Report

reporttype1Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10016154serious1Date Last Updated17/06/2015receiptdateformat102companynumbUS-SANOFI-AVENTIS-2012SA041936occurcountryUSseriousnessother1duplicate1Date Received17/03/2014seriousnesshospitalization1transmissiondate21/08/2015primarysourcecountryUSseriousnessdisabling1

Primary Source

reportercountryUSqualification1

Patient

Onset Age61Unit of Onset Ageyearspatientagegroup5SexFemale

Contents

Reaction
- 1)
- 2)
- 3)
- 4)
- 5)
- 6)
- 7)
- 8)
- 9)
- 10)
- 11)
Drug
summary

Reaction

1)

reactionmeddraversionpt18.0ReactionDeformityOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionLoss of employmentOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionPsychological traumaOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionEconomic problemOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionMultiple injuriesOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt18.0ReactionTensionOutcomeUnknown

7)

reactionmeddraversionpt18.0ReactionPhysical disabilityOutcomeUnknown

8)

reactionmeddraversionpt18.0ReactionSocial problemOutcomeUnknown

9)

reactionmeddraversionpt18.0ReactionAnhedoniaOutcomeUnknown

10)

reactionmeddraversionpt18.0ReactionGastrointestinal haemorrhageOutcomeRecovered/resolved

11)

reactionmeddraversionpt18.0ReactionPainOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductNITROSTATdrugstructuredosagenumb.4drugstructuredosageunit003drugadministrationroute060drugindicationCHEST PAIN

activesubstance

activesubstancenameNITROGLYCERIN

openFDA Info on Medication

Application NumberNDA021134Brand NameNITROSTATGeneric NameNITROGLYCERINManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0417, 0071-0418, 0071-0419Product TypeHUMAN PRESCRIPTION DRUGRouteSUBLINGUALActive IngredientsNITROGLYCERINRXCUI198038, 198039, 198040, 207331, 207346, 207361spl_idb21bdc0d-86ca-4a5f-9695-a7a8064f5bedspl_set_id79ba021e-183c-4b4d-822e-4ff5ef54ca61Package NDC0071-0417-24, 0071-0418-24, 0071-0418-13, 0071-0419-24NUIN0000175415, M0014874, N0000009909Established Pharmacologic ClassNitrate Vasodilator [EPC]Chemical StructureNitrates [CS]Physiologic/Pharmacodynamic EffectVasodilation [PE]UNIIG59M7S0WS3

2)

drugcharacterization2medicinalproductVITAMIN E

activesubstance

activesubstancename.ALPHA.-TOCOPHEROL

3)

drugcharacterization2medicinalproductIMITREXdrugstructuredosagenumb50drugstructuredosageunit003drugadministrationroute048drugindicationMIGRAINE

activesubstance

activesubstancenameSUMATRIPTAN\SUMATRIPTAN SUCCINATE

openFDA Info on Medication

Application NumberNDA020080, NDA020132, NDA020626Brand NameIMITREXGeneric NameSUMATRIPTANManufacturersGlaxoSmithKline LLCproduct_ndc 0173-0449, 0173-0739, 0173-0479, 0173-0478, 0173-0735, 0173-0736, 0173-0737, 017 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUS, ORAL, NASALActive IngredientsSUMATRIPTAN SUCCINATE, SUMATRIPTANRXCUI 208452, 313165, 758523, 860088, 1657160, 1657173, 208450, 209169, 284460, 313160 ... spl_id 09b593bc-1a39-4a59-83da-ff02b99aabc3, 38f8e92e-6b77-4c8d-9069-09973b45be2c, 8a09 ... spl_set_id fee7d073-0b99-48f2-7985-0d8cf970894b, 584abe73-8290-4484-ff8e-5890831c095e, cc11 ... Package NDC 0173-0739-00, 0173-0739-02, 0173-0479-00, 0173-0478-00, 0173-0449-02, 0173-0735- ... UNIIJ8BDZ68989, 8R78F6L9VONUIN0000175763, N0000175764, N0000175765Mechanism of ActionSerotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA]Established Pharmacologic ClassSerotonin-1b and Serotonin-1d Receptor Agonist [EPC]

4)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804

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

5)

drugcharacterization2medicinalproductERTAPENEM

activesubstance

activesubstancenameERTAPENEM

openFDA Info on Medication

Application NumberNDA021337, ANDA208790, ANDA209133, ANDA207647Brand NameERTAPENEMGeneric NameERTAPENEM SODIUM, ERTAPENEMManufacturers Par Pharmaceutical Inc., Fresenius Kabi USA, LLC, AuroMedics Pharma LLC, Apotex ... product_ndc 42023-221, 63323-823, 55150-282, 60505-6196, 44567-820, 0409-3510, 44647-051, 68 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUSActive IngredientsERTAPENEM SODIUMRXCUI1734683spl_id 3304b702-daf2-48ac-950e-2ae613398ee1, c0ef4f56-7e7e-4056-a21d-e692ba18b45b, 964a ... spl_set_id 41304b1d-7db4-468a-ab1d-04e56fb50de4, 657855f2-7c92-4aa8-9c3d-51d08e56a09a, 666c ... Package NDC 42023-221-89, 42023-221-85, 42023-221-01, 42023-221-10, 63323-823-01, 63323-823- ... UNII2T90KE67L0

6)

drugcharacterization1medicinalproductPLAVIXdrugbatchnumbUNKNOWNdrugauthorizationnumb020839drugstructuredosagenumb75drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformFILM-COATED TABLETdrugadministrationroute048drugindicationCORONARY ARTERY DISEASEdrugstartdateformat102drugstartdate26/10/2001drugenddateformat102drugenddate19/06/2009actiondrug1

activesubstance

activesubstancenameCLOPIDOGREL BISULFATE

openFDA Info on Medication

Application NumberNDA020839Brand NamePLAVIXGeneric NameCLOPIDOGRELManufacturerssanofi-aventis U.S. LLC, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnershipproduct_ndc0024-1171, 0024-1332, 63653-1171, 63653-1332Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLOPIDOGREL BISULFATERXCUI213169, 309362, 749196, 749198spl_idcb770afe-b6de-469f-9d9c-3db134394d4d, 12eb3088-f30b-4bb5-aee0-113114b5a08cspl_set_idde8b0b67-eb25-4684-83b5-7ad785314227, 01b14603-8f29-4fa3-8d7e-9d523f802e0bPackage NDC 0024-1171-90, 0024-1332-30, 63653-1171-6, 63653-1171-1, 63653-1171-3, 63653-1171 ... UNII08I79HTP27

7)

drugcharacterization2medicinalproductSALMETEROL

activesubstance

activesubstancenameSALMETEROL

8)

drugcharacterization2medicinalproductCELEBREXdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804

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

9)

drugcharacterization2medicinalproductZYRTECdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804

activesubstance

activesubstancenameCETIRIZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022429Brand NameZYRTECGeneric NameCETIRIZINE HYDROCHLORIDEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-779Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCETIRIZINE HYDROCHLORIDERXCUI1014675, 1020023spl_idd7532844-79d8-4648-ab9b-e5d3d3ad76f9spl_set_id605adf29-734f-451a-8ff3-74be7b5814a6Package NDC50580-779-12, 50580-779-25, 50580-779-40, 50580-779-65UNII64O047KTOA

10)

drugcharacterization2medicinalproductGLUCOSAMINEdrugstructuredosagenumb1500drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804

activesubstance

activesubstancenameGLUCOSAMINE

11)

drugcharacterization2medicinalproductVITAMIN B6drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804

activesubstance

activesubstancenamePYRIDOXINE HYDROCHLORIDE

12)

drugcharacterization2medicinalproductVERSED

activesubstance

activesubstancenameMIDAZOLAM HYDROCHLORIDE

13)

drugcharacterization2medicinalproductZEGERIDdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40-1100 MG

activesubstance

activesubstancenameOMEPRAZOLE\SODIUM BICARBONATE

openFDA Info on Medication

Application NumberNDA021636, NDA021849Brand NameZEGERIDGeneric NameOMEPRAZOLE AND SODIUM BICARBONATEManufacturersSantarus, Inc..product_ndc68012-052, 68012-054, 68012-102, 68012-104Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, SODIUM BICARBONATERXCUI616539, 616541, 646344, 646352, 753557, 753562, 753601, 753603spl_iddcde7549-bb2c-4d6c-87a9-b343df68a047spl_set_idcd6868b9-5824-442b-8d65-4db29ecb70a4Package NDC 68012-052-30, 68012-054-30, 68012-054-03, 68012-102-30, 68012-104-30, 68012-104- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 8MDF5V39QO

14)

drugcharacterization2medicinalproductDYCLONINE

activesubstance

activesubstancenameDYCLONINE

15)

drugcharacterization2medicinalproductATROVENTdrugstructuredosagenumb17drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb4drugintervaldosagedefinition805

activesubstance

activesubstancenameIPRATROPIUM BROMIDE

openFDA Info on Medication

Application NumberNDA021527Brand NameATROVENT HFAGeneric NameIPRATROPIUM BROMIDEManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0087Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsIPRATROPIUM BROMIDERXCUI836343, 836368spl_id694c27b3-b662-40bb-9cfd-bf7801fe8796spl_set_id170e98ef-5560-4068-be7d-e649068eb884Package NDC0597-0087-17UNIIJ697UZ2A9J

16)

drugcharacterization2medicinalproductNICOTINE.

activesubstance

activesubstancenameNICOTINE

openFDA Info on Medication

Application Number ANDA079216, ANDA090711, ANDA203690, ANDA079038, ANDA076775, NDA020076, ANDA07832 ... Brand Name NICOTINE, KIRKLAND SIGNATURE NICOTINE, NICOTAC NICOTINE POLACRILEX COATED FRUIT, ... Generic NameNICOTINE POLACRILEX, NICOTINE, NICOTINE POLARILEXManufacturers McKesson Corporation dba SKY Packaging, Costco Wholesale Company, Walgreen Compa ... product_ndc 63739-370, 63981-124, 0363-0124, 11822-3802, 63739-368, 30142-029, 59779-957, 66 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, BUCCAL, TRANSDERMAL, NASAL, RESPIRATORY (INHALATION)Active IngredientsNICOTINERXCUI 314119, 359817, 311975, 359818, 2049241, 198029, 198030, 198031, 892244, 1797886 ... spl_id bfe48c10-2d9d-450b-b893-050d6706d3eb, 1e3bdd50-a544-433c-a694-d8ddb4f2537b, 1a1e ... spl_set_id 17527002-5f98-438c-a3f2-5f4c7985ed1d, 33098a72-9146-4547-9d0b-ff28c8c80030, 4a81 ... Package NDC 63739-370-10, 63981-124-37, 0363-0124-10, 0363-0124-06, 0363-0124-05, 11822-3802 ... NUIN0000175706, M0014836Established Pharmacologic ClassCholinergic Nicotinic Agonist [EPC]Chemical StructureNicotine [CS]UNII6M3C89ZY6R

17)

drugcharacterization2medicinalproductLEVAQUIN

activesubstance

activesubstancenameLEVOFLOXACIN

openFDA Info on Medication

18)

drugcharacterization2medicinalproductCALCIUM

activesubstance

activesubstancenameCALCIUM

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

19)

drugcharacterization2medicinalproductADVAIR HFAdrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextINHALED ONCE, TWICE A DAYdrugadministrationroute055

activesubstance

activesubstancenameFLUTICASONE PROPIONATE\SALMETEROL XINAFOATE

openFDA Info on Medication

Application NumberNDA021254Brand NameADVAIR HFAGeneric NameFLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0715, 0173-0716, 0173-0717Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsFLUTICASONE PROPIONATE, SALMETEROL XINAFOATERXCUI 896231, 896235, 896236, 896237, 896239, 896243, 896244, 896245, 896267, 896271, ... spl_id499c58ac-7a9c-488d-ab84-74e90b8b7dc7spl_set_iddfaca6f9-3277-47b2-319d-1377917cb54cPackage NDC 0173-0715-20, 0173-0715-22, 0173-0716-20, 0173-0716-22, 0173-0717-20, 0173-0717- ... UNIIO2GMZ0LF5W, 6EW8Q962A5

20)

drugcharacterization2medicinalproductACCOLATEdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804

activesubstance

activesubstancenameZAFIRLUKAST

openFDA Info on Medication

Application NumberNDA020547Brand NameACCOLATEGeneric NameZAFIRLUKASTManufacturersPar Pharmaceutical, Inc.product_ndc49884-589, 49884-590Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZAFIRLUKASTRXCUI199655, 211776, 261313, 313758spl_id86871a45-8c7f-46fe-9a01-5f5fbe9e32ccspl_set_idd31ecca3-23ff-470e-8c91-1bea8a537b3cPackage NDC49884-589-02, 49884-590-02NUIN0000175777, N0000000083, N0000185504Established Pharmacologic ClassLeukotriene Receptor Antagonist [EPC]Mechanism of ActionLeukotriene Receptor Antagonists [MoA], Cytochrome P450 2C9 Inhibitors [MoA]UNIIXZ629S5L50

21)

drugcharacterization2medicinalproductLIPITORdrugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804

activesubstance

activesubstancenameATORVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA020702Brand NameLIPITORGeneric NameATORVASTATIN CALCIUMManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0155, 0071-0156, 0071-0157, 0071-0158Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATORVASTATIN CALCIUM TRIHYDRATERXCUI259255, 262095, 617310, 617311, 617312, 617314, 617318, 617320spl_id0ba214c6-250e-42a0-aea8-5e44aba04882spl_set_idc6e131fe-e7df-4876-83f7-9156fc4e8228Package NDC 0071-0155-23, 0071-0155-40, 0071-0155-10, 0071-0155-97, 0071-0156-23, 0071-0156- ... UNII48A5M73Z4Q

22)

drugcharacterization2medicinalproductVAGIFEMdrugstructuredosagenumb25drugstructuredosageunit003drugdosagetextTWICE A WEEKdrugdosageformSUPPOSITORY

activesubstance

activesubstancenameESTRADIOL

openFDA Info on Medication

Application NumberNDA020908Brand NameVAGIFEMGeneric NameESTRADIOLManufacturersNovo Nordiskproduct_ndc0169-5176Product TypeHUMAN PRESCRIPTION DRUGRouteVAGINALActive IngredientsESTRADIOLRXCUI884707, 884709spl_ida34ea2d3-d6a6-48f2-bd00-783a1e21be3dspl_set_ide5ad3cf6-dd96-4e64-af21-c1eee38d0b88Package NDC0169-5176-04, 0169-5176-03, 0169-5176-99NUIM0447348, N0000175825, N0000000100Chemical StructureEstradiol Congeners [CS]Established Pharmacologic ClassEstrogen [EPC]Mechanism of ActionEstrogen Receptor Agonists [MoA]UNII4TI98Z838E

23)

drugcharacterization2medicinalproductZOFRAN

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020103Brand NameZOFRANGeneric NameONDANSETRON HYDROCHLORIDEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0675, 0078-0676Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsONDANSETRON HYDROCHLORIDERXCUI104895, 104896, 198052, 312086spl_id5de8b98b-16d8-4540-8991-ebaace847a66spl_set_id555f81bc-4ce0-4f77-b394-b974838c4440Package NDC0078-0675-15, 0078-0676-15UNIINMH84OZK2B

24)

drugcharacterization2medicinalproductMORPHINE

activesubstance

activesubstancenameMORPHINE

openFDA Info on Medication

Brand NameOPIUM TINCTURE DEODORIZEDGeneric NameMORPHINEManufacturersEdenbridge Pharmaceuticals, LLCproduct_ndc42799-217Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMORPHINERXCUI830196spl_id5b376952-010f-adfc-e053-2a91aa0ae464spl_set_ide2a5697a-cc41-4cf1-b3a8-59b0268740d7Package NDC42799-217-01, 42799-217-02NUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]UNII76I7G6D29C

25)

drugcharacterization2medicinalproductPERCOCET

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 IngredientsOXYCODONE HYDROCHLORIDE, ACETAMINOPHENRXCUI1049214, 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

26)

drugcharacterization2medicinalproductDICYCLOMINEdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804

activesubstance

activesubstancenameDICYCLOMINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA207084, ANDA040161Brand NameDICYCLOMINEGeneric NameDICYCLOMINE HYDROCHLORIDEManufacturersAkorn, Inc., Hikma Pharmaceuticals USA Inc.product_ndc17478-015, 0143-1227Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, ORALActive IngredientsDICYCLOMINE HYDROCHLORIDERXCUI991065, 991086spl_idde0b319e-30eb-4257-a2ef-e6ae2bb3b5a7, 31219459-7057-4d7e-85db-a50f8a2cef95spl_set_id8e1592ba-03cd-4831-bd7c-4c0eeaa06fd1, 5a553bda-1e3d-4b80-913f-73dd54655033Package NDC17478-015-02, 0143-1227-01, 0143-1227-10UNIICQ903KQA31

27)

drugcharacterization2medicinalproductPROTONIXdrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804

activesubstance

activesubstancenamePANTOPRAZOLE SODIUM

openFDA Info on Medication

Application NumberNDA020988, NDA020987, NDA022020Brand NamePROTONIX I.V., PROTONIX DELAYED-RELEASEGeneric NamePANTOPRAZOLE SODIUMManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0008-0923, 0008-2001, 0008-4001, 0008-0841, 0008-0843, 0008-0844Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsPANTOPRAZOLE SODIUMRXCUI283669, 885257, 251872, 284400, 314200, 352125, 763306, 763308spl_id b326d5db-8b20-4ec4-ac25-78190fb3ac36, 1e8fa399-506d-4bcd-9097-dbf7850147bf, 7bdf ... spl_set_id 51e4144a-489e-436c-609a-39305f8f56ba, 5b5ddedd-d429-41a7-8573-10c3e9ad4e52, f39b ... Package NDC 0008-0923-51, 0008-0923-60, 0008-0923-55, 0008-2001-01, 0008-2001-25, 0008-2001- ... UNII6871619Q5X

28)

drugcharacterization2medicinalproductVITAMIN C

activesubstance

activesubstancenameASCORBIC ACID

29)

drugcharacterization2medicinalproductHYOSCYAMINEdrugstructuredosagenumb.125drugstructuredosageunit003drugadministrationroute060

activesubstance

activesubstancenameHYOSCYAMINE

openFDA Info on Medication

Brand NameHYOSCYAMINE, HYOSCYAMINE ER, HYOSCYAMINE SLGeneric NameHYOSCYAMINE SULFATEManufacturersPatrin Pharma, Wallace Pharmaceuticals Inc.product_ndc39328-048, 51525-0112, 51525-0115, 51525-0113, 39328-047Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYOSCYAMINE SULFATERXCUI1047881, 1047905, 1046770, 1046982, 1047895spl_id 12f9afe0-1263-4198-a6b4-6ce44479e3b3, ae0d2b1d-1ac2-4521-9de7-08c0d0e30413, a627 ... spl_set_id e09f23ca-e6f8-46c3-b713-97b86e3d5c97, 9fb71fa2-2ce8-429e-8719-58f3b12a6163, 5bbc ... Package NDC39328-048-16, 51525-0112-1, 51525-0115-1, 51525-0113-1, 39328-047-15UNIIF2R8V82B84

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drugcharacterization2medicinalproductDUONEB

activesubstance

activesubstancenameALBUTEROL SULFATE\IPRATROPIUM BROMIDE

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drugcharacterization2medicinalproductSENNAdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048

activesubstance

activesubstancenameSENNA LEAF\SENNOSIDES\SENNOSIDES A AND B

openFDA Info on Medication

Application Numberpart334Brand NameSENNAGeneric NameSENNA, SENNOSIDES, SENNA LEAFManufacturers Akron Pharma Inc., CVS Pharmacy, Boiron, TARGET Corporation, Advance Pharmaceuti ... product_ndc 71399-8237, 59779-586, 0220-4642, 11673-886, 17714-122, 0904-6434, 11822-6523, 6 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsSENNOSIDES A AND B, SENNOSIDES, SENNA LEAFRXCUI702311, 312935, 476827spl_id a95e938e-ed52-4328-b339-2c0b63a66b03, e46c9628-21d2-423c-9eda-4ace626960a1, 8761 ... spl_set_id 9e9c434a-7075-45d4-b7b3-0f83a33cf046, c3ba17b9-e34a-496d-9bb9-cd5c19c79f92, 80b3 ... Package NDC 71399-8237-8, 59779-586-25, 59779-586-50, 0220-4642-41, 11673-886-01, 17714-122- ... UNII1B5FPI42EN, 3FYP5M0IJX, AK7JF626KX

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drugcharacterization2medicinalproductELAVILdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804

activesubstance

activesubstancenameAMITRIPTYLINE HYDROCHLORIDE

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drugcharacterization2medicinalproductDILTIAZEMdrugstructuredosagenumb180drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804

activesubstance

activesubstancenameDILTIAZEM

34)

drugcharacterization2medicinalproductASPIRIN.drugstructuredosagenumb81drugstructuredosageunit003

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20090606

Report Duplicate

duplicatesourceAVENTISduplicatenumbUS-SANOFI-AVENTIS-2012SA041936

Receiver

receivertype6receiverorganizationFDA

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sendertype2senderorganizationFDA-Public Use

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