Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11112041primarysourcecountryUStransmissiondateformat102transmissiondate21/08/2015reporttype1serious1seriousnessother1receivedateformat102Date Received13/05/2015receiptdateformat102Date Last Updated13/05/2015fulfillexpeditecriteria2

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age25Unit of Onset AgeyearsWeight61.24SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionTherapeutic response changed

2)

reactionmeddraversionpt18.0ReactionSleep disorder

3)

reactionmeddraversionpt18.0ReactionProduct substitution issue

4)

reactionmeddraversionpt18.0ReactionProduct quality issue

Drug

1)

drugcharacterization2medicinalproductESZOPICLONE.

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)

drugcharacterization2medicinalproductOMEPRAZOLE.

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA206877, ANDA075757, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, EQUALINE OMEPRAZOLE DELAYED RELEASE, KIRKLAND ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Supervalu Inc, Costco Wholesale Company, INNOVUS PHARMACEUTI ... product_ndc 46122-281, 41163-614, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 621 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, bd28c8a0-73e5-4c81-bc0e-b2c1504a88c3, 8c9d ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 16bf0c57-0376-48b3-90e5-502d61d1b6eb, 48a4 ... Package NDC 46122-281-04, 46122-281-74, 41163-614-01, 63981-915-55, 57483-740-01, 57483-740- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

3)

drugcharacterization1medicinalproductAMBIENdrugstructuredosagenumb20drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformPILLULESdrugadministrationroute048drugindicationINSOMNIAdrugtreatmentduration30drugtreatmentdurationunit804drugrecurreadministration1drugadditional1

activesubstance

activesubstancenameZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberNDA021774, NDA019908Brand NameAMBIEN CR, AMBIENGeneric NameZOLPIDEM TARTRATEManufacturerssanofi-aventis U.S. LLCproduct_ndc0024-5501, 0024-5521, 0024-5401, 0024-5421Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854880, 854882, 854894, 854896, 854873, 854875, 854876, 854878spl_id8138a0a9-168c-46d2-b13e-e7e84f27eaee, c8f05d12-bc35-43cb-8b65-588bec02c73dspl_set_id404c858c-89ac-4c9d-8a96-8702a28e6e76, c36cadf4-65a4-4466-b409-c82020b42452Package NDC 0024-5501-31, 0024-5501-10, 0024-5521-31, 0024-5521-50, 0024-5521-10, 0024-5401- ... UNIIWY6W63843K

4)

drugcharacterization2medicinalproductBUPROPION

activesubstance

activesubstancenameBUPROPION

openFDA Info on Medication

Application NumberANDA202304, ANDA201567Brand NameBUPROPIONGeneric NameBUPROPION HYDROCHLORIDE, BUPROPIONManufacturers Solco Healthcare US LLC, Zydus Pharmaceuticals (USA) Inc., Cadila Healthcare Lim ... product_ndc43547-288, 43547-289, 43547-290, 68382-353, 68382-354, 65841-780, 65841-836Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUPROPION HYDROCHLORIDERXCUI993503, 993518, 993536, 993541, 993557spl_id 1e71f995-cdb3-43e5-a181-1121c54df18d, 87110421-ed0b-479f-9f4b-2f421e8ebe6c, b789 ... spl_set_id 39b2d509-1281-4464-9cf1-a94bbc18b84b, 8d937ca3-3351-40f1-8192-348ba0c68162, 78d3 ... Package NDC 43547-288-06, 43547-288-09, 43547-288-10, 43547-288-50, 43547-289-06, 43547-289- ... UNIIZG7E5POY8O

5)

drugcharacterization2medicinalproductTRAMADOL

activesubstance

activesubstancenameTRAMADOL

summary

narrativeincludeclinicalCASE EVENT DATE: 20140820