Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10049821serious1Date Last Updated01/04/2014receiptdateformat102companynumbUS-009507513-1012USA01882occurcountryUSseriousnessother1duplicate1Date Received01/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUSseriousnessdisabling1

Primary Source

reportercountryUSqualification5

Patient

Weight58.6SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionIntramedullary rod insertionOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionIntramedullary rod insertionOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionLow turnover osteopathyOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionOsteoporosisOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionStress fractureOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionFallOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionHypertensionOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionHyperlipidaemiaOutcomeUnknown

9)

reactionmeddraversionpt17.0ReactionHaemoglobin decreasedOutcomeRecovering/resolving

10)

reactionmeddraversionpt17.0ReactionHaematocrit decreasedOutcomeRecovering/resolving

11)

reactionmeddraversionpt17.0ReactionCardiac failure congestiveOutcomeUnknown

12)

reactionmeddraversionpt17.0ReactionBreast cancer stage IIOutcomeUnknown

13)

reactionmeddraversionpt17.0ReactionModified radical mastectomyOutcomeUnknown

14)

reactionmeddraversionpt17.0ReactionIntraductal proliferative breast lesionOutcomeUnknown

15)

reactionmeddraversionpt17.0ReactionMastectomyOutcomeUnknown

16)

reactionmeddraversionpt17.0ReactionDeafnessOutcomeUnknown

17)

reactionmeddraversionpt17.0ReactionBreast reconstructionOutcomeUnknown

18)

reactionmeddraversionpt17.0ReactionAtypical femur fractureOutcomeUnknown

19)

reactionmeddraversionpt17.0ReactionAtypical femur fractureOutcomeUnknown

20)

reactionmeddraversionpt17.0ReactionTooth disorderOutcomeUnknown

21)

reactionmeddraversionpt17.0ReactionBlood potassium abnormalOutcomeUnknown

22)

reactionmeddraversionpt17.0ReactionTooth disorderOutcomeUnknown

23)

reactionmeddraversionpt17.0ReactionSinus disorderOutcomeUnknown

24)

reactionmeddraversionpt17.0ReactionHypercholesterolaemiaOutcomeNot recovered/not resolved

25)

reactionmeddraversionpt17.0ReactionTooth disorderOutcomeUnknown

26)

reactionmeddraversionpt17.0ReactionHypothyroidismOutcomeUnknown

27)

reactionmeddraversionpt17.0ReactionNervousnessOutcomeUnknown

28)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeUnknown

29)

reactionmeddraversionpt17.0ReactionDental cariesOutcomeUnknown

30)

reactionmeddraversionpt17.0ReactionSinus disorderOutcomeUnknown

31)

reactionmeddraversionpt17.0ReactionBone lossOutcomeUnknown

32)

reactionmeddraversionpt17.0ReactionGingival disorderOutcomeUnknown

33)

reactionmeddraversionpt17.0ReactionFungal infectionOutcomeUnknown

34)

reactionmeddraversionpt17.0ReactionViral cardiomyopathyOutcomeUnknown

35)

reactionmeddraversionpt17.0ReactionAtrophic vulvovaginitisOutcomeUnknown

36)

reactionmeddraversionpt17.0ReactionBlood parathyroid hormone increasedOutcomeUnknown

37)

reactionmeddraversionpt17.0ReactionHypercalciuriaOutcomeUnknown

38)

reactionmeddraversionpt17.0ReactionHaemorrhagic anaemiaOutcomeRecovering/resolving

39)

reactionmeddraversionpt17.0ReactionCardiomyopathyOutcomeUnknown

40)

reactionmeddraversionpt17.0ReactionGingival abscessOutcomeUnknown

41)

reactionmeddraversionpt17.0ReactionHaematocrit decreasedOutcomeUnknown

42)

reactionmeddraversionpt17.0ReactionBlood potassium decreasedOutcomeUnknown

43)

reactionmeddraversionpt17.0ReactionBlood creatinine increasedOutcomeUnknown

44)

reactionmeddraversionpt17.0ReactionFull blood count abnormalOutcomeUnknown

45)

reactionmeddraversionpt17.0ReactionRed blood cell count decreasedOutcomeUnknown

46)

reactionmeddraversionpt17.0ReactionDrug intoleranceOutcomeUnknown

47)

reactionmeddraversionpt17.0ReactionHypotensionOutcomeRecovered/resolved

48)

reactionmeddraversionpt17.0ReactionTinnitusOutcomeUnknown

49)

reactionmeddraversionpt17.0ReactionUpper respiratory tract infectionOutcomeUnknown

50)

reactionmeddraversionpt17.0ReactionKyphosisOutcomeUnknown

51)

reactionmeddraversionpt17.0ReactionTonsillectomyOutcomeUnknown

52)

reactionmeddraversionpt17.0ReactionArthritisOutcomeUnknown

53)

reactionmeddraversionpt17.0ReactionDepressionOutcomeUnknown

54)

reactionmeddraversionpt17.0ReactionFlatulenceOutcomeUnknown

55)

reactionmeddraversionpt17.0ReactionDrug ineffectiveOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductFOSAMAXdrugauthorizationnumb020560drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK UNK, QDdrugdosageformTABLETdrugadministrationroute048drugindicationOSTEOPOROSIS PROPHYLAXISactiondrug5

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)

drugcharacterization1medicinalproductFOSAMAXdrugauthorizationnumb020560drugstructuredosagenumb70drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext70 MG, QWdrugdosageformTABLETdrugadministrationroute048drugindicationOSTEOPENIAactiondrug5

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)

drugcharacterization1medicinalproductFOSAMAXdrugauthorizationnumb020560drugdosageformTABLETdrugindicationOSTEOPOROSISactiondrug5

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

4)

drugcharacterization2medicinalproductCENTRUM (MINERALS (UNSPECIFIED) (+) VITAMINS (UNSPECIFIED))drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK UNK, QDdrugdosageformTABLETdrugadministrationroute048

5)

drugcharacterization2medicinalproductCENTRUM SILVERdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK UNK, QDdrugdosageformTABLETdrugadministrationroute048

6)

drugcharacterization2medicinalproductXANAXdrugadministrationroute048drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia and Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_iddfdda989-af0a-4c14-871c-b26b7b6da50e, d95506a3-aba6-47f4-83c4-443a4cce678bspl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

7)

drugcharacterization2medicinalproductPEPCIDdrugdosageformTABLETdrugadministrationroute048drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA019527, ANDA075805Brand NamePEPCIDGeneric NameFAMOTIDINEManufacturersSalix Pharmaceuticals, Inc, Bausch Health Americas Inc.product_ndc65649-211, 0187-4420, 0187-4440Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFAMOTIDINERXCUI206873, 310274, 104094, 104095, 284245, 310273spl_id9e8f6a6d-4f04-4201-8d8e-802f08125adc, 117ab388-f0c2-4d9b-9cd0-1b7c478a665cspl_set_id4f1a0b58-f7c8-485e-a317-432e1c374d2f, a06502d9-7903-4f37-833e-e5763d502defPackage NDC65649-211-24, 0187-4420-30, 0187-4420-10, 0187-4440-30, 0187-4440-10NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]UNII5QZO15J2Z8

8)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, QD

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

9)

drugcharacterization2medicinalproductTAMOXIFEN CITRATEdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, QDdrugstartdateformat602drugstartdate//1997

openFDA Info on Medication

Application NumberANDA213358, ANDA206694, NDA021807, ANDA075797, ANDA070929, ANDA074732Brand NameTAMOXIFEN CITRATE, SOLTAMOXGeneric NameTAMOXIFEN CITRATEManufacturers Aurobindo Pharma Limited, Cadila Healthcare Limited, Fortovia Therapeutics Inc., ... product_ndc 59651-299, 59651-300, 70771-1184, 70771-1185, 89141-123, 51862-446, 51862-447, 6 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTAMOXIFEN CITRATERXCUI198240, 313195, 389230, 644304spl_id a596c715-8e30-43c1-aba3-4fe5de6729fa, 10bf4f8f-3e14-42f0-a5c8-ee569027a602, 892c ... spl_set_id a596c715-8e30-43c1-aba3-4fe5de6729fa, 70052366-80f3-41bc-b2dd-c1efe9317243, bd72 ... Package NDC 59651-299-60, 59651-300-30, 59651-300-90, 70771-1184-6, 70771-1184-9, 70771-1184 ... UNII7FRV7310N6

10)

drugcharacterization2medicinalproductCOREGdrugstructuredosagenumb6.25drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext6.25 MG, BIDdrugadministrationroute048drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA022012, NDA020297Brand NameCOREG CR, COREGGeneric NameCARVEDILOL PHOSPHATE, CARVEDILOLManufacturersGlaxoSmithKline LLCproduct_ndc 0007-3370, 0007-3371, 0007-3372, 0007-3373, 0007-3383, 0007-3385, 0007-3387, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCARVEDILOL PHOSPHATE, CARVEDILOLRXCUI 860510, 860512, 860516, 860518, 860522, 860524, 860532, 860534, 200031, 200032, ... spl_idfa474dd1-fddd-4f3b-9ac6-338b160458ee, d1eb3353-1a6e-4fa8-ae95-7a3e94ee1da8spl_set_id06400a4c-42b4-440a-92b4-1f47f98ac7ba, c57982f2-c7da-488a-7ea9-b9609439ac68Package NDC 0007-3370-13, 0007-3371-13, 0007-3372-13, 0007-3373-13, 0007-3373-61, 0007-3383- ... UNIIEQT531S367, 0K47UL67F2NUIN0000000099, N0000009923, N0000009924, N0000175553, N0000175556Mechanism of Action Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenerg ... Established Pharmacologic Classalpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]

11)

drugcharacterization2medicinalproductTHERAPY UNSPECIFIEDdrugrecurreadministration3

12)

drugcharacterization2medicinalproductVITAMIN D (UNSPECIFIED)drugstructuredosagenumb1000drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1000 DF, QDdrugindicationOSTEOPOROSISdrugrecurreadministration3

13)

drugcharacterization2medicinalproductCALCIUM (UNSPECIFIED)drugindicationOSTEOPOROSISdrugrecurreadministration3

14)

drugcharacterization2medicinalproductESTROGENS (UNSPECIFIED)drugdosagetextUNKdrugindicationOSTEOPOROSISdrugenddateformat610drugenddate/07/1997drugrecurreadministration3

15)

drugcharacterization2medicinalproductCORTICOSTEROIDS (UNSPECIFIED)drugadministrationroute061drugindicationPSORIASISdrugrecurreadministration3

16)

drugcharacterization2medicinalproductPREDNISONEdrugindicationCOLITIS ULCERATIVEdrugrecurreadministration3

openFDA Info on Medication

Application Number NDA202020, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA040584, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., GeneYork Pharmaceuticals Group LLC, Mylan Pharma ... product_ndc 75987-020, 75987-021, 75987-022, 71329-106, 0378-0640, 0378-0641, 0378-0642, 060 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id be29c86d-242b-42a7-9488-ecf6f76426cd, 4384c1d1-059b-4689-9f3d-1078de814ce8, 88a6 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, be50449f-3aa8-46b7-9246-2dbd5f04f2b1, fec0 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

Report Duplicate

duplicatesourceMERCKduplicatenumbUS-009507513-1012USA01882

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use