Report

Version of Safety Report ID8Safety Report ID13118718primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate13/01/2021reporttype1serious1seriousnessdeath1seriousnessother1receivedateformat102Date Received16/01/2017receiptdateformat102Date Last Updated05/10/2020fulfillexpeditecriteria1companynumbUS-ASTRAZENECA-2017SE02434duplicate1

Report Duplicate

duplicatesourceASTRAZENECAduplicatenumbUS-ASTRAZENECA-2017SE02434

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age57Unit of Onset AgeyearsWeight60.3SexFemale

Contents

Reaction
- 1)
- 2)
- 3)
- 4)
Drug
summary

Reaction

1)

reactionmeddraversionpt23.1ReactionAcute kidney injuryOutcomeUnknown

2)

reactionmeddraversionpt23.1ReactionChronic kidney diseaseOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt23.1ReactionRenal failureOutcomeUnknown

4)

reactionmeddraversionpt23.1ReactionChronic kidney disease-mineral and bone disorderOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductTRAZODONEdrugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100.0MG UNKNOWNdrugstartdateformat102drugstartdate05/04/2012

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

openFDA Info on Medication

2)

drugcharacterization2medicinalproductREQUIPdrugdosagetextEVERY EVENINGdrugdosageformTABLETdrugadministrationroute065

activesubstance

activesubstancenameROPINIROLE HYDROCHLORIDE

3)

drugcharacterization2medicinalproductROPINIROLE HCLdrugdosageformTABLETdrugadministrationroute065

activesubstance

activesubstancenameROPINIROLE HYDROCHLORIDE

4)

drugcharacterization1medicinalproductNEXIUMdrugauthorizationnumb021153drugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40.0MG UNKNOWNdrugadministrationroute048drugindicationGASTROOESOPHAGEAL REFLUX DISEASEdrugstartdateformat602drugstartdate//2007drugenddateformat602drugenddate//2016actiondrug4

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMRXCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, ... spl_id84c822de-ebe2-4a39-9944-7e38e1961dde, 24d37125-c3cf-48e0-9e50-75cbc818e7c1spl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43H

5)

drugcharacterization2medicinalproductCRESTORdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute065

activesubstance

activesubstancenameROSUVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA021366Brand NameCRESTORGeneric NameROSUVASTATIN CALCIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0310-7560, 0310-7570, 0310-7580, 0310-7590, 0310-0751, 0310-0755, 0310-0752, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsROSUVASTATIN CALCIUMRXCUI859419, 859421, 859424, 859426, 859747, 859749, 859751, 859753spl_id08039402-2a60-4599-83b5-1c63b85ead70, d9298e4d-e35f-4ba4-9fdf-1a8d0358707fspl_set_id325a5d0e-9a72-4015-9fcd-1655fb504cee, bb0f3b5e-4bc6-41c9-66b9-6257e2513512Package NDC 0310-7560-90, 0310-7570-90, 0310-7580-90, 0310-7590-30, 0310-0755-90, 0310-0751- ... UNII83MVU38M7Q

6)

drugcharacterization2medicinalproductLYRICAdrugstructuredosagenumb75drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute065

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

Application NumberNDA021446, NDA022488Brand NameLYRICAGeneric NamePREGABALINManufacturersParke-Davis Div of Pfizer Inc, U.S. Pharmaceuticalsproduct_ndc 0071-1012, 0071-1013, 0071-1014, 0071-1015, 0071-1016, 0071-1017, 0071-1019, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 607018, 607020, ... spl_idb9b1285a-2cb3-4789-8b0e-8d5e1b253534, bfdec19d-6a54-449c-95b4-908d28e5369aspl_set_id60185c88-ecfd-46f9-adb9-b97c6b00a553, ce1a4b9d-3127-4416-8bf2-fee5899fc0baPackage NDC 0071-1012-68, 0071-1013-41, 0071-1013-68, 0071-1014-41, 0071-1014-68, 0071-1015- ... UNII55JG375S6M

7)

drugcharacterization2medicinalproductCARVEDILOL.drugindicationBLOOD PRESSURE ABNORMAL

activesubstance

activesubstancenameCARVEDILOL

openFDA Info on Medication

Application Number ANDA076373, ANDA078384, ANDA077316, ANDA077614, NDA020297, ANDA078332, ANDA07822 ... Brand NameCARVEDILOL, COREGGeneric NameCARVEDILOLManufacturers Teva Pharmaceuticals USA, Inc., Bayshore Pharmaceuticals LLC, Mylan Pharmaceutic ... product_ndc 0093-0051, 0093-0135, 0093-7295, 0093-7296, 76385-110, 76385-111, 76385-112, 763 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCARVEDILOLRXCUI200031, 200032, 200033, 686924, 212388, 212389, 212390, 686926spl_id a369c0d5-8f93-4b0d-a5a0-8125af1309f7, 6502da81-eb40-40f3-b4f0-c658f6df8829, c2e2 ... spl_set_id 68c275e8-992a-4520-8065-ab6d615d89cc, 33dfcf29-19d6-46ba-b8ed-d59d2226ad07, e502 ... Package NDC 0093-0051-01, 0093-0051-05, 0093-0135-01, 0093-0135-05, 0093-7295-01, 0093-7295- ... NUIN0000000099, N0000009923, N0000009924, N0000175553, N0000175556Mechanism of Action Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenerg ... Established Pharmacologic Classalpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]UNII0K47UL67F2

8)

drugcharacterization2medicinalproductSENNAdrugdosagetext2 TABLETS AT BEDTIMEdrugdosageformTABLETdrugadministrationroute065drugindicationDRUG ABUSE

activesubstance

activesubstancenameSENNA LEAF\SENNOSIDES\SENNOSIDES A AND B

openFDA Info on Medication

Application Numberpart334Brand NameSENNA, SENNA TABSGeneric NameSENNA, SENNOSIDES, SENNA LEAF, SENNOSIDES 8.6 MG TABLETSManufacturers Akron Pharma Inc., CVS Pharmacy, Boiron, TARGET Corporation, H E B, Advance Phar ... product_ndc 71399-8237, 59779-586, 0220-4642, 11673-886, 37808-675, 17714-122, 0904-6434, 46 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsSENNOSIDES A AND B, SENNOSIDES, SENNA LEAFRXCUI702311, 312935, 476827spl_id a95e938e-ed52-4328-b339-2c0b63a66b03, 1ad1b084-e6c7-45d4-b0fd-07cbb4c851e8, 8761 ... spl_set_id 9e9c434a-7075-45d4-b7b3-0f83a33cf046, c3ba17b9-e34a-496d-9bb9-cd5c19c79f92, 80b3 ... Package NDC 71399-8237-8, 59779-586-50, 59779-586-25, 0220-4642-41, 11673-886-01, 37808-675- ... UNII1B5FPI42EN, 3FYP5M0IJX, AK7JF626KX

9)

drugcharacterization2medicinalproductDOCUSATE SODIUM.drugindicationFAECES HARDdrugstartdateformat602drugstartdate//2015

activesubstance

activesubstancenameDOCUSATE SODIUM

openFDA Info on Medication

Application Numberpart334Brand Name DOCU LIQUID, DOCUSATE SODIUM 100MG TWO-TONE, STOOL SOFTENER LAXATIVE, STOOL SOFT ... Generic NameDOCUSATE SODIUM, DOCUSATE SODIUM LIQUIDManufacturers Hi-Tech Pharmacal Co., Inc., Humanwell PuraCap Pharmaceutical (Wuhan), Ltd., TAR ... product_ndc 50383-349, 50383-771, 53345-018, 11673-853, 41163-853, 69842-169, 53345-008, 411 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsDOCUSATE SODIUMRXCUI 1248119, 1115005, 1247759, 1247756, 1245715, 1245468, 1245686, 1247877, 1190184, ... spl_id 95123bfd-7085-439a-bd82-091bc5548b0c, d4701ff2-fb16-4473-97a3-a25a6a29f4b6, 42e4 ... spl_set_id 7fdc4368-4888-4792-86d3-c8a828e4fff2, 85c64624-428d-46fa-8071-f42b8feec049, 8910 ... Package NDC 50383-771-16, 50383-349-10, 50383-349-11, 53345-018-01, 53345-018-02, 11673-853- ... UNIIF05Q2T2JA0

10)

drugcharacterization2medicinalproductPROCARDIA XLdrugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute065

activesubstance

activesubstancenameNIFEDIPINE

openFDA Info on Medication

Application NumberNDA019684Brand NamePROCARDIA XLGeneric NameNIFEDIPINEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0069-2650, 0069-2660, 0069-2670Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNIFEDIPINERXCUI207772, 207773, 207774, 1812011, 1812013, 1812015spl_id19b5d6c8-4916-44f9-b2a5-0c2e303f405fspl_set_id8ebcb33c-f43b-4b36-9f94-9774b2a59e06Package NDC 0069-2650-66, 0069-2650-72, 0069-2650-41, 0069-2660-66, 0069-2660-72, 0069-2660- ... NUIN0000000069, N0000175421, M0006414Mechanism of ActionCalcium Channel Antagonists [MoA]Established Pharmacologic ClassDihydropyridine Calcium Channel Blocker [EPC]Chemical StructureDihydropyridines [CS]UNIII9ZF7L6G2L

11)

drugcharacterization2medicinalproductDEPO-MEDROLdrugdosagetext40 MGdrugdosageformINJECTION

activesubstance

activesubstancenameMETHYLPREDNISOLONE ACETATE

openFDA Info on Medication

Application NumberNDA011757Brand NameDEPO-MEDROLGeneric NameMETHYLPREDNISOLONE ACETATEManufacturersPharmacia & Upjohn Company LLCproduct_ndc0009-0274, 0009-0280, 0009-0306, 0009-3073, 0009-3475Product TypeHUMAN PRESCRIPTION DRUGRouteINTRALESIONAL, INTRAMUSCULAR, INTRASYNOVIAL, SOFT TISSUE, INTRA-ARTICULARActive IngredientsMETHYLPREDNISOLONE ACETATERXCUI 1358510, 1358512, 1358610, 1358612, 1358617, 1358619, 1743779, 1743781, 1743855, ... spl_id a5e769c3-2f35-4c4c-b032-ca745ad3092a, 05019624-5f4d-4839-a5c5-09f85b9f2d64, b2ea ... spl_set_id 823b0010-2b57-4e76-b5ac-4a8c2963438f, bf1b104d-85cb-414d-a366-78068c82c883, 9a7b ... Package NDC 0009-0274-01, 0009-0280-02, 0009-0280-51, 0009-0280-03, 0009-0280-52, 0009-0306- ... UNII43502P7F0P

12)

drugcharacterization2medicinalproductCARVEDILOL.

activesubstance

activesubstancenameCARVEDILOL

openFDA Info on Medication

13)

drugcharacterization2medicinalproductAMBIENdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804

activesubstance

activesubstancenameZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberNDA021774, NDA019908Brand NameAMBIEN CR, AMBIENGeneric NameZOLPIDEM TARTRATEManufacturerssanofi-aventis U.S. LLCproduct_ndc0024-5501, 0024-5521, 0024-5401, 0024-5421Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854880, 854882, 854894, 854896, 854873, 854875, 854876, 854878spl_id8138a0a9-168c-46d2-b13e-e7e84f27eaee, c8f05d12-bc35-43cb-8b65-588bec02c73dspl_set_id404c858c-89ac-4c9d-8a96-8702a28e6e76, c36cadf4-65a4-4466-b409-c82020b42452Package NDC 0024-5501-31, 0024-5501-10, 0024-5521-31, 0024-5521-50, 0024-5521-10, 0024-5401- ... UNIIWY6W63843K

14)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugdosagetext3.0MG UNKNOWNdrugstartdateformat102drugstartdate23/12/2011

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

15)

drugcharacterization2medicinalproductPERCOCETdrugdosagetext10-325 MGdrugstartdateformat102drugstartdate11/01/2012

activesubstance

activesubstancenameACETAMINOPHEN\OXYCODONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA040330Brand NamePERCOCETGeneric NameOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENManufacturersEndo Pharmaceuticals Inc.product_ndc63481-623, 63481-627, 63481-628, 63481-629Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsACETAMINOPHEN, OXYCODONE HYDROCHLORIDERXCUI1049214, 1049221, 1049225, 1049625, 1049635, 1049637, 1049640, 1049642spl_id8a04ce2f-d576-469f-91bc-5ed75e27e47espl_set_id4dd36cf5-8f73-404a-8b1d-3bd53bd90c25Package NDC63481-627-70, 63481-623-70, 63481-623-85, 63481-628-70, 63481-629-70UNIIC1ENJ2TE6C, 362O9ITL9D

16)

drugcharacterization2medicinalproductCARAFATEdrugdosagetext24 MCGdrugdosageformCAPSULEdrugadministrationroute048

activesubstance

activesubstancenameSUCRALFATE

openFDA Info on Medication

Application NumberNDA019183, NDA018333Brand NameCARAFATEGeneric NameSUCRALFATEManufacturersAllergan, Inc.product_ndc58914-170, 58914-171Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSUCRALFATERXCUI208094, 313123, 208097, 314234spl_idbcbe5276-1063-49de-897d-e4c854ce5fa2, 300f7293-1224-48ef-a946-ec870723eb18spl_set_id0fb67b1c-b4c0-46f2-8a81-df1510e006aa, c87c6b50-6977-4fa7-ae98-40c0753f7aeePackage NDC58914-170-14, 58914-170-60, 58914-171-10NUIN0000175801, M0015420Established Pharmacologic ClassAluminum Complex [EPC]Chemical StructureOrganometallic Compounds [CS]UNIIXX73205DH5

17)

drugcharacterization2medicinalproductAMITIZA

activesubstance

activesubstancenameLUBIPROSTONE

openFDA Info on Medication

Application NumberNDA021908Brand NameAMITIZAGeneric NameLUBIPROSTONEManufacturersTakeda Pharmaceuticals America, Inc.product_ndc64764-080, 64764-240Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLUBIPROSTONERXCUI616578, 617768, 794639, 794641spl_id66132fab-c36d-4f07-9593-4352fa5380bfspl_set_idd474ac6a-444d-4aa6-9986-24be6fcf811dPackage NDC64764-080-60, 64764-080-40, 64764-240-60, 64764-240-10, 64764-240-40NUIN0000175573, N0000175456Established Pharmacologic ClassChloride Channel Activator [EPC]Mechanism of ActionChloride Channel Activators [MoA]UNII7662KG2R6K

18)

drugcharacterization2medicinalproductPREDNISONE.drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextFOR 10 DAYSdrugdosageformTABLETdrugadministrationroute065

activesubstance

activesubstancenamePREDNISONE

openFDA Info on Medication

Application Number NDA202020, ANDA215246, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., Novitium Pharma LLC, GeneYork Pharmaceuticals Gr ... product_ndc 75987-020, 75987-021, 75987-022, 70954-056, 71329-106, 0378-0640, 0378-0641, 037 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id 96a17428-b512-4fd9-a64d-50160d22aaaa, 7335a293-992b-490c-ab8a-66a7ca1eea30, 4384 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, 7335a293-992b-490c-ab8a-66a7ca1eea30, be50 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

19)

drugcharacterization1medicinalproductNEXIUMdrugauthorizationnumb021153drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40.0MG UNKNOWNdrugadministrationroute048drugindicationGASTROOESOPHAGEAL REFLUX DISEASEdrugstartdateformat102drugstartdate07/12/2011actiondrug4

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

20)

drugcharacterization2medicinalproductLISINOPRIL.drugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804

activesubstance

activesubstancenameLISINOPRIL

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

21)

drugcharacterization2medicinalproductZESTRILdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804

activesubstance

activesubstancenameLISINOPRIL

openFDA Info on Medication

Application NumberNDA019777Brand NameZESTRILGeneric NameLISINOPRILManufacturersAlmatica Pharma LLCproduct_ndc52427-438, 52427-439, 52427-440, 52427-441, 52427-442, 52427-443Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 104375, 104376, 104377, 104378, 197884, 205326, 206771, 213482, 311353, 311354, ... spl_ida0c07d04-e556-d2b2-fed7-f9eb2ab2ac31spl_set_ida95727ae-2bf1-e675-4a36-71043a8af3b8Package NDC 52427-438-90, 52427-439-90, 52427-440-90, 52427-441-90, 52427-442-90, 52427-443- ... UNIIE7199S1YWR

22)

drugcharacterization2medicinalproductESTRADIOL.

activesubstance

activesubstancenameESTRADIOL

openFDA Info on Medication

Application Number NDA020538, NDA020655, ANDA040197, NDA020908, ANDA075182, NDA020375, ANDA205256, ... Brand Name ESTRADIOL, ALORA, ESTRACE, VAGIFEM, MENOSTAR, YUVAFEM, ESTRADIOL VAGINAL INSERTS ... Generic NameESTRADIOL, ESTRADIOL,Manufacturers Sandoz Inc, Allergan, Inc., Novo Nordisk, Mylan Pharmaceuticals Inc., Bayer Heal ... product_ndc 0781-7129, 0781-7138, 0781-7144, 0781-7156, 0781-7167, 0023-5885, 0023-5886, 002 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteTRANSDERMAL, ORAL, VAGINAL, TOPICALActive IngredientsESTRADIOL, ESTRADIOL HEMIHYDRATERXCUI 241946, 242891, 242892, 248478, 1149632, 310173, 310180, 486155, 1149645, 197657 ... spl_id 9a1c6881-b6bc-45b9-ac5c-c5912e30d921, 4ec6701d-54cd-4f8f-8449-02f43094950e, 7d28 ... spl_set_id c4da6de7-9ab1-4fcf-88f3-fe785019e6e7, ac676026-14be-486a-9d64-6702bd9e51ea, a380 ... Package NDC 0781-7129-58, 0781-7129-83, 0781-7129-40, 0781-7138-58, 0781-7138-83, 0781-7138- ... NUIM0447348, N0000175825, N0000000100Chemical StructureEstradiol Congeners [CS]Established Pharmacologic ClassEstrogen [EPC]Mechanism of ActionEstrogen Receptor Agonists [MoA]UNII4TI98Z838E, CXY7B3Q98Z

23)

drugcharacterization2medicinalproductASPIRIN.

activesubstance

activesubstancenameASPIRIN

openFDA Info on Medication

Application Numberpart343, NDA203697Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN TABLET 325MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 36800-545, 0363-0587, 70000-0218, 63 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 260847, 198471, 825180 ... spl_id 70f66f99-a450-4ab6-a3b9-c5d9207e0a79, da59962f-0c77-5c08-e053-2a95a90aaee7, 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

24)

drugcharacterization1medicinalproductNEXIUMdrugauthorizationnumb021153drugstructuredosagenumb40drugstructuredosageunit003drugdosagetextGENERIC40.0MG UNKNOWNdrugadministrationroute065drugindicationGASTROOESOPHAGEAL REFLUX DISEASEdrugstartdateformat602drugstartdate//2015drugenddateformat602drugenddate//2016actiondrug4

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

25)

drugcharacterization2medicinalproductFENOFIBRATE/TRICORdrugstructuredosagenumb145drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute065

26)

drugcharacterization2medicinalproductZOLPIDEMdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10.0MG UNKNOWNdrugstartdateformat102drugstartdate05/06/2012

activesubstance

activesubstancenameZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberANDA077214Brand NameZOLPIDEMGeneric NameZOLPIDEM TARTRATEManufacturersACI Healthcare USA, Incproduct_ndc71093-155, 71093-156Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854873, 854876spl_ide4a5e984-a50b-4f1e-a50d-b1acd2b34d52spl_set_id021153ce-fe27-4ed1-8d88-b4157b0ed734Package NDC71093-155-06, 71093-155-04, 71093-156-04, 71093-156-06UNIIWY6W63843K

27)

drugcharacterization2medicinalproductMULTIVITAMINSdrugdosageformTABLETdrugadministrationroute065

activesubstance

activesubstancenameVITAMINS

28)

drugcharacterization2medicinalproductLEXAPROdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute065

activesubstance

activesubstancenameESCITALOPRAM OXALATE

openFDA Info on Medication

Application NumberNDA021323Brand NameLEXAPROGeneric NameESCITALOPRAMManufacturersAllergan, Inc.product_ndc0456-2005, 0456-2010, 0456-2020, 0456-2101Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESCITALOPRAM OXALATERXCUI349332, 351249, 351250, 351285, 352272, 352273, 404408, 404420spl_idd6a08762-d20a-47c9-b92e-b5dde195489cspl_set_id13bb8267-1cab-43e5-acae-55a4d957630aPackage NDC 0456-2005-01, 0456-2010-01, 0456-2010-11, 0456-2010-63, 0456-2020-01, 0456-2020- ... UNII5U85DBW7LO

29)

drugcharacterization2medicinalproductCENTRUM MVTdrugadministrationroute065

30)

drugcharacterization1medicinalproductNEXIUMdrugauthorizationnumb021153drugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40.0MG UNKNOWNdrugdosageformCAPSULEdrugadministrationroute048drugindicationGASTROOESOPHAGEAL REFLUX DISEASEdrugstartdateformat102drugstartdate14/09/2013actiondrug4

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

31)

drugcharacterization2medicinalproductSYNTHROIDdrugdosagetext112 MCGdrugdosageformTABLETdrugadministrationroute065

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM

openFDA Info on Medication

Application NumberNDA021402Brand NameSYNTHROIDGeneric NameLEVOTHYROXINE SODIUMManufacturersAbbVie Inc.product_ndc 0074-3727, 0074-7149, 0074-4341, 0074-4552, 0074-5182, 0074-6624, 0074-6594, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, ... spl_ided6f6960-2439-4bb0-bb7f-c7d05e4d37a5spl_set_id1e11ad30-1041-4520-10b0-8f9d30d30fccPackage NDC 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341- ... UNII9J765S329G

32)

drugcharacterization2medicinalproductFUROSEMIDE.drugindicationDIURETIC THERAPY

activesubstance

activesubstancenameFUROSEMIDE

openFDA Info on Medication

Application Number ANDA077293, ANDA207552, ANDA213902, NDA016273, ANDA070655, ANDA212174, ANDA07043 ... Brand Name TOXYCOLOGY MEDICATED COLLECTION SYSTEM, FUROSEMIDE, LASIX, DIASCREEN 12-PANEL ME ... Generic NameFUROSEMIDEManufacturers IT3 Medical LLC, Amneal Pharmaceuticals LLC, Gland Pharma Limited, Validus Pharm ... product_ndc 70529-549, 70121-1076, 70121-1163, 70121-1164, 68083-432, 68083-433, 68083-434, ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 310429, 1038558, 1719286, 1719290, 1719291, 197732, 200801, 200809, 205732, 3139 ... spl_id 29531d06-4e7f-4e26-93d0-1d98e58966d2, c22d0330-1b76-420a-a84b-8ea59f8733a7, e7bd ... spl_set_id a78407a8-3d3e-4eb5-9e3f-b32a1b8015e4, d5b9f12e-d1e9-42de-90f2-c9ba33a86457, 6447 ... Package NDC 70529-549-01, 70529-061-08, 68345-883-50, 70121-1163-1, 70121-1163-5, 70121-1164 ... RouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsFUROSEMIDENUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

33)

drugcharacterization2medicinalproductFENTANYL.drugindicationPAIN

activesubstance

activesubstancenameFENTANYL

openFDA Info on Medication

Application NumberNDA022569, NDA202788, ANDA202097, ANDA077449, NDA021947, NDA019813, ANDA076258Brand NameLAZANDA, SUBSYS, FENTANYL SYSTEM, FENTANYL, FENTORA, DURAGESIC (FENTANYL SYSTEM)Generic NameFENTANYLManufacturers West Therapeutic Development LLC, West Therapeutics Development, LLC, Alvogen, A ... product_ndc 71500-110, 71500-140, 71500-130, 71500-001, 71500-002, 71500-004, 71500-006, 715 ... Product TypeHUMAN PRESCRIPTION DRUGRouteNASAL, SUBLINGUAL, TRANSDERMAL, BUCCALActive IngredientsFENTANYL CITRATE, FENTANYLRXCUI 1115573, 1115575, 1115577, 1115579, 1729320, 1729322, 1237050, 1237055, 1237057, ... spl_id be24d79a-2287-2b3a-e053-2a95a90a8243, c10a64fb-0dc8-b077-e053-2995a90a374f, d22b ... spl_set_id 73f38bde-2132-2b5a-e053-2a91aa0a6efb, be7670d5-b88a-13bd-e053-2995a90a2f78, 2427 ... Package NDC 71500-140-01, 71500-130-01, 71500-110-01, 71500-001-10, 71500-002-30, 71500-004- ... UNIIMUN5LYG46H, UF599785JZNUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]

34)

drugcharacterization2medicinalproductPREMARINdrugstructuredosagenumb1.25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute048

activesubstance

activesubstancenameESTROGENS, CONJUGATED

openFDA Info on Medication

Application NumberNDA020216, NDA010402, NDA004782Brand NamePREMARIN VAGINAL, PREMARINGeneric NameCONJUGATED ESTROGENS, ESTROGENS, CONJUGATEDManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0046-0872, 0046-0749, 0046-1100, 0046-1101, 0046-1102, 0046-1104, 0046-1103Product TypeHUMAN PRESCRIPTION DRUGRouteVAGINAL, INTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsESTROGENS, CONJUGATEDRXCUI 688240, 688242, 211975, 310203, 150840, 197660, 197661, 197662, 202301, 208513, ... spl_id b54269c0-58cc-40b9-80fe-91740e9ed83f, 73618f81-e08d-4f94-807c-8a58395ec2a2, 9cd6 ... spl_set_id 96609623-528e-4aba-cabe-7254aed816d5, 87e2da8d-432c-4ed5-67a1-dc26294b2295, 258e ... Package NDC 0046-0872-04, 0046-0872-21, 0046-0749-05, 0046-1101-81, 0046-1102-81, 0046-1102- ... NUIN0000175825, N0000000100, M0007792Established Pharmacologic ClassEstrogen [EPC]Mechanism of ActionEstrogen Receptor Agonists [MoA]Chemical StructureEstrogens, Conjugated (USP) [CS]UNIIIU5QR144QX

35)

drugcharacterization1medicinalproductPRILOSECdrugadministrationroute048actiondrug5drugadditional3

activesubstance

activesubstancenameOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022056Brand NamePRILOSECGeneric NameOMEPRAZOLE MAGNESIUMManufacturersCovis Pharma US, Incproduct_ndc70515-610, 70515-625Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE MAGNESIUMRXCUI797058, 797061, 797063, 797065spl_idba93d1bb-75ca-407c-b2e0-9aa66d8eed84spl_set_idb6761f84-53ac-4745-a8c8-1e5427d7e179Package NDC70515-625-01, 70515-610-01UNII426QFE7XLK

36)

drugcharacterization2medicinalproductCYMBALTAdrugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute065drugstartdateformat102drugstartdate05/04/2012

activesubstance

activesubstancenameDULOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021427Brand NameCYMBALTAGeneric NameDULOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3235, 0002-3240, 0002-3270Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDULOXETINE HYDROCHLORIDERXCUI596926, 596928, 596930, 596932, 596934, 615186spl_id892f05de-dd11-4ae3-9a85-ce9cfcbeaaccspl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

37)

drugcharacterization2medicinalproductDURAGESIC/FENTANYLdrugdosagetext50 MCG/HR PATCH EVERY 3 DAYSdrugstartdateformat102drugstartdate11/01/2012

38)

drugcharacterization2medicinalproductDESYRELdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

39)

drugcharacterization2medicinalproductVITAMIN DdrugindicationSUPPLEMENTATION THERAPY

activesubstance

activesubstancenameVITAMIN D NOS

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturers Strides Pharma Science Limited, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac ... product_ndc64380-737, 23155-809Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725, 9c09c2d2-ef29-4654-be7d-ed3b2b508f43spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36, 96da2c1e-6c5e-4df0-8166-3de53c08a701Package NDC64380-737-06, 64380-737-25, 23155-809-01NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

40)

drugcharacterization2medicinalproductHYDROXYZINE HCLdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextFOR 10 DAYSdrugdosageformTABLETdrugadministrationroute065

activesubstance

activesubstancenameHYDROXYZINE HYDROCHLORIDE

openFDA Info on Medication

41)

drugcharacterization2medicinalproductFOSAMAXdrugdosagetext70 MGdrugdosageformTABLETdrugadministrationroute048

activesubstance

activesubstancenameALENDRONATE SODIUM

openFDA Info on Medication

Application NumberNDA020560Brand NameFOSAMAXGeneric NameALENDRONATE SODIUMManufacturersOrganon LLCproduct_ndc78206-135Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALENDRONATE SODIUMspl_id45c4d91e-eb8e-4259-92b0-4428b79c43cbspl_set_id14e931fd-2c5f-4d90-b7db-5980706f4a56Package NDC78206-135-01UNII2UY4M2U3RA

42)

drugcharacterization1medicinalproductNEXIUMdrugauthorizationnumb021153drugstructuredosagenumb40drugstructuredosageunit003drugdosagetextGENERIC 40.0MG UNKNOWNdrugadministrationroute065drugindicationGASTROOESOPHAGEAL REFLUX DISEASEdrugstartdateformat602drugstartdate//2015drugenddateformat602drugenddate//2016actiondrug4

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

43)

drugcharacterization2medicinalproductSYNTHROIDdrugdosagetext125 MCGdrugdosageformTABLETdrugadministrationroute065

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM

openFDA Info on Medication

44)

drugcharacterization2medicinalproductPLAQUENILdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804

activesubstance

activesubstancenameHYDROXYCHLOROQUINE SULFATE

openFDA Info on Medication

Application NumberNDA009768Brand NamePLAQUENILGeneric NameHYDROXYCHLOROQUINE SULFATEManufacturersConcordia Pharmaceuticals Inc.product_ndc59212-562Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROXYCHLOROQUINE SULFATERXCUI979092, 979094spl_idda37c8d1-331e-4549-aabc-68e2e4207df8spl_set_id34496b43-05a2-45fb-a769-52b12e099341Package NDC59212-562-10, 59212-562-60, 59212-562-11UNII8Q2869CNVH

45)

drugcharacterization2medicinalproductXANAX/ALPRAZOLAMdrugstructuredosagenumb1drugstructuredosageunit003drugdosagetext1-3 TIMES A DAYdrugstartdateformat102drugstartdate03/01/2012

46)

drugcharacterization2medicinalproductHYDROXYCHLOROQUINE

activesubstance

activesubstancenameHYDROXYCHLOROQUINE

summary

narrativeincludeclinicalCASE EVENT DATE: 2007

Adverse Event Report

Report

Report Duplicate

Primary Source

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Patient

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activesubstance

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activesubstance

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