Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10143432primarysourcecountryUStransmissiondateformat102transmissiondate12/12/2014reporttype1serious2receivedateformat102Date Received29/04/2014receiptdateformat102Date Last Updated29/04/2014fulfillexpeditecriteria2

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionDrug ineffective

Drug

1)

drugcharacterization1medicinalproductESZOPICLONEdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate11/02/2014drugenddateformat102drugenddate22/04/2014drugadditional1

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)

drugcharacterization1medicinalproductVISTARILdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationINSOMNIAdrugstartdateformat102drugstartdate23/01/2014drugenddateformat102drugenddate02/02/2014drugadditional1

openFDA Info on Medication

Application NumberNDA011459Brand NameVISTARILGeneric NameHYDROXYZINE PAMOATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0069-5410, 0069-5420, 0069-5440Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROXYZINE PAMOATERXCUI995253, 995255, 995274, 995276, 995278, 995280spl_id2fb74df1-48cd-43c5-b99f-6967faf02da2spl_set_idc271f97f-040e-492b-9194-2c8b74675a95Package NDC0069-5410-66, 0069-5420-66, 0069-5440-93, 0069-5440-97UNIIM20215MUFR