Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10028731serious1Date Last Updated21/03/2014receiptdateformat102companynumbUS-009507513-0705USA02655occurcountryUSseriousnessother1duplicate1Date Received21/03/2014seriousnesshospitalization1transmissiondate02/10/2014primarysourcecountryUSseriousnessdisabling1

Primary Source

reportercountryUSqualification1

Patient

Weight64.41SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionOsteomyelitisOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionOsteonecrosis of jawOutcomeRecovering/resolving

3)

reactionmeddraversionpt17.0ReactionDepressionOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionHerpes zosterOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionAcute sinusitisOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionLymphadenitisOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionChondrocalcinosis pyrophosphateOutcomeRecovering/resolving

9)

reactionmeddraversionpt17.0ReactionOral herpesOutcomeUnknown

10)

reactionmeddraversionpt17.0ReactionPharyngeal cystOutcomeUnknown

11)

reactionmeddraversionpt17.0ReactionRib fractureOutcomeUnknown

12)

reactionmeddraversionpt17.0ReactionThoracic vertebral fractureOutcomeRecovering/resolving

13)

reactionmeddraversionpt17.0ReactionOesophageal candidiasisOutcomeUnknown

14)

reactionmeddraversionpt17.0ReactionImpaired gastric emptyingOutcomeUnknown

15)

reactionmeddraversionpt17.0ReactionRheumatoid arthritisOutcomeNot recovered/not resolved

16)

reactionmeddraversionpt17.0ReactionLarge intestine polypOutcomeUnknown

17)

reactionmeddraversionpt17.0ReactionHypertensionOutcomeUnknown

18)

reactionmeddraversionpt17.0ReactionBone disorderOutcomeUnknown

19)

reactionmeddraversionpt17.0ReactionFractureOutcomeUnknown

20)

reactionmeddraversionpt17.0ReactionFallOutcomeUnknown

21)

reactionmeddraversionpt17.0ReactionFoot deformityOutcomeUnknown

22)

reactionmeddraversionpt17.0ReactionArthropathyOutcomeUnknown

23)

reactionmeddraversionpt17.0ReactionSpinal osteoarthritisOutcomeUnknown

24)

reactionmeddraversionpt17.0ReactionOsteopeniaOutcomeUnknown

25)

reactionmeddraversionpt17.0ReactionDry eyeOutcomeUnknown

26)

reactionmeddraversionpt17.0ReactionHypoaesthesiaOutcomeUnknown

27)

reactionmeddraversionpt17.0ReactionFatigueOutcomeUnknown

28)

reactionmeddraversionpt17.0ReactionWeight decreasedOutcomeUnknown

29)

reactionmeddraversionpt17.0ReactionHypoaesthesiaOutcomeUnknown

30)

reactionmeddraversionpt17.0ReactionParaesthesiaOutcomeUnknown

31)

reactionmeddraversionpt17.0ReactionDysphagiaOutcomeUnknown

32)

reactionmeddraversionpt17.0ReactionDyspepsiaOutcomeUnknown

33)

reactionmeddraversionpt17.0ReactionBlood calcium increasedOutcomeUnknown

34)

reactionmeddraversionpt17.0ReactionArthropathyOutcomeUnknown

35)

reactionmeddraversionpt17.0ReactionTendon disorderOutcomeUnknown

36)

reactionmeddraversionpt17.0ReactionInsomniaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductFOSAMAXdrugauthorizationnumb020560drugstructuredosagenumb70drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext70 MG, QWdrugdosageformTABLETdrugadministrationroute048drugindicationOSTEOPOROSISdrugstartdateformat610drugstartdate/03/1998drugenddateformat610drugenddate/05/2006actiondrug4

openFDA Info on Medication

Application NumberNDA020560Brand NameFOSAMAXGeneric NameALENDRONATE SODIUMManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0031Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALENDRONATE SODIUMRXCUI904431, 904433spl_id37333f48-be6f-455d-878b-328bc51259c4spl_set_idf2dcfb39-a7c2-4e39-9e35-852a3a74f947Package NDC0006-0031-44UNII2UY4M2U3RA

2)

drugcharacterization1medicinalproductFOSAMAXdrugauthorizationnumb020560drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, QDdrugdosageformTABLETdrugadministrationroute048drugindicationSPINAL COMPRESSION FRACTUREdrugstartdateformat102drugstartdate04/11/1999drugenddateformat102drugenddate06/10/2002actiondrug4

openFDA Info on Medication

Application NumberNDA020560Brand NameFOSAMAXGeneric NameALENDRONATE SODIUMManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0031Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALENDRONATE SODIUMRXCUI904431, 904433spl_id37333f48-be6f-455d-878b-328bc51259c4spl_set_idf2dcfb39-a7c2-4e39-9e35-852a3a74f947Package NDC0006-0031-44UNII2UY4M2U3RA

3)

drugcharacterization2medicinalproductMORPHINEdrugindicationSPINAL COMPRESSION FRACTUREdrugstartdateformat602drugstartdate//1998drugenddateformat602drugenddate//2006

openFDA Info on Medication

Brand NameOPIUM TINCTURE DEODORIZEDGeneric NameMORPHINEManufacturersEdenbridge Pharmaceuticals, LLCproduct_ndc42799-217Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMORPHINERXCUI830196spl_id5b376952-010f-adfc-e053-2a91aa0ae464spl_set_ide2a5697a-cc41-4cf1-b3a8-59b0268740d7Package NDC42799-217-01, 42799-217-02NUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]UNII76I7G6D29C

4)

drugcharacterization2medicinalproductZOLOFTdrugindicationDEPRESSIONdrugstartdateformat602drugstartdate//1998

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)

drugcharacterization2medicinalproductMETICORTENdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, QDdrugdosageformTABLETdrugstartdateformat102drugstartdate01/01/1988drugrecurreadministration3

Report Duplicate

duplicatesourceMERCKduplicatenumbUS-009507513-0705USA02655

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use