Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-SA-2014SA037387occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10144940Date Received30/04/2014transmissiondate12/12/2014serious2Date Last Updated30/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age86Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionHypersensitivityOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductDEMEROLdrugbatchnumbUNKNOWNdrugauthorizationnumb005010drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

openFDA Info on Medication

Application NumberNDA021171, NDA005010Brand NameDEMEROLGeneric NameMEPERIDINE HYDROCHLORIDEManufacturersHospira, Inc., Validus Pharmaceuticals LLCproduct_ndc 0409-1176, 0409-1178, 0409-1179, 0409-1180, 0409-1203, 0409-1253, 0409-1254, 040 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, ORALActive IngredientsMEPERIDINE HYDROCHLORIDERXCUI 860792, 861459, 861463, 861473, 861493, 861494, 861520, 861522, 861529, 861617, ... spl_ida34dc52c-247a-4edc-b229-e7c292e00131, 5690ed8f-652d-4494-be6f-786a74f4caa8spl_set_idb31d1308-28c3-43f4-e0a6-2f3ed76b8975, 5cb2674c-a70d-4022-9188-3f711cccff5ePackage NDC 0409-1176-03, 0409-1176-30, 0409-1178-03, 0409-1178-30, 0409-1179-03, 0409-1179- ... UNIIN8E7F7Q170

2)

drugcharacterization2medicinalproductFORTEOdrugstructuredosagenumb.08drugstructuredosageunit012drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextSUB-Q PEN INJECTOR, IN THIGH OR ABDOMINAL WALLdrugadministrationroute058drugstartdateformat102drugstartdate20/09/2013

openFDA Info on Medication

Application NumberNDA021318Brand NameFORTEOGeneric NameTERIPARATIDEManufacturersEli Lilly and Companyproduct_ndc0002-8400Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsTERIPARATIDERXCUI1435115, 1435117spl_id97585e49-e229-40c5-8291-62b8160a326cspl_set_idaae667c5-381f-4f92-93df-2ed6158d07b0Package NDC0002-8400-01, 0002-8400-99NUIM0015931, N0000180852Chemical StructureParathyroid Hormone [CS]Established Pharmacologic ClassParathyroid Hormone Analog [EPC]UNII10T9CSU89I

3)

drugcharacterization2medicinalproductCALCIUMdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate20/09/2013

openFDA Info on Medication

Brand Name P D ALL, ONLYCAL, RESTO L, P D M, RESTORATION TREATMENT, TALL G U, C P RE, D T B ... Generic NameCALCIUMManufacturerscoexleaders co.,ltd.product_ndc 81445-0002, 81445-0005, 81445-0006, 81445-0003, 81445-0001, 81445-0008, 81445-00 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCALCIUMspl_id b9e7d910-8df8-ca9a-e053-2995a90a0d05, b9eb3dea-4f3e-1d23-e053-2995a90a4eb2, b9eb ... spl_set_id b9e7d869-d218-d60c-e053-2995a90af542, b9eb3cc9-e340-c77d-e053-2995a90a1628, b9eb ... Package NDC 81445-0002-1, 81445-0005-1, 81445-0006-1, 81445-0003-1, 81445-0001-1, 81445-0008 ... NUIM0003153, N0000175901, N0000175597, N0000020074Chemical StructureCalcium [CS]Established Pharmacologic ClassCalcium [EPC], Phosphate Binder [EPC]Mechanism of ActionPhosphate Chelating Activity [MoA]UNIISY7Q814VUP

4)

drugcharacterization2medicinalproductRANITIDINEdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute048drugstartdateformat102drugstartdate20/09/2013

openFDA Info on Medication

Application Number ANDA091429, NDA021698, ANDA076195, ANDA200172, ANDA207579, ANDA207578, ANDA07865 ... Brand Name COOL MINT ACID REDUCER, ZANTAC MAXIMUM STRENGTH 150 COOL MINT, HARRIS TEETER ACI ... Generic NameRANITIDINE, RANITIDINE HYDROCHLORIDEManufacturers Rite Aid Corporation, Boehringer Ingelheim Pharmaceuticals Inc., Harris Teeter, ... product_ndc 11822-0950, 0597-0120, 69256-876, 37808-303, 69842-293, 41520-609, 58602-733, 58 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsRANITIDINE HYDROCHLORIDE, RANITIDINERXCUI 198191, 827189, 312773, 198193, 1090518, 705610, 643046, 198190, 198192, 827183, ... spl_id 0ebab972-16c7-4733-b1bc-e063d53f9e87, 97cb5218-4c7e-5ae5-e053-2995a90af3f2, a43a ... spl_set_id 4784c5b2-58eb-4b7c-b6e9-13dde7610a37, 888d9feb-fc9b-49cc-8361-30b5da86ea05, a43a ... Package NDC 11822-0950-1, 11822-0950-0, 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120- ... UNIIBK76465IHM, 884KT10YB7NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]

5)

drugcharacterization2medicinalproductCOSOPTdrugstructuredosagenumb1drugstructuredosageunit031drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformEYE DROPSdrugstartdateformat102drugstartdate20/09/2013

openFDA Info on Medication

Application NumberNDA020869Brand NameCOSOPTGeneric NameDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEManufacturersAkornproduct_ndc17478-605Product TypeHUMAN PRESCRIPTION DRUGRouteOPHTHALMICActive IngredientsDORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATERXCUI1923432, 1923433spl_id930622f9-6867-4f59-9b1a-20280a31e104spl_set_idb7aa1986-1c24-4733-96b3-e6d8e1d44558Package NDC17478-605-10UNIIQZO5366EW7, P8Y54F701R

6)

drugcharacterization2medicinalproductVESICAREdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate20/09/2013

openFDA Info on Medication

Application NumberNDA021518, NDA209529Brand NameVESICARE, VESICARE LSGeneric NameSOLIFENACIN SUCCINATEManufacturersAstellas Pharma US, Inc.product_ndc51248-150, 51248-151, 51248-250Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSOLIFENACIN SUCCINATERXCUI477367, 477372, 539815, 539817, 2375321, 2375325spl_id1d7a7ff5-31d2-4957-90e5-173d2200ddb1, 47710f09-a9ef-4007-8a89-cbb8fadc6b4bspl_set_id9acee910-cdb2-4052-b8b3-c26aff1c8716, e0300384-e980-45d5-8ed4-48a2618671aePackage NDC 51248-150-52, 51248-150-03, 51248-150-01, 51248-151-52, 51248-151-03, 51248-151- ... UNIIKKA5DLD701

7)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate20/09/2013

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

8)

drugcharacterization2medicinalproductASPIRINdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate20/09/2013

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

9)

drugcharacterization2medicinalproductCADUETdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate20/09/2013

openFDA Info on Medication

Application NumberNDA021540Brand NameCADUETGeneric NameAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc 0069-2150, 0069-2960, 0069-2970, 0069-2980, 0069-2170, 0069-2190, 0069-2260, 006 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATERXCUI 404011, 404013, 597967, 597971, 597974, 597977, 597980, 597984, 597987, 597990, ... spl_id70a66e0a-9a80-4ba9-95e3-96bd2b82036fspl_set_id6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6Package NDC 0069-2960-30, 0069-2970-30, 0069-2980-30, 0069-2150-30, 0069-2170-30, 0069-2190- ... UNII48A5M73Z4Q, 864V2Q084H

10)

drugcharacterization2medicinalproductHYDROCORTISONEdrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2TIMES EVERY DAY TO THE EFFECTED AREASdrugdosageformRECTAL CREAMdrugadministrationroute061drugstartdateformat102drugstartdate20/09/2013

openFDA Info on Medication

Application Number part348, ANDA088799, ANDA040351, ANDA089682, ANDA080706, NDA213876, ANDA040646, ... Brand Name HARRIS TEETER ANTI-ITCH WITH ALOE, DG HEALTH HYDROCORTISONE, PROCTOSOL-HC, GOOD ... Generic Name HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, ANTI-ITCH, HYDROCORTI ... Manufacturers Harris Teeter, Dolgencorp, LLC, Sun Pharmaceutical Industries, Inc., Amerisource ... product_ndc 72036-407, 55910-646, 10631-407, 24385-276, 67091-280, 69396-069, 61010-4402, 70 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteTOPICAL, ORAL, RECTALActive IngredientsHYDROCORTISONE, HYDROCORTISONE ACETATERXCUI 106258, 103403, 310891, 1540356, 203105, 197785, 1790684, 206352, 1043063, 19870 ... spl_id 2b90d9a3-ebb1-4aee-8a9c-6601618b7738, 27dc9e09-fc4f-4b66-a303-177725f3a513, 297a ... spl_set_id 1755c97e-87a3-43c7-ab61-3e971a7b3135, 27dc9e09-fc4f-4b66-a303-177725f3a513, 5652 ... Package NDC 72036-407-28, 55910-646-25, 10631-407-01, 24385-276-03, 67091-280-28, 69396-069- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIWI4X0X7BPJ, 3X7931PO74

11)

drugcharacterization2medicinalproductKETOCONAZOLEdrugdosagetextAPPLY BY TOPICAL ROUTE EVERY DAY TO THE EFFECTED AREASdrugdosageformCREAMdrugadministrationroute061drugstartdateformat102drugstartdate20/09/2013

openFDA Info on Medication

Application Number NDA020310, ANDA076942, ANDA210457, NDA019927, ANDA075581, ANDA075912, ANDA091550 ... Brand NameNIZORAL, KETOCONAZOLE, KETODAN, NIZORAL A-D, EXTINA, XOLEGELGeneric NameKETOCONAZOLEManufacturers Kramer Laboratories, THIRTY MADISON INC, Strides Shasun Limited, Janssen Pharmac ... product_ndc 55505-192, 71713-097, 64380-827, 50458-680, 0093-3219, 71337-035, 45802-532, 355 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteTOPICAL, ORALActive IngredientsKETOCONAZOLERXCUI 240812, 608844, 106336, 197853, 206978, 203088, 728550, 1300272, 729768, 647253, ... spl_id 80d6fb45-72b6-49ab-8e49-81350caacddf, f7243345-244e-4393-9ab5-b62bc0eed144, a130 ... spl_set_id 63840ff7-d447-4f4e-a05b-1fbed2da8a25, 1f5cd9f4-0db4-4062-b5ec-c33611265e02, 6d4b ... Package NDC 55505-192-40, 55505-192-33, 55505-192-57, 55505-192-59, 71713-097-04, 64380-827- ... NUIN0000175487, M0002083, N0000182141, N0000190115, N0000185503Established Pharmacologic ClassAzole Antifungal [EPC]Chemical StructureAzoles [CS]Mechanism of Action Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Gl ... UNIIR9400W927I

12)

drugcharacterization2medicinalproductTRAMADOLdrugstructuredosagenumb1drugstructuredosageunit032drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate20/09/2013

13)

drugcharacterization2medicinalproductGLYCERYL TRINITRATEdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 SUBLINGUAL TABLET EVERY 5 MINdrugdosageformSUBLINGUAL TABLETdrugindicationCHEST PAINdrugstartdateformat102drugstartdate20/09/2013

openFDA Info on Medication

Brand NameGLONOINUMGeneric NameGLYCERYL TRINITRATEManufacturersSeroyal USAproduct_ndc62106-5945Product TypeHUMAN OTC DRUGRouteORALActive IngredientsNITROGLYCERINspl_id9a6689a3-638e-2b1f-e053-2995a90a64b0spl_set_id1b7cb5e7-e1f7-093d-e054-00144ff8d46cPackage NDC62106-5945-4NUIN0000175415, M0014874, N0000009909Established Pharmacologic ClassNitrate Vasodilator [EPC]Chemical StructureNitrates [CS]Physiologic/Pharmacodynamic EffectVasodilation [PE]UNIIG59M7S0WS3

14)

drugcharacterization2medicinalproductLUMIGANdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 GTT IN BOTH EYESdrugdosageformEYE DROPSdrugadministrationroute031drugstartdateformat102drugstartdate20/09/2013

openFDA Info on Medication

Application NumberNDA022184Brand NameLUMIGANGeneric NameBIMATOPROSTManufacturersAllergan, Inc.product_ndc0023-3205Product TypeHUMAN PRESCRIPTION DRUGRouteOPHTHALMICActive IngredientsBIMATOPROSTRXCUI1009339, 1009341spl_id5283edec-7ee3-4370-8345-44bae7759880spl_set_ida5e67c75-db88-4372-bb07-c8dd15c97631Package NDC0023-3205-02, 0023-3205-03, 0023-3205-05, 0023-3205-08NUIN0000175454, M0017805Established Pharmacologic ClassProstaglandin Analog [EPC]Chemical StructureProstaglandins [CS]UNIIQXS94885MZ

15)

drugcharacterization2medicinalproductCOUMADINdrugdosageformTABLETdrugstartdateformat102drugstartdate20/09/2013

openFDA Info on Medication

16)

drugcharacterization2medicinalproductCENTRUM SILVERdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate20/09/2013

17)

drugcharacterization2medicinalproductSTOOL SOFTENERdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute048drugstartdateformat102drugstartdate20/09/2013

openFDA Info on Medication

Application Numberpart334Brand Name STOOL SOFTENER WITH LAXATIVE, STOOL SOFTENER, STOOL SOFTENER EXTRA STRENGTH, STO ... Generic Name DOCUSATE SODIUM AND SENNOSIDES, DOCUSATE SODIUM, DOCUSATE CALCIUM, MARC GLASSMAN ... Manufacturers AmerisourceBergen (Good Neighbor Pharmacy) 46122, CVS PHARMACY, INC., CVS Pharma ... product_ndc 46122-567, 69842-169, 69842-483, 68016-408, 0363-2570, 55301-655, 46122-451, 683 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsDOCUSATE SODIUM, SENNOSIDES, DOCUSATE CALCIUMRXCUI998740, 1115005, 1245376, 1245468, 1791612spl_id 0a092a40-e3dc-4509-a613-6fed0ae94255, 468f2bab-b388-4bfc-af88-abacdd46a129, 7b62 ... spl_set_id 0cf2f610-bff4-48b8-b640-2c3c708a47a8, 9665721c-40bf-4674-8430-399c70bdca47, 14b0 ... Package NDC 46122-567-78, 69842-169-48, 69842-483-10, 68016-408-01, 68016-408-25, 68016-408- ... UNIIF05Q2T2JA0, 3FYP5M0IJX, 6K7YS503HC

18)

drugcharacterization2medicinalproductPRILOSECdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate20/09/2013

openFDA Info on Medication

Application NumberNDA022056Brand NamePRILOSECGeneric NameOMEPRAZOLE MAGNESIUMManufacturersCovis Pharmaproduct_ndc70515-610, 70515-625Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE MAGNESIUMRXCUI797058, 797061, 797063, 797065spl_id1bd73b0f-b2c2-4409-94ce-1955c6ab119bspl_set_idb6761f84-53ac-4745-a8c8-1e5427d7e179Package NDC70515-625-01, 70515-610-01UNII426QFE7XLK

19)

drugcharacterization2medicinalproductCOZAARdrugstructuredosagenumb.5drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate20/09/2013

openFDA Info on Medication

Application NumberNDA020386Brand NameCOZAARGeneric NameLOSARTAN POTASSIUMManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0951, 0006-0952, 0006-0960Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLOSARTAN POTASSIUMRXCUI979480, 979482, 979485, 979487, 979492, 979494spl_id28c07f10-b266-4479-9e82-e217a34910b0spl_set_id5ac32c20-169d-475a-fc8a-934f758d6ab0Package NDC0006-0951-54, 0006-0952-31, 0006-0952-54, 0006-0960-31, 0006-0960-54UNII3ST302B24A

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duplicatesourceAVENTISduplicatenumbUS-SA-2014SA037387