Adverse Event Report

Report

reporttype1receiptdateformat102Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID11096320Date Received06/05/2015transmissiondate21/08/2015serious1Date Last Updated06/05/2015primarysourcecountryUSseriousnessdisabling1

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age67Unit of Onset AgeyearsWeight99.79SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionAlopecia

2)

reactionmeddraversionpt18.0ReactionChronic kidney disease

Drug

1)

drugcharacterization2medicinalproductLAMOTRINE

2)

drugcharacterization2medicinalproductSIMBASTATIN

3)

drugcharacterization2medicinalproductLANTUS

activesubstance

activesubstancenameINSULIN GLARGINE

openFDA Info on Medication

Application NumberBLA021081Brand NameLANTUSGeneric NameINSULIN GLARGINEManufacturerssanofi-aventis U.S. LLCproduct_ndc0088-2220, 0088-2219, 0088-5021, 0088-5020Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsINSULIN GLARGINERXCUI285018, 311041, 847230, 847232spl_id0a57f187-f101-4268-851f-7f20c7f708f9, 4e455ace-94f4-4fa3-85eb-0152e5a06239spl_set_idd5e07a0c-7e14-4756-9152-9fea485d654a, 6328c99d-d75f-43ef-b19e-7e71f91e57f6Package NDC 0088-2220-33, 0088-2220-34, 0088-2219-00, 0088-2219-01, 0088-2219-05, 0088-5021- ... NUIN0000004931, N0000175453Chemical StructureInsulin [Chemical/Ingredient]Established Pharmacologic ClassInsulin Analog [EPC]UNII2ZM8CX04RZ

4)

drugcharacterization2medicinalproductLISINOPRIL.

activesubstance

activesubstancenameLISINOPRIL

openFDA Info on Medication

Application Number ANDA076063, ANDA077321, NDA208401, ANDA078402, ANDA212041, ANDA076180, ANDA07616 ... Brand NameLISINOPRIL, QBRELIS, PRINIVIL, ZESTRILGeneric NameLISINOPRILManufacturers Hikma Pharmaceuticals USA Inc., International Laboratories, LLC, Azurity Pharmac ... product_ndc 0143-9713, 0143-9715, 0143-9714, 54458-872, 54458-877, 54458-874, 54458-873, 526 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 311354, 314076, 314077, 197884, 1806884, 1806890, 205326, 311353, 206764, 206765 ... spl_id 533f6e0f-04a0-4ef7-81b8-0a7be07ddd1a, b685bb45-44a6-4afc-bb3e-940bce536bda, 2fdc ... spl_set_id b70933da-55b2-4025-a00e-63ce3e6b7fdf, 6eef83b4-ce4c-462b-bcfa-eefa525e682d, 9f6e ... Package NDC 0143-9715-01, 0143-9715-10, 0143-9715-99, 0143-9714-01, 0143-9714-10, 0143-9714- ... UNIIE7199S1YWR

5)

drugcharacterization1medicinalproductDEPAKOTEdrugauthorizationnumb019680drugstructuredosagenumb1000drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 500 MG DAILY, ONCE DAILY, TAKEN BY MOUTHdrugadministrationroute048drugindicationBIPOLAR DISORDERdrugtreatmentduration3drugtreatmentdurationunit801drugadditional2

activesubstance

activesubstancenameDIVALPROEX SODIUM

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 SODIUMRXCUI 1099563, 1099565, 1099569, 1099571, 1099625, 1099626, 1099678, 1099679, 1099870, ... spl_id bda1168f-9cb8-cfc6-ccea-f576f45e25a6, 3c11ce81-9241-56ec-0783-7843408c10b9, f636 ... spl_set_id 0dc024ce-efc8-4690-7cb5-639c728fccac, 08a65cf4-7749-4ceb-6895-8f4805e2b01f, 4619 ... Package NDC 0074-3826-13, 0074-3826-11, 0074-7126-13, 0074-7126-53, 0074-7126-11, 0074-7126- ... UNII644VL95AO6

6)

drugcharacterization2medicinalproductALLOPURINOL.

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]

7)

drugcharacterization2medicinalproductFENFRIBRATE

8)

drugcharacterization2medicinalproductC-PAP ,ACJOME

9)

drugcharacterization2medicinalproductSERTRALINE

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

10)

drugcharacterization2medicinalproductTRAZODONE

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

11)

drugcharacterization2medicinalproductASPIRIN.

activesubstance

activesubstancenameASPIRIN

openFDA Info on Medication

Application Numberpart343Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN 81MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 0363-0587, 70000-0218, 70000-0170, 6 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 198471, 825180, 198464 ... spl_id a1833a99-76cc-47fb-80fb-3a6507a2db3e, acc2acbd-b310-e26a-e053-2a95a90a1874, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

12)

drugcharacterization2medicinalproductGABAPENTIN.

activesubstance

activesubstancenameGABAPENTIN

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 6e41ce47-a6cc-4c34-84f1-305747df38c2, 5fc4 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

13)

drugcharacterization2medicinalproductVITAMIN C

activesubstance

activesubstancenameASCORBIC ACID

14)

drugcharacterization2medicinalproductHOMEOPATHIC BLADDER CONFIDENCE

15)

drugcharacterization2medicinalproductJANUVIA

activesubstance

activesubstancenameSITAGLIPTIN PHOSPHATE

openFDA Info on Medication

Application NumberNDA021995Brand NameJANUVIAGeneric NameSITAGLIPTINManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0112, 0006-0221, 0006-0277Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSITAGLIPTIN PHOSPHATERXCUI665033, 665036, 665038, 665040, 665042, 665044spl_id26191c72-2372-41ac-8ddf-e28322dcb9ccspl_set_idf85a48d0-0407-4c50-b0fa-7673a160bf01Package NDC 0006-0221-01, 0006-0221-28, 0006-0221-31, 0006-0221-54, 0006-0112-01, 0006-0112- ... UNIITS63EW8X6F