Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-GILEAD-2014-0101089occurcountryUSVersion of Safety Report ID3receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10152801Date Received05/05/2014transmissiondate12/12/2014serious2Date Last Updated19/05/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionAngerOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionEmotional disorderOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionAbnormal behaviourOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionAggressionOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionMental disorderOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionAgitationOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionIrritabilityOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductSOVALDIdrugauthorizationnumb204671drugdosagetextUNKdrugdosageformTABLETdrugadministrationroute065drugindicationHEPATITIS Cdrugstartdateformat102drugstartdate07/02/2014actiondrug5

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

2)

drugcharacterization2medicinalproductRIBAVIRINdrugrecurreadministration3

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

3)

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

4)

drugcharacterization2medicinalproductATIVANdrugrecurreadministration3

openFDA Info on Medication

Application NumberNDA017794, NDA018140Brand NameATIVANGeneric NameLORAZEPAMManufacturersBausch Health US LLC, West-Ward Pharmaceuticals Corp.product_ndc0187-0063, 0187-0064, 0187-0065, 0641-6000, 0641-6001, 0641-6003, 0641-6002Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsLORAZEPAMspl_idb87ffa4d-6634-4d66-a907-3eba6911444c, 30a1b292-640f-477d-b193-f564e84d0436spl_set_id89057c93-8155-4040-acec-64e877bd2b4c, 5fc0e987-61c9-40c4-b0d5-fcea07c8733ePackage NDC 0187-0063-01, 0187-0063-50, 0187-0063-10, 0187-0064-01, 0187-0064-50, 0187-0064- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769LRXCUI206819, 206820, 238100, 238101, 1665188, 1665190, 1665326, 1665327

5)

drugcharacterization2medicinalproductABILIFYdrugrecurreadministration3

openFDA Info on Medication

Application NumberNDA021436Brand NameABILIFYGeneric NameARIPIPRAZOLEManufacturersOtsuka America Pharmaceutical, Inc.product_ndc 59148-006, 59148-007, 59148-008, 59148-009, 59148-010, 59148-011, 59148-013, 591 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsARIPIPRAZOLERXCUI 349490, 349545, 349547, 349553, 352307, 352308, 352309, 352310, 402131, 404602, ... spl_id85ae6d7d-eb0f-44b1-bb1f-b58d196124a4spl_set_idc040bd1d-45b7-49f2-93ea-aed7220b30acPackage NDC 59148-006-13, 59148-006-92, 59148-007-13, 59148-007-35, 59148-007-94, 59148-008- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNII82VFR53I78

6)

drugcharacterization2medicinalproductATRIPLAdrugdosageformTABLETdrugrecurreadministration3

openFDA Info on Medication

Application NumberNDA021937Brand NameATRIPLAGeneric NameEFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATEManufacturersGilead Sciences, LLCproduct_ndc15584-0101Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsEFAVIRENZ, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATERXCUI643066, 643070spl_idb670fd52-7f65-e416-e053-2a95a90ac7b7spl_set_id2e97aa6d-09f7-46df-9499-63db7e9bac35Package NDC15584-0101-1NUI 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 ... Chemical StructureNucleoside Analog [Chemical/Ingredient]UNIIJE6H2O27P8, G70B4ETF4S, OTT9J7900I

7)

drugcharacterization2medicinalproductPROZACdrugrecurreadministration3

openFDA Info on Medication

Application NumberNDA018936Brand NamePROZACGeneric NameFLUOXETINE HYDROCHLORIDEManufacturersDista Products Companyproduct_ndc0777-3104, 0777-3105, 0777-3107Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFLUOXETINE HYDROCHLORIDERXCUI104849, 205535, 261287, 310384, 310385, 313989spl_idef027dfe-1ccd-4c52-ad10-c76d6834d10cspl_set_idc88f33ed-6dfb-4c5e-bc01-d8e36dd97299Package NDC0777-3104-02, 0777-3105-02, 0777-3105-07, 0777-3105-30, 0777-3107-30UNIII9W7N6B1KJ

Report Duplicate

duplicatesourceGILEADduplicatenumbUS-GILEAD-2014-0101089