Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-JNJFOC-20140319327occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10108953Date Received25/04/2014transmissiondate12/12/2014serious2Date Last Updated25/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Weight135.17SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionParkinsonismOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionAdverse eventOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionOff label useOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionBlood pressure fluctuationOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionBlood glucose abnormalOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionTrismusOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt17.0ReactionMuscle spasmsOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt17.0ReactionWeight increasedOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt17.0ReactionIncreased appetiteOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt17.0ReactionConstipationOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt17.0ReactionDry mouthOutcomeUnknown

12)

reactionmeddraversionpt17.0ReactionTremorOutcomeUnknown

13)

reactionmeddraversionpt17.0ReactionChest painOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductINVEGA SUSTENNAdrugauthorizationnumb022264drugdosagetext3 WEEKS AGOdrugdosageformINJECTIONdrugadministrationroute030drugindicationBIPOLAR DISORDERdrugstartdateformat610drugstartdate/03/2014actiondrug4drugrecurreadministration2

openFDA Info on Medication

Application NumberNDA022264Brand NameINVEGA SUSTENNAGeneric NamePALIPERIDONE PALMITATEManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-560, 50458-561, 50458-562, 50458-563, 50458-564Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULARActive IngredientsPALIPERIDONE PALMITATERXCUI858048, 858051, 858052, 858053, 858054, 858055, 858056, 858057, 858073, 858074spl_id86e7f21e-638b-11ea-8ce6-7c2bfc2ca371spl_set_id1af14e42-951d-414d-8564-5d5fce138554Package NDC 50458-560-01, 50458-561-01, 50458-562-01, 50458-563-01, 50458-563-03, 50458-564- ... UNIIR8P8USM8FR

2)

drugcharacterization1medicinalproductINVEGA ERdrugauthorizationnumb021999drugstructuredosagenumb9drugstructuredosageunit003drugdosageformOROS (Oral Osmotic) Therapeutic System Tabletdrugadministrationroute048drugindicationBIPOLAR DISORDERdrugstartdateformat602drugstartdate//2013actiondrug4drugrecurreadministration2

3)

drugcharacterization2medicinalproductZOLOFTdrugdosageformTABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2013drugenddateformat610drugenddate/03/2014

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

4)

drugcharacterization2medicinalproductCOGENTINdrugstructuredosagenumb.5drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUnspecifieddrugadministrationroute065drugindicationADVERSE DRUG REACTION

openFDA Info on Medication

Application NumberNDA012015Brand NameCOGENTINGeneric NameBENZTROPINE MESYLATEManufacturersOak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)product_ndc76478-611Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUSActive IngredientsBENZTROPINE MESYLATERXCUI885205, 885207spl_id9f21b8d1-371b-472c-9e88-c6a8ee56d051spl_set_idb707bc17-3ab4-47a9-a83e-ebd1d384a9d8Package NDC76478-611-02UNIIWMJ8TL7510

5)

drugcharacterization2medicinalproductBUSPIRONE HCLdrugstructuredosagenumb15drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA208829Brand NameBUSPIRONE HCLGeneric NameBUSPIRONE HYDROCHLORIDEManufacturersAmneal Pharmaceuticals NY LLCproduct_ndc69238-1115, 69238-1116, 69238-1117, 69238-1118, 69238-1119Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUSPIRONE HYDROCHLORIDERXCUI866018, 866083, 866090, 866094, 866111spl_id5e00599c-64da-4fe2-a5e1-ebb9d03d959cspl_set_id33999f17-f689-40a1-955a-fb19c0590e0ePackage NDC 69238-1115-1, 69238-1115-5, 69238-1116-1, 69238-1116-5, 69238-1117-1, 69238-1117 ... UNII207LT9J9OC

6)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb150drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat610drugstartdate/03/2014

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

Report Duplicate

duplicatesourceJANSSENduplicatenumbUS-JNJFOC-20140319327