Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10128448serious1Date Last Updated28/04/2014receiptdateformat102companynumbUS-ROCHE-1388942occurcountryUSduplicate1Date Received28/04/2014transmissiondate12/12/2014primarysourcecountryUSseriousnessdisabling1

Primary Source

reportercountryUSqualification1

Patient

Onset Age57Unit of Onset AgeyearsWeight66SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionAtaxiaOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionTremorOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionDyspnoeaOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionBalance disorderOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductRIBAVIRINdrugauthorizationnumb021511drugstructuredosagenumb600drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationHEPATITIS Cdrugstartdateformat102drugstartdate06/03/2014drugenddateformat102drugenddate11/03/2014actiondrug1

openFDA Info on Medication

Application NumberNDA018859, ANDA077094, ANDA207366, ANDA077224, ANDA079111, ANDA079117, NDA021546Brand NameVIRAZOLE, RIBAVIRIN, REBETOLGeneric NameRIBAVIRINManufacturers Bausch Health US, LLC, Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) In ... product_ndc 0187-0007, 65841-046, 65841-603, 65841-632, 65841-129, 68382-046, 68382-127, 683 ... Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION), ORALActive IngredientsRIBAVIRINRXCUI207406, 312818, 248109, 597718, 597722, 790286, 312817, 248112, 352007, 544400spl_id 73a3e060-c827-40d8-925c-2d02b9313070, 1596fe48-b374-4c0c-b2ae-1ceb802ca2ba, b46a ... spl_set_id adf16e64-345f-469a-b987-3fbdd17e0ac2, 666e8b22-f519-460b-a774-88a621d56139, 0899 ... Package NDC 0187-0007-14, 0187-0007-01, 65841-046-03, 65841-046-28, 65841-046-10, 65841-046- ... NUIN0000175459, N0000175466Established Pharmacologic ClassNucleoside Analog Antiviral [EPC]UNII49717AWG6K

2)

drugcharacterization1medicinalproductSOVALDIdrugadministrationroute065drugindicationHEPATITIS Cdrugstartdateformat102drugstartdate06/03/2014drugenddateformat102drugenddate11/03/2014actiondrug1

openFDA Info on Medication

Application NumberNDA204671, NDA212480Brand NameSOVALDIGeneric NameSOFOSBUVIRManufacturersGilead Sciences, Inc.product_ndc61958-1501, 61958-1503, 61958-1504, 61958-1505Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSOFOSBUVIRRXCUI1484916, 1484922, 2203891, 2203893, 2203993, 2203999, 2204090, 2204092spl_idb6ff385d-224a-0bad-e053-2995a90adcd4spl_set_id80beab2c-396e-4a37-a4dc-40fdb62859cfPackage NDC61958-1501-1, 61958-1503-1, 61958-1504-1, 61958-1505-1NUIN0000191493, N0000191258, N0000175459Established Pharmacologic ClassHepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]Mechanism of ActionRNA Replicase Inhibitors [MoA]UNIIWJ6CA3ZU8B

3)

drugcharacterization2medicinalproductMETHADONE

openFDA Info on Medication

Application NumberANDA204166Brand NameMETHADONE HYDROCHLORIDEGeneric NameMETHADONEManufacturersVistaPharm, Inc.product_ndc66689-836Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETHADONE HYDROCHLORIDERXCUI864706spl_id00594a6e-2875-4640-95cc-e8bcff7541bcspl_set_id4a44bde6-c348-4316-b0e0-c24b407cb823Package NDC66689-836-99UNII229809935B

4)

drugcharacterization2medicinalproductPENTOXIFYLLINE

openFDA Info on Medication

Application NumberANDA075191, ANDA075028Brand NamePENTOXIFYLLINEGeneric NamePENTOXIFYLLINEManufacturersApotex Corp., Oceanside Pharmaceuticalsproduct_ndc60505-0033, 68682-101Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPENTOXIFYLLINERXCUI312301spl_id54a10062-0b81-f7ca-1a60-f7b12f8469b8, 62112305-39c0-451d-82aa-b1fbdeceb790spl_set_id40ae2d9a-0d95-640d-0640-f76e7e1a13cb, c28cf3c3-8c13-46c6-a051-6de99db19882Package NDC 60505-0033-6, 60505-0033-7, 60505-0033-9, 60505-0033-8, 68682-101-10, 68682-101- ... NUIN0000175895, N0000009065Established Pharmacologic ClassBlood Viscosity Reducer [EPC]Physiologic/Pharmacodynamic EffectHematologic Activity Alteration [PE]UNIISD6QCT3TSU

5)

drugcharacterization2medicinalproductLANSOPRAZOLE

openFDA Info on Medication

Application Number ANDA202319, ANDA203306, ANDA203187, ANDA202366, NDA208025, ANDA091269, ANDA20217 ... Brand Name EQUALINE LANSOPRAZOLE, LANSOPRAZOLE, EQUATE LANSOPRAZOLE DELAYED RELEASE, EQUATE ... Generic NameLANSOPRAZOLE, LANSOPRAZOLE DELAYED RELEASEManufacturers Supervalu Inc, HEB, Chain Drug Consortium, LLC, Cadila Healthcare Limited, Perri ... product_ndc 41163-117, 37808-448, 68016-758, 65841-769, 65841-770, 45802-245, 49035-411, 490 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLANSOPRAZOLERXCUI596843, 311277, 351261, 206205, 206206, 351260, 596918, 866152spl_id a9daca89-e2f8-40bf-9beb-4267aaac7d3e, c7379031-b622-41be-8afd-ac1f44ff4e33, a60e ... spl_set_id ea8efda5-9d08-446b-9424-68a98122589a, 3496e421-3d42-4b1e-9ea2-0ffc03bb81ed, 5452 ... Package NDC 41163-117-01, 41163-117-02, 41163-117-03, 37808-448-14, 37808-448-42, 68016-758- ... NUIN0000175525, N0000000147, N0000009724Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA]Physiologic/Pharmacodynamic EffectInhibition Gastric Acid Secretion [PE]UNII0K5C5T2QPG

6)

drugcharacterization2medicinalproductTIOTROPIUM

7)

drugcharacterization2medicinalproductTRAMADOL

8)

drugcharacterization2medicinalproductALBUTEROL

openFDA Info on Medication

Application Number ANDA210948, ANDA077788, ANDA213657, ANDA211397, ANDA208804, ANDA207046, ANDA0728 ... Brand NameALBUTEROL, ALBUTEROL SULFATEGeneric NameALBUTEROL SULFATE, ALBUTEROLManufacturers Nivagen Pharmaceuticals Inc, VistaPharm, Inc., Aurobindo Pharma Limited, Virtus ... product_ndc 75834-273, 75834-274, 66689-100, 59651-333, 59651-334, 69543-290, 69543-291, 692 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALBUTEROL SULFATERXCUI197316, 197318, 755497spl_id b736135f-6e13-3e29-e053-2a95a90a67f4, 737932ca-a391-48c3-96c5-14de8ae1000e, ff9b ... spl_set_id b735e92d-eb1a-6fc1-e053-2995a90afce2, c7713a63-af2a-40d3-8deb-cbb92d5f1cd3, ff9b ... Package NDC 75834-273-01, 75834-274-01, 66689-100-16, 66689-100-08, 59651-333-01, 59651-333- ... UNII021SEF3731

9)

drugcharacterization2medicinalproductLIDODERM

openFDA Info on Medication

Application NumberNDA020612Brand NameLIDODERMGeneric NameLIDOCAINEManufacturersEndo Pharmaceuticals, Inc.product_ndc63481-687Product TypeHUMAN PRESCRIPTION DRUGRouteCUTANEOUSActive IngredientsLIDOCAINERXCUI1011705, 1745091spl_id9c6118a9-8702-4025-e053-2995a90a50adspl_set_idf1c40164-4626-4290-9012-c00e33420a33Package NDC63481-687-01, 63481-687-06NUIN0000175682, M0000897, N0000175426, N0000175976Established Pharmacologic ClassAmide Local Anesthetic [EPC], Antiarrhythmic [EPC]Chemical StructureAmides [CS]Physiologic/Pharmacodynamic EffectLocal Anesthesia [PE]UNII98PI200987

10)

drugcharacterization2medicinalproductEPZICOM

openFDA Info on Medication

Application NumberNDA021652Brand NameEPZICOMGeneric NameABACAVIR SULFATE AND LAMIVUDINEManufacturersViiV Healthcare Companyproduct_ndc49702-206Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsABACAVIR SULFATE, LAMIVUDINERXCUI602393, 602395spl_ide11f2794-db6f-40eb-8fa9-0aeda8453c21spl_set_idf1139e7f-2db9-4961-9da3-9b7f2088736fPackage NDC49702-206-13NUIN0000175656, N0000175462, N0000175459, N0000009947Established Pharmacologic Class Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human ... Mechanism of ActionNucleoside Reverse Transcriptase Inhibitors [MoA]UNIIJ220T4J9Q2, 2T8Q726O95

11)

drugcharacterization2medicinalproductSUSTIVA

openFDA Info on Medication

Application NumberNDA020972, NDA021360Brand NameSUSTIVAGeneric NameEFAVIRENZManufacturersBristol-Myers Squibb Pharma Companyproduct_ndc0056-0470, 0056-0474, 0056-0510Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsEFAVIRENZRXCUI205290, 205292, 213390, 213392, 349477, 352143spl_id092e0b1d-a576-4e96-bc9b-8d3f43cbb2dfspl_set_id32d6371e-ba56-4294-b732-6d43627c5c47Package NDC0056-0470-30, 0056-0474-92, 0056-0510-30NUI N0000175463, N0000175460, N0000009948, N0000190118, N0000187064, N0000185504, N0 ... Established Pharmacologic Class Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhib ... Mechanism of Action Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Cytochrome P450 3A Induce ... UNIIJE6H2O27P8

12)

drugcharacterization2medicinalproductLASIX

openFDA Info on Medication

Application NumberNDA016273Brand NameLASIXGeneric NameFUROSEMIDEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-060, 30698-067, 30698-066Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFUROSEMIDERXCUI197732, 200801, 200809, 205732, 310429, 313988spl_id95a46760-e587-41a3-9ff3-c8dd8505f694spl_set_id2c9b4d8f-0770-482d-a9e6-9c616a440b1aPackage NDC 30698-067-01, 30698-067-10, 30698-060-01, 30698-060-10, 30698-060-50, 30698-066- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

13)

drugcharacterization2medicinalproductALDACTONE (UNITED STATES)

14)

drugcharacterization2medicinalproductPRAVASTATIN

15)

drugcharacterization2medicinalproductSYMBICORT

openFDA Info on Medication

Application NumberNDA021929Brand NameSYMBICORTGeneric NameBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0186-0370, 0186-0372Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsBUDESONIDE, FORMOTEROL FUMARATERXCUI1246288, 1246290, 1246304, 1246306, 1246314, 1246315, 1246316, 1246317spl_id5b03fd09-2533-4975-88da-a0b9c8495d1espl_set_idfafa4cf1-99c2-43d5-73ad-51f256de3be0Package NDC 0186-0370-20, 0186-0370-28, 0186-0370-60, 0186-0372-20, 0186-0372-28, 0186-0372- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIQ3OKS62Q6X, W34SHF8J2K

16)

drugcharacterization2medicinalproductADDERALL

openFDA Info on Medication

Application NumberANDA040422, NDA021303Brand NameADDERALL, ADDERALL XRGeneric Name DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, ... ManufacturersTeva Pharmaceuticals USA, Inc., Takeda Pharmaceuticals America, Inc.product_ndc 57844-105, 57844-117, 57844-110, 57844-112, 57844-115, 57844-120, 57844-130, 540 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive Ingredients DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMI ... RXCUI 541363, 541365, 541878, 541879, 541892, 541894, 577957, 577960, 577961, 577962, ... spl_ide9cd0754-917c-4545-8963-e0b5b8fe544a, 05c01190-093d-41b3-8fe6-4ad8d6e2aee3spl_set_idf22635fe-821d-4cde-aa12-419f8b53db81, aff45863-ffe1-4d4f-8acf-c7081512a6c0Package NDC 57844-105-01, 57844-117-01, 57844-110-01, 57844-112-01, 57844-115-01, 57844-120- ... UNII6DPV8NK46S, G83415V073, O1ZPV620O4, JJ768O327N

17)

drugcharacterization2medicinalproductSERTRALINE

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

18)

drugcharacterization2medicinalproductARIPIPRAZOLE

openFDA Info on Medication

Application Number ANDA207240, ANDA205363, ANDA205064, ANDA090472, ANDA090165, NDA207202, ANDA21047 ... Brand NameARIPIPRAZOLE, ABILIFY MYCITE, ABILIFY, ABILIFY MAINTENAGeneric NameARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLEManufacturers Dr. Reddy's Laboratories Inc, Solco Healthcare U.S., LLC, Exelan Pharmaceuticals ... product_ndc 43598-733, 43598-734, 43547-302, 43547-303, 43547-304, 43547-305, 43547-306, 435 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsARIPIPRAZOLERXCUI 643019, 643022, 349490, 349545, 349547, 349553, 402131, 602964, 643027, 643058, ... spl_id 412b3755-0b3f-4493-a460-ab8b25c37ab6, 1a1ae3f9-f3ef-4cea-b3ba-527f085fd87c, ae9e ... spl_set_id 394ea4a4-3991-4f98-b38f-56e9335d66b3, 686d0088-ac61-41df-8909-ae12f7957644, 7051 ... Package NDC 43598-733-30, 43598-734-30, 43547-302-03, 43547-302-09, 43547-302-10, 43547-302- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNII82VFR53I78

19)

drugcharacterization2medicinalproductCLARITIN

openFDA Info on Medication

Application NumberNDA020704, NDA019658, NDA021952, NDA021891, NDA021993Brand NameCLARITIN REDITABS, CLARITIN, CLARITIN LIQUI-GELSGeneric NameLORATADINEManufacturersBayer Healthcare LLC., Bayer HealthCare LLC., Bayer HealthCare LLCproduct_ndc 11523-4329, 11523-7157, 11523-0007, 11523-6655, 11523-1527, 11523-7237, 11523-71 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLORATADINERXCUI311373, 744830, 206805, 311372, 828269, 836338, 665078, 668469, 672558, 904026spl_id 9999c20a-a166-64be-e053-2995a90ad2ce, bb8f183a-a014-b076-e053-2995a90a1d1e, 55ed ... spl_set_id b681ea25-d00b-4c8a-8054-cc6f983ce337, acf2d393-53d7-062f-e053-2995a90a0d60, ac32 ... Package NDC 11523-7157-2, 11523-7157-3, 11523-7157-4, 11523-7157-7, 11523-7157-8, 11523-7157 ... UNII7AJO3BO7QN

20)

drugcharacterization2medicinalproductK-DUR

21)

drugcharacterization2medicinalproductFLONASE

openFDA Info on Medication

Application NumberNDA205434Brand NameFLONASE ALLERGY RELIEFGeneric NameFLUTICASONE PROPIONATEManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLCproduct_ndc0135-0576Product TypeHUMAN OTC DRUGRouteNASALActive IngredientsFLUTICASONE PROPIONATERXCUI1797907, 1797933spl_id746e63f3-5386-4e7b-811d-8cfd3e9120d8spl_set_idb6134ba0-b70a-4eac-9a82-cef64b242c1dPackage NDC 0135-0576-01, 0135-0576-02, 0135-0576-03, 0135-0576-04, 0135-0576-12, 0135-0576- ... UNIIO2GMZ0LF5W

Report Duplicate

duplicatesourceROCHEduplicatenumbUS-ROCHE-1388942

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use