Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10284696serious1Date Last Updated08/07/2014receiptdateformat102companynumbUS-GILEAD-2014-0107949occurcountryUSseriousnessother1duplicate1Date Received08/07/2014transmissiondate26/03/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Reaction

1)

reactionmeddraversionpt17.1ReactionAortic valve replacementOutcomeUnknown

2)

reactionmeddraversionpt17.1ReactionHypertensionOutcomeUnknown

3)

reactionmeddraversionpt17.1ReactionDiabetes mellitusOutcomeUnknown

4)

reactionmeddraversionpt17.1ReactionChronic obstructive pulmonary diseaseOutcomeUnknown

5)

reactionmeddraversionpt17.1ReactionUnevaluable eventOutcomeUnknown

6)

reactionmeddraversionpt17.1ReactionCoronary artery diseaseOutcomeUnknown

7)

reactionmeddraversionpt17.1ReactionFallOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductBUMEXdrugrecurreadministration3

activesubstance

activesubstancenameBUMETANIDE

openFDA Info on Medication

Application NumberNDA018225Brand NameBUMEXGeneric NameBUMETANIDEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-630, 30698-631, 30698-632Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUMETANIDERXCUI197417, 197418, 197419, 205488, 205489, 205490spl_ida8cdbcbb-2436-4157-9929-e1138035de53spl_set_id32dfbea3-eb2b-4070-8605-57ce3e6d5a2fPackage NDC30698-630-01, 30698-631-01, 30698-632-01NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII0Y2S3XUQ5H

2)

drugcharacterization2medicinalproductNEURONTINdrugrecurreadministration3

activesubstance

activesubstancenameGABAPENTIN

openFDA Info on Medication

Application NumberNDA020882, NDA020235, NDA021129Brand NameNEURONTINGeneric NameGABAPENTINManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0401, 0071-0803, 0071-0805, 0071-0806, 0071-0513, 0071-2012Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 105028, 105029, 105030, 261280, 261281, 283523, 310430, 310431, 310432, 310433, ... spl_id597965f8-e2d2-4010-b57b-482f6e59a810spl_set_idee9ad9ed-6d9f-4ee1-9d7f-cfad438df388Package NDC 0071-0803-24, 0071-0803-40, 0071-0805-24, 0071-0805-40, 0071-0806-24, 0071-0806- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

3)

drugcharacterization2medicinalproductZOLOFTdrugrecurreadministration3

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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)

drugcharacterization2medicinalproductALLOPURINOL.drugrecurreadministration3

activesubstance

activesubstancenameALLOPURINOL

openFDA Info on Medication

Application Number NDA020298, ANDA203154, ANDA071450, ANDA204467, NDA018832, NDA018877, NDA016084, ... Brand NameALOPRIM, ALLOPURINOL, ZYLOPRIMGeneric NameALLOPURINOLManufacturers Mylan Institutional LLC, Accord Healthcare Inc., Sun Pharmaceutical Industries, ... product_ndc 67457-978, 16729-134, 16729-135, 53489-156, 53489-157, 23155-693, 23155-694, 059 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsALLOPURINOL SODIUM, ALLOPURINOLRXCUI252931, 261265, 197319, 197320, 213995, 213998spl_id 2acff21e-7d8f-4b03-b7b7-9400f54f66ac, 9010eb1b-3580-b221-e053-2995a90a3feb, a9f5 ... spl_set_id 018525b1-e37d-4ff2-9dc3-36b3d90ac3e0, 682dd8b8-fc6e-47c5-95b7-82d7ad96b750, fd8f ... Package NDC 67457-978-50, 16729-134-10, 16729-134-01, 16729-134-16, 16729-134-17, 16729-135- ... UNII428673RC2Z, 63CZ7GJN5INUIN0000175698, N0000000206Established Pharmacologic ClassXanthine Oxidase Inhibitor [EPC]Mechanism of ActionXanthine Oxidase Inhibitors [MoA]

5)

drugcharacterization2medicinalproductMUCINEXdrugrecurreadministration3

activesubstance

activesubstancenameGUAIFENESIN

openFDA Info on Medication

Application NumberNDA021282, part341Brand NameMUCINEX, MUCINEX MAXIMUM STRENGTH, MUCINEX FAST-MAX SEVERE COLDGeneric Name GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHEN ... ManufacturersRB Health (US) LLCproduct_ndc63824-008, 63824-023, 63824-020Product TypeHUMAN OTC DRUGRouteORALActive Ingredients GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCH ... RXCUI636522, 891301, 310621, 891297, 1116572spl_id a41a03f3-908a-4f4d-a456-d5e3696f6f01, 28208539-5a7e-4abe-8eea-02323da52933, 4dca ... spl_set_id dd379cdd-90ab-42e0-ad89-f50d3220f611, 47f5323c-ee3a-400d-b133-31d9c286fafd, bee0 ... Package NDC 63824-008-36, 63824-008-32, 63824-008-34, 63824-008-69, 63824-008-27, 63824-008- ... UNII495W7451VQ, 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ

6)

drugcharacterization1medicinalproductRANEXAdrugauthorizationnumb021526drugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext500 MG, BIDdrugdosageformTABLETdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameRANOLAZINE

openFDA Info on Medication

Application NumberNDA021526Brand NameRANEXAGeneric NameRANOLAZINEManufacturersGilead Sciences, Inc.product_ndc61958-1003, 61958-1004Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRANOLAZINERXCUI616749, 728231, 860737, 860738spl_idb56c6449-a982-c64c-e053-2a95a90a136aspl_set_idbeb482de-f251-476b-9d38-40577c36f5a3Package NDC 61958-1003-1, 61958-1003-2, 61958-1003-3, 61958-1004-1, 61958-1004-2, 61958-1004 ... NUIN0000175427, N0000190114, N0000185503, N0000182137, N0000187061Established Pharmacologic ClassAnti-anginal [EPC]Mechanism of Action Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Cytochrome ... UNIIA6IEZ5M406

7)

drugcharacterization2medicinalproductNOVOLOGdrugrecurreadministration3

activesubstance

activesubstancenameINSULIN ASPART

openFDA Info on Medication

Application NumberBLA020986Brand NameNOVOLOGGeneric NameINSULIN ASPARTManufacturersNovo Nordiskproduct_ndc0169-3303, 0169-7501, 0169-6339, 0169-6338, 0169-2001Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, SUBCUTANEOUSActive IngredientsINSULIN ASPARTRXCUI311040, 351926, 1653196, 1653198, 1653202, 1653204spl_id952147fd-80b2-481b-bc17-e94ac49f1bb1spl_set_id3a1e73a2-3009-40d0-876c-b4cb2be56fc5Package NDC 0169-7501-11, 0169-7501-90, 0169-3303-12, 0169-3303-91, 0169-3303-90, 0169-6339- ... NUIM0011417, N0000175453Chemical StructureInsulin [CS]Established Pharmacologic ClassInsulin Analog [EPC]UNII059QF0KO0R, D933668QVX

8)

drugcharacterization2medicinalproductLIPITORdrugrecurreadministration3

activesubstance

activesubstancenameATORVASTATIN CALCIUM

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

9)

drugcharacterization2medicinalproductPLAVIXdrugrecurreadministration3

activesubstance

activesubstancenameCLOPIDOGREL BISULFATE

openFDA Info on Medication

Application NumberNDA020839Brand NamePLAVIXGeneric NameCLOPIDOGRELManufacturerssanofi-aventis U.S. LLC, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnershipproduct_ndc0024-1171, 0024-1332, 63653-1171, 63653-1332Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLOPIDOGREL BISULFATERXCUI213169, 309362, 749196, 749198spl_idcb770afe-b6de-469f-9d9c-3db134394d4d, 12eb3088-f30b-4bb5-aee0-113114b5a08cspl_set_idde8b0b67-eb25-4684-83b5-7ad785314227, 01b14603-8f29-4fa3-8d7e-9d523f802e0bPackage NDC 0024-1171-90, 0024-1332-30, 63653-1171-6, 63653-1171-1, 63653-1171-3, 63653-1171 ... UNII08I79HTP27

10)

drugcharacterization2medicinalproductLAD ACETONEdrugrecurreadministration3

11)

drugcharacterization2medicinalproductASAdrugrecurreadministration3

activesubstance

activesubstancenameASPIRIN

12)

drugcharacterization2medicinalproductZANTACdrugrecurreadministration3

activesubstance

activesubstancenameRANITIDINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA019090Brand NameZANTACGeneric NameRANITIDINE HYDROCHLORIDEManufacturersTeligent, Inc., Teligent Pharma, Inc.product_ndc52565-096, 52565-101, 52565-102Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUSActive IngredientsRANITIDINE HYDROCHLORIDERXCUI104084, 312772, 1859553, 1859554spl_id4a3400a1-5ac0-407f-b4c9-cc75b5da4b82, f893211b-dae4-417b-8d5a-e4f54d0d3833spl_set_id95dc4515-7690-4881-ae14-9f8655a68dfe, c1b12354-9409-4e76-bcdc-024c190d6583Package NDC52565-096-04, 52565-101-25, 52565-102-05UNIIBK76465IHM

13)

drugcharacterization2medicinalproductADVAIR HFAdrugrecurreadministration3

activesubstance

activesubstancenameFLUTICASONE PROPIONATE\SALMETEROL XINAFOATE

openFDA Info on Medication

Application NumberNDA021254Brand NameADVAIR HFAGeneric NameFLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0715, 0173-0716, 0173-0717Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsFLUTICASONE PROPIONATE, SALMETEROL XINAFOATEspl_id296f1772-58d7-4742-abc6-4557165605b2spl_set_iddfaca6f9-3277-47b2-319d-1377917cb54cPackage NDC 0173-0715-20, 0173-0715-22, 0173-0716-20, 0173-0716-22, 0173-0717-20, 0173-0717- ... UNIIO2GMZ0LF5W, 6EW8Q962A5

Report Duplicate

duplicatesourceGILEADduplicatenumbUS-GILEAD-2014-0107949

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use