Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10152530primarysourcecountryUStransmissiondateformat102transmissiondate12/12/2014reporttype1serious2receivedateformat102Date Received02/05/2014receiptdateformat102Date Last Updated02/05/2014fulfillexpeditecriteria2

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age54Unit of Onset AgeyearsWeight78.93SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionTremor

Drug

1)

drugcharacterization1medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext3MG?30 ONE PO QHS?BY MOUTHdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate23/04/2014drugenddateformat102drugenddate25/04/2014drugadditional1

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

2)

drugcharacterization2medicinalproductCALCIUM+D

3)

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

4)

drugcharacterization2medicinalproductMVI

5)

drugcharacterization2medicinalproductFLAXSEED OIL

6)

drugcharacterization2medicinalproductMEGA RED KRILL OIL