Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10062843serious1Date Last Updated21/08/2014receiptdateformat102companynumbUS-BAYER-2014-051412occurcountryUSduplicate1Date Received07/04/2014seriousnesshospitalization1transmissiondate26/03/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age27Unit of Onset Ageyearspatientagegroup5Weight48.73SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionPain

2)

reactionmeddraversionpt17.1ReactionAnxiety

3)

reactionmeddraversionpt17.1ReactionPulmonary embolism

4)

reactionmeddraversionpt17.1ReactionGeneral physical health deterioration

5)

reactionmeddraversionpt17.1ReactionEmotional distress

6)

reactionmeddraversionpt17.1ReactionInjury

Drug

1)

drugcharacterization2medicinalproductZANAFLEX

activesubstance

activesubstancenameTIZANIDINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020397, NDA021447Brand NameZANAFLEXGeneric NameTIZANIDINE HYDROCHLORIDEManufacturersCovis Pharmaproduct_ndc70515-594, 70515-602, 70515-604, 70515-606Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTIZANIDINE HYDROCHLORIDERXCUI153735, 313413, 485484, 485485, 485486, 580267, 583165, 583211spl_id8f9774b0-1a53-4e5e-913b-d9f0055e8daaspl_set_id043d9e51-bfa2-4add-9058-5ece332f7e99Package NDC70515-602-15, 70515-604-15, 70515-606-15, 70515-594-15UNIIB53E3NMY5C

2)

drugcharacterization1medicinalproductYASMINdrugauthorizationnumb021098drugdosagetextUNKdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugindicationCONTRACEPTIONdrugstartdateformat610drugstartdate/03/2008drugenddateformat610drugenddate/01/2012actiondrug1

activesubstance

activesubstancenameDROSPIRENONE\ETHINYL ESTRADIOL

openFDA Info on Medication

Application NumberNDA021098Brand NameYASMINGeneric NameDROSPIRENONE AND ETHINYL ESTRADIOLManufacturersBayer HealthCare Pharmaceuticals Inc.product_ndc50419-402Product TypeHUMAN PRESCRIPTION DRUGRXCUI284207, 748797, 748800, 748857spl_id0972cd1d-53a1-465e-b09c-5be40ef658cbspl_set_idd7ea6a60-5a56-4f81-b206-9b27b7e58875Package NDC50419-402-03

3)

drugcharacterization1medicinalproductYASMINdrugauthorizationnumb021098drugdosageformFILM-COATED TABLETdrugindicationACNEactiondrug1

activesubstance

activesubstancenameDROSPIRENONE\ETHINYL ESTRADIOL

openFDA Info on Medication

Application NumberNDA021098Brand NameYASMINGeneric NameDROSPIRENONE AND ETHINYL ESTRADIOLManufacturersBayer HealthCare Pharmaceuticals Inc.product_ndc50419-402Product TypeHUMAN PRESCRIPTION DRUGRXCUI284207, 748797, 748800, 748857spl_id0972cd1d-53a1-465e-b09c-5be40ef658cbspl_set_idd7ea6a60-5a56-4f81-b206-9b27b7e58875Package NDC50419-402-03

4)

drugcharacterization1medicinalproductOCELLAdrugauthorizationnumb021098drugdosagetextUNKdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugindicationCONTRACEPTIONdrugstartdateformat610drugstartdate/03/2008drugenddateformat610drugenddate/01/2012actiondrug1

activesubstance

activesubstancenameDROSPIRENONE\ETHINYL ESTRADIOL

openFDA Info on Medication

Application NumberNDA021098Brand NameOCELLAGeneric NameDROSPIRENONE AND ETHINYL ESTRADIOLManufacturersTEVA PHARMACEUTICALS USA, INC.product_ndc0555-9131Product TypeHUMAN PRESCRIPTION DRUGRXCUI284207, 748797, 748800, 801185spl_id68b57216-cb7d-4a74-8ac9-4b2cc7b7d3cespl_set_id0d729f4d-2fa3-47f6-8a1f-d8cfea4cff37Package NDC0555-9131-79, 0555-9131-67

5)

drugcharacterization2medicinalproductGLUCOSAMINE [GLUCOSAMINE]

6)

drugcharacterization2medicinalproductCLOBETASOLdrugstructuredosagenumb.05drugstructuredosageunit030drugdosagetext0.05 %, UNKdrugstartdateformat102drugstartdate31/10/2011

activesubstance

activesubstancenameCLOBETASOL

7)

drugcharacterization2medicinalproductOMEPRAZOLE.

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA075757, ANDA206877, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, AC ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., OHM ... product_ndc 46122-281, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 62175-136, 078 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, 8c9d9c38-9da6-4f99-9f08-26ec4693fa55, ce5c ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c ... Package NDC 46122-281-04, 46122-281-74, 63981-915-55, 57483-740-01, 57483-740-42, 51660-029- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

8)

drugcharacterization2medicinalproductZOLOFT

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

9)

drugcharacterization2medicinalproductSERTRALINEdrugdosagetextUNKdrugindicationANXIETYdrugstartdateformat602drugstartdate//2006

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

10)

drugcharacterization2medicinalproductCIMETIDINEdrugdosagetextUNKdrugindicationPRURITUSdrugstartdateformat602drugstartdate//2007

activesubstance

activesubstancenameCIMETIDINE

openFDA Info on Medication

Application NumberANDA074151, ANDA074463, ANDA075285, ANDA074553, ANDA074246, NDA020238Brand Name CIMETIDINE, CIMETIDINE ACID REDUCER, GOOD SENSE HEARTBURN RELIEF, ACID REDUCER, ... Generic NameCIMETIDINE, CIMETIDINE HYDROCHLORIDEManufacturers Teva Pharmaceuticals USA, Inc., Walgreen Company, Pharmaceutical Associates, Inc ... product_ndc 0093-8192, 0093-8204, 0093-8305, 0363-0022, 0121-0649, 0113-0022, 30142-323, 243 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsCIMETIDINE, CIMETIDINE HYDROCHLORIDERXCUI197506, 197507, 197508, 197505, 212787, 104062spl_id a631a243-834a-432b-84a6-7e3cebbb8b5c, 702a0ec1-f349-4fe2-92c3-f9fd4cf1efb0, b9d4 ... spl_set_id 496e258d-a5fd-42da-9a86-73afc8be359b, 7087f4bb-992b-4680-a9a7-452ce74eed2d, cdae ... Package NDC 0093-8192-01, 0093-8192-05, 0093-8204-01, 0093-8204-05, 0093-8305-01, 0093-8305- ... NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]UNII80061L1WGD, WF10491673

11)

drugcharacterization1medicinalproductOCELLAdrugauthorizationnumb021098drugdosageformFILM-COATED TABLETdrugindicationACNEactiondrug1

activesubstance

activesubstancenameDROSPIRENONE\ETHINYL ESTRADIOL

openFDA Info on Medication

Application NumberNDA021098Brand NameOCELLAGeneric NameDROSPIRENONE AND ETHINYL ESTRADIOLManufacturersTEVA PHARMACEUTICALS USA, INC.product_ndc0555-9131Product TypeHUMAN PRESCRIPTION DRUGRXCUI284207, 748797, 748800, 801185spl_id68b57216-cb7d-4a74-8ac9-4b2cc7b7d3cespl_set_id0d729f4d-2fa3-47f6-8a1f-d8cfea4cff37Package NDC0555-9131-79, 0555-9131-67

12)

drugcharacterization2medicinalproductIBUPROFEN.

activesubstance

activesubstancenameIBUPROFEN

openFDA Info on Medication

Application Number ANDA077349, ANDA206568, ANDA074937, ANDA091355, ANDA075139, ANDA078682, ANDA0791 ... Brand Name CAREONE IBUPROFEN, IBUPROFEN, HEALTH MART CHILDRENS IBUPROFEN, IBUPROFEN MINIS, ... Generic Name IBUPROFEN, IBUPROFEN TABLETS, IBUPROFEN 200MG, IBUPROFEN ORAL, IBUPFROFEN, IBUPR ... Manufacturers American Sales Company, Family Dollar (FAMILY WELLNESS), Strategic Sourcing Serv ... product_ndc 41520-495, 55319-745, 62011-0214, 49738-510, 59779-392, 11822-3307, 50804-199, 7 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsIBUPROFEN, IBUPROFEN SODIUMRXCUI 310965, 310964, 197803, 204442, 310963, 731536, 197805, 197806, 197807, 206905, ... spl_id 0647c7c2-b153-4d8c-b72b-f63d43c41853, 720dc13b-5778-44fa-a4d2-e35db0b2d589, 397d ... spl_set_id 03cdff8a-8890-440d-82b5-54ce809f88cc, 135f910d-a5cd-46e9-9436-015170cc7e38, 1d81 ... Package NDC 41520-495-71, 41520-495-78, 55319-745-30, 55319-745-80, 55319-745-16, 62011-0214 ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, RM1CE97Z4N

13)

drugcharacterization2medicinalproductTAGAMET

activesubstance

activesubstancenameCIMETIDINE

openFDA Info on Medication

Application NumberNDA020238Brand NameTAGAMETGeneric NameCIMETIDINEManufacturersMedtech Products Inc.product_ndc63029-222Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCIMETIDINERXCUI104062, 197505spl_id8dc828bd-a3e5-44f2-aa13-b456520c7542spl_set_ide6401e0a-8612-42e8-bf89-2d67243f28dcPackage NDC 63029-222-02, 63029-222-01, 63029-222-03, 63029-222-04, 63029-222-05, 63029-222- ... NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]UNII80061L1WGD

summary

narrativeincludeclinicalCASE EVENT DATE: 20120107

Report Duplicate

duplicatesourceBAYERduplicatenumbUS-BAYER-2014-051412

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use