Adverse Event Report

Report

reporttype1Version of Safety Report ID5receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10224156serious1Date Last Updated15/06/2015receiptdateformat102companynumbPHEH2012US026126occurcountryUSseriousnessother1duplicate1Date Received09/06/2014transmissiondate21/08/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionMouth ulcerationOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionToothacheOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionPhlebolithOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionThermal burnOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionVertebral foraminal stenosisOutcomeUnknown

6)

reactionmeddraversionpt18.0ReactionHead injuryOutcomeUnknown

7)

reactionmeddraversionpt18.0ReactionViral infectionOutcomeUnknown

8)

reactionmeddraversionpt18.0ReactionCerebral ventricle dilatationOutcomeUnknown

9)

reactionmeddraversionpt18.0ReactionMemory impairmentOutcomeUnknown

10)

reactionmeddraversionpt18.0ReactionHearing impairedOutcomeUnknown

11)

reactionmeddraversionpt18.0ReactionMicturition urgencyOutcomeUnknown

12)

reactionmeddraversionpt18.0ReactionConfusional stateOutcomeUnknown

13)

reactionmeddraversionpt18.0ReactionOsteomyelitisOutcomeUnknown

14)

reactionmeddraversionpt18.0ReactionSpinal fractureOutcomeUnknown

15)

reactionmeddraversionpt18.0ReactionThrombocytopeniaOutcomeUnknown

16)

reactionmeddraversionpt18.0ReactionOedema peripheralOutcomeUnknown

17)

reactionmeddraversionpt18.0ReactionTendernessOutcomeUnknown

18)

reactionmeddraversionpt18.0ReactionInfectionOutcomeUnknown

19)

reactionmeddraversionpt18.0ReactionOsteoarthritisOutcomeUnknown

20)

reactionmeddraversionpt18.0ReactionHand dermatitisOutcomeUnknown

21)

reactionmeddraversionpt18.0ReactionUrinary tract infectionOutcomeUnknown

22)

reactionmeddraversionpt18.0ReactionJoint effusionOutcomeUnknown

23)

reactionmeddraversionpt18.0ReactionHypercalcaemiaOutcomeUnknown

24)

reactionmeddraversionpt18.0ReactionMental status changesOutcomeUnknown

25)

reactionmeddraversionpt18.0ReactionLeft ventricular hypertrophyOutcomeUnknown

26)

reactionmeddraversionpt18.0ReactionCervical vertebral fractureOutcomeUnknown

27)

reactionmeddraversionpt18.0ReactionCerebral small vessel ischaemic diseaseOutcomeUnknown

28)

reactionmeddraversionpt18.0ReactionMetastases to lymph nodesOutcomeUnknown

29)

reactionmeddraversionpt18.0ReactionSwellingOutcomeUnknown

30)

reactionmeddraversionpt18.0ReactionLethargyOutcomeUnknown

31)

reactionmeddraversionpt18.0ReactionRashOutcomeUnknown

32)

reactionmeddraversionpt18.0ReactionPainOutcomeUnknown

33)

reactionmeddraversionpt18.0ReactionInjuryOutcomeUnknown

34)

reactionmeddraversionpt18.0ReactionEmotional distressOutcomeUnknown

35)

reactionmeddraversionpt18.0ReactionAnxietyOutcomeUnknown

36)

reactionmeddraversionpt18.0ReactionWoundOutcomeUnknown

37)

reactionmeddraversionpt18.0ReactionMetastases to boneOutcomeUnknown

38)

reactionmeddraversionpt18.0ReactionCholelithiasisOutcomeUnknown

39)

reactionmeddraversionpt18.0ReactionAnaemiaOutcomeUnknown

40)

reactionmeddraversionpt18.0ReactionRotator cuff syndromeOutcomeUnknown

41)

reactionmeddraversionpt18.0ReactionRib fractureOutcomeUnknown

42)

reactionmeddraversionpt18.0ReactionSinusitisOutcomeUnknown

43)

reactionmeddraversionpt18.0ReactionSynovial cystOutcomeUnknown

44)

reactionmeddraversionpt18.0ReactionUpper limb fractureOutcomeUnknown

45)

reactionmeddraversionpt18.0ReactionVision blurredOutcomeUnknown

46)

reactionmeddraversionpt18.0ReactionCataract nuclearOutcomeUnknown

47)

reactionmeddraversionpt18.0ReactionCerebrovascular disorderOutcomeUnknown

48)

reactionmeddraversionpt18.0ReactionJaw fractureOutcomeUnknown

49)

reactionmeddraversionpt18.0ReactionSubdural haematomaOutcomeUnknown

50)

reactionmeddraversionpt18.0ReactionPresbyacusisOutcomeUnknown

51)

reactionmeddraversionpt18.0ReactionDeliriumOutcomeUnknown

52)

reactionmeddraversionpt18.0ReactionHypoxiaOutcomeUnknown

53)

reactionmeddraversionpt18.0ReactionSensory lossOutcomeUnknown

54)

reactionmeddraversionpt18.0ReactionDehydrationOutcomeUnknown

55)

reactionmeddraversionpt18.0ReactionMuscular weaknessOutcomeUnknown

56)

reactionmeddraversionpt18.0ReactionPeripheral swellingOutcomeUnknown

57)

reactionmeddraversionpt18.0ReactionTherapeutic response decreasedOutcomeUnknown

58)

reactionmeddraversionpt18.0ReactionOsteonecrosis of jawOutcomeUnknown

59)

reactionmeddraversionpt18.0ReactionExposed bone in jawOutcomeUnknown

60)

reactionmeddraversionpt18.0ReactionMalignant neoplasm progressionOutcomeUnknown

61)

reactionmeddraversionpt18.0ReactionMetastases to skinOutcomeUnknown

62)

reactionmeddraversionpt18.0ReactionMetastases to meningesOutcomeUnknown

63)

reactionmeddraversionpt18.0ReactionPain in jawOutcomeUnknown

64)

reactionmeddraversionpt18.0ReactionPlasma cell myelomaOutcomeUnknown

65)

reactionmeddraversionpt18.0ReactionDeafnessOutcomeUnknown

66)

reactionmeddraversionpt18.0ReactionMetastases to liverOutcomeUnknown

67)

reactionmeddraversionpt18.0ReactionStomatitisOutcomeUnknown

68)

reactionmeddraversionpt18.0ReactionNeck painOutcomeUnknown

69)

reactionmeddraversionpt18.0ReactionGait disturbanceOutcomeUnknown

70)

reactionmeddraversionpt18.0ReactionCoughOutcomeUnknown

71)

reactionmeddraversionpt18.0ReactionPruritusOutcomeUnknown

72)

reactionmeddraversionpt18.0ReactionDeformityOutcomeUnknown

73)

reactionmeddraversionpt18.0ReactionTooth abscessOutcomeUnknown

74)

reactionmeddraversionpt18.0ReactionPeriodontal diseaseOutcomeUnknown

75)

reactionmeddraversionpt18.0ReactionImpaired healingOutcomeUnknown

76)

reactionmeddraversionpt18.0ReactionHyperlipidaemiaOutcomeUnknown

77)

reactionmeddraversionpt18.0ReactionPathological fractureOutcomeUnknown

78)

reactionmeddraversionpt18.0ReactionAortic valve incompetenceOutcomeUnknown

79)

reactionmeddraversionpt18.0ReactionMacular degenerationOutcomeUnknown

80)

reactionmeddraversionpt18.0ReactionOsteosclerosisOutcomeUnknown

81)

reactionmeddraversionpt18.0ReactionCheilitisOutcomeUnknown

82)

reactionmeddraversionpt18.0ReactionFallOutcomeUnknown

83)

reactionmeddraversionpt18.0ReactionBundle branch block rightOutcomeUnknown

84)

reactionmeddraversionpt18.0ReactionElectrocardiogram repolarisation abnormalityOutcomeUnknown

85)

reactionmeddraversionpt18.0ReactionCardiac failure congestiveOutcomeUnknown

86)

reactionmeddraversionpt18.0ReactionMassOutcomeUnknown

87)

reactionmeddraversionpt18.0ReactionGingival swellingOutcomeUnknown

88)

reactionmeddraversionpt18.0ReactionHumerus fractureOutcomeUnknown

89)

reactionmeddraversionpt18.0ReactionRib deformityOutcomeUnknown

90)

reactionmeddraversionpt18.0ReactionChest wall tumourOutcomeUnknown

91)

reactionmeddraversionpt18.0ReactionRespiratory tract congestionOutcomeUnknown

92)

reactionmeddraversionpt18.0ReactionUrinary incontinenceOutcomeUnknown

93)

reactionmeddraversionpt18.0ReactionAstheniaOutcomeUnknown

94)

reactionmeddraversionpt18.0ReactionFace injuryOutcomeUnknown

95)

reactionmeddraversionpt18.0ReactionErythemaOutcomeUnknown

96)

reactionmeddraversionpt18.0ReactionHypertensionOutcomeUnknown

97)

reactionmeddraversionpt18.0ReactionCentral nervous system lesionOutcomeUnknown

98)

reactionmeddraversionpt18.0ReactionMalignant melanomaOutcomeUnknown

99)

reactionmeddraversionpt18.0ReactionMetastatic malignant melanomaOutcomeUnknown

100)

reactionmeddraversionpt18.0ReactionUterine leiomyomaOutcomeUnknown

101)

reactionmeddraversionpt18.0ReactionSpinal cord compressionOutcomeUnknown

102)

reactionmeddraversionpt18.0ReactionDry age-related macular degenerationOutcomeUnknown

103)

reactionmeddraversionpt18.0ReactionAcute kidney injuryOutcomeUnknown

104)

reactionmeddraversionpt18.0ReactionDyspnoeaOutcomeUnknown

105)

reactionmeddraversionpt18.0ReactionLacerationOutcomeUnknown

106)

reactionmeddraversionpt18.0ReactionSkin abrasionOutcomeUnknown

107)

reactionmeddraversionpt18.0ReactionHaematomaOutcomeUnknown

108)

reactionmeddraversionpt18.0ReactionBone callus excessiveOutcomeUnknown

109)

reactionmeddraversionpt18.0ReactionSkin lesionOutcomeUnknown

110)

reactionmeddraversionpt18.0ReactionDecubitus ulcerOutcomeUnknown

111)

reactionmeddraversionpt18.0ReactionLip swellingOutcomeUnknown

112)

reactionmeddraversionpt18.0ReactionDecreased appetiteOutcomeUnknown

113)

reactionmeddraversionpt18.0ReactionMusculoskeletal painOutcomeUnknown

114)

reactionmeddraversionpt18.0ReactionFatigueOutcomeUnknown

115)

reactionmeddraversionpt18.0ReactionDiarrhoeaOutcomeUnknown

116)

reactionmeddraversionpt18.0ReactionDry skinOutcomeUnknown

117)

reactionmeddraversionpt18.0ReactionPhysical disabilityOutcomeUnknown

118)

reactionmeddraversionpt18.0ReactionPurulent dischargeOutcomeUnknown

119)

reactionmeddraversionpt18.0ReactionBone lesionOutcomeUnknown

120)

reactionmeddraversionpt18.0ReactionJaundiceOutcomeUnknown

121)

reactionmeddraversionpt18.0ReactionBile duct obstructionOutcomeUnknown

122)

reactionmeddraversionpt18.0ReactionJugular vein thrombosisOutcomeUnknown

123)

reactionmeddraversionpt18.0ReactionNeuropathy peripheralOutcomeUnknown

124)

reactionmeddraversionpt18.0ReactionMuscle atrophyOutcomeUnknown

125)

reactionmeddraversionpt18.0ReactionMetastases to spleenOutcomeUnknown

126)

reactionmeddraversionpt18.0ReactionCerebral atrophyOutcomeUnknown

127)

reactionmeddraversionpt18.0ReactionCerebellar atrophyOutcomeUnknown

128)

reactionmeddraversionpt18.0ReactionChronic sinusitisOutcomeUnknown

129)

reactionmeddraversionpt18.0ReactionPollakiuriaOutcomeUnknown

130)

reactionmeddraversionpt18.0ReactionBalance disorderOutcomeUnknown

131)

reactionmeddraversionpt18.0ReactionSubdural haemorrhageOutcomeUnknown

132)

reactionmeddraversionpt18.0ReactionFacial bones fractureOutcomeUnknown

133)

reactionmeddraversionpt18.0ReactionTooth lossOutcomeUnknown

134)

reactionmeddraversionpt18.0ReactionFemur fractureOutcomeUnknown

135)

reactionmeddraversionpt18.0ReactionJoint injuryOutcomeUnknown

136)

reactionmeddraversionpt18.0ReactionInterstitial lung diseaseOutcomeUnknown

137)

reactionmeddraversionpt18.0ReactionRespiratory failureOutcomeUnknown

138)

reactionmeddraversionpt18.0ReactionBone painOutcomeUnknown

139)

reactionmeddraversionpt18.0ReactionPallorOutcomeUnknown

140)

reactionmeddraversionpt18.0ReactionSkin discolourationOutcomeUnknown

141)

reactionmeddraversionpt18.0ReactionThirstOutcomeUnknown

142)

reactionmeddraversionpt18.0ReactionMobility decreasedOutcomeUnknown

143)

reactionmeddraversionpt18.0ReactionMetastases to central nervous systemOutcomeUnknown

144)

reactionmeddraversionpt18.0ReactionCerebral haemorrhageOutcomeUnknown

145)

reactionmeddraversionpt18.0ReactionHerpes simplexOutcomeUnknown

146)

reactionmeddraversionpt18.0ReactionPyogenic granulomaOutcomeUnknown

147)

reactionmeddraversionpt18.0ReactionTooth depositOutcomeUnknown

148)

reactionmeddraversionpt18.0ReactionChest painOutcomeUnknown

149)

reactionmeddraversionpt18.0ReactionVascular calcificationOutcomeUnknown

150)

reactionmeddraversionpt18.0ReactionSquamous cell carcinoma of skinOutcomeUnknown

151)

reactionmeddraversionpt18.0ReactionRalesOutcomeUnknown

152)

reactionmeddraversionpt18.0ReactionEcchymosisOutcomeUnknown

153)

reactionmeddraversionpt18.0ReactionDental discomfortOutcomeUnknown

154)

reactionmeddraversionpt18.0ReactionDementiaOutcomeUnknown

155)

reactionmeddraversionpt18.0ReactionBack painOutcomeUnknown

156)

reactionmeddraversionpt18.0ReactionSinus tachycardiaOutcomeUnknown

157)

reactionmeddraversionpt18.0ReactionPain in extremityOutcomeUnknown

158)

reactionmeddraversionpt18.0ReactionHyperkalaemiaOutcomeUnknown

159)

reactionmeddraversionpt18.0ReactionNauseaOutcomeUnknown

160)

reactionmeddraversionpt18.0ReactionContusionOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductFEMARAdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameLETROZOLE

openFDA Info on Medication

Application NumberNDA020726Brand NameFEMARAGeneric NameLETROZOLEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0249Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLETROZOLERXCUI153124, 200064spl_idc480ab42-8321-4cfb-acef-95c2c4b7c811spl_set_id82b77d74-085f-45ac-a7dd-1f5c038bf406Package NDC0078-0249-15NUIN0000175563, N0000175080Established Pharmacologic ClassAromatase Inhibitor [EPC]Mechanism of ActionAromatase Inhibitors [MoA]UNII7LKK855W8I

2)

drugcharacterization2medicinalproductOMEPRAZOLE.drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QDdrugdosageformCAPSULEdrugadministrationroute048drugindicationABDOMINAL DISCOMFORTactiondrug5

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA075757, ANDA206877, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, AC ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., OHM ... product_ndc 46122-281, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 62175-136, 078 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, 8c9d9c38-9da6-4f99-9f08-26ec4693fa55, ce5c ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c ... Package NDC 46122-281-04, 46122-281-74, 63981-915-55, 57483-740-01, 57483-740-42, 51660-029- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

3)

drugcharacterization1medicinalproductPAMIDRONATEdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenamePAMIDRONATE DISODIUM

4)

drugcharacterization1medicinalproductZOMETAdrugauthorizationnumb021223drugstructuredosagenumb3.5drugstructuredosageunit003drugdosagetext3.5 MGdrugdosageformSOLUTION FOR INJECTIONdrugadministrationroute042drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate07/04/2006drugenddateformat610drugenddate/04/2009actiondrug1

activesubstance

activesubstancenameZOLEDRONIC ACID

5)

drugcharacterization2medicinalproductLISINOPRIL.drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QDdrugdosageformTABLETdrugadministrationroute048drugindicationHYPERTENSIONactiondrug5

activesubstance

activesubstancenameLISINOPRIL

openFDA Info on Medication

Application Number ANDA076063, ANDA077321, NDA208401, ANDA078402, ANDA212041, ANDA076180, ANDA07616 ... Brand NameLISINOPRIL, QBRELIS, PRINIVIL, ZESTRILGeneric NameLISINOPRILManufacturers Hikma Pharmaceuticals USA Inc., International Laboratories, LLC, Azurity Pharmac ... product_ndc 0143-9713, 0143-9715, 0143-9714, 54458-872, 54458-877, 54458-874, 54458-873, 526 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 311354, 314076, 314077, 197884, 1806884, 1806890, 205326, 311353, 206764, 206765 ... spl_id 533f6e0f-04a0-4ef7-81b8-0a7be07ddd1a, b685bb45-44a6-4afc-bb3e-940bce536bda, 2fdc ... spl_set_id b70933da-55b2-4025-a00e-63ce3e6b7fdf, 6eef83b4-ce4c-462b-bcfa-eefa525e682d, 9f6e ... Package NDC 0143-9715-01, 0143-9715-10, 0143-9715-99, 0143-9714-01, 0143-9714-10, 0143-9714- ... UNIIE7199S1YWR

6)

drugcharacterization2medicinalproductINSULINdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameINSULIN NOS

7)

drugcharacterization2medicinalproductZOLOFTdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

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)

drugcharacterization2medicinalproductMILK OF MAGNESIAdrugstructuredosagenumb30drugstructuredosageunit012drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext30 ML, QD (400 MG/5ML)drugdosageformSUSPENSIONdrugadministrationroute048drugindicationCONSTIPATIONactiondrug5

activesubstance

activesubstancenameMAGNESIUM HYDROXIDE

openFDA Info on Medication

Application Numberpart334, part331Brand NameMILK OF MAGNESIAGeneric NameMAGNESIUM HYDROXIDE, MILK OF MAGNESIAManufacturers RITE AID PHARMACY, Major Pharmaceuticals, DOLGENCORP, INC., Aurohealth LLC, Meij ... product_ndc 11822-3329, 0904-6756, 55910-649, 58602-321, 41250-949, 37808-064, 72036-005, 30 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsMAGNESIUM HYDROXIDERXCUI253017, 314087, 307675, 1049906spl_id 98cfd7f0-7e1d-2444-e053-2a95a90af737, 35de3bdb-d476-4bd2-9d36-666f6c6ecb53, bad8 ... spl_set_id 5fb30d6d-b82c-1955-e053-2991aa0ab8cd, 35de3bdb-d476-4bd2-9d36-666f6c6ecb53, b699 ... Package NDC 11822-3329-8, 0904-6756-14, 55910-649-12, 58602-321-16, 58602-321-32, 41250-949- ... UNIINBZ3QY004S, 362O9ITL9D, TC2D6JAD40

9)

drugcharacterization2medicinalproductZETIAdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameEZETIMIBE

openFDA Info on Medication

Application NumberNDA021445Brand NameZETIAGeneric NameEZETIMIBEManufacturersMerck Sharp & Dohme Corp.product_ndc66582-414Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsEZETIMIBERXCUI349556, 352304spl_id2215c0c2-5f8d-4025-92b4-20b80d64194bspl_set_ida773b0b2-d31c-4ff4-b9e8-1eb2d3a4d62aPackage NDC 66582-414-31, 66582-414-54, 66582-414-74, 66582-414-76, 66582-414-29, 66582-414- ... NUIN0000008553, N0000175911Physiologic/Pharmacodynamic EffectDecreased Cholesterol Absorption [PE]Established Pharmacologic ClassDietary Cholesterol Absorption Inhibitor [EPC]UNIIEOR26LQQ24

10)

drugcharacterization2medicinalproductXELODAdrugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext500 MG, BIDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameCAPECITABINE

openFDA Info on Medication

Application NumberNDA020896Brand NameXELODAGeneric NameCAPECITABINEManufacturersGenentech, Inc.product_ndc0004-1100, 0004-1101Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCAPECITABINERXCUI200327, 200328, 213292, 213293spl_id7228932d-2f21-49d5-bcda-f7bf19928afdspl_set_ida1de8bba-3b1d-4c9d-ab8a-32d2c05e67c8Package NDC0004-1100-20, 0004-1101-50NUIN0000000233, N0000175595Mechanism of ActionNucleic Acid Synthesis Inhibitors [MoA]Established Pharmacologic ClassNucleoside Metabolic Inhibitor [EPC]UNII6804DJ8Z9U

11)

drugcharacterization2medicinalproductDIABINESEdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameCHLORPROPAMIDE

Report Duplicate

duplicatesourceNOVARTISduplicatenumbPHEH2012US026126

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use