Adverse Event Report

Report

Version of Safety Report ID3Safety Report ID10976004primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/05/2016reporttype1serious1seriousnessother1receivedateformat102Date Received01/04/2015receiptdateformat102Date Last Updated04/03/2016fulfillexpeditecriteria1companynumbUS-SHIONOGI, INC.-2015000333duplicate1

Report Duplicate

duplicatesourceSHIONOGIduplicatenumbUS-SHIONOGI, INC.-2015000333

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age56Unit of Onset AgeyearsWeight59.41SexFemale

Reaction

1)

reactionmeddraversionpt19.0ReactionThrombosisOutcomeRecovered/resolved

2)

reactionmeddraversionpt19.0ReactionInfluenza like illnessOutcomeRecovered/resolved

3)

reactionmeddraversionpt19.0ReactionJoint dislocationOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt19.0ReactionVaginal dischargeOutcomeRecovered/resolved

5)

reactionmeddraversionpt19.0ReactionTinnitusOutcomeRecovered/resolved

6)

reactionmeddraversionpt19.0ReactionLabelled drug-disease interaction medication errorOutcomeUnknown

7)

reactionmeddraversionpt19.0ReactionDrug interactionOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt19.0ReactionVision blurredOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt19.0ReactionAsthenopiaOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt19.0ReactionFallOutcomeRecovered/resolved

11)

reactionmeddraversionpt19.0ReactionHeadacheOutcomeUnknown

12)

reactionmeddraversionpt19.0ReactionMigraineOutcomeUnknown

13)

reactionmeddraversionpt19.0ReactionImpaired work abilityOutcomeUnknown

14)

reactionmeddraversionpt19.0ReactionBlindness transientOutcomeRecovered/resolved

15)

reactionmeddraversionpt19.0ReactionFoot fractureOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductPRAVASTATINdrugdosagetextUNKdrugadministrationroute065drugindicationFAMILIAL RISK FACTOR

activesubstance

activesubstancenamePRAVASTATIN\PRAVASTATIN SODIUM

2)

drugcharacterization2medicinalproductPROTONIXdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePANTOPRAZOLE SODIUM

openFDA Info on Medication

Application NumberNDA020988, NDA020987, NDA022020Brand NamePROTONIX I.V., PROTONIX DELAYED-RELEASEGeneric NamePANTOPRAZOLE SODIUMManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0008-0923, 0008-2001, 0008-4001, 0008-0841, 0008-0843, 0008-0844Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsPANTOPRAZOLE SODIUMRXCUI283669, 885257, 251872, 284400, 314200, 352125, 763306, 763308spl_id 027ca15a-8c9f-422a-8e8d-374f68db15cc, ffc4c349-c863-49bf-b179-caa42b759898, 9dd8 ... spl_set_id 51e4144a-489e-436c-609a-39305f8f56ba, 5b5ddedd-d429-41a7-8573-10c3e9ad4e52, f39b ... Package NDC 0008-0923-51, 0008-0923-60, 0008-0923-55, 0008-2001-01, 0008-2001-25, 0008-2001- ... UNII6871619Q5X

3)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNKdrugadministrationroute065drugindicationSLEEP DISORDER

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

4)

drugcharacterization2medicinalproductLEVOXYLdrugdosagetextUNKdrugadministrationroute065drugindicationBASEDOW^S DISEASE

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM

openFDA Info on Medication

Application NumberNDA021301Brand NameLEVOXYLGeneric NameLEVOTHYROXINE SODIUMManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc 60793-850, 60793-851, 60793-852, 60793-853, 60793-854, 60793-855, 60793-856, 607 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 966157, 966164, 966170, 966175, 966184, 966190, 966194, 966200, ... spl_ide230c170-2a16-47d0-bce7-ac0414c192f7spl_set_id758588c3-c63e-491b-0aa2-4f50d80cb174Package NDC 60793-850-10, 60793-850-01, 60793-851-10, 60793-851-01, 60793-852-10, 60793-852- ... UNII9J765S329G

5)

drugcharacterization2medicinalproductXANAXdrugdosagetextUNKdrugadministrationroute065drugindicationANXIETY

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0094, 0009-0029, 0009-0055, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_idf364e489-b47b-4283-a7fe-d5b15f77447e, bf933d5a-53e2-4454-a040-cacc061bca92spl_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

6)

drugcharacterization1medicinalproductPLAVIXdrugdosagetextUNKdrugadministrationroute065drugindicationINTRACRANIAL ANEURYSMdrugstartdateformat602drugstartdate//2013drugenddateformat102drugenddate08/12/2014

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_id4e097e4e-304d-4830-a350-d617662aa303, fdbc18a6-b364-4f85-9fd1-71d04b3a7ab1spl_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

7)

drugcharacterization1medicinalproductPLAVIXdrugdosagetextUNKdrugadministrationroute065drugstartdateformat610drugstartdate/01/2015drugenddateformat102drugenddate19/02/2015

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_id4e097e4e-304d-4830-a350-d617662aa303, fdbc18a6-b364-4f85-9fd1-71d04b3a7ab1spl_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

8)

drugcharacterization1medicinalproductOSPHENAdrugbatchnumb008596drugauthorizationnumb203505drugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext60 MG, QDdrugdosageformTABLETdrugadministrationroute065drugindicationDYSPAREUNIAdrugstartdateformat102drugstartdate22/05/2014drugenddateformat102drugenddate08/12/2014actiondrug1

activesubstance

activesubstancenameOSPEMIFENE

openFDA Info on Medication

Application NumberNDA203505Brand NameOSPHENAGeneric NameOSPEMIFENEManufacturersShionogi Inc.product_ndc59630-580Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOSPEMIFENERXCUI1370976, 1370982spl_id4a8a769e-20aa-463a-80d6-1262dbe085a9spl_set_id8462d6ab-e3cd-4efa-a360-75bf8f917287Package NDC59630-580-90, 59630-580-18, 59630-580-55NUIN0000175826, N0000000168Established Pharmacologic ClassEstrogen Agonist/Antagonist [EPC]Mechanism of ActionSelective Estrogen Receptor Modulators [MoA]UNIIB0P231ILBK

9)

drugcharacterization1medicinalproductOSPHENAdrugbatchnumb008596drugauthorizationnumb203505drugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext60 MG, QDdrugdosageformTABLETdrugadministrationroute065drugstartdateformat610drugstartdate/01/2015drugenddateformat102drugenddate19/02/2015actiondrug1

activesubstance

activesubstancenameOSPEMIFENE

openFDA Info on Medication

Application NumberNDA203505Brand NameOSPHENAGeneric NameOSPEMIFENEManufacturersShionogi Inc.product_ndc59630-580Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOSPEMIFENERXCUI1370976, 1370982spl_id4a8a769e-20aa-463a-80d6-1262dbe085a9spl_set_id8462d6ab-e3cd-4efa-a360-75bf8f917287Package NDC59630-580-90, 59630-580-18, 59630-580-55NUIN0000175826, N0000000168Established Pharmacologic ClassEstrogen Agonist/Antagonist [EPC]Mechanism of ActionSelective Estrogen Receptor Modulators [MoA]UNIIB0P231ILBK

10)

drugcharacterization2medicinalproductMELATONINdrugdosagetextUNKdrugadministrationroute065drugindicationSLEEP DISORDER

activesubstance

activesubstancenameMELATONIN

openFDA Info on Medication

Brand NameMELATONIN, MELATONIN PHENOLIC, MELATONIN CORD, MELATONIN 1527Generic NameMELATONINManufacturers BioActive Nutritional, Inc., Energique, Inc., Professional Complementary Health ... product_ndc43857-0086, 44911-0247, 44911-0194, 63083-1527, 43742-0771Product TypeHUMAN OTC DRUGRouteORALActive IngredientsMELATONINspl_id e189499d-9da3-43fc-8a0b-9d5dd0923b11, 904c041a-ff84-4152-9b10-ea5d1b669d24, 0673 ... spl_set_id cd82eb5d-a44a-4512-ad65-0fffae70d1d0, 895cb8a5-33ea-4764-86a6-1da513dcd2c1, 9a59 ... Package NDC43857-0086-1, 44911-0247-1, 44911-0194-1, 63083-1527-1, 43742-0771-1UNIIJL5DK93RCL

11)

drugcharacterization2medicinalproductXANAXdrugindicationPANIC ATTACK

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0094, 0009-0029, 0009-0055, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_idf364e489-b47b-4283-a7fe-d5b15f77447e, bf933d5a-53e2-4454-a040-cacc061bca92spl_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

12)

drugcharacterization2medicinalproductHYDROCODONEdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextPRNdrugadministrationroute065drugindicationPAIN

activesubstance

activesubstancenameHYDROCODONE

13)

drugcharacterization2medicinalproductIMITREXdrugdosagetextUNKdrugadministrationroute065drugindicationMIGRAINE

activesubstance

activesubstancenameSUMATRIPTAN SUCCINATE

openFDA Info on Medication

Application NumberNDA020080, NDA020132, NDA020626Brand NameIMITREXGeneric NameSUMATRIPTANManufacturersGlaxoSmithKline LLCproduct_ndc 0173-0478, 0173-0739, 0173-0479, 0173-0735, 0173-0736, 0173-0737, 0173-0523, 017 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUS, ORAL, NASALActive IngredientsSUMATRIPTAN SUCCINATE, SUMATRIPTANRXCUI 758523, 860088, 1657160, 1657173, 208450, 209169, 284460, 313160, 313161, 315223 ... spl_id ae0a5f62-ace2-491d-bcb4-49c28bf1e0f1, db469bf0-d651-450f-87cb-9fcaa88459be, 7aca ... spl_set_id fee7d073-0b99-48f2-7985-0d8cf970894b, 584abe73-8290-4484-ff8e-5890831c095e, cc11 ... Package NDC 0173-0739-00, 0173-0739-02, 0173-0479-00, 0173-0478-00, 0173-0735-00, 0173-0736- ... UNIIJ8BDZ68989, 8R78F6L9VONUIN0000175763, N0000175764, N0000175765Mechanism of ActionSerotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA]Established Pharmacologic ClassSerotonin-1b and Serotonin-1d Receptor Agonist [EPC]

summary

narrativeincludeclinicalCASE EVENT DATE: 201411