962-140, 57962-280, 57962-420, 57962-560Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsIBRUTINIBRXCUI 1442986, 1442992, 1994360, 1994362, 2000017, 2000019, 2000021, 2000023, 2000025, ... spl_id2a4539ae-0397-449f-be90-150262cdff51spl_set_id0dfd0279-ff17-4ea9-89be-9803c71bab44Package NDC 57962-007-12, 57962-070-28, 57962-014-28, 57962-140-09, 57962-140-12, 57962-280- ... NUIN0000175605, N0000175076Established Pharmacologic ClassKinase Inhibitor [EPC]Mechanism of ActionProtein Kinase Inhibitors [MoA]UNII1X70OSD4VX

2)

drugcharacterization2medicinalproductOMEPRAZOLE.

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA206877, ANDA075757, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, EQUALINE OMEPRAZOLE DELAYED RELEASE, KIRKLAND ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Supervalu Inc, Costco Wholesale Company, INNOVUS PHARMACEUTI ... product_ndc 46122-281, 41163-614, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 621 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, bd28c8a0-73e5-4c81-bc0e-b2c1504a88c3, 8c9d ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 16bf0c57-0376-48b3-90e5-502d61d1b6eb, 48a4 ... Package NDC 46122-281-04, 46122-281-74, 41163-614-01, 63981-915-55, 57483-740-01, 57483-740- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

3)

drugcharacterization2medicinalproductLEVOTHYROXINE.drugstructuredosagenumb50drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationHYPOTHYROIDISMdrugstartdateformat102drugstartdate17/11/2014drugenddateformat102drugenddate29/11/2014

activesubstance

activesubstancenameLEVOTHYROXINE

openFDA Info on Medication

Brand NameLEVOTHYROXINEGeneric NameLEVOTHYROXINEManufacturersDeseret Biologicals, Inc.product_ndc43742-0955Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLEVOTHYROXINEspl_id7c431149-4f46-4c4f-a5bb-c1b1fb705283spl_set_id1a467f8b-2611-4936-af2b-098e4791d6aePackage NDC43742-0955-1NUIN0000175945, M0021504Established Pharmacologic Classl-Thyroxine [EPC]Chemical StructureThyroxine [CS]UNIIQ51BO43MG4

4)

drugcharacterization2medicinalproductLEVOTHYROXINE.drugdosageformTABLETdrugadministrationroute048drugindicationHYPOTHYROIDISMdrugstartdateformat102drugstartdate30/11/2014

activesubstance

activesubstancenameLEVOTHYROXINE

openFDA Info on Medication

Brand NameLEVOTHYROXINEGeneric NameLEVOTHYROXINEManufacturersDeseret Biologicals, Inc.product_ndc43742-0955Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLEVOTHYROXINEspl_id7c431149-4f46-4c4f-a5bb-c1b1fb705283spl_set_id1a467f8b-2611-4936-af2b-098e4791d6aePackage NDC43742-0955-1NUIN0000175945, M0021504Established Pharmacologic Classl-Thyroxine [EPC]Chemical StructureThyroxine [CS]UNIIQ51BO43MG4

5)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb2drugstructuredosageunit003

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

6)

drugcharacterization1medicinalproductIMBRUVICAdrugbatchnumbL0406499B1drugstructuredosagenumb420drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute048drugindicationWALDENSTROM^S MACROGLOBULINAEMIAdrugstartdateformat102drugstartdate07/11/2014drugenddateformat102drugenddate29/11/2014actiondrug1drugrecurreadministration2

activesubstance

activesubstancenameIBRUTINIB

openFDA Info on Medication

Application NumberNDA205552, NDA210563Brand NameIMBRUVICAGeneric NameIBRUTINIBManufacturersPharmacyclics LLCproduct_ndc57962-007, 57962-070, 57962-014, 57962-140, 57962-280, 57962-420, 57962-560Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsIBRUTINIBRXCUI 1442986, 1442992, 1994360, 1994362, 2000017, 2000019, 2000021, 2000023, 2000025, ... spl_id2a4539ae-0397-449f-be90-150262cdff51spl_set_id0dfd0279-ff17-4ea9-89be-9803c71bab44Package NDC 57962-007-12, 57962-070-28, 57962-014-28, 57962-140-09, 57962-140-12, 57962-280- ... NUIN0000175605, N0000175076Established Pharmacologic ClassKinase Inhibitor [EPC]Mechanism of ActionProtein Kinase Inhibitors [MoA]UNII1X70OSD4VX

7)

drugcharacterization2medicinalproductALENDRONATE

activesubstance

activesubstancenameALENDRONATE SODIUM

openFDA Info on Medication

Application NumberANDA090258Brand NameALENDRONATEGeneric NameALENDRONATE SODIUM, ALENDRONATE SODIUM TABLETManufacturers Virtus Pharmaceuticals, Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd., Mar ... product_ndc69543-130, 69543-131, 60723-205, 60723-207, 10135-718, 10135-719Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALENDRONATE SODIUMRXCUI904396, 904431spl_id d42c7c03-3f82-6a67-e053-2995a90a6ebc, d0f979c3-26f8-2393-e053-2995a90a0e1d, ccc0 ... spl_set_id 5c49d7fc-c76a-40c9-8c43-68b731230f0e, a24fd39c-34a7-4de2-9439-781e612189ca, b634 ... Package NDC 69543-130-04, 69543-130-12, 69543-130-20, 69543-131-04, 69543-131-12, 69543-131- ... UNII2UY4M2U3RA

8)

drugcharacterization2medicinalproductPREDNISONE.

activesubstance

activesubstancenamePREDNISONE

openFDA Info on Medication

Application Number NDA202020, ANDA215246, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., Novitium Pharma LLC, GeneYork Pharmaceuticals Gr ... product_ndc 75987-020, 75987-021, 75987-022, 70954-056, 71329-106, 0378-0640, 0378-0641, 037 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id 96a17428-b512-4fd9-a64d-50160d22aaaa, 7335a293-992b-490c-ab8a-66a7ca1eea30, 4384 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, 7335a293-992b-490c-ab8a-66a7ca1eea30, be50 ... 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

9)

drugcharacterization2medicinalproductLEVOTHYROXINE.drugstructuredosagenumb100drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationHYPOTHYROIDISMdrugstartdateformat102drugstartdate30/11/2014

activesubstance

activesubstancenameLEVOTHYROXINE

openFDA Info on Medication

Brand NameLEVOTHYROXINEGeneric NameLEVOTHYROXINEManufacturersDeseret Biologicals, Inc.product_ndc43742-0955Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLEVOTHYROXINEspl_id7c431149-4f46-4c4f-a5bb-c1b1fb705283spl_set_id1a467f8b-2611-4936-af2b-098e4791d6aePackage NDC43742-0955-1NUIN0000175945, M0021504Established Pharmacologic Classl-Thyroxine [EPC]Chemical StructureThyroxine [CS]UNIIQ51BO43MG4

10)

drugcharacterization2medicinalproductDEXILANTdrugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804

activesubstance

activesubstancenameDEXLANSOPRAZOLE

openFDA Info on Medication

Application NumberNDA022287Brand NameDEXILANTGeneric NameDEXLANSOPRAZOLEManufacturersTakeda Pharmaceuticals America, Inc.product_ndc64764-171, 64764-175Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDEXLANSOPRAZOLERXCUI833204, 833213, 902624, 902626spl_ide8db649c-1cef-4838-a2e9-1262b2ba4c34spl_set_id9819f033-3bbe-442e-8e92-45fec77b237dPackage NDC 64764-171-30, 64764-171-90, 64764-171-19, 64764-171-11, 64764-171-01, 64764-171- ... NUIN0000175525, N0000000147Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA]UNIIUYE4T5I70X

11)

drugcharacterization2medicinalproductMIRAPEXdrugstructuredosagenumb.25drugstructuredosageunit003

activesubstance

activesubstancenamePRAMIPEXOLE DIHYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022421Brand NameMIRAPEX ERGeneric NamePRAMIPEXOLE DIHYDROCHLORIDEManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0109, 0597-0285, 0597-0113, 0597-0286, 0597-0115, 0597-0287, 0597-0116Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPRAMIPEXOLE DIHYDROCHLORIDERXCUI 901534, 901537, 901541, 901543, 901546, 901547, 901550, 901551, 901555, 901557, ... spl_id77d8974c-9e8a-4700-8445-458b31b6ce31spl_set_ide2902ed1-cfeb-4815-adc3-129c577917a1Package NDC 0597-0109-30, 0597-0109-07, 0597-0109-17, 0597-0285-30, 0597-0285-07, 0597-0285- ... UNII3D867NP06J

12)

drugcharacterization2medicinalproductTESTOSTERONE.drugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803

activesubstance

activesubstancenameTESTOSTERONE

openFDA Info on Medication

Application Number NDA022309, ANDA205781, ANDA204268, ANDA210835, ANDA076737, ANDA208620, ANDA21230 ... Brand Name ANDROGEL, TESTOSTERONE, VOGELXO, TESTIM, ANDRODERM, FORTESTA, TESTOPEL, NATESTO ... Generic NameTESTOSTERONE, TESTOSTERONE,, TESTOSTERONE CYPIONATEManufacturers AbbVie Inc., Zydus Pharmaceuticals USA Inc, Padagis Israel Pharmaceuticals Ltd, ... 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, NASAL, INTRAMUSCULARActive IngredientsTESTOSTERONE, TESTOSTERONE CYPIONATERXCUI 1597075, 1597076, 1597120, 1597121, 1597126, 1597127, 1596780, 1597123, 1597129, ... spl_id d34e7ee8-3f6b-4473-8e1b-f3a90467fb6c, 52cc0e06-8081-21e1-e3f6-cebcda7bc3f8, b25d ... 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]UNII3XMK78S47O, M0XW1UBI14

summary

narrativeincludeclinicalCASE EVENT DATE: 20141129