Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11155706primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/08/2015reporttype1serious1seriousnessother1receivedateformat102Date Received02/06/2015receiptdateformat102Date Last Updated02/06/2015fulfillexpeditecriteria1companynumbUS-MYLANLABS-2015M1012633duplicate1

Report Duplicate

duplicatesourceMYLANduplicatenumbUS-MYLANLABS-2015M1012633

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Reaction

1)

reactionmeddraversionpt18.0ReactionDisturbance in attentionOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionMotor dysfunctionOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.0ReactionBrain injuryOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.0ReactionUnevaluable eventOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt18.0ReactionAmnesiaOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductGLIMEPIRIDE.drugdosagetextUNKdrugindicationDIABETES MELLITUSdrugrecurreadministration3

activesubstance

activesubstancenameGLIMEPIRIDE

openFDA Info on Medication

Application Number ANDA077911, ANDA077091, ANDA091220, ANDA078181, NDA020496, ANDA077370, ANDA20275 ... Brand NameGLIMEPIRIDE, AMARYLGeneric NameGLIMEPIRIDEManufacturers Carlsbad Technology, Inc., Dr. Reddy's Laboratories Limited, Micro Labs Limited, ... product_ndc 61442-115, 61442-116, 61442-117, 55111-320, 55111-321, 55111-322, 42571-100, 425 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGLIMEPIRIDERXCUI199245, 199246, 199247, 153842, 1361493, 1361495, 153591, 153843, 153845spl_id 94f7e51b-3f92-8633-e053-2995a90a8cf1, e3d50334-9896-b2f9-a481-8383eb84b16a, d228 ... spl_set_id 72d88c6d-2f0a-4bf8-aa7f-1e1811794187, 07ad4366-4b21-f633-49f3-c2b35f88168d, 60e9 ... Package NDC 61442-115-01, 61442-115-05, 61442-115-10, 61442-116-01, 61442-116-05, 61442-116- ... NUIN0000175608, M0020795Established Pharmacologic ClassSulfonylurea [EPC]Chemical StructureSulfonylurea Compounds [CS]UNII6KY687524K

2)

drugcharacterization2medicinalproductFISH OILdrugdosagetextUNK

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

3)

drugcharacterization1medicinalproductESZOPICLONE.drugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext3 MG, HSdrugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate10/04/2015actiondrug4

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application Number ANDA091124, ANDA091166, ANDA091103, ANDA091113, ANDA091024, ANDA208451, ANDA2029 ... Brand NameESZOPICLONE, LUNESTAGeneric NameESZOPICLONEManufacturers Lupin Pharmaceuticals, Inc., Glenmark Pharmaceuticals Inc. USA, Sun Pharmaceutic ... product_ndc 68180-322, 68180-323, 68180-324, 68462-382, 68462-383, 68462-384, 47335-586, 473 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, OROPHARYNGEALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id c15b2322-c078-46c1-8959-9288faaab19e, 8d6002b1-95d9-445c-8ace-e6dccea36852, 95e9 ... spl_set_id 7068c455-691e-4c56-9857-b7b4e13f4784, 584dc66c-063a-4552-a056-74b811e2bc80, 8bb1 ... Package NDC 68180-322-01, 68180-322-11, 68180-322-13, 68180-323-01, 68180-323-02, 68180-323- ... UNIIUZX80K71OE

4)

drugcharacterization2medicinalproductMETFORMINdrugdosagetextUNK

activesubstance

activesubstancenameMETFORMIN HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA200690, ANDA209674, ANDA209313Brand NameMETFORMIN HYDROCHLORIDE, METFORMINGeneric NameMETFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MGManufacturers Mylan Pharmaceuticals Inc., Ingenus Pharmaceuticals, LLC, Granules Pharmaceutica ... product_ndc0378-6001, 0378-6002, 50742-633, 50742-634, 70010-491, 70010-492Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETFORMIN HYDROCHLORIDERXCUI1807894, 1807917, 860975, 860981spl_id b1d71739-26c3-43d3-9088-60bef3689e74, d7e2ad60-7a17-4c65-b836-e56644be754d, d164 ... spl_set_id 7e41818c-60e9-4bcf-9586-7bb8d33d5e89, 49a0b5c2-ebaf-4c4c-905f-dfd1962ac647, 6d6e ... Package NDC 0378-6002-91, 0378-6001-91, 50742-633-60, 50742-633-90, 50742-633-10, 50742-634- ... UNII786Z46389E

5)

drugcharacterization2medicinalproductVITAMINS /00067501/drugdosagetextUNK

activesubstance

activesubstancenameVITAMINS

6)

drugcharacterization2medicinalproductBABY ASPIRINdrugdosagetextUNK

activesubstance

activesubstancenameASPIRIN

7)

drugcharacterization1medicinalproductESZOPICLONE.drugauthorizationnumb091151drugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext3 MG, HSdrugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate01/05/2014drugenddateformat102drugenddate10/04/2015actiondrug2

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application Number ANDA091124, ANDA091166, ANDA091103, ANDA091113, ANDA091024, ANDA208451, ANDA2029 ... Brand NameESZOPICLONE, LUNESTAGeneric NameESZOPICLONEManufacturers Lupin Pharmaceuticals, Inc., Glenmark Pharmaceuticals Inc. USA, Sun Pharmaceutic ... product_ndc 68180-322, 68180-323, 68180-324, 68462-382, 68462-383, 68462-384, 47335-586, 473 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, OROPHARYNGEALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id c15b2322-c078-46c1-8959-9288faaab19e, 8d6002b1-95d9-445c-8ace-e6dccea36852, 95e9 ... spl_set_id 7068c455-691e-4c56-9857-b7b4e13f4784, 584dc66c-063a-4552-a056-74b811e2bc80, 8bb1 ... Package NDC 68180-322-01, 68180-322-11, 68180-322-13, 68180-323-01, 68180-323-02, 68180-323- ... UNIIUZX80K71OE

8)

drugcharacterization2medicinalproductAMLODIPINEdrugdosagetextUNKdrugindicationHYPERTENSIONdrugrecurreadministration3

activesubstance

activesubstancenameAMLODIPINE BESYLATE

openFDA Info on Medication

Application NumberNDA214439, NDA211340Brand NameNORLIQVA, KATERZIAGeneric NameAMLODIPINEManufacturersCMP Pharma, Inc., Azurity Pharmaceuticals, Inc.product_ndc46287-035, 52652-5001Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE, AMLODIPINE BENZOATERXCUI2599173, 2599179, 2184120, 2184126spl_id63a6bb49-fb68-4351-be5f-a6b6e8f6b540, df623dda-e184-4011-8fce-4e729b2e6b2dspl_set_idc1730a51-4383-4c61-a9a1-7e1326bd0abe, df673a4d-acb8-444c-a472-c87ab8cbd366Package NDC46287-035-15, 52652-5001-1NUIN0000000069, N0000175421, N0000175566, M0006414, N0000190114Mechanism of ActionCalcium Channel Antagonists [MoA], Cytochrome P450 3A Inhibitors [MoA]Established Pharmacologic ClassDihydropyridine Calcium Channel Blocker [EPC], Calcium Channel Blocker [EPC]Chemical StructureDihydropyridines [CS]UNII1J444QC288, XD75TQ8A2P

9)

drugcharacterization2medicinalproductPRAVASTATINdrugdosagetextUNKdrugindicationBLOOD CHOLESTEROL INCREASEDdrugrecurreadministration3

activesubstance

activesubstancenamePRAVASTATIN\PRAVASTATIN SODIUM

summary

narrativeincludeclinicalCASE EVENT DATE: 2014