Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10763947primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/07/2015reporttype3serious2receivedateformat102Date Received04/02/2015receiptdateformat102Date Last Updated04/02/2015fulfillexpeditecriteria2companynumbUS-ACORDA-ACO_102410_2014duplicate1

Report Duplicate

duplicatesourceACORDAduplicatenumbUS-ACORDA-ACO_102410_2014

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionAlopeciaOutcomeRecovering/resolving

2)

reactionmeddraversionpt18.0ReactionAbdominal pain upperOutcomeRecovering/resolving

Drug

1)

drugcharacterization2medicinalproductCITALOPRAMdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameCITALOPRAM HYDROBROMIDE

openFDA Info on Medication

Application Number ANDA077048, ANDA077043, NDA215428, ANDA077534, ANDA077042, ANDA077031, ANDA07728 ... Brand NameCITALOPRAM, CITALOPRAM HYDROBROMIDE, CELEXAGeneric NameCITALOPRAM TABLETS, CITALOPRAM TABLET, CITALOPRAM, CITALOPRAM HYDROBROMIDEManufacturers Cosette Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Almatica Pharma L ... product_ndc 0713-4740, 0713-4741, 0713-4742, 0054-0062, 52427-691, 69097-822, 69097-823, 690 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsCITALOPRAM HYDROBROMIDE, CITALOPRAMRXCUI200371, 283672, 309314, 309313, 2591786, 213344, 213345, 284591spl_id 8eadc3e4-81a3-4b3b-aa1c-1dc65151f94c, 3b571c67-5234-44ad-8276-e29b1ceabec3, bde4 ... spl_set_id cf7b6823-108b-ebff-8f41-91f8b8325e3a, 29408d84-7b00-4cee-969c-8095f8083ff5, 2f81 ... Package NDC 0713-4740-01, 0713-4740-05, 0713-4741-01, 0713-4741-05, 0713-4742-01, 0713-4742- ... UNIII1E9D14F36, 0DHU5B8D6VNUIN0000175696, N0000000109Established Pharmacologic ClassSerotonin Reuptake Inhibitor [EPC]Mechanism of ActionSerotonin Uptake Inhibitors [MoA]

2)

drugcharacterization2medicinalproductOXYBUTYNINdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameOXYBUTYNIN

openFDA Info on Medication

Application NumberANDA202332, NDA021351, NDA202211Brand NameOXYBUTYNIN, OXYTROL, OXYTROL FOR WOMENGeneric NameOXYBUTYNINManufacturersZydus Pharmaceuticals (USA) Inc., Cadila Healthcare Limited, Allergan, Inc.product_ndc 68382-255, 68382-256, 68382-257, 70771-1086, 70771-1087, 70771-1088, 0023-6153, ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORAL, TRANSDERMALActive IngredientsOXYBUTYNIN CHLORIDE, OXYBUTYNINRXCUI863619, 863628, 863636, 403799, 404448spl_id f8631e88-7755-4b29-848c-7ef657463803, 38ac4e71-8edf-4dd1-ba35-8e84006d4b48, 07d7 ... spl_set_id c042bf06-79a3-4dc7-ae05-3ef3cfae9d44, f405a774-bd91-4513-b7c7-c44f0596d988, 20de ... Package NDC 68382-255-06, 68382-255-14, 68382-255-16, 68382-255-01, 68382-255-05, 68382-255- ... UNIIL9F3D9RENQ, K9P6MC7092NUIN0000175700, N0000000125Established Pharmacologic ClassCholinergic Muscarinic Antagonist [EPC]Mechanism of ActionCholinergic Muscarinic Antagonists [MoA]

3)

drugcharacterization2medicinalproductTIZANIDINE (TIZANIDINE)drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameTIZANIDINE

4)

drugcharacterization2medicinalproductMETHENAMINE MANDELATE.drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameMETHENAMINE MANDELATE

openFDA Info on Medication

Brand NameMETHENAMINE MANDELATEGeneric NameMETHENAMINE MANDELATEManufacturers Seton Pharmaceuticals, Edenbridge Pharmaceuticals LLC., Method Pharmaceuticals, ... product_ndc13925-107, 42799-105, 42799-106, 58657-460, 62135-200, 62135-201Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETHENAMINE MANDELATERXCUI992153, 992184spl_id d8dcc152-9596-4eaf-b4cb-cd4f7d62151e, 42dda043-7e70-4fcd-9fcc-96f70d751efa, d45f ... spl_set_id d21a1fdb-7111-4038-975f-f93de44d63a7, cc299e8a-cf9a-4dc6-b6e6-972141e59296, a3f3 ... Package NDC 13925-107-01, 42799-106-01, 42799-106-99, 42799-105-01, 42799-105-99, 58657-460- ... UNII695N30CINR

5)

drugcharacterization2medicinalproductFISH OILdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameFISH OIL

openFDA Info on Medication

Application NumberNDA210589Brand NameOMEGAVENGeneric NameFISH OILManufacturersFresenius Kabi USA, LLCproduct_ndc63323-205Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsFISH OILRXCUI2053499, 2053504, 2053513, 2053514spl_idc4f460d5-da90-4b9b-aff1-df3176a43d47spl_set_id5d9d0b24-e139-48bf-ab2d-536fb59cf8e0Package NDC63323-205-21, 63323-205-50, 63323-205-31, 63323-205-00UNIIXGF7L72M0F

6)

drugcharacterization1medicinalproductAUBAGIOdrugstructuredosagenumb7drugstructuredosageunit003drugdosagetext7 MG, UNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug3

activesubstance

activesubstancenameTERIFLUNOMIDE

openFDA Info on Medication

Application NumberNDA202992Brand NameAUBAGIOGeneric NameTERIFLUNOMIDEManufacturersGenzyme Corporationproduct_ndc58468-0210, 58468-0211Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTERIFLUNOMIDERXCUI1310525, 1310531, 1310533, 1310535spl_idb945dc1c-772e-48d8-94c1-f8b8b53cbcfdspl_set_id4650d12c-b9c8-4525-b07f-a2d773eca155Package 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

7)

drugcharacterization2medicinalproductLUNESTAdrugindicationPRODUCT 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

8)

drugcharacterization2medicinalproductFLUDROCORTISONEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameFLUDROCORTISONE

9)

drugcharacterization2medicinalproductFIORINALdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameASPIRIN\BUTALBITAL\CAFFEINE

openFDA Info on Medication

Application NumberNDA017534Brand NameFIORINALGeneric NameBUTALBITAL, ASPIRIN, AND CAFFEINEManufacturersAllergan, Inc.product_ndc0023-6146Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsASPIRIN, BUTALBITAL, CAFFEINERXCUI211310, 238134spl_iddc70b221-f006-4eec-9a65-3498d548d4faspl_set_id26f62036-2fec-4aa2-905b-e38bbd0fd3f5Package NDC0023-6146-01NUI N0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832, N0000 ... Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic Effect Decreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE], Ce ... Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS], Barbiturates [CS], Xanthines [CS]Established Pharmacologic Class Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], ... UNIIR16CO5Y76E, KHS0AZ4JVK, 3G6A5W338E

10)

drugcharacterization2medicinalproductVITAMIN DdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameCHOLECALCIFEROL

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturers Strides Pharma Science Limited, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac ... product_ndc64380-737, 23155-809Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725, 9c09c2d2-ef29-4654-be7d-ed3b2b508f43spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36, 96da2c1e-6c5e-4df0-8166-3de53c08a701Package NDC64380-737-06, 64380-737-25, 23155-809-01NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

11)

drugcharacterization1medicinalproductAMPYRAdrugauthorizationnumb022250drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, BIDdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug4

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

12)

drugcharacterization2medicinalproductVITAMIN B12drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameCYANOCOBALAMIN

13)

drugcharacterization2medicinalproductCRANBERRY.drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameCRANBERRY