Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-009507513-1403USA008810occurcountryUSVersion of Safety Report ID2receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10045950Date Received30/03/2014transmissiondate12/12/2014serious2Date Last Updated14/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionBone painOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionNeuropsychiatric syndromeOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionFeeling abnormalOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionDepressionOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionAttention deficit/hyperactivity disorderOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionDecreased appetiteOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt17.0ReactionAdverse eventOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt17.0ReactionFatigueOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductREBETOLdrugauthorizationnumb020903drugstructuredosagenumb2drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 DF, BIDdrugdosageformCAPSULEdrugadministrationroute048drugstartdateformat102drugstartdate10/10/2002drugenddateformat102drugenddate03/09/2003actiondrug1

openFDA Info on Medication

Application NumberNDA021546Brand NameREBETOLGeneric NameRIBAVIRINManufacturersMerck Sharp & Dohme Corp.product_ndc0085-1318, 0085-1351, 0085-1385, 0085-1194Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRIBAVIRINRXCUI248112, 312817, 352007, 544400spl_idc1e62cfb-c88b-4f4a-bfc0-351c71f64062spl_set_id04d2b6f4-bd9b-4871-9527-92c81aa2d4d0Package NDC0085-1351-05, 0085-1385-07, 0085-1194-03, 0085-1318-01NUIN0000175459, N0000175466Established Pharmacologic ClassNucleoside Analog Antiviral [EPC]UNII49717AWG6K

2)

drugcharacterization1medicinalproductPEGINTRONdrugdosagetextCAME IN A BOX WITH 2 VIALS AND 2 SYRINGESdrugdosageformPOWDER FOR INJECTIONdrugindicationHEPATITIS Cdrugstartdateformat102drugstartdate10/10/2002drugenddateformat102drugenddate03/09/2003actiondrug1

openFDA Info on Medication

Application NumberBLA103949Brand NamePEGINTRONGeneric NamePEGINTERFERON ALFA-2BManufacturersMerck Sharp & Dohme Corp.product_ndc 0085-1297, 0085-1323, 0085-1316, 0085-1370, 0085-4353, 0085-4354, 0085-4355, 008 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsPEGINTERFERON ALFA-2BRXCUI 284192, 284193, 284194, 284195, 731333, 731334, 731345, 731348, 760029, 760039, ... spl_id519a40d2-566f-4d64-8ffb-35813db6c6aespl_set_idb70816bb-913a-467f-acb8-67ef62cf8dacPackage NDC 0085-1323-01, 0085-1323-02, 0085-1316-01, 0085-1316-02, 0085-1297-03, 0085-1297- ... NUIN0000175521, M0025711Established Pharmacologic ClassInterferon alpha [EPC]Chemical StructureInterferon-alpha [CS]UNIIG8RGG88B68

3)

drugcharacterization2medicinalproductLEXAPROdrugrecurreadministration3

openFDA Info on Medication

Application NumberNDA021323Brand NameLEXAPROGeneric NameESCITALOPRAM OXALATEManufacturersAllergan, Inc.product_ndc0456-2005, 0456-2010, 0456-2020, 0456-2101Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESCITALOPRAM OXALATERXCUI349332, 351249, 351250, 351285, 352272, 352273, 404408, 404420spl_id3b8a75b8-8bcc-463f-99f3-3dcaef07ea53spl_set_id13bb8267-1cab-43e5-acae-55a4d957630aPackage NDC 0456-2005-01, 0456-2010-01, 0456-2010-11, 0456-2010-63, 0456-2020-01, 0456-2020- ... UNII5U85DBW7LO

4)

drugcharacterization2medicinalproductZOLOFTdrugrecurreadministration3

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

5)

drugcharacterization2medicinalproductSEROQUELdrugrecurreadministration3

openFDA Info on Medication

Application NumberNDA022047, NDA020639Brand NameSEROQUEL XR, SEROQUELGeneric NameQUETIAPINEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0310-0280, 0310-0282, 0310-0283, 0310-0284, 0310-0281, 0310-0271, 0310-0275, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI 721791, 721793, 721794, 721795, 721796, 721797, 853201, 853202, 895670, 895671, ... spl_id1a826d85-aac4-42e4-a3e2-a18df915dc33, bca31730-a1ed-4b8f-93d8-2f64143a91faspl_set_id473a3ac4-67f4-4782-baa9-7f9bdd8761f4, 0584dda8-bc3c-48fe-1a90-79608f78e8a0Package NDC 0310-0282-39, 0310-0282-94, 0310-0282-60, 0310-0283-39, 0310-0283-55, 0310-0283- ... UNII2S3PL1B6UJ

6)

drugcharacterization2medicinalproductSONATAdrugrecurreadministration3

7)

drugcharacterization2medicinalproductTRAZODONE HYDROCHLORIDEdrugrecurreadministration3

openFDA Info on Medication

Application Number ANDA071523, ANDA071524, ANDA071525, ANDA071258, ANDA071196, ANDA205253, ANDA0731 ... Brand NameTRAZODONE HYDROCHLORIDEGeneric NameTRAZODONE HYDROCHLORIDEManufacturers Teva Pharmaceuticals USA, Inc., Apotex Corp, Cadila Healthcare Limited, Zydus Ph ... product_ndc 50111-433, 50111-434, 50111-441, 50111-560, 50111-561, 50111-450, 60505-2653, 60 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTRAZODONE HYDROCHLORIDERXCUI856364, 856373, 856377, 856369spl_id 0b9d395f-1d2e-472c-a4c7-684463a9c2b4, 84dfd283-a241-a0a9-6679-8b1c9b819c4d, b87b ... spl_set_id 4006d439-e2de-4590-82e9-fc9d56e3ec1b, 71961ab1-951d-1493-f76c-2ff25cca2a85, 43d4 ... Package NDC 50111-433-01, 50111-433-02, 50111-433-03, 50111-434-01, 50111-434-02, 50111-434- ... UNII6E8ZO8LRNM

Report Duplicate

duplicatesourceMERCKduplicatenumbUS-009507513-1403USA008810