Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10039852serious1Date Last Updated13/04/2015receiptdateformat102companynumbSE-JNJFOC-20140310052occurcountrySEseriousnessother1duplicate1Date Received26/03/2014transmissiondate21/08/2015primarysourcecountrySE

Primary Source

reportercountrySEqualification5

Patient

Onset Age29Unit of Onset Ageyearspatientagegroup5Weight59SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionDrug effect incompleteOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionMyalgiaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.0ReactionAlopeciaOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.0ReactionMood swingsOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt18.0ReactionTensionOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt18.0ReactionDrug effect variableOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt18.0ReactionPalpitationsOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt18.0ReactionTremorOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt18.0ReactionPruritusOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt18.0ReactionHyperhidrosisOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt18.0ReactionHypoaesthesiaOutcomeNot recovered/not resolved

12)

reactionmeddraversionpt18.0ReactionContusionOutcomeNot recovered/not resolved

13)

reactionmeddraversionpt18.0ReactionPain in extremityOutcomeNot recovered/not resolved

14)

reactionmeddraversionpt18.0ReactionSkin exfoliationOutcomeNot recovered/not resolved

15)

reactionmeddraversionpt18.0ReactionAggressionOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductSERTRALINEdrugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

2)

drugcharacterization1medicinalproductCONCERTAdrugbatchnumbUNKNOWNdrugauthorizationnumb021121drugdosageformSUSTAINED RELEASE TABLETSdrugadministrationroute048drugindicationATTENTION DEFICIT/HYPERACTIVITY DISORDERdrugstartdateformat610drugstartdate/05/2013drugenddateformat610drugenddate/11/2013actiondrug1drugrecurreadministration2

activesubstance

activesubstancenameMETHYLPHENIDATE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021121Brand NameCONCERTAGeneric NameMETHYLPHENIDATE HYDROCHLORIDEManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-585, 50458-588, 50458-586, 50458-587Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETHYLPHENIDATE HYDROCHLORIDERXCUI1091155, 1091157, 1091170, 1091172, 1091185, 1091187, 1091210, 1091212spl_id83de4a92-67e6-11e9-8dc3-11c90099106dspl_set_id1a88218c-5b18-4220-8f56-526de1a276cdPackage NDC50458-585-01, 50458-588-01, 50458-586-01, 50458-587-01UNII4B3SC438HI

3)

drugcharacterization2medicinalproductPREDNISOLONE.drugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePREDNISOLONE

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

summary

narrativeincludeclinicalCASE EVENT DATE: 201305

Report Duplicate

duplicatesourceJANSSENduplicatenumbSE-JNJFOC-20140310052

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use