Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10038658serious1Date Last Updated26/03/2014receiptdateformat102companynumbFR-JNJFOC-20140312680occurcountryFRduplicate1Date Received26/03/2014seriousnesshospitalization1transmissiondate02/10/2014primarysourcecountryFR

Primary Source

reportercountryFRqualification3

Patient

Onset Age62Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionSerotonin syndromeOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionDrug interactionOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionDrug interactionOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionTachycardiaOutcomeRecovered/resolved

5)

reactionmeddraversionpt17.0ReactionHypertensionOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductTOPALGICdrugauthorizationnumb020281drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETSdrugadministrationroute048drugindicationPAINdrugenddateformat102drugenddate11/02/2014actiondrug1drugrecurreadministration2

2)

drugcharacterization3medicinalproductVERAPAMILdrugstructuredosagenumb240drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUnspecifieddrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate09/02/2014actiondrug4

3)

drugcharacterization3medicinalproductVERAPAMILdrugstructuredosagenumb120drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUnspecifieddrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/02/2014drugenddateformat102drugenddate08/02/2014actiondrug4

4)

drugcharacterization3medicinalproductSERTRALINEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUnspecifieddrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugenddateformat102drugenddate11/02/2014actiondrug1

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

5)

drugcharacterization2medicinalproductMOLSIDOMINEdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUnspecifieddrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

6)

drugcharacterization2medicinalproductPROCORALANdrugstructuredosagenumb7.5drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUnspecifieddrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

7)

drugcharacterization2medicinalproductLISINOPRILdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUnspecifieddrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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

8)

drugcharacterization2medicinalproductLASILIXdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUnspecifieddrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

9)

drugcharacterization2medicinalproductGLIMEPIRIDEdrugstructuredosagenumb6drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUnspecifieddrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA077911, ANDA077091, ANDA091220, ANDA078181, NDA020496, ANDA077370, ANDA20275 ... Brand NameGLIMEPIRIDE, AMARYLGeneric NameGLIMEPIRIDEManufacturers Carlsbad Technology, Inc., Dr. Reddy's Laboratories Limited, Micro Labs Limited, ... product_ndc 61442-115, 61442-116, 61442-117, 55111-320, 55111-321, 55111-322, 42571-100, 425 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGLIMEPIRIDERXCUI199245, 199246, 199247, 153842, 1361493, 1361495, 153591, 153843, 153845spl_id 94f7e51b-3f92-8633-e053-2995a90a8cf1, e3d50334-9896-b2f9-a481-8383eb84b16a, ab8d ... spl_set_id 72d88c6d-2f0a-4bf8-aa7f-1e1811794187, 07ad4366-4b21-f633-49f3-c2b35f88168d, 60e9 ... Package NDC 61442-115-01, 61442-115-05, 61442-115-10, 61442-116-01, 61442-116-05, 61442-116- ... NUIN0000175608, M0020795Established Pharmacologic ClassSulfonylurea [EPC]Chemical StructureSulfonylurea Compounds [CS]UNII6KY687524K

10)

drugcharacterization2medicinalproductMETFORMINEdrugstructuredosagenumb1700drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUnspecifieddrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

11)

drugcharacterization2medicinalproductATORVASTATINdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUnspecifieddrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

12)

drugcharacterization2medicinalproductPREDNISOLONEdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUnspecifieddrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA040401, ANDA080354, ANDA202179, ANDA040775Brand NamePREDNISOLONE, MILLIPRED, PREDNISOLONE SODIUM PHOSPHATEGeneric NamePREDNISOLONEManufacturers Hi-Tech Pharmacal Co., Inc., Aytu Therapeutics, Mylan Pharmaceuticals Inc., Lann ... product_ndc50383-042, 23594-505, 0378-4710, 0378-4715, 0378-4730, 0527-5406Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISOLONE, PREDNISOLONE SODIUM PHOSPHATERXCUI 283077, 198142, 808118, 1005830, 1005831, 1013114, 1235042, 643123, 643125, 6431 ... spl_id c4cdae5e-103f-47b3-90b9-8797c544136e, 53c7d3cf-3691-4150-b720-d592931737db, 13ad ... spl_set_id 6b201232-4a52-487c-b963-a98539469e5d, 863ad743-eec0-46f0-beba-c1556384c636, f658 ... Package NDC 50383-042-48, 50383-042-24, 23594-505-01, 23594-505-50, 23594-505-02, 23594-505- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII9PHQ9Y1OLM, IV021NXA9J

Report Duplicate

duplicatesourceJANSSENduplicatenumbFR-JNJFOC-20140312680

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use