Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10150200primarysourcecountryUStransmissiondateformat102transmissiondate12/12/2014reporttype1serious1seriousnesshospitalization1receivedateformat102Date Received01/05/2014receiptdateformat102Date Last Updated01/05/2014fulfillexpeditecriteria2

Primary Source

reportercountryUSqualification2

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age86Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionFeeling abnormal

2)

reactionmeddraversionpt17.0ReactionFeeding disorder

3)

reactionmeddraversionpt17.0ReactionFall

4)

reactionmeddraversionpt17.0ReactionConfusional state

Drug

1)

drugcharacterization1medicinalproductFESOTERODINEdrugstructuredosagenumb8drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationHYPERTONIC BLADDERdrugstartdateformat102drugstartdate27/09/2013drugenddateformat102drugenddate29/09/2013drugrecurreadministration2drugadditional2

2)

drugcharacterization2medicinalproductALBUTEROL

openFDA Info on Medication

Application Number ANDA210948, ANDA213657, ANDA211397, ANDA208804, ANDA072894, ANDA207046, ANDA2088 ... Brand NameALBUTEROLGeneric NameALBUTEROL SULFATE, ALBUTEROLManufacturers Nivagen Pharmaceuticals Inc, Aurobindo Pharma Limited, Virtus Pharmaceuticals LL ... product_ndc 75834-273, 75834-274, 59651-333, 59651-334, 69543-290, 69543-291, 69238-1344, 69 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALBUTEROL SULFATERXCUI197316, 197318spl_id 5b89a3bb-e3bb-421d-89f7-f180e01a1b4d, d3cb4534-a60a-4476-928c-6eb52ac01cf8, b9cd ... spl_set_id b735e92d-eb1a-6fc1-e053-2995a90afce2, ff9b287b-e4a4-4c12-ad2f-6b7d55b20dc6, 3f81 ... Package NDC 75834-273-01, 75834-274-01, 59651-333-01, 59651-333-05, 59651-334-01, 59651-334- ... UNII021SEF3731

3)

drugcharacterization2medicinalproductALENDRONATE

openFDA Info on Medication

Application NumberANDA090258Brand NameALENDRONATEGeneric NameALENDRONATE SODIUM, ALENDRONATE SODIUM TABLETManufacturers Virtus Pharmaceuticals, Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd., Mar ... product_ndc69543-130, 69543-131, 60723-205, 60723-207, 10135-718, 10135-719Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALENDRONATE SODIUMRXCUI904396, 904431spl_id d42c7c03-3f82-6a67-e053-2995a90a6ebc, d0f979c3-26f8-2393-e053-2995a90a0e1d, ccc0 ... spl_set_id 5c49d7fc-c76a-40c9-8c43-68b731230f0e, a24fd39c-34a7-4de2-9439-781e612189ca, b634 ... Package NDC 69543-130-04, 69543-130-12, 69543-130-20, 69543-131-04, 69543-131-12, 69543-131- ... UNII2UY4M2U3RA

4)

drugcharacterization2medicinalproductALLOPURINOL

openFDA Info on Medication

Application Number NDA020298, ANDA203154, ANDA212363, ANDA071450, ANDA204467, NDA018832, NDA018877, ... Brand NameALOPRIM, ALLOPURINOL, ZYLOPRIMGeneric NameALLOPURINOLManufacturers Mylan Institutional LLC, Accord Healthcare Inc., Gland Pharma Limited, Sun Pharm ... product_ndc 67457-978, 16729-134, 16729-135, 68083-380, 53489-156, 53489-157, 23155-693, 231 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsALLOPURINOL SODIUM, ALLOPURINOLRXCUI252931, 261265, 197319, 197320, 213995, 213998spl_id 2acff21e-7d8f-4b03-b7b7-9400f54f66ac, d10d00c1-a0d9-6fd8-e053-2a95a90a588a, 6a0e ... spl_set_id 018525b1-e37d-4ff2-9dc3-36b3d90ac3e0, 682dd8b8-fc6e-47c5-95b7-82d7ad96b750, 4839 ... 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)

drugcharacterization2medicinalproductAMLODIPINE

openFDA Info on Medication

Application NumberNDA214439, NDA211340Brand NameNORLIQVA, KATERZIAGeneric NameAMLODIPINEManufacturersCMP Pharma, Inc., Azurity Pharmaceuticals, Inc.product_ndc46287-035, 52652-5001Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE, AMLODIPINE BENZOATERXCUI2599173, 2599179, 2184120, 2184126spl_id63a6bb49-fb68-4351-be5f-a6b6e8f6b540, df623dda-e184-4011-8fce-4e729b2e6b2dspl_set_idc1730a51-4383-4c61-a9a1-7e1326bd0abe, df673a4d-acb8-444c-a472-c87ab8cbd366Package NDC46287-035-15, 52652-5001-1NUIN0000000069, N0000175421, N0000175566, M0006414, N0000190114Mechanism of ActionCalcium Channel Antagonists [MoA], Cytochrome P450 3A Inhibitors [MoA]Established Pharmacologic ClassDihydropyridine Calcium Channel Blocker [EPC], Calcium Channel Blocker [EPC]Chemical StructureDihydropyridines [CS]UNII1J444QC288, XD75TQ8A2P

6)

drugcharacterization2medicinalproductDOCUSATE

7)

drugcharacterization2medicinalproductESOMEPRAZOLE

openFDA Info on Medication

Application NumberANDA207193, ANDA212866, ANDA207673Brand Name KIRKLAND SIGNATURE ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE, DG HEALTH ESOMEPRAZOLE ... Generic NameESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUMManufacturers Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., Dolgencorp, LLC, Walgre ... product_ndc 63981-898, 57483-900, 55910-250, 0363-1898, 46122-641, 50594-029, 63304-740, 692 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUMRXCUI606726, 433733spl_id 495105e5-3361-48c3-bdac-14828718eeff, 35efed44-c129-4bd6-8547-de9f88468907, 6b0b ... spl_set_id 4a87d5d5-c98b-4dc5-81be-50183342b047, b3d10f0b-52af-408c-9b3d-f8f25f7c42bd, 8f97 ... Package NDC 63981-898-03, 57483-900-42, 55910-250-01, 55910-250-02, 55910-250-03, 0363-1898- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIN3PA6559FT, R6DXU4WAY9

8)

drugcharacterization2medicinalproductCYCLOBENZAPRINE

openFDA Info on Medication

Application NumberANDA090478, ANDA071611Brand NameCYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINEGeneric NameCYCLOBENZAPRINE, CYCLOBENZAPRINE HYDROCHLORIDEManufacturersCipla USA Inc., Rising Health, LLCproduct_ndc69097-845, 69097-846, 57237-266Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCYCLOBENZAPRINE HYDROCHLORIDERXCUI828320, 828348, 828299spl_id0e5c376d-9599-4825-9226-016d40cf6113, 09330886-13f8-44cc-98d2-883f3e0514b4spl_set_id575a31fb-04c5-4001-88a7-c33adbacc6a8, b12fb4ea-182e-462b-b6ed-cfd2f6bb71e8Package NDC69097-845-07, 69097-845-15, 69097-846-07, 69097-846-15, 57237-266-01UNII0VE05JYS2P

9)

drugcharacterization2medicinalproductLISINOPRIL

openFDA Info on Medication

Application Number ANDA076063, ANDA077321, ANDA077622, NDA208401, ANDA078402, ANDA208920, ANDA21204 ... Brand NameLISINOPRIL, QBRELIS, ZESTRILGeneric NameLISINOPRILManufacturers Hikma Pharmaceuticals USA Inc., International Laboratories, LLC, Rising Pharma H ... product_ndc 0143-9713, 0143-9715, 0143-9714, 54458-872, 54458-877, 54458-874, 54458-873, 165 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 311354, 314076, 314077, 197884, 205326, 311353, 1806884, 1806890, 104375, 104376 ... spl_id 533f6e0f-04a0-4ef7-81b8-0a7be07ddd1a, b685bb45-44a6-4afc-bb3e-940bce536bda, c031 ... spl_set_id b70933da-55b2-4025-a00e-63ce3e6b7fdf, 6eef83b4-ce4c-462b-bcfa-eefa525e682d, c031 ... Package NDC 0143-9715-01, 0143-9715-10, 0143-9715-99, 0143-9714-01, 0143-9714-10, 0143-9714- ... UNIIE7199S1YWR

10)

drugcharacterization2medicinalproductESZOPICLONE

openFDA Info on Medication

Application Number ANDA091124, ANDA091166, ANDA091103, ANDA091113, ANDA091024, ANDA208451, ANDA2029 ... Brand NameESZOPICLONE, LUNESTAGeneric NameESZOPICLONEManufacturers Lupin Pharmaceuticals, Inc., Glenmark Pharmaceuticals Inc. USA, Sun Pharmaceutic ... product_ndc 68180-322, 68180-323, 68180-324, 68462-382, 68462-383, 68462-384, 47335-586, 473 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, OROPHARYNGEALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id c15b2322-c078-46c1-8959-9288faaab19e, 8d6002b1-95d9-445c-8ace-e6dccea36852, 95e9 ... spl_set_id 7068c455-691e-4c56-9857-b7b4e13f4784, 584dc66c-063a-4552-a056-74b811e2bc80, 8bb1 ... Package NDC 68180-322-01, 68180-322-11, 68180-322-13, 68180-323-01, 68180-323-02, 68180-323- ... UNIIUZX80K71OE