Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10197402serious1Date Last Updated07/07/2014receiptdateformat102companynumbIT-PFIZER INC-2014144451occurcountryITduplicate1Date Received27/05/2014seriousnesshospitalization1transmissiondate26/03/2015primarysourcecountryIT

Primary Source

reportercountryITqualification1

Patient

Onset Age27Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionDrug abuseOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.1ReactionIntentional self-injuryOutcomeRecovering/resolving

3)

reactionmeddraversionpt17.1ReactionSoporOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductCARBOLITHIUMdrugdosagetextUNKdrugadministrationroute048drugstartdateformat610drugstartdate/06/2013actiondrug1

activesubstance

activesubstancenameLITHIUM CARBONATE

2)

drugcharacterization1medicinalproductCARBOLITHIUMdrugstructuredosagenumb5drugstructuredosageunit032drugdosagetext5 DF, TOTALdrugadministrationroute048drugstartdateformat102drugstartdate19/05/2014drugenddateformat102drugenddate19/05/2014actiondrug1

activesubstance

activesubstancenameLITHIUM CARBONATE

3)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugstructuredosagenumb5drugstructuredosageunit032drugdosagetext5 DF, TOTALdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugstartdateformat102drugstartdate19/05/2014drugenddateformat102drugenddate19/05/2014actiondrug1

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

4)

drugcharacterization1medicinalproductSEROQUELdrugstructuredosagenumb20drugstructuredosageunit032drugdosagetext20 DF, TOTALdrugadministrationroute048drugstartdateformat102drugstartdate19/05/2014drugenddateformat102drugenddate19/05/2014actiondrug1

activesubstance

activesubstancenameQUETIAPINE FUMARATE

openFDA Info on Medication

Application NumberNDA022047, NDA020639Brand NameSEROQUEL XR, SEROQUELGeneric NameQUETIAPINEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0310-0280, 0310-0282, 0310-0283, 0310-0284, 0310-0281, 0310-0271, 0310-0275, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI 721791, 721793, 721794, 721795, 721796, 721797, 853201, 853202, 895670, 895671, ... spl_id1a826d85-aac4-42e4-a3e2-a18df915dc33, bca31730-a1ed-4b8f-93d8-2f64143a91faspl_set_id473a3ac4-67f4-4782-baa9-7f9bdd8761f4, 0584dda8-bc3c-48fe-1a90-79608f78e8a0Package NDC 0310-0282-39, 0310-0282-94, 0310-0282-60, 0310-0283-39, 0310-0283-55, 0310-0283- ... UNII2S3PL1B6UJ

5)

drugcharacterization1medicinalproductSEROQUELdrugdosagetext150 UNK, UNKdrugadministrationroute048drugstartdateformat610drugstartdate/06/2013actiondrug1

activesubstance

activesubstancenameQUETIAPINE FUMARATE

openFDA Info on Medication

Application NumberNDA022047, NDA020639Brand NameSEROQUEL XR, SEROQUELGeneric NameQUETIAPINEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0310-0280, 0310-0282, 0310-0283, 0310-0284, 0310-0281, 0310-0271, 0310-0275, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI 721791, 721793, 721794, 721795, 721796, 721797, 853201, 853202, 895670, 895671, ... spl_id1a826d85-aac4-42e4-a3e2-a18df915dc33, bca31730-a1ed-4b8f-93d8-2f64143a91faspl_set_id473a3ac4-67f4-4782-baa9-7f9bdd8761f4, 0584dda8-bc3c-48fe-1a90-79608f78e8a0Package NDC 0310-0282-39, 0310-0282-94, 0310-0282-60, 0310-0283-39, 0310-0283-55, 0310-0283- ... UNII2S3PL1B6UJ

6)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugdosagetext50 UNK, UNKdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugstartdateformat610drugstartdate/06/2013actiondrug1

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

summary

narrativeincludeclinicalCASE EVENT DATE: 20140519

Report Duplicate

duplicatesourcePFIZERduplicatenumbIT-PFIZER INC-2014144451

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use