Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10260285primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate12/12/2014reporttype1serious2receivedateformat102Date Received25/06/2014receiptdateformat102Date Last Updated25/06/2014fulfillexpeditecriteria2companynumbUS-SA-2014SA052637duplicate1

Report Duplicate

duplicatesourceAVENTISduplicatenumbUS-SA-2014SA052637

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age51Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionAbdominal pain upperOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionAlopeciaOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductAUBAGIOdrugbatchnumbUNKdrugauthorizationnumb202992drugstructuredosagenumb7drugstructuredosageunit003drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug3

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

2)

drugcharacterization1medicinalproductAMPYRAdrugbatchnumbUNKdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug4

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

3)

drugcharacterization2medicinalproductTIZANIDINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA208622, NDA020397, NDA021447, ANDA078868, ANDA210021, ANDA213223, ANDA213544 ... Brand NameTIZANIDINE HYDROCHLORIDE, ZANAFLEXGeneric NameTIZANIDINE HYDROCHLORIDEManufacturers Cadila Healthcare Limited, Covis Pharma US, Inc, Apotex Corp., Nivagen Pharmaceu ... product_ndc 70771-1067, 70771-1068, 70771-1069, 70515-594, 70515-602, 70515-604, 70515-606, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTIZANIDINE HYDROCHLORIDE, TIZANIDINERXCUI485484, 485485, 485486, 153735, 313413, 580267, 583165, 583211, 313412spl_id ac68e443-89c9-42b1-aa4c-66a32746d81e, 4caebc2e-bf10-442a-b24d-c3b51876c67f, 80e7 ... spl_set_id 5f4889d1-1387-4c90-9b76-00beda3c1683, 043d9e51-bfa2-4add-9058-5ece332f7e99, 3dd0 ... Package NDC 70771-1067-8, 70771-1067-5, 70771-1067-4, 70771-1068-8, 70771-1068-5, 70771-1068 ... UNIIB53E3NMY5C, 6AI06C00GWNUIN0000009918, N0000175554Mechanism of ActionAdrenergic alpha2-Agonists [MoA]Established Pharmacologic ClassCentral alpha-2 Adrenergic Agonist [EPC]

4)

drugcharacterization2medicinalproductLUNESTA

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

5)

drugcharacterization2medicinalproductCITALOPRAM HYDROCHLORIDE

6)

drugcharacterization2medicinalproductOXYBUTYNIN HYDROCHLORIDE

7)

drugcharacterization2medicinalproductMETHENAMINE 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

8)

drugcharacterization2medicinalproductFLUDROCORTISONE ACETATE

openFDA Info on Medication

Application NumberANDA215279, ANDA040431, ANDA040425Brand NameFLUDROCORTISONE ACETATEGeneric NameFLUDROCORTISONE ACETATEManufacturers Novitium Pharma LLC, Amneal Pharmaceuticals of New York LLC, Amneal Pharmaceutic ... product_ndc70954-252, 0115-7033, 69238-7033, 42291-764, 0555-0997Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFLUDROCORTISONE ACETATEspl_id 96dbbf53-962b-49a4-a60d-91ae0b9fb9ff, fcc5d5c8-1ae7-4e2a-9ed1-bf0084e8de66, 9dc0 ... spl_set_id 96dbbf53-962b-49a4-a60d-91ae0b9fb9ff, 4ed382df-f2d5-46a4-a68b-aba807777093, 5136 ... Package NDC 70954-252-10, 70954-252-20, 70954-252-30, 0115-7033-01, 0115-7033-02, 0115-7033- ... UNIIV47IF0PVH4RXCUI313979

9)

drugcharacterization2medicinalproductFIORINAL

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 D

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)

drugcharacterization2medicinalproductVITAMIN B12

12)

drugcharacterization2medicinalproductFISH 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

13)

drugcharacterization2medicinalproductCRANBERRY EXTRACT