Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-PFIZER INC-2014092946occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10058521Date Received04/04/2014transmissiondate12/12/2014serious2Date Last Updated04/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age35Unit of Onset AgeyearsWeight88.44SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionDrug interactionOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionHyperhidrosisOutcomeRecovering/resolving

3)

reactionmeddraversionpt17.0ReactionPalpitationsOutcomeRecovering/resolving

4)

reactionmeddraversionpt17.0ReactionDizzinessOutcomeRecovering/resolving

5)

reactionmeddraversionpt17.0ReactionPresyncopeOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductZITHROMAXdrugauthorizationnumb50670drugdosagetextUNKdrugindicationNASOPHARYNGITISdrugstartdateformat102drugstartdate23/03/2014drugenddateformat102drugenddate25/03/2014actiondrug1

openFDA Info on Medication

Brand NameZITHROMAXGeneric NameAZITHROMYCIN DIHYDRATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc 0069-9500, 0069-3060, 0069-3070, 0069-3110, 0069-3120, 0069-3130, 0069-3140, 006 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsAZITHROMYCIN DIHYDRATERXCUI 212446, 308460, 105260, 141963, 211307, 226827, 248656, 308459, 749780, 749783, ... spl_id 6ea307ee-5dc2-4ef8-9520-5dffec6a3e55, b829a0c5-0929-457e-843c-b9f349c1d99f, ae41 ... spl_set_id fb3d03d8-c7c1-48c4-b5ac-91ed0398f0d2, db52b91e-79f7-4cc1-9564-f2eee8e31c45, 3b63 ... Package NDC 0069-9500-01, 0069-3060-30, 0069-3060-75, 0069-3060-86, 0069-3070-30, 0069-3070- ... UNII5FD1131I7SApplication NumberNDA050711, NDA050784, NDA050710, NDA050733, NDA050693

2)

drugcharacterization3medicinalproductZOLOFTdrugauthorizationnumb019839drugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, DAILYdrugindicationANXIETYactiondrug5

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

3)

drugcharacterization3medicinalproductZOLOFTdrugauthorizationnumb019839drugindicationDEPRESSIONactiondrug5

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

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014092946