Report

Version of Safety Report ID1Safety Report ID11043581primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/08/2015reporttype1serious1seriousnessdisabling1seriousnessother1receivedateformat102Date Received17/04/2015receiptdateformat102Date Last Updated17/04/2015fulfillexpeditecriteria1companynumbUS-SA-2015SA046555duplicate1

Report Duplicate

duplicatesourceAVENTISduplicatenumbUS-SA-2015SA046555

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age56Unit of Onset Ageyearspatientagegroup5SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionAsthenopiaOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionInfluenza like illnessOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.0ReactionLethargyOutcomeRecovered/resolved

4)

reactionmeddraversionpt18.0ReactionRespiratory tract congestionOutcomeRecovered/resolved

5)

reactionmeddraversionpt18.0ReactionFallOutcomeUnknown

6)

reactionmeddraversionpt18.0ReactionNasal congestionOutcomeRecovered/resolved

7)

reactionmeddraversionpt18.0ReactionEye swellingOutcomeRecovered/resolved

8)

reactionmeddraversionpt18.0ReactionJoint dislocationOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt18.0ReactionVaginal dischargeOutcomeRecovered/resolved

10)

reactionmeddraversionpt18.0ReactionArthralgiaOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt18.0ReactionSinus headacheOutcomeRecovered/resolved

12)

reactionmeddraversionpt18.0ReactionDrug interactionOutcomeUnknown

13)

reactionmeddraversionpt18.0ReactionStent placementOutcomeUnknown

14)

reactionmeddraversionpt18.0ReactionBlindness transientOutcomeRecovered/resolved

15)

reactionmeddraversionpt18.0ReactionBrain operationOutcomeUnknown

16)

reactionmeddraversionpt18.0ReactionImpaired work abilityOutcomeUnknown

17)

reactionmeddraversionpt18.0ReactionFatigueOutcomeNot recovered/not resolved

18)

reactionmeddraversionpt18.0ReactionThrombosisOutcomeRecovered/resolved

19)

reactionmeddraversionpt18.0ReactionInsomniaOutcomeRecovered/resolved

20)

reactionmeddraversionpt18.0ReactionEar infectionOutcomeRecovered/resolved

21)

reactionmeddraversionpt18.0ReactionVision blurredOutcomeNot recovered/not resolved

22)

reactionmeddraversionpt18.0ReactionFoot fractureOutcomeNot recovered/not resolved

23)

reactionmeddraversionpt18.0ReactionTinnitusOutcomeRecovered/resolved

24)

reactionmeddraversionpt18.0ReactionConfusional stateOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization3medicinalproductPLAVIXdrugbatchnumbUNKNOWNdrugauthorizationnumb020839drugadministrationroute065drugindicationINTRACRANIAL ANEURYSMdrugstartdateformat610drugstartdate/01/2015drugenddateformat102drugenddate19/02/2015actiondrug1

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

2)

drugcharacterization3medicinalproductOSPHENAdrugbatchnumb008596drugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute065drugindicationDYSPAREUNIAdrugstartdateformat602drugstartdate//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

3)

drugcharacterization2medicinalproductLEVOXYL

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

4)

drugcharacterization2medicinalproductPROTONIX

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

5)

drugcharacterization2medicinalproductHYDROCODONE

activesubstance

activesubstancenameHYDROCODONE

6)

drugcharacterization1medicinalproductPLAVIXdrugbatchnumbUNKNOWNdrugauthorizationnumb020839drugadministrationroute065drugindicationINTRACRANIAL ANEURYSMdrugstartdateformat602drugstartdate//2013drugenddateformat102drugenddate08/12/2014actiondrug1

activesubstance

activesubstancenameCLOPIDOGREL BISULFATE

openFDA Info on Medication

7)

drugcharacterization2medicinalproductMELATONIN

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

8)

drugcharacterization2medicinalproductPRAVASTATIN

activesubstance

activesubstancenamePRAVASTATIN\PRAVASTATIN SODIUM

9)

drugcharacterization2medicinalproductIMITREX

activesubstance

activesubstancenameSUMATRIPTAN\SUMATRIPTAN 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]

10)

drugcharacterization2medicinalproductXANAX

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, 0009-0055, 0009-0029, 0009-0090, 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

11)

drugcharacterization2medicinalproductLUNESTA

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

12)

drugcharacterization3medicinalproductOSPHENAdrugbatchnumb008596drugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute065drugindicationDYSPAREUNIAdrugstartdateformat610drugstartdate/01/2015drugenddateformat102drugenddate18/02/2015actiondrug1

Adverse Event Report

Report

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Primary Source

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Receiver

Patient

Reaction

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Drug

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activesubstance

openFDA Info on Medication

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activesubstance

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activesubstance

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activesubstance

openFDA Info on Medication

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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activesubstance

openFDA Info on Medication

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activesubstance

openFDA Info on Medication

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activesubstance

openFDA Info on Medication

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activesubstance

openFDA Info on Medication

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