Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10310399primarysourcecountryUStransmissiondateformat102transmissiondate26/03/2015reporttype1serious2receivedateformat102Date Received16/07/2014receiptdateformat102Date Last Updated16/07/2014fulfillexpeditecriteria2

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age49Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionVomiting

2)

reactionmeddraversionpt17.1ReactionInfluenza like illness

3)

reactionmeddraversionpt17.1ReactionMalaise

4)

reactionmeddraversionpt17.1ReactionProduct substitution issue

5)

reactionmeddraversionpt17.1ReactionFeeling of body temperature change

6)

reactionmeddraversionpt17.1ReactionPosture abnormal

Drug

1)

drugcharacterization1medicinalproductESZOPICLONE.drugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextSTRENGTH 3MG 1 BEDTIME BY MOUTHdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate11/07/2014drugenddateformat102drugenddate12/07/2014drugadditional1

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

2)

drugcharacterization2medicinalproductVITAMIN D

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

3)

drugcharacterization2medicinalproductJUICE PLUS FRUITS + VEGETABLES

4)

drugcharacterization2medicinalproductLOSARTAN

activesubstance

activesubstancenameLOSARTAN

5)

drugcharacterization2medicinalproductOMEGA 3 KRILL OIL

summary

narrativeincludeclinicalCASE EVENT DATE: 20140711