Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-JNJFOC-20140215653occurcountryUSVersion of Safety Report ID3receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10039702Date Received26/03/2014transmissiondate12/12/2014serious2Date Last Updated27/05/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification2

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age45Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionIncorrect route of drug administrationOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionParaesthesiaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionMuscular weaknessOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductINVEGA SUSTENNAdrugauthorizationnumb022264drugstructuredosagenumb234drugstructuredosageunit003drugdosageformINJECTIONdrugadministrationroute030drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate12/07/2013actiondrug4drugrecurreadministration2

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_idd76b9144-d2d3-4d6d-89cd-bb86b89b1ceaspl_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)

drugcharacterization2medicinalproductLIPITORdrugstructuredosagenumb40drugstructuredosageunit003drugdosageformUnspecifieddrugadministrationroute065

openFDA Info on Medication

Application NumberNDA020702Brand NameLIPITORGeneric NameATORVASTATIN CALCIUMManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0155, 0071-0156, 0071-0157, 0071-0158Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATORVASTATIN CALCIUM TRIHYDRATERXCUI259255, 262095, 617310, 617311, 617312, 617314, 617318, 617320spl_id0ba214c6-250e-42a0-aea8-5e44aba04882spl_set_idc6e131fe-e7df-4876-83f7-9156fc4e8228Package NDC 0071-0155-23, 0071-0155-40, 0071-0155-10, 0071-0155-97, 0071-0156-23, 0071-0156- ... UNII48A5M73Z4Q

3)

drugcharacterization2medicinalproductBENZTROPINEdrugstructuredosagenumb2drugstructuredosageunit003drugdosageformUnspecifieddrugadministrationroute065

openFDA Info on Medication

Application NumberANDA090294Brand NameBENZTROPINE MESYLATEGeneric NameBENZTROPINEManufacturersCipla USA Inc.product_ndc69097-826, 69097-827, 69097-832Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBENZTROPINE MESYLATERXCUI885209, 885213, 885219spl_id3d362141-de53-4949-b9a5-34f2b7bb0e75spl_set_id3d2732f9-b8a9-4e83-91e7-da616ddcb786Package NDC 69097-826-02, 69097-826-07, 69097-826-15, 69097-827-02, 69097-827-07, 69097-827- ... UNIIWMJ8TL7510

4)

drugcharacterization2medicinalproductZYRTECdrugstructuredosagenumb20drugstructuredosageunit003drugdosageformUnspecifieddrugadministrationroute048

openFDA Info on Medication

Application NumberNDA022429Brand NameZYRTECGeneric NameCETIRIZINE HYDROCHLORIDEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-779Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCETIRIZINE HYDROCHLORIDERXCUI1014675, 1020023spl_idd7532844-79d8-4648-ab9b-e5d3d3ad76f9spl_set_id605adf29-734f-451a-8ff3-74be7b5814a6Package NDC50580-779-12, 50580-779-25, 50580-779-40, 50580-779-65UNII64O047KTOA

5)

drugcharacterization2medicinalproductDEPAKOTEdrugdosagetext2000MG/100MGdrugdosageformUnspecifieddrugadministrationroute048

openFDA Info on Medication

Application NumberNDA021168, NDA018723, NDA019680Brand NameDEPAKOTE ER, DEPAKOTE, DEPAKOTE SPRINKLESGeneric NameDIVALPROEX SODIUMManufacturersAbbVie Inc.product_ndc0074-3826, 0074-7126, 0074-6212, 0074-6214, 0074-6215, 0074-6114Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIVALPROEX SODIUMspl_id 94344b70-6db3-4dd1-891a-16ccf096a3eb, bb31c7ee-b0a3-42ab-a6b3-b27b3441db1e, 9aef ... spl_set_id 0dc024ce-efc8-4690-7cb5-639c728fccac, 08a65cf4-7749-4ceb-6895-8f4805e2b01f, 4619 ... Package NDC 0074-3826-11, 0074-3826-13, 0074-7126-11, 0074-7126-72, 0074-7126-13, 0074-7126- ... UNII644VL95AO6

6)

drugcharacterization2medicinalproductSINGULAIRdrugstructuredosagenumb10drugstructuredosageunit003drugdosageformUnspecifieddrugadministrationroute065

openFDA Info on Medication

Application NumberNDA020829, NDA020830, NDA021409Brand NameSINGULAIRGeneric NameMONTELUKAST SODIUMManufacturersMerck Sharp & Dohme Corp.product_ndc0006-9117, 0006-3841, 0006-1711, 0006-9275Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406spl_id96717981-6ea2-4720-a749-e14f1559511fspl_set_id8c166755-7711-4df9-d689-8836a1a70885Package NDC 0006-3841-30, 0006-3841-14, 0006-1711-31, 0006-1711-54, 0006-9275-31, 0006-9275- ... UNIIU1O3J18SFL

7)

drugcharacterization2medicinalproductPROTONIXdrugstructuredosagenumb40drugstructuredosageunit003drugdosageformUnspecifieddrugadministrationroute065

openFDA Info on Medication

Application NumberNDA020988, NDA020987, NDA022020Brand NamePROTONIX I.V., PROTONIX DELAYED-RELEASEGeneric NamePANTOPRAZOLE SODIUMManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0008-0923, 0008-2001, 0008-4001, 0008-0841, 0008-0843, 0008-0844Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsPANTOPRAZOLE SODIUMRXCUI283669, 885257, 251872, 284400, 314200, 352125, 763306, 763308spl_id b326d5db-8b20-4ec4-ac25-78190fb3ac36, 1e8fa399-506d-4bcd-9097-dbf7850147bf, 7bdf ... spl_set_id 51e4144a-489e-436c-609a-39305f8f56ba, 5b5ddedd-d429-41a7-8573-10c3e9ad4e52, f39b ... Package NDC 0008-0923-51, 0008-0923-60, 0008-0923-55, 0008-2001-01, 0008-2001-25, 0008-2001- ... UNII6871619Q5X

8)

drugcharacterization2medicinalproductPROPRANOLOLdrugdosagetext20MG/10MGdrugdosageformUnspecifieddrugadministrationroute065

openFDA Info on Medication

Application NumberANDA075826Brand NamePROPRANOLOLGeneric NamePROPRANOLOL HYDROCHLORIDEManufacturersFresenius Kabi USA, LLCproduct_ndc63323-604Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsPROPRANOLOL HYDROCHLORIDERXCUI856443spl_iddb24d808-268b-4bec-bd48-7b66d2bb5951spl_set_idf14ea537-dd5c-4c78-9037-9a85e9e610efPackage NDC63323-604-01UNIIF8A3652H1V

9)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb200drugstructuredosageunit003drugdosageformUnspecifieddrugadministrationroute065

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

10)

drugcharacterization2medicinalproductTRAZODONEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUnspecifieddrugadministrationroute065

11)

drugcharacterization2medicinalproductVITAMIN B3drugstructuredosagenumb400drugstructuredosageunit003drugdosageformUnspecifieddrugadministrationroute065

Report Duplicate

duplicatesourceJANSSENduplicatenumbUS-JNJFOC-20140215653