Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID12095960primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate26/05/2016reporttype3serious2receivedateformat102Date Received20/02/2016receiptdateformat102Date Last Updated20/02/2016fulfillexpeditecriteria2companynumbUS-ACORDA-ACO_109566_2015duplicate1

Report Duplicate

duplicatesourceACORDAduplicatenumbUS-ACORDA-ACO_109566_2015

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Weight136.5SexFemale

Reaction

1)

reactionmeddraversionpt19.0ReactionMalaiseOutcomeUnknown

2)

reactionmeddraversionpt19.0ReactionBalance disorderOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt19.0ReactionHypotensionOutcomeRecovering/resolving

4)

reactionmeddraversionpt19.0ReactionHeart rate decreasedOutcomeRecovering/resolving

Drug

1)

drugcharacterization2medicinalproductBACLOFEN.drugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA209102, ANDA215885, ANDA209594, ANDA074584, ANDA2100 ... Brand NameBACLOFEN, BACLOFEN (INTRATHECAL), LYVISPAH, OZOBAX, FLEQSUVYGeneric NameBACLOFENManufacturers Northstar RxLLC, TruPharma LLC, Lifestar Pharma LLC, Mylan Institutional LLC, Up ... product_ndc 16714-071, 16714-072, 52817-319, 52817-320, 52817-321, 70756-085, 70756-288, 707 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 430902, 1300890, 308517, 1666613, 2586589, 2586595, 2586596, 258 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, b8da4a75-4c34-1d06-e053-2a95a90a7886, f4a6 ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 68aa591e-ea98-4438-9a4a-4f7e9ea2b285, f9dd ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 52817-319-10, 52817-320- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

2)

drugcharacterization2medicinalproductHYDROCHLOROTHIAZIDE.drugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameHYDROCHLOROTHIAZIDE

openFDA Info on Medication

Application Number ANDA040780, ANDA203018, ANDA040412, ANDA085182, ANDA203561, ANDA078164, ANDA0870 ... Brand NameHYDROCHLOROTHIAZIDEGeneric NameHYDROCHLOROTHIAZIDEManufacturers Aurobindo Pharma Limited, ScieGen Pharmaceuticals, Inc., Solco Healthcare U.S., ... product_ndc 65862-133, 65862-134, 50228-111, 50228-112, 43547-397, 43547-398, 23155-008, 231 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCHLOROTHIAZIDERXCUI197770, 310798, 199903, 429503spl_id 857dd673-6ba8-485c-b96b-14291666b852, 5c6f4c6a-cc43-4f4d-bc16-688310c98c72, d8ce ... spl_set_id 01f1f478-5493-439f-9b99-f4f82023781c, 02e96a51-1d56-460c-8c20-3d6f37e0ce46, 60c9 ... Package NDC 65862-133-01, 65862-133-99, 65862-134-01, 65862-134-99, 50228-111-30, 50228-111- ... NUIN0000175359, N0000175419, M0471776Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide Diuretic [EPC]Chemical StructureThiazides [CS]UNII0J48LPH2TH

3)

drugcharacterization2medicinalproductASPIRIN.drugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameASPIRIN

openFDA Info on Medication

Application Numberpart343, NDA203697Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN TABLET 325MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 36800-545, 0363-0587, 70000-0218, 63 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 260847, 198471, 825180 ... spl_id 70f66f99-a450-4ab6-a3b9-c5d9207e0a79, da59962f-0c77-5c08-e053-2a95a90aaee7, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

4)

drugcharacterization2medicinalproductSYNTHROIDdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM

openFDA Info on Medication

Application NumberNDA021402Brand NameSYNTHROIDGeneric NameLEVOTHYROXINE SODIUMManufacturersAbbVie Inc.product_ndc 0074-3727, 0074-7149, 0074-4341, 0074-4552, 0074-5182, 0074-6624, 0074-6594, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, ... spl_ided6f6960-2439-4bb0-bb7f-c7d05e4d37a5spl_set_id1e11ad30-1041-4520-10b0-8f9d30d30fccPackage NDC 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341- ... UNII9J765S329G

5)

drugcharacterization1medicinalproductAMPYRAdrugauthorizationnumb022250drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb12drugintervaldosagedefinition805drugdosagetext10 MG, Q 12 HRSdrugdosageformTABLETdrugadministrationroute048drugindicationGAIT DISTURBANCEactiondrug1

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

6)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

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

7)

drugcharacterization2medicinalproductJANUMETdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameMETFORMIN HYDROCHLORIDE\SITAGLIPTIN PHOSPHATE

openFDA Info on Medication

Application NumberNDA022044, NDA202270Brand NameJANUMET, JANUMET XRGeneric NameSITAGLIPTIN AND METFORMIN HYDROCHLORIDEManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0575, 0006-0577, 0006-0078, 0006-0080, 0006-0081Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATERXCUI 861769, 861771, 861819, 861821, 1243827, 1243833, 1243842, 1243843, 1243846, 124 ... spl_id53efa1d9-741f-4546-82e3-a7806ac8cfea, 36188f52-07db-41d9-92b5-297adf8b54e9spl_set_idd19c7ed0-ad5c-426e-b2df-722508f97d67, 64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50Package NDC 0006-0575-82, 0006-0575-61, 0006-0575-62, 0006-0575-01, 0006-0575-52, 0006-0575- ... UNII786Z46389E, TS63EW8X6F

8)

drugcharacterization2medicinalproductMIRAPEXdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenamePRAMIPEXOLE DIHYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022421Brand NameMIRAPEX ERGeneric NamePRAMIPEXOLE DIHYDROCHLORIDEManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0109, 0597-0285, 0597-0113, 0597-0286, 0597-0115, 0597-0287, 0597-0116Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPRAMIPEXOLE DIHYDROCHLORIDERXCUI 901534, 901537, 901541, 901543, 901546, 901547, 901550, 901551, 901555, 901557, ... spl_id77d8974c-9e8a-4700-8445-458b31b6ce31spl_set_ide2902ed1-cfeb-4815-adc3-129c577917a1Package NDC 0597-0109-30, 0597-0109-07, 0597-0109-17, 0597-0285-30, 0597-0285-07, 0597-0285- ... UNII3D867NP06J

9)

drugcharacterization2medicinalproductNEXIUMdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMRXCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, ... spl_id84c822de-ebe2-4a39-9944-7e38e1961dde, 24d37125-c3cf-48e0-9e50-75cbc818e7c1spl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43H