Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10027789serious1Date Last Updated31/03/2014seriousnesslifethreatening1receiptdateformat102companynumbGB-NOVOPROD-402864occurcountryGBduplicate1Date Received21/03/2014seriousnesshospitalization1transmissiondate02/10/2014primarysourcecountryGB

Primary Source

reportercountryGBqualification2

Patient

Onset Age51Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionPulmonary embolismOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionDeep vein thrombosisOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionIncorrect route of drug administrationOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionOff label useOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductVAGIFEMdrugbatchnumbUNKNOWNdrugauthorizationnumb020908drugstructuredosagenumb75drugstructuredosageunit004drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext75 UG, BIWdrugdosageformVAGINAL TABLETdrugadministrationroute062drugindicationHYSTERECTOMYdrugstartdateformat602drugstartdate//2009drugenddateformat102drugenddate04/02/2014actiondrug1

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

2)

drugcharacterization2medicinalproductAMITRIPTYLINEdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugadministrationroute065

3)

drugcharacterization2medicinalproductBUDESONIDEdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugadministrationroute065

openFDA Info on Medication

Application Number ANDA078202, ANDA078949, NDA203634, ANDA204548, NDA020746, NDA020929, ANDA205457, ... Brand Name BUDESONIDE, RHINOCORT ALLERGY, PULMICORT RESPULES, UCERIS, BUDESONIDE (ENTERIC C ... Generic NameBUDESONIDEManufacturers Apotex Corp., Rite Aid, Walgreens, Oceanside Pharmaceuticals, Teva Pharmaceutica ... product_ndc 60505-0820, 60505-0821, 60505-6206, 11822-1700, 0363-0048, 68682-309, 0093-6817, ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteRESPIRATORY (INHALATION), NASAL, ORAL, RECTALActive IngredientsBUDESONIDERXCUI 252559, 349094, 351109, 1797929, 1366550, 1797931, 616817, 616819, 616830, 12442 ... spl_id 19e56efe-5076-e888-4634-1fcff544a418, 4e43d846-5ba3-d617-6078-afe50f6381a6, 8a02 ... spl_set_id 9ca16deb-4390-ed45-a584-280da063b205, a49e054e-e9ba-7103-3ab0-d4dc930c382f, 9d51 ... Package NDC 60505-0820-0, 60505-0821-0, 60505-6206-3, 11822-1700-1, 0363-0048-01, 68682-309- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIQ3OKS62Q6X

4)

drugcharacterization2medicinalproductCALCICHEW D3drugbatchnumbUNKNOWNdrugdosagetextUNKdrugadministrationroute065

5)

drugcharacterization2medicinalproductCLOPIDOGRELdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugadministrationroute065

openFDA Info on Medication

Application Number ANDA076999, ANDA090540, ANDA203751, ANDA201686, ANDA206376, ANDA202925, ANDA2029 ... Brand NameCLOPIDOGREL, PLAVIXGeneric NameCLOPIDOGREL, CLOPIDOGREL BISULFATEManufacturers Teva Pharmaceuticals USA, Inc., Rising Pharmaceuticals, Inc., Amneal Pharmaceuti ... product_ndc 0093-7314, 64980-343, 65162-414, 70710-1417, 43547-484, 43547-485, 16729-218, 16 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLOPIDOGREL BISULFATERXCUI309362, 749196, 213169, 749198spl_id eabdb8dc-24aa-4457-b0ec-5e152a1046b9, a8ba2342-855a-42ed-ac81-a9c44c24a08e, 0fc6 ... spl_set_id bc747f6d-f52c-4dcb-bda5-2d0a9f954147, 36c48914-b1be-4c51-9b06-c9d9d7353e92, 0d01 ... Package NDC 0093-7314-05, 0093-7314-56, 0093-7314-98, 64980-343-03, 64980-343-09, 64980-343- ... UNII08I79HTP27

6)

drugcharacterization2medicinalproductDICYCLOMINE /00068601/drugbatchnumbUNKNOWNdrugdosagetextUNKdrugadministrationroute065

7)

drugcharacterization2medicinalproductFERROUS FUMARATEdrugbatchnumbUNKOWNdrugdosagetextUNKdrugadministrationroute065

8)

drugcharacterization2medicinalproductLACTULOSEdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugadministrationroute065

openFDA Info on Medication

Application Number ANDA074076, ANDA074623, ANDA074712, ANDA090503, ANDA203762, ANDA075993, ANDA2095 ... Brand NameLACTULOSE, KRISTALOSE, CONSTULOSE, ENULOSE, GENERLACGeneric NameLACTULOSEManufacturers Hi-Tech Pharmacal Co., Inc., Pharmaceutical Associates, Inc,, Cumberland Pharmac ... product_ndc 50383-779, 0121-0577, 0121-4577, 0121-1154, 66220-719, 66220-729, 45963-439, 136 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, RECTALActive IngredientsLACTULOSERXCUI391937, 1251190, 1251192, 1251194, 1251196, 544452, 755470, 544455spl_id 841d4b42-5176-4d3d-ac1c-4d10c535fbb3, 9c9999b9-8d1e-67f7-e053-2995a90aac96, 22d5 ... spl_set_id 19455240-16b6-4e25-a5c9-a6c965e5ec19, 0f19e4ed-c90a-4330-a7fa-bf911aa98f09, 535d ... Package NDC 50383-779-15, 50383-779-17, 50383-779-30, 50383-779-31, 50383-779-33, 50383-779- ... NUIN0000175811, N0000010288, N0000175833, N0000009871Established Pharmacologic ClassOsmotic Laxative [EPC]Mechanism of ActionOsmotic Activity [MoA], Acidifying Activity [MoA]Physiologic/Pharmacodynamic EffectStimulation Large Intestine Fluid/Electrolyte Secretion [PE]UNII9U7D5QH5AE

9)

drugcharacterization2medicinalproductOMEPRAZOLEdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugadministrationroute065

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

10)

drugcharacterization2medicinalproductPENTASAdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugadministrationroute065

openFDA Info on Medication

Application NumberNDA020049Brand NamePENTASAGeneric NameMESALAMINEManufacturersTakeda Pharmaceuticals America, Inc.product_ndc54092-189, 54092-191Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMESALAMINERXCUI206791, 314092, 476362, 580286spl_idc69ba849-555c-4b23-8010-e32ab00dee21spl_set_ide39d9a3d-5d3a-4bb6-aab1-fdbb2a598606Package NDC54092-189-81, 54092-191-08, 54092-191-12NUIN0000175781, M0000971Established Pharmacologic ClassAminosalicylate [EPC]Chemical StructureAminosalicylic Acids [CS]UNII4Q81I59GXC

11)

drugcharacterization2medicinalproductPREGABALINdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugadministrationroute065

openFDA Info on Medication

Application Number ANDA209357, ANDA206912, NDA209501, ANDA203459, ANDA212865, ANDA091157, ANDA20762 ... Brand NamePREGABALIN, LYRICA CR, LYRICAGeneric NamePREGABALINManufacturers MSN LABORATORIES PRIVATE LIMITED, Camber Pharmaceuticals, Inc., Parke-Davis Div ... product_ndc 69539-011, 69539-012, 69539-013, 69539-014, 69539-015, 69539-016, 69539-017, 695 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 1988974, 1988977 ... spl_id 6a062096-6569-45c1-9184-11e9973cc3c8, 241c4b7e-f719-4828-8639-ea613b8a6583, df98 ... spl_set_id 993bedd3-2f7c-40ff-87dc-8a55c6c7a3c7, 241c4b7e-f719-4828-8639-ea613b8a6583, 2d83 ... Package NDC 69539-011-90, 69539-011-99, 69539-011-11, 69539-011-06, 69539-012-90, 69539-012- ... UNII55JG375S6M

12)

drugcharacterization2medicinalproductSALBUTAMOLdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugadministrationroute065

13)

drugcharacterization2medicinalproductSERETIDEdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugadministrationroute065

14)

drugcharacterization2medicinalproductSERTRALINEdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugadministrationroute065

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

15)

drugcharacterization2medicinalproductTIOTROPIUM BROMIDEdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugadministrationroute065

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

16)

drugcharacterization2medicinalproductTRAMADOLdrugbatchnumbUNKNOWNdrugdosagetextUNKdrugadministrationroute065

Report Duplicate

duplicatesourceNOVO NORDISKduplicatenumbGB-NOVOPROD-402864

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use