Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11423111primarysourcecountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious1seriousnessother1receivedateformat102Date Received26/08/2015receiptdateformat102Date Last Updated26/08/2015fulfillexpeditecriteria2

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age67Unit of Onset AgeyearsWeight123.83SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionFeeling abnormal

2)

reactionmeddraversionpt18.1ReactionLoss of consciousness

3)

reactionmeddraversionpt18.1ReactionDiplopia

4)

reactionmeddraversionpt18.1ReactionMental impairment

Drug

1)

drugcharacterization2medicinalproductZOCOR

activesubstance

activesubstancenameSIMVASTATIN

openFDA Info on Medication

Application NumberNDA019766Brand NameZOCORGeneric NameSIMVASTATINManufacturersOrganon LLCproduct_ndc78206-179, 78206-182, 78206-181, 78206-180Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSIMVASTATINRXCUI104490, 104491, 152923, 198211, 200345, 213319, 312961, 314231spl_id50f92ae8-00c3-4467-8482-237a5ee3aaf6spl_set_id8f55d5de-5a4f-4a39-8c84-c53976dd6af9Package NDC 78206-179-01, 78206-179-02, 78206-182-01, 78206-182-02, 78206-181-02, 78206-181- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNIIAGG2FN16EV

2)

drugcharacterization2medicinalproductSAVELLA

activesubstance

activesubstancenameMILNACIPRAN HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022256Brand NameSAVELLAGeneric NameMILNACIPRAN HYDROCHLORIDEManufacturersAllergan, Inc.product_ndc0456-1500, 0456-1512, 0456-1525, 0456-1550, 0456-1510Product TypeHUMAN PRESCRIPTION DRUGRouteORALRXCUI833135, 833139, 833141, 833143, 833144, 833146, 833147, 833149, 833150, 833151spl_id5cb4b5fa-97d9-4c0a-abcf-c27b8a42d797spl_set_id16a4a314-f97e-4e91-95e9-576a3773d284Package NDC 0456-1512-60, 0456-1512-11, 0456-1512-63, 0456-1525-60, 0456-1525-11, 0456-1525- ... UNIIRNZ43O5WW5Active IngredientsMILNACIPRAN HYDROCHLORIDE

3)

drugcharacterization2medicinalproductPRAMIPEXOLE.

activesubstance

activesubstancenamePRAMIPEXOLE

openFDA Info on Medication

Application NumberANDA203855, ANDA202206Brand NamePRAMIPEXOLE, PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASEGeneric NamePRAMIPEXOLEManufacturersCamber Pharmaceuticals, Inc., Par Pharmaceutical, Inc.product_ndc 31722-906, 31722-907, 31722-908, 31722-909, 31722-910, 31722-911, 10370-251, 103 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPRAMIPEXOLE DIHYDROCHLORIDERXCUI 858625, 859033, 859040, 859044, 859048, 859052, 901534, 901541, 901546, 901550, ... spl_id540a17f8-b64d-41e1-a96b-d55bc8c48f3d, 4b42cbf3-6700-4c2d-95a2-edb74067858aspl_set_ida7405a56-de1c-4875-b57f-210c991474ba, 79d73ae4-beaf-4a99-b0f3-d66438c122bdPackage NDC 31722-906-90, 31722-906-10, 31722-906-05, 31722-907-90, 31722-907-10, 31722-907- ... UNII3D867NP06J

4)

drugcharacterization2medicinalproductNIFEDICAL XL

activesubstance

activesubstancenameNIFEDIPINE

5)

drugcharacterization1medicinalproductLYRICAdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 PILL 3X A DAY THREE TIMES DAILY TAKEN BY MOUTHdrugadministrationroute048drugindicationFIBROMYALGIAdrugstartdateformat102drugstartdate03/07/2015drugenddateformat102drugenddate05/08/2015drugadditional1

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

6)

drugcharacterization2medicinalproductTOPROL XL

activesubstance

activesubstancenameMETOPROLOL SUCCINATE

openFDA Info on Medication

Application NumberNDA019962Brand NameTOPROL XLGeneric NameMETOPROLOL SUCCINATEManufacturersAralez Pharmaceuticals US Inc.product_ndc70347-025, 70347-050, 70347-100, 70347-200Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOPROLOL SUCCINATERXCUI866412, 866414, 866419, 866421, 866427, 866429, 866436, 866438spl_ided7de3bc-9f5b-4763-953c-b112d322e0ffspl_set_id991fe00b-498b-400e-9e5b-921cb07d9b2cPackage NDC 70347-025-01, 70347-025-02, 70347-025-03, 70347-050-01, 70347-050-02, 70347-050- ... UNIITH25PD4CCB

7)

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

8)

drugcharacterization2medicinalproductSUCRALFATE.

activesubstance

activesubstancenameSUCRALFATE

openFDA Info on Medication

Application NumberNDA019183, ANDA070848, NDA018333, ANDA074415, ANDA215576, ANDA211884, ANDA209356Brand NameSUCRALFATE, CARAFATEGeneric NameSUCRALFATE, SUCRALFATE ORALManufacturers Dash Pharmaceuticals LLC, Teva Pharmaceuticals USA, Inc., Greenstone LLC, Allerg ... product_ndc 69339-148, 0093-2210, 59762-0401, 58914-170, 29033-003, 0254-1011, 58914-171, 69 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSUCRALFATERXCUI313123, 314234, 208094, 208097spl_id 3d0de6fb-6d76-4ad8-8cb6-cabd6d4513f0, 40bf98b4-12b3-4ccc-8ff8-5097f2c18fd2, 37d3 ... spl_set_id c76c7bcb-d481-43ff-809b-da8e0e88f096, c7a43df7-eb37-4273-9250-87953b1fd270, ae58 ... Package NDC 69339-148-01, 69339-148-17, 69339-148-19, 0093-2210-98, 0093-2210-01, 0093-2210- ... NUIN0000175801, M0015420Established Pharmacologic ClassAluminum Complex [EPC]Chemical StructureOrganometallic Compounds [CS]UNIIXX73205DH5

summary

narrativeincludeclinicalCASE EVENT DATE: 20150805