Report

reporttype1Version of Safety Report ID11receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10022313serious1Date Last Updated23/09/2015receiptdateformat102companynumbUS-SANOFI-AVENTIS-2012SA041897occurcountryUSseriousnessother1duplicate1Date Received19/03/2014seriousnesshospitalization1transmissiondate25/11/2015primarysourcecountryUSseriousnessdisabling1

Primary Source

reportercountryUSqualification1

Patient

Onset Age56Unit of Onset Ageyearspatientagegroup5Weight66.67SexMale

Contents

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

Reaction

1)

reactionmeddraversionpt18.1ReactionPainOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.1ReactionSocial problemOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.1ReactionPhysical disabilityOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.1ReactionPsychological traumaOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt18.1ReactionMultiple injuriesOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt18.1ReactionTensionOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt18.1ReactionEconomic problemOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt18.1ReactionDeformityOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt18.1ReactionAnhedoniaOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt18.1ReactionLoss of employmentOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt18.1ReactionGastrointestinal haemorrhageOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductMETOPROLOLdrugstructuredosagenumb.5drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb12drugintervaldosagedefinition805drugdosageformTABLETdrugadministrationroute048drugindicationPANIC DISORDER

activesubstance

activesubstancenameMETOPROLOL

openFDA Info on Medication

Application NumberANDA078950, ANDA091045, ANDA202871Brand NameMETOPROLOL, METOPROLOL TARTRATEGeneric NameMETOPROLOL TARTRATE, METOPROLOLManufacturers Baxter Healthcare Corporation, Fresenius Kabi USA, LLC, Alembic Pharmaceuticals ... product_ndc 36000-033, 63323-660, 62332-112, 62332-113, 62332-114, 46708-290, 46708-291, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsMETOPROLOL TARTRATERXCUI866508, 866511, 866514, 866924spl_id 202a1ff0-38f7-4bf2-ade7-6ede8fa64486, 94a4f468-def9-95b9-e053-2995a90a3428, bd31 ... spl_set_id 09566368-f91d-43a3-b683-30c844fb125a, be1c686e-37a5-4a53-945b-68a6ead35134, 2483 ... Package NDC 36000-033-10, 63323-660-05, 62332-112-30, 62332-112-31, 62332-112-91, 62332-113- ... UNIIW5S57Y3A5L

2)

drugcharacterization2medicinalproductDILTIAZEM

activesubstance

activesubstancenameDILTIAZEM

3)

drugcharacterization2medicinalproductNEXIUM

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_id416c365d-7271-4804-9285-643858cf578b, ac4ba22b-f431-4ab4-b239-0e220ad804ddspl_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

4)

drugcharacterization2medicinalproductPRAVASTATINdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

activesubstance

activesubstancenamePRAVASTATIN\PRAVASTATIN SODIUM

5)

drugcharacterization2medicinalproductTRAZODONEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

6)

drugcharacterization2medicinalproductPROVENTILdrugstructuredosagenumb90drugstructuredosageunit004drugadministrationroute055

activesubstance

activesubstancenameALBUTEROL

7)

drugcharacterization2medicinalproductBIAXINdrugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048

activesubstance

activesubstancenameCLARITHROMYCIN

8)

drugcharacterization2medicinalproductESOMEPRAZOLE

activesubstance

activesubstancenameESOMEPRAZOLE

openFDA Info on Medication

Application NumberANDA207193, ANDA209202, ANDA212866, ANDA207673Brand Name KIRKLAND SIGNATURE ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE, DG HEALTH ESOMEPRAZOLE ... Generic NameESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUMManufacturers Costco Wholesale Company, Actavis Pharma, Inc., Dolgencorp, LLC, Walgreen Compan ... product_ndc 63981-898, 0591-4187, 55910-250, 0363-1898, 46122-641, 50594-029, 63304-740, 692 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM DIHYDRATE, ESOMEPRAZOLE MAGNESIUMRXCUI606726, 433733spl_id 495105e5-3361-48c3-bdac-14828718eeff, 6fe03f24-f64b-4c07-9564-52f3b7381d4d, 8f97 ... spl_set_id 4a87d5d5-c98b-4dc5-81be-50183342b047, 5b583358-f25d-4bd4-add2-89e4f56f5d41, 8f97 ... Package NDC 63981-898-03, 0591-4187-14, 0591-4187-42, 0591-4187-96, 55910-250-01, 55910-250- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIN3PA6559FT, 36H71644EQ, R6DXU4WAY9

9)

drugcharacterization1medicinalproductPLAVIXdrugbatchnumbUNKNOWNdrugauthorizationnumb020839drugstructuredosagenumb75drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationMYOCARDIAL INFARCTIONdrugstartdateformat102drugstartdate07/08/2009drugenddateformat102drugenddate25/12/2011actiondrug1

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

10)

drugcharacterization2medicinalproductASPIRIN.drugstructuredosagenumb81drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

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

11)

drugcharacterization2medicinalproductPROZACdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute048

activesubstance

activesubstancenameFLUOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA018936Brand NamePROZACGeneric NameFLUOXETINE HYDROCHLORIDEManufacturersDista Products Companyproduct_ndc0777-3104, 0777-3105, 0777-3107Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFLUOXETINE HYDROCHLORIDERXCUI104849, 205535, 261287, 310384, 310385, 313989spl_idef027dfe-1ccd-4c52-ad10-c76d6834d10cspl_set_idc88f33ed-6dfb-4c5e-bc01-d8e36dd97299Package NDC0777-3104-02, 0777-3105-02, 0777-3105-07, 0777-3105-30, 0777-3107-30UNIII9W7N6B1KJ

12)

drugcharacterization2medicinalproductFERROUS SULFATEdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

activesubstance

activesubstancenameFERROUS SULFATE\FERROUS SULFATE, DRIED

openFDA Info on Medication

Brand NameFERROUS SULFATE, FERRUM SULPHURICUMGeneric NameFERROUS SULFATE, IRON SUPPLEMENT THERAPYManufacturers Richmond Pharmaceuticals, Inc., Boiron, Healthlife of USA, Washington Homeopathi ... product_ndc54738-963, 0220-2111, 69517-133, 68428-941, 71919-293Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFERROUS SULFATERXCUI310325spl_id 9a63ba0a-0ded-744b-e053-2a95a90a9344, 8723d1f8-ed45-3373-e053-2991aa0a81d7, 655e ... spl_set_id 58dd4f30-980b-44bc-9f8e-8d4626854b91, 7a4087d8-d054-bbdc-e053-2991aa0ae8cf, 3810 ... Package NDC 54738-963-01, 54738-963-03, 0220-2111-41, 69517-133-30, 68428-941-03, 68428-941- ... UNII39R4TAN1VT

13)

drugcharacterization2medicinalproductNITROGLYCERINEdrugstructuredosagenumb1drugstructuredosageunit032drugdosageformTABLETdrugadministrationroute060drugindicationCHEST PAIN

activesubstance

activesubstancenameNITROGLYCERIN

14)

drugcharacterization2medicinalproductZOCORdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804

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

15)

drugcharacterization2medicinalproductABILIFY

activesubstance

activesubstancenameARIPIPRAZOLE

openFDA Info on Medication

Application NumberNDA021436Brand NameABILIFYGeneric NameARIPIPRAZOLEManufacturersOtsuka America Pharmaceutical, Inc.product_ndc 59148-006, 59148-007, 59148-008, 59148-009, 59148-010, 59148-011, 59148-013, 591 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsARIPIPRAZOLERXCUI 349490, 349545, 349547, 349553, 352307, 352308, 352309, 352310, 402131, 404602, ... spl_id85ae6d7d-eb0f-44b1-bb1f-b58d196124a4spl_set_idc040bd1d-45b7-49f2-93ea-aed7220b30acPackage NDC 59148-006-13, 59148-006-92, 59148-007-13, 59148-007-35, 59148-007-94, 59148-008- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNII82VFR53I78

16)

drugcharacterization2medicinalproductNICOTINE.drugstructuredosagenumb21drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextFORM: PATCH

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)

drugcharacterization2medicinalproductLISINOPRIL.drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationPANIC DISORDER

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

18)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

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

19)

drugcharacterization2medicinalproductALPRAZOLAM.drugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA078088 ... Brand Name ALPRAZOLAM, XANAX XR, ALPRAZOLAM ER, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZO ... Generic NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia and Upjohn Co ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 687022, 687023, ... spl_id 05c4e062-e29d-4e46-a6f0-302025edd596, 84ebf58b-deef-4f35-ba5e-e901288c2997, dfdd ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

20)

drugcharacterization2medicinalproductSPIRIVAdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute055

activesubstance

activesubstancenameTIOTROPIUM BROMIDE MONOHYDRATE

openFDA Info on Medication

Application NumberNDA021395Brand NameSPIRIVA HANDIHALERGeneric NameTIOTROPIUM BROMIDEManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0075Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, RESPIRATORY (INHALATION)Active IngredientsTIOTROPIUM BROMIDE MONOHYDRATERXCUI485032, 580261spl_id61e158db-bf32-4cb5-8e5e-72acd953e493spl_set_id820839ef-e53d-47e8-a3b9-d911ff92e6a9Package NDC0597-0075-41, 0597-0075-75, 0597-0075-47UNIIL64SXO195N

21)

drugcharacterization2medicinalproductBYSTOLICdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804

activesubstance

activesubstancenameNEBIVOLOL HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021742Brand NameBYSTOLICGeneric NameNEBIVOLOL HYDROCHLORIDEManufacturersAllergan, Inc.product_ndc0456-1402, 0456-1405, 0456-1410, 0456-1420Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNEBIVOLOL HYDROCHLORIDERXCUI387013, 751612, 751616, 751618, 751620, 751623, 827073, 827075spl_idd39ebddf-024d-4b86-a95e-7a2e2b990ebfspl_set_id8b8ad213-1dc8-454e-a524-075685c0e1a8Package NDC 0456-1402-01, 0456-1402-30, 0456-1402-63, 0456-1402-90, 0456-1405-01, 0456-1405- ... UNIIJGS34J7L9I

22)

drugcharacterization2medicinalproductATIVAN

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application NumberNDA017794, NDA018140Brand NameATIVANGeneric NameLORAZEPAMManufacturersBausch Health US LLC, West-Ward Pharmaceuticals Corp.product_ndc0187-0063, 0187-0064, 0187-0065, 0641-6000, 0641-6001, 0641-6003, 0641-6002Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsLORAZEPAMspl_idb87ffa4d-6634-4d66-a907-3eba6911444c, 30a1b292-640f-477d-b193-f564e84d0436spl_set_id89057c93-8155-4040-acec-64e877bd2b4c, 5fc0e987-61c9-40c4-b0d5-fcea07c8733ePackage NDC 0187-0063-01, 0187-0063-50, 0187-0063-10, 0187-0064-01, 0187-0064-50, 0187-0064- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769LRXCUI206819, 206820, 238100, 238101, 1665188, 1665190, 1665326, 1665327

23)

drugcharacterization2medicinalproductFOLIC ACID.

activesubstance

activesubstancenameFOLIC ACID

openFDA Info on Medication

Application Number ANDA040796, ANDA204418, ANDA202437, ANDA091145, ANDA211064, ANDA202522, ANDA0407 ... Brand NameFOLIC ACID, VENEXA, VITREXYL, VITRANOLGeneric NameFOLIC ACIDManufacturers Leading Pharma, LLC, Marlex Pharmaceuticals Inc, PureTek Corporation, Cadila Pha ... product_ndc 69315-127, 10135-182, 59088-176, 71209-007, 58657-150, 11534-165, 58657-151, 731 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSActive Ingredients FOLIC ACID, .ALPHA.-TOCOPHEROL ACETATE, DL-, MAGNESIUM OXIDE, CHROMIUM NICOTINAT ... RXCUI310410, 237786spl_id 92322e52-3179-4738-8c8a-14fef62311d4, ba726c8a-bfad-11f7-e053-2995a90a239e, ba13 ... spl_set_id 1ba8c407-9613-4319-ac40-0a429cb0f3f4, 35cd5498-0af8-4bcc-a755-bf30f37b091a, ba13 ... Package NDC 69315-127-01, 69315-127-10, 10135-182-01, 10135-182-10, 59088-176-54, 71209-007- ... UNII 935E97BOY8, WR1WPI7EW8, 3A3U0GI71G, A150AY412V, 68Y4CF58BV, 81AH48963U, H6241UJ2 ... NUIM0022797, N0000175952, N0000193618, M0001797, M0022794, N0000175951Chemical StructureVitamin D [CS], Ascorbic Acid [CS], Vitamin B 12 [CS]Established Pharmacologic ClassVitamin D [EPC], Vitamin C [EPC], Vitamin B12 [EPC]

24)

drugcharacterization2medicinalproductSIMVASTATIN.drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationPANIC DISORDER

activesubstance

activesubstancenameSIMVASTATIN

openFDA Info on Medication

Application Number NDA206679, ANDA078155, ANDA077691, ANDA078103, ANDA090383, ANDA078034, ANDA07783 ... Brand NameFLOLIPID, SIMVASTATIN, ZOCORGeneric NameSIMVASTATINManufacturers Salerno Pharmaceuticals Co., Accord Healthcare, Inc., NorthStar Rx LLC, Lupin Ph ... product_ndc 29273-401, 29273-402, 16729-004, 16729-156, 16729-005, 16729-006, 16729-007, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSIMVASTATINRXCUI 1790679, 1944262, 1944264, 1944266, 198211, 200345, 312961, 312962, 314231, 1044 ... spl_id 37ec6157-4088-4638-8eba-74a6aa1238d3, a467e8e1-fe36-61f4-e053-2a95a90a3c3c, 81d3 ... spl_set_id 6ee17d10-6eb1-452a-99e8-02381368b3fe, 871251c0-36a1-4a32-9eab-ff6c1e925ca9, 0376 ... Package NDC 29273-401-04, 29273-402-04, 16729-156-10, 16729-156-15, 16729-156-17, 16729-004- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNIIAGG2FN16EV

25)

drugcharacterization2medicinalproductXANAX

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

26)

drugcharacterization2medicinalproductPOTASSIUM CHLORIDE.

activesubstance

activesubstancenamePOTASSIUM CHLORIDE

openFDA Info on Medication

Brand Name KALI MURIATICUM, POTASSIUM CHLORIDE, SORE THROAT 911, KLOR-CON M, POTASSIUM CHLO ... Generic NamePOTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASEManufacturers Hyland's, Camber Pharmaceuticals, Inc., Epic Pharma, LLC, DelCorean, LLC, Actavi ... product_ndc 54973-5224, 31722-133, 31722-134, 31722-135, 42806-094, 35484-204, 62037-559, 62 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, TOPICAL, INTRAVENOUS, PARENTERAL, SUBLINGUALActive IngredientsPOTASSIUM CHLORIDE, POTASSIUM CATIONspl_id 603fa445-ab7d-3929-e053-2a91aa0afb47, 4dca93f2-d9a9-4ecb-89d2-f67b819f82dc, ebba ... spl_set_id 2e8a4762-d28d-4b64-892f-913e04d18d2d, b1e827aa-b2fb-4fa5-984d-ddd94338ff53, 1373 ... Package NDC 54973-5224-1, 54973-5224-2, 31722-133-01, 31722-133-05, 31722-133-10, 31722-134- ... UNII660YQ98I10, 295O53K152Application Number ANDA214422, ANDA210200, ANDA077419, ANDA209922, ANDA209786, NDA018279, ANDA08020 ... RXCUI 403888, 1801294, 1801298, 1867544, 312504, 315183, 312515, 314182, 198116, 31252 ... NUIM0026737, N0000175600, N0000175811, N0000009371, N0000009726, N0000010288Chemical StructurePotassium Compounds [CS]Established Pharmacologic ClassPotassium Salt [EPC], Osmotic Laxative [EPC]Physiologic/Pharmacodynamic Effect Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Elect ... Mechanism of ActionOsmotic Activity [MoA]

27)

drugcharacterization2medicinalproductDIAZEPAM.drugindicationPANIC DISORDER

activesubstance

activesubstancenameDIAZEPAM

openFDA Info on Medication

Application Number ANDA072079, ANDA071134, ANDA071135, ANDA071136, NDA020124, ANDA210363, NDA020648 ... Brand NameDIAZEPAM, DIASTAT, VALTOCO, VALIUMGeneric NameDIAZEPAMManufacturers Hospira, Inc., Mayne Pharma, Meridian Medical Technologies, Inc., Dash Pharmaceu ... product_ndc 0409-1273, 51862-062, 51862-063, 51862-064, 11704-600, 69339-136, 66490-650, 686 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORAL, RECTAL, NASALActive IngredientsDIAZEPAMRXCUI 1807459, 197589, 197590, 197591, 1807452, 2120550, 801957, 801961, 801966, 22726 ... spl_id c2374258-57c6-4be5-89df-27d6cf5dc832, 49cd2631-74e5-4291-a491-b15b2fa31ee3, 8861 ... spl_set_id 41044928-dd1f-40bf-1fa6-709dff559124, 7d81850c-ad3f-4e2e-ac41-ed9c567aea4b, fa35 ... Package NDC 0409-1273-03, 0409-1273-32, 51862-062-01, 51862-062-05, 51862-062-10, 51862-063- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

28)

drugcharacterization2medicinalproductVOLTARENdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

activesubstance

activesubstancenameDICLOFENAC SODIUM

openFDA Info on Medication

Application NumberNDA022122Brand NameVOLTAREN ARTHRITIS PAIN, VOLTARENGeneric NameDICLOFENAC SODIUMManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLC, Endo Pharmaceuticals Inc.product_ndc0067-8152, 0067-8153, 63481-684Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteTOPICALActive IngredientsDICLOFENAC SODIUMRXCUI855633, 855635spl_ide70c4cce-71d6-457c-aef5-3729a101ebce, 16e1d289-8ac0-4070-b29e-e3a286d724c1spl_set_id30a94282-0892-442a-aa10-6525cbd4fe88, 60045fc6-f0d9-4f67-ba91-c3b317596437Package NDC 0067-8152-01, 0067-8152-02, 0067-8152-03, 0067-8152-04, 0067-8152-05, 0067-8153- ... UNIIQTG126297Q

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drugcharacterization1medicinalproductPLAVIXdrugbatchnumbUNKNOWNdrugauthorizationnumb020839drugstructuredosagenumb75drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationACUTE CORONARY SYNDROMEdrugstartdateformat102drugstartdate07/08/2009drugenddateformat102drugenddate25/12/2011actiondrug1

activesubstance

activesubstancenameCLOPIDOGREL BISULFATE

openFDA Info on Medication

30)

drugcharacterization2medicinalproductSERTRALINE

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

31)

drugcharacterization2medicinalproductTOPROL XLdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

activesubstance

activesubstancenameMETOPROLOL SUCCINATE

openFDA Info on Medication

Application NumberNDA019962Brand NameTOPROL XLGeneric NameMETOPROLOL SUCCINATEManufacturersAstraZeneca Pharmaceuticals LP, Aralez Pharmaceuticals US Inc.product_ndc 0186-1088, 0186-1090, 0186-1092, 0186-1094, 70347-025, 70347-050, 70347-100, 703 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOPROLOL SUCCINATERXCUI866412, 866414, 866419, 866421, 866427, 866429, 866436, 866438spl_id03b2ba2e-c4b7-449d-8e07-9c0e08171f66, 259b9a5f-b63a-44a0-8d05-1bb38cfc85bdspl_set_id4a5762c6-d7a2-4e4c-10b7-8832b36fa5f4, 991fe00b-498b-400e-9e5b-921cb07d9b2cPackage NDC 0186-1088-05, 0186-1088-39, 0186-1088-30, 0186-1088-35, 0186-1090-05, 0186-1090- ... UNIITH25PD4CCB

32)

drugcharacterization2medicinalproductPROMETHAZINE DMdrugseparatedosagenumb1drugintervaldosageunitnumb6drugintervaldosagedefinition805drugdosagetextDOSE:1 TEASPOON(S)drugadministrationroute048

activesubstance

activesubstancenameDEXTROMETHORPHAN HYDROBROMIDE\PROMETHAZINE HYDROCHLORIDE

openFDA Info on Medication

summary

narrativeincludeclinicalCASE EVENT DATE: 20111225

Report Duplicate

duplicatesourceAVENTISduplicatenumbUS-SANOFI-AVENTIS-2012SA041897

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use

Adverse Event Report

Report

Primary Source

Patient

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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