Adverse Event Report

Report

Version of Safety Report ID7Safety Report ID10698118primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate22/01/2020reporttype2serious1seriousnesshospitalization1seriousnessother1receivedateformat102Date Received08/01/2015receiptdateformat102Date Last Updated23/12/2019fulfillexpeditecriteria1companynumbUS-SANOFI-AVENTIS-2013SA069686duplicate1

Report Duplicate

duplicatesourceSANOFI AVENTISduplicatenumbUS-SANOFI-AVENTIS-2013SA069686

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age44Unit of Onset Ageyearspatientagegroup5SexFemale

Reaction

1)

reactionmeddraversionpt22.1ReactionBack injuryOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt22.1ReactionIntervertebral disc degenerationOutcomeUnknown

3)

reactionmeddraversionpt22.1ReactionPanic attackOutcomeRecovering/resolving

4)

reactionmeddraversionpt22.1ReactionGait disturbanceOutcomeUnknown

5)

reactionmeddraversionpt22.1ReactionBlood cholesterol increasedOutcomeUnknown

6)

reactionmeddraversionpt22.1ReactionMigraineOutcomeUnknown

7)

reactionmeddraversionpt22.1ReactionPainOutcomeUnknown

8)

reactionmeddraversionpt22.1ReactionGastrointestinal painOutcomeUnknown

9)

reactionmeddraversionpt22.1ReactionWeight decreasedOutcomeRecovered/resolved

10)

reactionmeddraversionpt22.1ReactionHeadacheOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt22.1ReactionInsomniaOutcomeUnknown

12)

reactionmeddraversionpt22.1ReactionRoad traffic accidentOutcomeUnknown

13)

reactionmeddraversionpt22.1ReactionBack disorderOutcomeUnknown

14)

reactionmeddraversionpt22.1ReactionPost-traumatic stress disorderOutcomeUnknown

15)

reactionmeddraversionpt22.1ReactionNauseaOutcomeRecovered/resolved

16)

reactionmeddraversionpt22.1ReactionTherapeutic response decreasedOutcomeUnknown

17)

reactionmeddraversionpt22.1ReactionLimb injuryOutcomeNot recovered/not resolved

18)

reactionmeddraversionpt22.1ReactionDecreased appetiteOutcomeRecovered/resolved

19)

reactionmeddraversionpt22.1ReactionOsteoporosisOutcomeUnknown

20)

reactionmeddraversionpt22.1ReactionAbdominal painOutcomeUnknown

21)

reactionmeddraversionpt22.1ReactionWhite blood cell count decreasedOutcomeNot recovered/not resolved

22)

reactionmeddraversionpt22.1ReactionNeck injuryOutcomeRecovering/resolving

23)

reactionmeddraversionpt22.1ReactionMultiple sclerosis relapseOutcomeUnknown

24)

reactionmeddraversionpt22.1ReactionFatigueOutcomeNot recovered/not resolved

25)

reactionmeddraversionpt22.1ReactionProduct dose omissionOutcomeUnknown

26)

reactionmeddraversionpt22.1ReactionHypothyroidismOutcomeUnknown

27)

reactionmeddraversionpt22.1ReactionFeeling abnormalOutcomeUnknown

28)

reactionmeddraversionpt22.1ReactionStressOutcomeUnknown

29)

reactionmeddraversionpt22.1ReactionNauseaOutcomeNot recovered/not resolved

30)

reactionmeddraversionpt22.1ReactionIntervertebral disc protrusionOutcomeNot recovered/not resolved

31)

reactionmeddraversionpt22.1ReactionSinusitisOutcomeNot recovered/not resolved

32)

reactionmeddraversionpt22.1ReactionWrong technique in product usage processOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductTERIFLUNOMIDE.drugauthorizationnumb202992drugstructuredosagenumb14drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext14 MG,QDdrugdosageformCOATED TABLETdrugadministrationroute048drugindicationMULTIPLE SCLEROSISdrugstartdateformat102drugstartdate26/06/2013drugenddateformat102drugenddate23/01/2016actiondrug4

activesubstance

activesubstancenameTERIFLUNOMIDE

openFDA Info on Medication

Application NumberNDA202992, ANDA209613, ANDA209677, ANDA209623Brand NameAUBAGIO, TERIFLUNOMIDEGeneric NameTERIFLUNOMIDEManufacturers Genzyme Corporation, Amneal Pharmaceuticals NY LLC, Amneal Pharmaceuticals of Ne ... product_ndc58468-0210, 58468-0211, 69238-1303, 69238-1304, 0115-1565, 69539-032, 69539-033Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTERIFLUNOMIDERXCUI1310525, 1310531, 1310533, 1310535spl_id b945dc1c-772e-48d8-94c1-f8b8b53cbcfd, 3cdb678e-3c0f-4331-a8d7-288741384e32, ed5b ... spl_set_id 4650d12c-b9c8-4525-b07f-a2d773eca155, 1f054d91-aede-4c1a-9aba-04f40d11e4d1, 57a0 ... Package NDC 58468-0211-1, 58468-0211-2, 58468-0211-4, 58468-0211-3, 58468-0210-2, 58468-0210 ... NUIN0000185502, N0000185501Established Pharmacologic ClassPyrimidine Synthesis Inhibitor [EPC]Mechanism of ActionDihydroorotate Dehydrogenase Inhibitors [MoA]UNII1C058IKG3B

2)

drugcharacterization1medicinalproductTERIFLUNOMIDE.drugauthorizationnumb202992drugstructuredosagenumb14drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext14 MG,QDdrugdosageformCOATED TABLETdrugadministrationroute048actiondrug4

activesubstance

activesubstancenameTERIFLUNOMIDE

openFDA Info on Medication

Application NumberNDA202992, ANDA209613, ANDA209677, ANDA209623Brand NameAUBAGIO, TERIFLUNOMIDEGeneric NameTERIFLUNOMIDEManufacturers Genzyme Corporation, Amneal Pharmaceuticals NY LLC, Amneal Pharmaceuticals of Ne ... product_ndc58468-0210, 58468-0211, 69238-1303, 69238-1304, 0115-1565, 69539-032, 69539-033Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTERIFLUNOMIDERXCUI1310525, 1310531, 1310533, 1310535spl_id b945dc1c-772e-48d8-94c1-f8b8b53cbcfd, 3cdb678e-3c0f-4331-a8d7-288741384e32, ed5b ... spl_set_id 4650d12c-b9c8-4525-b07f-a2d773eca155, 1f054d91-aede-4c1a-9aba-04f40d11e4d1, 57a0 ... Package NDC 58468-0211-1, 58468-0211-2, 58468-0211-4, 58468-0211-3, 58468-0210-2, 58468-0210 ... NUIN0000185502, N0000185501Established Pharmacologic ClassPyrimidine Synthesis Inhibitor [EPC]Mechanism of ActionDihydroorotate Dehydrogenase Inhibitors [MoA]UNII1C058IKG3B

3)

drugcharacterization2medicinalproductURIBELdrugdosagetextUNKdrugindicationPROPHYLAXISactiondrug5drugadditional3

activesubstance

activesubstancename HYOSCYAMINE SULFATE\METHENAMINE\METHYLENE BLUE\PHENYL SALICYLATE\SODIUM PHOSPHAT ...

openFDA Info on Medication

Brand NameURIBELGeneric Name METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYL ... ManufacturersMission Pharmacal Companyproduct_ndc0178-0740Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive Ingredients HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, SODIUM PHOS ... RXCUI1087365, 1087367spl_idb82a3baa-f8a2-5bf8-e053-2995a90af9d1spl_set_id812cd318-cf6d-416f-e053-2a91aa0a1716Package NDC0178-0740-01UNIIF2R8V82B84, J50OIX95QV, T42P99266K, 28A37T47QO, 593YOG76RN

4)

drugcharacterization2medicinalproductLYRICAdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb8drugintervaldosagedefinition805drugdosagetext50 MG,TIDdrugstartdateformat610drugstartdate/12/2015actiondrug5drugadditional3

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

Application NumberNDA021446, NDA022488Brand NameLYRICAGeneric NamePREGABALINManufacturersParke-Davis Div of Pfizer Inc, U.S. Pharmaceuticalsproduct_ndc 0071-1012, 0071-1013, 0071-1014, 0071-1015, 0071-1016, 0071-1017, 0071-1019, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 607018, 607020, ... spl_idb9b1285a-2cb3-4789-8b0e-8d5e1b253534, bfdec19d-6a54-449c-95b4-908d28e5369aspl_set_id60185c88-ecfd-46f9-adb9-b97c6b00a553, ce1a4b9d-3127-4416-8bf2-fee5899fc0baPackage NDC 0071-1012-68, 0071-1013-41, 0071-1013-68, 0071-1014-41, 0071-1014-68, 0071-1015- ... UNII55JG375S6M

5)

drugcharacterization2medicinalproductGABAPENTIN.drugdosagetextUNKactiondrug5drugadditional3

activesubstance

activesubstancenameGABAPENTIN

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 59afc809-201f-4cf8-95f6-67ae52c0a327, 4553 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

6)

drugcharacterization2medicinalproductAMPYRAdrugdosagetextUNKdrugindicationGAIT DISTURBANCEdrugstartdateformat102drugstartdate01/01/2014drugenddateformat102drugenddate23/01/2016actiondrug5drugadditional3

activesubstance

activesubstancenameDALFAMPRIDINE

openFDA Info on Medication

Application NumberNDA022250Brand NameAMPYRAGeneric NameDALFAMPRIDINEManufacturersAcorda Therapeutics, Inc.product_ndc10144-427Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDALFAMPRIDINERXCUI897021, 897025spl_idd17992b6-a426-7196-e053-2a95a90a8282spl_set_id550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783Package NDC10144-427-60NUIN0000192795, N0000175448Established Pharmacologic ClassPotassium Channel Blocker [EPC]Mechanism of ActionPotassium Channel Antagonists [MoA]UNIIBH3B64OKL9

7)

drugcharacterization2medicinalproductAMBIENdrugdosagetextUNKactiondrug5drugadditional3

activesubstance

activesubstancenameZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberNDA021774, NDA019908Brand NameAMBIEN CR, AMBIENGeneric NameZOLPIDEM TARTRATEManufacturerssanofi-aventis U.S. LLCproduct_ndc0024-5501, 0024-5521, 0024-5401, 0024-5421Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854880, 854882, 854894, 854896, 854873, 854875, 854876, 854878spl_id8138a0a9-168c-46d2-b13e-e7e84f27eaee, c8f05d12-bc35-43cb-8b65-588bec02c73dspl_set_id404c858c-89ac-4c9d-8a96-8702a28e6e76, c36cadf4-65a4-4466-b409-c82020b42452Package NDC 0024-5501-31, 0024-5501-10, 0024-5521-31, 0024-5521-50, 0024-5521-10, 0024-5401- ... UNIIWY6W63843K

8)

drugcharacterization2medicinalproductSEROQUELdrugdosagetextUNKdrugindicationSLEEP DISORDERactiondrug5drugadditional3

activesubstance

activesubstancenameQUETIAPINE FUMARATE

openFDA Info on Medication

Application NumberNDA022047, NDA020639Brand NameSEROQUEL XR, SEROQUELGeneric NameQUETIAPINEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0310-0280, 0310-0282, 0310-0283, 0310-0284, 0310-0281, 0310-0271, 0310-0275, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI 721791, 721793, 721794, 721795, 721796, 721797, 853201, 853202, 895670, 895671, ... spl_idc3b26ed5-6f3a-4ca5-80a5-b98380040294, 37cb4cbf-8192-4921-b17c-e562467fc018spl_set_id473a3ac4-67f4-4782-baa9-7f9bdd8761f4, 0584dda8-bc3c-48fe-1a90-79608f78e8a0Package NDC 0310-0282-39, 0310-0282-94, 0310-0282-60, 0310-0283-39, 0310-0283-55, 0310-0283- ... UNII2S3PL1B6UJ

9)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNKdrugindicationSLEEP DISORDERactiondrug5drugadditional3

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

10)

drugcharacterization2medicinalproductZANAFLEXdrugdosagetextUNKactiondrug5drugadditional3

activesubstance

activesubstancenameTIZANIDINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020397, NDA021447Brand NameZANAFLEXGeneric NameTIZANIDINE HYDROCHLORIDEManufacturersCovis Pharma US, Incproduct_ndc70515-594, 70515-602, 70515-604, 70515-606Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTIZANIDINE HYDROCHLORIDERXCUI153735, 313413, 485484, 485485, 485486, 580267, 583165, 583211spl_id4caebc2e-bf10-442a-b24d-c3b51876c67fspl_set_id043d9e51-bfa2-4add-9058-5ece332f7e99Package NDC70515-602-15, 70515-604-15, 70515-606-15, 70515-594-15UNIIB53E3NMY5C

11)

drugcharacterization2medicinalproductAMPYRAdrugindicationBALANCE DISORDERactiondrug5drugadditional3

activesubstance

activesubstancenameDALFAMPRIDINE

openFDA Info on Medication

Application NumberNDA022250Brand NameAMPYRAGeneric NameDALFAMPRIDINEManufacturersAcorda Therapeutics, Inc.product_ndc10144-427Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDALFAMPRIDINERXCUI897021, 897025spl_idd17992b6-a426-7196-e053-2a95a90a8282spl_set_id550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783Package NDC10144-427-60NUIN0000192795, N0000175448Established Pharmacologic ClassPotassium Channel Blocker [EPC]Mechanism of ActionPotassium Channel Antagonists [MoA]UNIIBH3B64OKL9

summary

narrativeincludeclinicalCASE EVENT DATE: 20130628