Adverse Event Report

Report

Safety Report ID5015436-8transmissiondateformat102transmissiondate13/10/2006serious1seriousnesslifethreatening1seriousnesshospitalization1receivedateformat102Date Received01/06/2006receiptdateformat102Date Last Updated18/09/1997fulfillexpeditecriteria1companynumbCDN/97/00530/LEX

Primary Source

reportercountryCANADA

Sender

senderorganizationFDA-Public UseReceiver-

Patient

Onset Age22Unit of Onset AgeyearsSexMale

Reaction

1)

ReactionABDOMINAL PAIN

2)

ReactionAGRANULOCYTOSIS

3)

ReactionHICCUPS

4)

ReactionNEUTROPENIA

5)

ReactionSOMNOLENCE

6)

ReactionVOMITING

Drug

1)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb19758drugadministrationroute048drugindicationSCHIZOPHRENIFORM DISORDERdrugstartdateformat102drugstartdate10/04/1997drugenddateformat102drugenddate17/09/1997drugtreatmentduration154drugtreatmentdurationunit804

openFDA Info on Medication

Application NumberNDA019758Brand NameCLOZARILGeneric NameCLOZAPINEManufacturersHLS Therapeutics (USA), Inc.product_ndc69809-0126, 69809-0127, 69809-0130, 69809-0135Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLOZAPINERXCUI104775, 104776, 197535, 197536, 309374, 429212, 2269079, 2269081spl_id29feed9f-c971-4c63-bcfc-0776c12215cfspl_set_id90876802-0e3a-44c9-9ff7-1754dfbe736aPackage NDC69809-0126-5, 69809-0127-5, 69809-0130-5, 69809-0135-5NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIJ60AR2IKIC

2)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstartdateformat102drugstartdate03/04/2006drugenddateformat102drugenddate21/05/2006drugtreatmentduration70560drugtreatmentdurationunit806

openFDA Info on Medication

Application NumberNDA019758Brand NameCLOZARILGeneric NameCLOZAPINEManufacturersHLS Therapeutics (USA), Inc.product_ndc69809-0126, 69809-0127, 69809-0130, 69809-0135Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLOZAPINERXCUI104775, 104776, 197535, 197536, 309374, 429212, 2269079, 2269081spl_id29feed9f-c971-4c63-bcfc-0776c12215cfspl_set_id90876802-0e3a-44c9-9ff7-1754dfbe736aPackage NDC69809-0126-5, 69809-0127-5, 69809-0130-5, 69809-0135-5NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIJ60AR2IKIC

3)

drugcharacterization2medicinalproductLITHIUM CARBONATE

openFDA Info on Medication

Brand Name LITHIUM CARBONICUM, LITHIUM CARBONATE, LITHIUM CARBONATE ER, RHEUMATSM, LITHIUM ... Generic NameLITHIUM CARBONATE, LITHIUM CARBONATE EXTENDED-RELEASE TABLETManufacturers Boiron, Mylan Pharmaceuticals Inc., Heritage Pharmaceuticals Inc. d/b/a Avet Pha ... product_ndc 0220-3128, 0378-1300, 23155-763, 0054-2526, 0054-8528, 0054-4527, 0054-8526, 005 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLITHIUM CARBONATEspl_id 861df6e6-46cc-632d-e053-2a91aa0ae9a3, 4dea5284-2539-43e3-8002-fed27008f189, 84eb ... spl_set_id 861df6e6-46cb-632d-e053-2a91aa0ae9a3, 785a0327-998b-4154-9461-b72cb78e2739, 074e ... Package NDC 0220-3128-41, 0378-1300-01, 0378-1300-05, 23155-763-05, 23155-763-01, 0054-8528- ... UNII2BMD2GNA4V, 5Z6E9K79YVApplication Number ANDA202288, ANDA205532, NDA017812, NDA018558, ANDA204445, ANDA090702, ANDA202219 ... RXCUI197891, 197889, 197890, 197893, 311355, 756059, 197892, 206786