Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-PFIZER INC-2014100947occurcountryUSVersion of Safety Report ID7receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10076961Date Received14/04/2014transmissiondate13/01/2021serious2Date Last Updated15/12/2020primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age31Unit of Onset AgeyearsWeight90.72SexFemale

Reaction

1)

reactionmeddraversionpt23.1ReactionProduct dose omission issueOutcomeUnknown

2)

reactionmeddraversionpt23.1ReactionIncorrect dose administeredOutcomeUnknown

3)

reactionmeddraversionpt23.1ReactionIntentional product misuseOutcomeUnknown

4)

reactionmeddraversionpt23.1ReactionProduct use complaintOutcomeUnknown

5)

reactionmeddraversionpt23.1ReactionFeeling abnormalOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition804drugdosagetext50 MG, ALTERNATE DAYdrugdosageformFILM-COATED TABLETdrugadministrationroute048actiondrug5drugadditional3

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

2)

drugcharacterization2medicinalproductEUCRISAdrugdosagetextUNK

activesubstance

activesubstancenameCRISABOROLE

openFDA Info on Medication

Application NumberNDA207695Brand NameEUCRISAGeneric NameCRISABOROLEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc55724-211Product TypeHUMAN PRESCRIPTION DRUGRouteTOPICALActive IngredientsCRISABOROLERXCUI1865957, 1865962spl_id6dd0b01f-ac99-4920-8f34-c58f23f80459spl_set_id609b77de-1ca3-4783-b8f5-01a9c0f1d77dPackage NDC55724-211-21, 55724-211-11, 55724-211-42, 55724-211-23NUIN0000182961, N0000182960Established Pharmacologic ClassPhosphodiesterase 4 Inhibitor [EPC]Mechanism of ActionPhosphodiesterase 4 Inhibitors [MoA]UNIIQ2R47HGR7P

3)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugstructuredosagenumb.5drugstructuredosageunit032drugdosagetext0.5 DF, DAILY (50-MG TABLET CUT INTO HALF)drugdosageformFILM-COATED TABLETdrugadministrationroute048drugindicationANXIETYdrugstartdateformat610drugstartdate/11/2001actiondrug5drugadditional3

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)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugstructuredosagenumb150drugstructuredosageunit003drugdosagetext150 MG, DAILYdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugindicationGENERALISED ANXIETY DISORDERdrugstartdateformat610drugstartdate/11/2001actiondrug5drugadditional3

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

5)

drugcharacterization1medicinalproductZOLOFTdrugbatchnumbAX1873drugauthorizationnumb019839drugstructuredosagenumb150drugstructuredosageunit003drugdosagetext150 MG, DAILYdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugstartdateformat610drugstartdate/04/2020actiondrug5drugadditional3

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

6)

drugcharacterization2medicinalproductSKELAXINEdrugdosagetextUNK

activesubstance

activesubstancenameACETAMINOPHEN\CHLORZOXAZONE

7)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100 MGdrugdosageformFILM-COATED TABLETactiondrug5drugadditional3

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

8)

drugcharacterization2medicinalproductPREVACIDdrugstructuredosagenumb30drugstructuredosageunit003drugdosagetext30 MG, DAILYdrugindicationGASTROOESOPHAGEAL REFLUX DISEASE

activesubstance

activesubstancenameLANSOPRAZOLE

openFDA Info on Medication

Application NumberNDA020406, NDA022327Brand NamePREVACID, PREVACID 24 HRGeneric NameLANSOPRAZOLEManufacturers Takeda Pharmaceuticals America, Inc., GlaxoSmithKline Consumer Healthcare Holdin ... product_ndc64764-046, 64764-541, 64764-543, 64764-544, 0067-6286Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsLANSOPRAZOLERXCUI206205, 206206, 311277, 351260, 351261, 596843, 596918, 866152spl_ide9cb8e8b-589a-4d5d-9615-4bbd8dda0033, f2b830fb-0c23-494a-9d4c-76748dd7e1c6spl_set_id71ba78cb-7e46-43eb-9425-fa130f537f84, fd4629d5-b876-4ae9-bb32-c3560ad416a9Package NDC 64764-541-30, 64764-541-19, 64764-541-11, 64764-541-05, 64764-046-13, 64764-046- ... NUIN0000175525, N0000000147, N0000009724Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA]Physiologic/Pharmacodynamic EffectInhibition Gastric Acid Secretion [PE]UNII0K5C5T2QPG

summary

narrativeincludeclinicalCASE EVENT DATE: 200111

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014100947