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

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

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

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

Adverse Event Report

Report

Report Duplicate

Primary Source

Sender

Receiver

Patient

Reaction

1)

2)

3)

4)

5)

6)

7)

8)

9)

10)

11)

12)

13)

14)

15)

Drug

1)

activesubstance

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

13)

activesubstance

openFDA Info on Medication

summary

Media

Newsletter

Follow us

Connect with us