Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10142946serious1Date Last Updated30/05/2014receiptdateformat102companynumbUS-BAYER-2014-062939occurcountryUSseriousnessother1duplicate1Date Received30/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age38Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionDeep vein thrombosisOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionPulmonary embolismOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionSubdural haematoma

4)

reactionmeddraversionpt17.0ReactionToxicity to various agents

5)

reactionmeddraversionpt17.0ReactionPain

6)

reactionmeddraversionpt17.0ReactionPain in extremityOutcomeRecovered/resolved

7)

reactionmeddraversionpt17.0ReactionInjuryOutcomeRecovered/resolved

8)

reactionmeddraversionpt17.0ReactionGeneral physical health deterioration

9)

reactionmeddraversionpt17.0ReactionAnxiety

10)

reactionmeddraversionpt17.0ReactionEmotional distress

11)

reactionmeddraversionpt17.0ReactionNauseaOutcomeRecovered/resolved

12)

reactionmeddraversionpt17.0ReactionMalaise

13)

reactionmeddraversionpt17.0ReactionThrombophlebitis superficial

14)

reactionmeddraversionpt17.0ReactionCellulitis

15)

reactionmeddraversionpt17.0ReactionAsthenia

16)

reactionmeddraversionpt17.0ReactionFatigue

17)

reactionmeddraversionpt17.0ReactionThrombosis

18)

reactionmeddraversionpt17.0ReactionUnresponsive to stimuli

19)

reactionmeddraversionpt17.0ReactionLoss of consciousness

20)

reactionmeddraversionpt17.0ReactionFall

21)

reactionmeddraversionpt17.1ReactionPeripheral venous disease

Drug

1)

drugcharacterization1medicinalproductYASMINdrugauthorizationnumb021098drugdosagetextUNKdrugdosageformFILM-COATED TABLETdrugstartdateformat102drugstartdate13/07/2002drugenddateformat610drugenddate/08/2002

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

2)

drugcharacterization1medicinalproductYAZdrugdosageformFILM-COATED TABLET

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

3)

drugcharacterization2medicinalproductZOLOFT

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

4)

drugcharacterization2medicinalproductPROMETHEGAN

openFDA Info on Medication

Application NumberANDA087165, ANDA040428Brand NamePROMETHEGANGeneric NamePROMETHAZINE HYDROCHLORIDEManufacturersCosette Pharmaceuticals, Inc.product_ndc0713-0132, 0713-0526, 0713-0536Product TypeHUMAN PRESCRIPTION DRUGRouteRECTALActive IngredientsPROMETHAZINE HYDROCHLORIDERXCUI992478, 992481, 992441, 992445, 992454, 992459spl_idbefb320c-137c-4cc5-a9f2-daa1e22b86ad, 5ffe2959-7806-445e-b9b3-c273f3cff312spl_set_id636bb9bc-0cc5-4d6a-85be-6471acf01ffc, 5f079815-f48b-8b21-2130-7f791d967c9aPackage NDC 0713-0132-12, 0713-0132-10, 0713-0536-12, 0713-0536-10, 0713-0526-12, 0713-0526- ... UNIIR61ZEH7I1I

5)

drugcharacterization2medicinalproductFUROSEMIDE AL

6)

drugcharacterization2medicinalproductAUGMENTIN

openFDA Info on Medication

Application NumberNDA050575, NDA050564, NDA050720Brand NameAUGMENTINGeneric NameAMOXICILLIN AND CLAVULANATE POTASSIUMManufacturersNeopharma Incproduct_ndc72508-004, 72508-012, 72508-021, 72508-018, 72508-006Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMOXICILLIN, CLAVULANATE POTASSIUMRXCUI562251, 562508, 617296, 617302, 617322, 617333, 617339, 824186, 824190, 824194spl_idfff71910-9217-475a-af12-5e4ef4b11a60spl_set_id16779d75-67ad-46ff-b9c8-4e464fbeeb08Package NDC 72508-012-01, 72508-012-03, 72508-012-05, 72508-004-07, 72508-004-10, 72508-004- ... UNIIQ42OMW3AT8, 804826J2HU

7)

drugcharacterization2medicinalproductCLOTRIMAZOLE

openFDA Info on Medication

Application Number ANDA074165, part333C, NDA021143, ANDA078338, ANDA072641, ANDA076387, ANDA074580, ... Brand Name CLOTRIMAZOLE, LOTRIMIN, HEB ANTIFUNGAL, ANTI-FUNGAL CREAM, CLOTRIMAZOLE 1% ATHLE ... Generic Name CLOTRIMAZOLE, DRS. CLOTRIMAZOLE, FAMILY WELLNESS CLOTRIMAZOLE, CLOTRIMAZOLE TOPI ... Manufacturers Rite Aid Corporation, Delpharm Montreal Inc., The Podiatree Company, Chain Drug ... product_ndc 11822-0220, 69213-6549, 54633-018, 68016-035, 51672-2062, 37808-305, 73538-001, ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteVAGINAL, TOPICAL, ORAL, EXTRACORPOREALActive IngredientsCLOTRIMAZOLERXCUI 309368, 261159, 309367, 199603, 309370, 1299969, 1049535, 1045620, 418475, 14269 ... spl_id dfd560b5-e4f9-4b31-8049-c451f575cd88, abab2160-f61d-f1fe-e053-2995a90a854d, 7923 ... spl_set_id 384c8113-87aa-4fbd-942a-5f02c4e88536, 4e2cd6ec-ed9e-1f45-e054-00144ff88e88, 7923 ... Package NDC 11822-0220-6, 69213-6549-1, 54633-018-30, 68016-035-06, 51672-2062-0, 37808-305- ... NUIN0000175487, M0002083Established Pharmacologic ClassAzole Antifungal [EPC]Chemical StructureAzoles [CS]UNIIG07GZ97H65

8)

drugcharacterization2medicinalproductZYPREXA

openFDA Info on Medication

Application NumberNDA020592, NDA021086, NDA021253, NDA022173Brand NameZYPREXA, ZYPREXA ZYDIS, ZYPREXA INTRAMUSCULAR, ZYPREXA RELPREVVGeneric NameOLANZAPINE, OLANZAPINE PAMOATEManufacturersEli Lilly and Companyproduct_ndc 0002-4115, 0002-4112, 0002-4116, 0002-4117, 0002-4415, 0002-4420, 0002-4453, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULARActive IngredientsOLANZAPINERXCUI 153046, 153047, 153048, 200034, 212405, 261337, 283639, 284514, 312076, 312077, ... spl_idab87dd62-b7a0-4b0c-92e3-a14eac38b76e, 1510c949-be2b-4de1-a10a-edb597fe51e2spl_set_idd5051fbc-846b-4946-82df-341fb1216341, f9a73185-88de-4d7b-b3c0-bbf231483241Package NDC 0002-4112-30, 0002-4115-30, 0002-4116-30, 0002-4117-30, 0002-4415-30, 0002-4420- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIN7U69T4SZR

9)

drugcharacterization2medicinalproductBUSPAR

10)

drugcharacterization2medicinalproductBUSPIRONE

11)

drugcharacterization2medicinalproductDIFLUCAN

openFDA Info on Medication

Application NumberNDA019949, NDA020090Brand NameDIFLUCANGeneric NameFLUCONAZOLEManufacturersRoerigproduct_ndc0049-3410, 0049-3420, 0049-3500, 0049-3430, 0049-3440, 0049-3450Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFLUCONAZOLERXCUI 197698, 197699, 197700, 197701, 201900, 201901, 207106, 207107, 207108, 207112, ... spl_idd5315485-b183-4999-86dd-632523d02813spl_set_idf694c617-3383-416c-91b6-b94fda371204Package NDC 0049-3410-30, 0049-3420-30, 0049-3420-41, 0049-3500-79, 0049-3430-30, 0049-3430- ... NUIN0000175487, M0002083, N0000182140, N0000182141, N0000185504Established Pharmacologic ClassAzole Antifungal [EPC]Chemical StructureAzoles [CS]Mechanism of Action Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Cyt ... UNII8VZV102JFY

12)

drugcharacterization2medicinalproductCLONAZEPAM

openFDA Info on Medication

Application Number ANDA077171, ANDA074569, ANDA074869, ANDA077194, ANDA077147, ANDA074979, ANDA2110 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Par Pharmaceutical, Inc., Teva Pharmaceuticals USA, Inc., Actavis Pharma, Inc., ... product_ndc 49884-306, 49884-307, 49884-308, 49884-309, 49884-310, 0093-0832, 0093-3212, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_id a95f8799-0bb3-41d6-aa27-8a291127ad54, 90dc0b61-37a3-4e54-bde3-7e4c3f7dae98, 9b58 ... spl_set_id 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069b1a0-7c06-4252-b44e-e2eef065d9b8, a58f ... Package NDC 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02, 0093-0832- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

Report Duplicate

duplicatesourceBAYERduplicatenumbUS-BAYER-2014-062939

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use