Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10362954serious1Date Last Updated15/05/2015receiptdateformat102companynumbUS-PFIZER INC-2014216683occurcountryUSseriousnessother1duplicate1Date Received05/08/2014transmissiondate21/08/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age71Unit of Onset AgeyearsSexFemale

Contents

Reaction
- 1)
Drug
summary

Reaction

1)

reactionmeddraversionpt18.0ReactionDiabetes mellitusOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductLYRICAdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, 2X/DAY

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, 0fbd5d1f-30cd-464d-a1d6-71e8057a9377spl_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

2)

drugcharacterization2medicinalproductPREVACIDdrugdosagetextUNKdrugstartdateformat602drugstartdate//2000

activesubstance

activesubstancenameLANSOPRAZOLE

openFDA Info on Medication

Application NumberNDA020406, NDA022327Brand NamePREVACID, PREVACID 24 HRGeneric NameLANSOPRAZOLEManufacturers Takeda Pharmaceuticals America, Inc., GlaxoSmithKline Consumer Healthcare Holdin ... product_ndc64764-046, 64764-541, 64764-543, 64764-544, 0067-6286Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsLANSOPRAZOLERXCUI206205, 206206, 311277, 351260, 351261, 596843, 596918, 866152spl_ide9cb8e8b-589a-4d5d-9615-4bbd8dda0033, f2b830fb-0c23-494a-9d4c-76748dd7e1c6spl_set_id71ba78cb-7e46-43eb-9425-fa130f537f84, fd4629d5-b876-4ae9-bb32-c3560ad416a9Package NDC 64764-541-30, 64764-541-19, 64764-541-11, 64764-541-05, 64764-046-13, 64764-046- ... NUIN0000175525, N0000000147, N0000009724Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA]Physiologic/Pharmacodynamic EffectInhibition Gastric Acid Secretion [PE]UNII0K5C5T2QPG

3)

drugcharacterization2medicinalproductESTRADIOL.drugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, 1X/DAY

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, Qualgen LLC, Allergan, Inc., Novo Nordisk, Mylan Pharmaceuticals Inc ... product_ndc 0781-7129, 0781-7138, 0781-7144, 0781-7156, 0781-7167, 69761-006, 0023-5885, 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 16615373-38bc-49ef-a7df-e48aad6f5325, abe65034-0a2d-4a1f-8452-25f211563f2f, 157d ... spl_set_id c4da6de7-9ab1-4fcf-88f3-fe785019e6e7, 1536dc3b-ec2a-40a8-90b6-42e1d4f5326b, ac67 ... 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

4)

drugcharacterization2medicinalproductMEDROXYPROGESTERONE ACETATE.drugstructuredosagenumb2.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2.5 MG, 1X/DAY

activesubstance

activesubstancenameMEDROXYPROGESTERONE ACETATE

openFDA Info on Medication

Application Number NDA011839, NDA020246, ANDA210761, ANDA040159, ANDA210760, ANDA077235, ANDA077334 ... Brand NameMEDROXYPROGESTERONE ACETATE, PROVERA, DEPO-SUBQ PROVERA, DEPO-PROVERAGeneric NameMEDROXYPROGESTERONE ACETATEManufacturers Greenstone LLC, NorthStar RxLLC, Teva Pharmaceuticals USA, Inc., Sun Pharmaceuti ... product_ndc 59762-0055, 59762-3740, 59762-3741, 59762-3742, 59762-0058, 59762-0056, 59762-45 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, SUBCUTANEOUSActive IngredientsMEDROXYPROGESTERONE ACETATERXCUI 1000114, 1000135, 1000141, 1000126, 1000153, 1000124, 1000139, 1000145, 1000156, ... spl_id 79175bd0-479f-4b42-b7f3-35a7fb840192, b97dc959-e813-4e9d-852b-cfcd18f3cd4f, a9e6 ... spl_set_id 2627eb11-06bf-4a45-9172-094468e3ca07, 428481bb-b7cf-4d76-b57d-0d6bfa2b6ac3, f762 ... Package NDC 59762-3740-1, 59762-3740-5, 59762-3741-1, 59762-3741-4, 59762-3742-2, 59762-3742 ... UNIIC2QI4IOI2G

5)

drugcharacterization2medicinalproductEXCEDRIN MIGRAINEdrugdosagetext2 WHEN NEEDEDdrugstartdateformat602drugstartdate//2000

activesubstance

activesubstancenameACETAMINOPHEN\ASPIRIN\CAFFEINE

openFDA Info on Medication

Application NumberNDA020802, part343Brand NameEXCEDRIN MIGRAINEGeneric Name ACETAMINOPHEN, ASPIRIN, AND CAFFEINE, ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEIN ... Manufacturers Lil' Drug Store Products, Inc., Jones Contract Packaging Services, GlaxoSmithKli ... product_ndc66715-9749, 67414-239, 0067-8201, 0067-2039, 0067-2040Product TypeHUMAN OTC DRUGRouteORALActive IngredientsACETAMINOPHEN, ASPIRIN, CAFFEINERXCUI209468, 308297spl_id ada417cb-5fa9-4f93-8107-33cb2b8ce88e, 98ba7620-8383-33b4-e053-2a95a90a7a49, 920c ... spl_set_id 40aeb2c5-a37b-446d-9918-8378a75ff327, c4168e4d-3dfc-4e51-a32e-14704cb59c66, 920c ... Package NDC 66715-9749-3, 67414-239-02, 0067-8201-03, 0067-2039-02, 0067-2039-08, 0067-2039- ... NUI N0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832, N0000 ... Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic Effect Decreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE], Ce ... Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS], Xanthines [CS]Established Pharmacologic Class Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], ... UNII362O9ITL9D, R16CO5Y76E, 3G6A5W338E

6)

drugcharacterization2medicinalproductESTRADIOL.drugdosagetextUNKdrugstartdateformat602drugstartdate//2000

activesubstance

activesubstancenameESTRADIOL

openFDA Info on Medication

7)

drugcharacterization2medicinalproductAMITIZAdrugstructuredosagenumb8drugstructuredosageunit003drugdosagetext8MG, 1-3X DAILY AS NEEDED

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_id13cd7c3a-6e60-4f2d-a588-eb452fc711d0spl_set_idd474ac6a-444d-4aa6-9986-24be6fcf811dPackage NDC64764-080-60, 64764-240-60, 64764-240-10NUIN0000175573, N0000175456Established Pharmacologic ClassChloride Channel Activator [EPC]Mechanism of ActionChloride Channel Activators [MoA]UNII7662KG2R6K

8)

drugcharacterization2medicinalproductPLAQUENILdrugdosagetextUNK

activesubstance

activesubstancenameHYDROXYCHLOROQUINE SULFATE

openFDA Info on Medication

Application NumberNDA009768Brand NamePLAQUENILGeneric NameHYDROXYCHLOROQUINE SULFATEManufacturersConcordia Pharmaceuticals Inc.product_ndc59212-562Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROXYCHLOROQUINE SULFATERXCUI979092, 979094spl_id763bd0fa-4ae7-451d-bf90-db9237f6a009spl_set_id34496b43-05a2-45fb-a769-52b12e099341Package NDC59212-562-10, 59212-562-60, 59212-562-11UNII8Q2869CNVH

9)

drugcharacterization2medicinalproductVITAMIN Ddrugstructuredosagenumb2000drugstructuredosageunit025drugdosagetext2000 IU, DAILYdrugstartdateformat602drugstartdate//2004

activesubstance

activesubstancenameCHOLECALCIFEROL

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturersStrides Pharma Science Limitedproduct_ndc64380-737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36Package NDC64380-737-06, 64380-737-25NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

10)

drugcharacterization2medicinalproductLYRICAdrugdosagetextUNKdrugstartdateformat602drugstartdate//2009

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

11)

drugcharacterization2medicinalproductGLIMEPIRIDE.drugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, 1X/DAY

activesubstance

activesubstancenameGLIMEPIRIDE

openFDA Info on Medication

Application Number ANDA077911, ANDA077091, ANDA091220, ANDA078181, NDA020496, ANDA077370, ANDA20275 ... Brand NameGLIMEPIRIDE, AMARYLGeneric NameGLIMEPIRIDEManufacturers Carlsbad Technology, Inc., Dr. Reddy's Laboratories Limited, Micro Labs Limited, ... product_ndc 61442-115, 61442-116, 61442-117, 55111-320, 55111-321, 55111-322, 42571-100, 425 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGLIMEPIRIDERXCUI199245, 199246, 199247, 153842, 1361493, 1361495, 153591, 153843, 153845spl_id 94f7e51b-3f92-8633-e053-2995a90a8cf1, e3d50334-9896-b2f9-a481-8383eb84b16a, ab8d ... spl_set_id 72d88c6d-2f0a-4bf8-aa7f-1e1811794187, 07ad4366-4b21-f633-49f3-c2b35f88168d, 60e9 ... Package NDC 61442-115-01, 61442-115-05, 61442-115-10, 61442-116-01, 61442-116-05, 61442-116- ... NUIN0000175608, M0020795Established Pharmacologic ClassSulfonylurea [EPC]Chemical StructureSulfonylurea Compounds [CS]UNII6KY687524K

12)

drugcharacterization2medicinalproductBUMETANIDE.drugdosagetextUNKdrugstartdateformat602drugstartdate//2000

activesubstance

activesubstancenameBUMETANIDE

openFDA Info on Medication

Application Number ANDA074225, NDA018225, ANDA209916, ANDA202900, ANDA209724, ANDA079196, ANDA07470 ... Brand NameBUMETANIDE, BUMEXGeneric NameBUMETANIDEManufacturers Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Validus Pharmaceu ... product_ndc 14539-700, 14539-701, 14539-702, 30698-630, 30698-631, 30698-632, 0832-0540, 083 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsBUMETANIDERXCUI197417, 197418, 197419, 205488, 205489, 205490, 282486, 1727569spl_id 138f8bdd-34a5-49c6-832f-0d343aa95c7b, a8cdbcbb-2436-4157-9929-e1138035de53, a2d6 ... spl_set_id a51d798c-5847-49b2-ba94-434131848199, 32dfbea3-eb2b-4070-8605-57ce3e6d5a2f, ff5d ... Package NDC 14539-700-01, 14539-700-05, 14539-700-10, 14539-701-01, 14539-701-05, 14539-701- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII0Y2S3XUQ5H

13)

drugcharacterization2medicinalproductK-DUR 20drugdosagetextUNKdrugstartdateformat602drugstartdate//2000

14)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb150drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext150 MG, 1X/DAY

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

15)

drugcharacterization2medicinalproductLISINOPRIL.drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, 1X/DAYdrugstartdateformat602drugstartdate//2000

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

16)

drugcharacterization2medicinalproductFIORICETdrugdosagetext1 EVERY 6HRS AS NEEDED

activesubstance

activesubstancenameACETAMINOPHEN\BUTALBITAL\CAFFEINE

openFDA Info on Medication

Application NumberANDA040885Brand NameFIORICETGeneric NameBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEManufacturersActavis Pharma, Inc.product_ndc52544-080Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUTALBITAL, ACETAMINOPHEN, CAFFEINERXCUI889520, 1432261spl_id4d2ef153-e4dc-4bfb-bae5-f05615393c33spl_set_idc018be7d-f7b8-45e2-97b8-8e7a71740657Package NDC52544-080-01NUIN0000175693, M0002177, N0000175739, N0000175729, N0000175790, M0023046Established Pharmacologic ClassBarbiturate [EPC], Central Nervous System Stimulant [EPC], Methylxanthine [EPC]Chemical StructureBarbiturates [CS], Xanthines [CS]Physiologic/Pharmacodynamic EffectCentral Nervous System Stimulation [PE]UNIIKHS0AZ4JVK, 362O9ITL9D, 3G6A5W338E

17)

drugcharacterization2medicinalproductBUMETANIDE.drugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MG, 2X/DAYdrugstartdateformat602drugstartdate//2000

activesubstance

activesubstancenameBUMETANIDE

openFDA Info on Medication

18)

drugcharacterization2medicinalproductXANAXdrugdosagetext50 MG 2/3 DAILY AS NEEDEDdrugstartdateformat602drugstartdate//2000

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia and Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_iddfdda989-af0a-4c14-871c-b26b7b6da50e, d95506a3-aba6-47f4-83c4-443a4cce678bspl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

19)

drugcharacterization2medicinalproductSTOOL SOFTENERdrugdosagetextAS NEEDEDdrugstartdateformat602drugstartdate//2000

activesubstance

activesubstancenameDOCUSATE CALCIUM

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

20)

drugcharacterization2medicinalproductPREVACIDdrugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext30 MG, 2X/DAY

activesubstance

activesubstancenameLANSOPRAZOLE

openFDA Info on Medication

21)

drugcharacterization2medicinalproductMEDROXYPROGESTERONE ACETATE.drugdosagetextUNKdrugstartdateformat602drugstartdate//2000

activesubstance

activesubstancenameMEDROXYPROGESTERONE ACETATE

openFDA Info on Medication

22)

drugcharacterization2medicinalproductK-DUR 20drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2X/DAY

23)

drugcharacterization2medicinalproductZOCORdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, 1X/DAYdrugstartdateformat602drugstartdate//2000

activesubstance

activesubstancenameSIMVASTATIN

openFDA Info on Medication

Application NumberNDA019766Brand NameZOCORGeneric NameSIMVASTATINManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0543, 0006-0749, 0006-0740, 0006-0735Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSIMVASTATINRXCUI104490, 104491, 152923, 198211, 200345, 213319, 312961, 314231spl_id41a60de3-6740-43c7-a8d7-7dbfd0a8d6a0spl_set_idfdbfe194-b845-42c5-bb87-a48118bc72e7Package NDC 0006-0543-31, 0006-0543-54, 0006-0749-31, 0006-0749-54, 0006-0740-54, 0006-0740- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNIIAGG2FN16EV

24)

drugcharacterization2medicinalproductTYLENOL EXTRA STRENGTHdrugdosagetextDAILYdrugstartdateformat602drugstartdate//2000

activesubstance

activesubstancenameACETAMINOPHEN

openFDA Info on Medication

Application Numberpart343Brand NameTYLENOL EXTRA STRENGTH, TYLENOL EXTRA STRENGTH CAPLETGeneric NameACETAMINOPHENManufacturers Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, JC World B ... product_ndc 50580-937, 50580-451, 50269-449, 66715-9747, 50580-378, 50580-209, 50580-590, 50 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsACETAMINOPHENRXCUI198440, 209459, 2374360, 2374361spl_id 680b1b8e-b082-44ff-937a-7ee9dd9381bc, af09a6cd-aadd-4223-b4c8-d9d4419a0276, 9d5d ... spl_set_id 103d109d-f520-409c-8da2-eb6b0fbec891, bb6533e5-e6a9-488c-b8ab-a6a06e87ede9, 68b0 ... Package NDC 50580-937-01, 50580-937-02, 50580-937-03, 50580-937-04, 50580-937-05, 50580-937- ... UNII362O9ITL9D

25)

drugcharacterization1medicinalproductCELEBREXdrugbatchnumbJ75608drugauthorizationnumb020998drugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext200 MG, 2X/DAYdrugdosageformCAPSULE, HARDdrugadministrationroute048drugindicationINFLAMMATORY PAINdrugstartdateformat602drugstartdate//2005actiondrug5

activesubstance

activesubstancenameCELECOXIB

openFDA Info on Medication

Application NumberNDA020998Brand NameCELEBREXGeneric NameCELECOXIBManufacturersG.D. Searle LLC Division of Pfizer Incproduct_ndc0025-1515, 0025-1520, 0025-1525, 0025-1530Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCELECOXIBRXCUI205322, 205323, 213468, 213469, 349514, 352314, 686379, 686381spl_idd2a1146b-f1a6-4467-9ba8-b10f94494f8espl_set_id8d52185d-421f-4e34-8db7-f7676db2a226Package NDC 0025-1515-01, 0025-1520-31, 0025-1520-51, 0025-1520-34, 0025-1525-31, 0025-1525- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIJCX84Q7J1L

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drugcharacterization1medicinalproductCELEBREXdrugbatchnumbC140270drugauthorizationnumb020998drugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext200 MG, 2X/DAYdrugdosageformCAPSULE, HARDdrugadministrationroute048drugindicationRHEUMATOID ARTHRITISactiondrug5

activesubstance

activesubstancenameCELECOXIB

openFDA Info on Medication

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drugcharacterization2medicinalproductTRAMADOL HYDROCHLORIDE.drugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, (EVERY 4-6 HRS AS NEEDED)

activesubstance

activesubstancenameTRAMADOL HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA200491, ANDA090404, ANDA205257, ANDA076003, ANDA091498, NDA022370, ANDA20349 ... Brand Name TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE, QDOLO, ULTRAM, ... Generic NameTRAMADOL HYDROCHLORIDEManufacturers Par Pharmaceutical, Inc., Zydus Pharmaceuticals (USA) Inc., Cadila Healthcare Li ... product_ndc 10370-221, 10370-222, 10370-223, 68382-319, 65841-754, 0378-4152, 0378-4153, 037 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTRAMADOL HYDROCHLORIDERXCUI 1946525, 1946527, 1946529, 835603, 833709, 833711, 833713, 1148478, 1148485, 114 ... spl_id 61dd48b3-af4b-456f-8e10-a2001df2a931, 1ddd72c1-be8f-4d56-9966-f9b5c45e98b9, f3ad ... spl_set_id bfdc4a52-a3a8-4f1e-8ab3-5c37d7a7d0a2, ee7179b7-6a08-4eeb-a787-5d697b02c4a2, 6f3a ... Package NDC 10370-221-11, 10370-222-11, 10370-223-11, 68382-319-01, 68382-319-05, 68382-319- ... UNII9N7R477WCK

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drugcharacterization2medicinalproductVITAMIN B12drugstructuredosagenumb2000drugstructuredosageunit025drugdosagetext2000 IU, DAILYdrugstartdateformat602drugstartdate//2004

activesubstance

activesubstancenameCYANOCOBALAMIN

summary

narrativeincludeclinicalCASE EVENT DATE: 2009

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014216683

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use

Adverse Event Report

Report

Primary Source

Patient

Reaction

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