Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10264493serious1Date Last Updated14/11/2014receiptdateformat102companynumbUS-BAYER-2014-095919occurcountryUSseriousnessother1duplicate1Date Received27/06/2014seriousnesshospitalization1transmissiondate28/05/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age31Unit of Onset Ageyearspatientagegroup5Weight58.5SexFemale

Contents

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

Reaction

1)

reactionmeddraversionpt18.0ReactionCerebrovascular accident

2)

reactionmeddraversionpt18.0ReactionCerebral haemorrhage

3)

reactionmeddraversionpt18.0ReactionIntracranial venous sinus thrombosisOutcomeRecovered/resolved

4)

reactionmeddraversionpt18.0ReactionSuperior sagittal sinus thrombosisOutcomeRecovered/resolved

5)

reactionmeddraversionpt18.0ReactionEpilepsy

6)

reactionmeddraversionpt18.0ReactionHaemorrhage intracranialOutcomeRecovered/resolved

7)

reactionmeddraversionpt18.0ReactionInjury

8)

reactionmeddraversionpt18.0ReactionSeizure

9)

reactionmeddraversionpt18.0ReactionThrombosis

Drug

1)

drugcharacterization1medicinalproductYAZdrugauthorizationnumb021676drugdosageformFILM-COATED TABLETdrugindicationMENSTRUAL CYCLE MANAGEMENTactiondrug1

activesubstance

activesubstancenameDROSPIRENONE\ETHINYL ESTRADIOL

openFDA Info on Medication

Application NumberNDA021676Brand NameYAZGeneric NameDROSPIRENONE AND ETHINYL ESTRADIOLManufacturersBayer HealthCare Pharmaceuticals Inc.product_ndc50419-405Product TypeHUMAN PRESCRIPTION DRUGRXCUI630734, 748797, 748798, 748856spl_idc138e16e-20a7-4893-9ff0-29f930446b38spl_set_id065f33e4-b587-4e66-b896-ca9ab7b7c876Package NDC50419-405-03

2)

drugcharacterization2medicinalproductBENTYLdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKdrugadministrationroute048drugstartdateformat102drugstartdate10/05/2012

activesubstance

activesubstancenameDICYCLOMINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA008370Brand NameBENTYLGeneric NameDICYCLOMINE HYDROCHLORIDEManufacturersAllergan, Inc.product_ndc58914-080Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULARActive IngredientsDICYCLOMINE HYDROCHLORIDERXCUI991065, 991069spl_idae7ad264-b53f-4545-b9aa-19278c523f68spl_set_idc56598d5-9cd1-4cce-b172-ac338775aec7Package NDC58914-080-52UNIICQ903KQA31

3)

drugcharacterization2medicinalproductLEXAPROdrugindicationDEPRESSION

activesubstance

activesubstancenameESCITALOPRAM OXALATE

openFDA Info on Medication

Application NumberNDA021323Brand NameLEXAPROGeneric NameESCITALOPRAM OXALATEManufacturersAllergan, Inc.product_ndc0456-2005, 0456-2010, 0456-2020, 0456-2101Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESCITALOPRAM OXALATERXCUI349332, 351249, 351250, 351285, 352272, 352273, 404408, 404420spl_idf7659260-4527-4446-9aa5-15a2895c5b0espl_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

4)

drugcharacterization2medicinalproductTYLENOL EXTRA STRENGTHdrugdosagetextUNKdrugstartdateformat102drugstartdate10/04/2012drugenddateformat102drugenddate10/05/2012

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

5)

drugcharacterization2medicinalproductMESALAMINE.drugstructuredosagenumb4drugstructuredosageunit002drugdosagetext4 G, UNKdrugadministrationroute054drugstartdateformat102drugstartdate19/05/2012

activesubstance

activesubstancenameMESALAMINE

openFDA Info on Medication

Application Number NDA022301, NDA204412, NDA021830, ANDA207873, ANDA203574, ANDA210509, ANDA204354, ... Brand Name MESALAMINE, DELZICOL, ASACOL HD, ZALDYON, CANASA, LIALDA, ROWASA, APRISO, SFROWA ... Generic NameMESALAMINE, MESALAMINE FILM COATEDManufacturers Teva Pharmaceuticals USA, Inc., Allergan, Inc., Mylan Pharmaceuticals Inc., Amne ... product_ndc 0093-9224, 0023-5853, 0023-5901, 0093-5907, 0378-7401, 69238-1274, 0378-9230, 68 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, RECTALActive IngredientsMESALAMINERXCUI 825130, 1368954, 1368960, 833234, 849383, 686429, 248420, 238151, 2108912, 58325 ... spl_id 41847ef1-fe3e-4263-8ac6-6d79dff5006d, 96bac46a-270a-4009-b243-36ebf58419bc, 6539 ... spl_set_id 8d27a608-3ba1-4799-be38-c00fb08ce3ce, 71b02324-9430-4269-825f-8fcac5eeaefb, 2f68 ... Package NDC 0093-9224-89, 0023-5853-00, 0023-5853-18, 0023-5901-18, 0093-5907-86, 0378-7401- ... NUIN0000175781, M0000971Established Pharmacologic ClassAminosalicylate [EPC]Chemical StructureAminosalicylic Acids [CS]UNII4Q81I59GXC

6)

drugcharacterization2medicinalproductAZATHIOPRINE.drugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, UNKdrugadministrationroute048drugstartdateformat102drugstartdate10/05/2012

activesubstance

activesubstancenameAZATHIOPRINE

openFDA Info on Medication

Application NumberANDA075252, ANDA077621, ANDA074069, NDA016324, ANDA208687, ANDA075568Brand NameAZASAN, AZATHIOPRINE, IMURANGeneric NameAZATHIOPRINEManufacturers Salix Pharmaceuticals Inc., Cadila Healthcare Limited, Zydus Pharmaceuticals (US ... product_ndc 65649-231, 65649-241, 65841-602, 68382-118, 68382-119, 68382-120, 68462-502, 683 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAZATHIOPRINERXCUI359228, 359229, 404475, 404476, 197388, 199310, 105611spl_id e89230f9-2906-4851-b714-b6ab491fe2f9, b9998061-a822-4988-bf0f-2c5d53ca2360, e246 ... spl_set_id 9050af7a-19c6-4670-937a-9445605de995, d65bc662-2ae8-4ddb-acc8-f616e72e6140, 1cd0 ... Package NDC 65649-231-41, 65649-241-41, 65841-602-01, 65841-602-05, 68382-118-01, 68382-118- ... NUIN0000000233, N0000175459, N0000175712, N0000008065Mechanism of ActionNucleic Acid Synthesis Inhibitors [MoA]Chemical StructureNucleoside Analog [Chemical/Ingredient], Purines [Chemical/Ingredient]Established Pharmacologic ClassPurine Antimetabolite [EPC]UNIIMRK240IY2L

7)

drugcharacterization2medicinalproductLEXAPROdrugindicationANXIETY

activesubstance

activesubstancenameESCITALOPRAM OXALATE

openFDA Info on Medication

8)

drugcharacterization1medicinalproductYAZdrugauthorizationnumb021676drugdosageformFILM-COATED TABLETdrugindicationACNEactiondrug1

activesubstance

activesubstancenameDROSPIRENONE\ETHINYL ESTRADIOL

openFDA Info on Medication

9)

drugcharacterization1medicinalproductYAZdrugauthorizationnumb021676drugdosageformFILM-COATED TABLETdrugindicationAFFECTIVE DISORDERactiondrug1

activesubstance

activesubstancenameDROSPIRENONE\ETHINYL ESTRADIOL

openFDA Info on Medication

10)

drugcharacterization2medicinalproductPREDNISONE.drugdosagetextUNKdrugstartdateformat102drugstartdate10/04/2012drugenddateformat102drugenddate10/05/2012

activesubstance

activesubstancenamePREDNISONE

openFDA Info on Medication

Application Number NDA202020, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA040584, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., GeneYork Pharmaceuticals Group LLC, Mylan Pharma ... product_ndc 75987-020, 75987-021, 75987-022, 71329-106, 0378-0640, 0378-0641, 0378-0642, 060 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id be29c86d-242b-42a7-9488-ecf6f76426cd, 4384c1d1-059b-4689-9f3d-1078de814ce8, 88a6 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, be50449f-3aa8-46b7-9246-2dbd5f04f2b1, fec0 ... 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

11)

drugcharacterization2medicinalproductROWASAdrugdosagetextUNKdrugstartdateformat102drugstartdate06/02/2012drugenddateformat102drugenddate10/04/2012

activesubstance

activesubstancenameMESALAMINE

openFDA Info on Medication

Application NumberNDA019618Brand NameROWASAGeneric NameMESALAMINEManufacturersMeda Pharmaceuticalsproduct_ndc0037-0066Product TypeHUMAN PRESCRIPTION DRUGRouteRECTALActive IngredientsMESALAMINEspl_idfde8c078-f9df-49d0-b34c-951c35e805a7spl_set_ide505ab99-1943-4216-a178-4d5dbe64e3b2Package NDC0037-0066-06, 0037-0066-05, 0037-0066-03NUIN0000175781, M0000971Established Pharmacologic ClassAminosalicylate [EPC]Chemical StructureAminosalicylic Acids [CS]UNII4Q81I59GXC

12)

drugcharacterization2medicinalproductSPIRONOLACTONE.drugdosagetextUNKdrugindicationACNEdrugstartdateformat602drugstartdate//2011

activesubstance

activesubstancenameSPIRONOLACTONE

openFDA Info on Medication

Application Number ANDA091426, ANDA040750, ANDA203512, ANDA203253, NDA012151, ANDA089424, ANDA20593 ... Brand NameSPIRONOLACTONE, ALDACTONEGeneric NameSPIRONOLACTONEManufacturers Amneal Pharmaceuticals LLC, Oxford Pharmaceuticals, LLC, Accord Healthcare, Inc. ... product_ndc 65162-511, 65162-514, 65162-515, 69584-852, 69584-853, 69584-854, 16729-225, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSPIRONOLACTONERXCUI198222, 198223, 313096spl_id 5c663162-67fb-4890-977c-70db2561d387, db73b6cc-b152-4ec1-8566-f4ead6f9ae6d, 9590 ... spl_set_id fb66327e-8261-46ae-b39a-4fa79d520844, 852684dc-e1c6-4caa-bccb-10ac90bbb3bb, 8a96 ... Package NDC 65162-511-03, 65162-511-06, 65162-511-09, 65162-511-10, 65162-511-11, 65162-511- ... NUIN0000175557, N0000011310Established Pharmacologic ClassAldosterone Antagonist [EPC]Mechanism of ActionAldosterone Antagonists [MoA]UNII27O7W4T232

13)

drugcharacterization2medicinalproductCORTENEMAdrugdosagetext100MG/60MLdrugadministrationroute054drugstartdateformat102drugstartdate10/05/2012

activesubstance

activesubstancenameHYDROCORTISONE

openFDA Info on Medication

Application NumberNDA016199Brand NameCORTENEMAGeneric NameHYDROCORTISONEManufacturersANI Pharmaceuticals, Inc.product_ndc62559-111Product TypeHUMAN PRESCRIPTION DRUGRouteRECTALActive IngredientsHYDROCORTISONERXCUI102250, 310878spl_id5947ebda-5e25-4171-a8c1-a1fde5a4879espl_set_ida307448a-ccc4-41a8-977a-11f28f0bded9Package NDC62559-111-11, 62559-111-07NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIWI4X0X7BPJ

14)

drugcharacterization2medicinalproductZOLOFTdrugindicationANXIETY

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)

drugcharacterization2medicinalproductPREDNISONE.drugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKdrugadministrationroute048drugstartdateformat102drugstartdate19/05/2012

activesubstance

activesubstancenamePREDNISONE

openFDA Info on Medication

16)

drugcharacterization2medicinalproductLIALDAdrugdosagetextUNKdrugadministrationroute048drugstartdateformat102drugstartdate10/04/2012

activesubstance

activesubstancenameMESALAMINE

openFDA Info on Medication

Application NumberNDA022000Brand NameLIALDAGeneric NameMESALAMINEManufacturersTakeda Pharmaceuticals America, Inc.product_ndc54092-476Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMESALAMINERXCUI686429, 686433spl_idfae5a172-e372-429b-a06f-65b9906ae707spl_set_id3098a080-be86-4265-9818-7fc4beab77b7Package NDC54092-476-08, 54092-476-01, 54092-476-12, 54092-476-02NUIN0000175781, M0000971Established Pharmacologic ClassAminosalicylate [EPC]Chemical StructureAminosalicylic Acids [CS]UNII4Q81I59GXC

17)

drugcharacterization2medicinalproductIMURANdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, UNKdrugadministrationroute048drugstartdateformat102drugstartdate19/05/2012

activesubstance

activesubstancenameAZATHIOPRINE

openFDA Info on Medication

Application NumberNDA016324Brand NameIMURANGeneric NameAZATHIOPRINEManufacturersSebela Pharmaceuticals Inc.product_ndc54766-590Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAZATHIOPRINERXCUI105611, 197388spl_id84897784-a8ea-4408-e053-2991aa0a9b9dspl_set_id606101a0-6244-7eff-e053-2a91aa0acaddPackage NDC54766-590-10NUIN0000000233, N0000175459, N0000175712, N0000008065Mechanism of ActionNucleic Acid Synthesis Inhibitors [MoA]Chemical StructureNucleoside Analog [Chemical/Ingredient], Purines [Chemical/Ingredient]Established Pharmacologic ClassPurine Antimetabolite [EPC]UNIIMRK240IY2L

18)

drugcharacterization1medicinalproductYAZdrugauthorizationnumb021676drugdosagetextUNKdrugdosageformFILM-COATED TABLETdrugindicationMENORRHAGIAdrugstartdateformat102drugstartdate15/02/2011drugenddateformat102drugenddate20/05/2012actiondrug1

activesubstance

activesubstancenameDROSPIRENONE\ETHINYL ESTRADIOL

openFDA Info on Medication

19)

drugcharacterization2medicinalproductPREDNISONE.drugstructuredosagenumb5drugstructuredosageunit003drugdosagetext5 MG, UNKdrugadministrationroute048drugstartdateformat102drugstartdate03/04/2012

activesubstance

activesubstancenamePREDNISONE

openFDA Info on Medication

20)

drugcharacterization2medicinalproductCANASAdrugdosagetextUNKdrugstartdateformat102drugstartdate10/04/2012

activesubstance

activesubstancenameMESALAMINE

openFDA Info on Medication

Application NumberNDA021252Brand NameCANASAGeneric NameMESALAMINEManufacturersAllergan, Inc.product_ndc58914-501Product TypeHUMAN PRESCRIPTION DRUGRouteRECTALActive IngredientsMESALAMINERXCUI248420, 583257spl_ida7db5020-05fe-4018-9685-02bfa2f95c8espl_set_id89d91601-152b-4398-bebe-af1c023e9935Package NDC58914-501-33, 58914-501-42, 58914-501-56NUIN0000175781, M0000971Established Pharmacologic ClassAminosalicylate [EPC]Chemical StructureAminosalicylic Acids [CS]UNII4Q81I59GXC

21)

drugcharacterization2medicinalproductVALTREXdrugdosagetextUNKdrugadministrationroute048drugstartdateformat102drugstartdate10/04/2012drugenddateformat102drugenddate10/05/2012

activesubstance

activesubstancenameVALACYCLOVIR HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020487Brand NameVALTREXGeneric NameVALACYCLOVIR HYDROCHLORIDEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0565, 0173-0933Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVALACYCLOVIR HYDROCHLORIDERXCUI108780, 212448, 313564, 313565spl_id3fb62f36-1199-4149-ada7-ba70b852ce4cspl_set_idf8e0d8f8-cb73-4206-a484-88f5c4fbd719Package NDC0173-0933-08, 0173-0933-10, 0173-0933-56, 0173-0565-04, 0173-0565-10UNIIG447S0T1VC

22)

drugcharacterization2medicinalproductFERROUS SULFATEdrugstructuredosagenumb325drugstructuredosageunit003drugdosagetext325 MG, UNKdrugadministrationroute048drugstartdateformat102drugstartdate10/05/2012

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

23)

drugcharacterization2medicinalproductZOLOFTdrugindicationDEPRESSION

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

24)

drugcharacterization1medicinalproductYAZdrugauthorizationnumb021676drugdosageformFILM-COATED TABLETdrugindicationDYSMENORRHOEAactiondrug1

activesubstance

activesubstancenameDROSPIRENONE\ETHINYL ESTRADIOL

openFDA Info on Medication

25)

drugcharacterization1medicinalproductYAZdrugauthorizationnumb021676drugdosageformFILM-COATED TABLETdrugindicationDYSMENORRHOEAactiondrug1

activesubstance

activesubstancenameDROSPIRENONE\ETHINYL ESTRADIOL

openFDA Info on Medication

summary

narrativeincludeclinicalCASE EVENT DATE: 201205

Report Duplicate

duplicatesourceBAYERduplicatenumbUS-BAYER-2014-095919

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use

Adverse Event Report

Report

Primary Source

Patient

Reaction

1)

2)

3)

4)

5)

6)

7)

8)

9)

Drug

1)

activesubstance

openFDA Info on Medication

2)

activesubstance

openFDA Info on Medication

3)

activesubstance

openFDA Info on Medication

4)

activesubstance

openFDA Info on Medication

5)

activesubstance

openFDA Info on Medication

6)

activesubstance

openFDA Info on Medication

7)

activesubstance

openFDA Info on Medication

8)

activesubstance

openFDA Info on Medication

9)

activesubstance

openFDA Info on Medication

10)

activesubstance

openFDA Info on Medication

11)

activesubstance

openFDA Info on Medication

12)

activesubstance

openFDA Info on Medication

13)

activesubstance

openFDA Info on Medication

14)

activesubstance

openFDA Info on Medication

15)

activesubstance

openFDA Info on Medication

16)

activesubstance

openFDA Info on Medication

17)

activesubstance

openFDA Info on Medication

18)

activesubstance

openFDA Info on Medication

19)

activesubstance

openFDA Info on Medication

20)

activesubstance

openFDA Info on Medication

21)

activesubstance

openFDA Info on Medication

22)

activesubstance