Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10458243primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate28/05/2015reporttype2serious1seriousnessother1receivedateformat102Date Received17/09/2014receiptdateformat102Date Last Updated29/10/2014fulfillexpeditecriteria2companynumbUS-AMGEN-USASP2014070737duplicate1

Report Duplicate

duplicatesourceAMGENduplicatenumbUS-AMGEN-USASP2014070737

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age50Unit of Onset Ageyearspatientagegroup5Weight62.59SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionLung disorderOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionScarOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionMusculoskeletal painOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionArthropathyOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionCataractOutcomeUnknown

6)

reactionmeddraversionpt18.0ReactionRashOutcomeRecovered/resolved

7)

reactionmeddraversionpt18.0ReactionHyperlipidaemiaOutcomeUnknown

8)

reactionmeddraversionpt18.0ReactionHand deformityOutcomeUnknown

9)

reactionmeddraversionpt18.0ReactionJoint range of motion decreasedOutcomeUnknown

10)

reactionmeddraversionpt18.0ReactionDysphoniaOutcomeUnknown

11)

reactionmeddraversionpt18.0ReactionInjection site painOutcomeNot recovered/not resolved

12)

reactionmeddraversionpt18.0ReactionFoot fractureOutcomeUnknown

13)

reactionmeddraversionpt18.0ReactionUpper limb fractureOutcomeUnknown

14)

reactionmeddraversionpt18.0ReactionAccidentOutcomeUnknown

15)

reactionmeddraversionpt18.0ReactionHypertensionOutcomeUnknown

16)

reactionmeddraversionpt18.0ReactionGastrooesophageal reflux diseaseOutcomeUnknown

17)

reactionmeddraversionpt18.0ReactionPulmonary massOutcomeUnknown

18)

reactionmeddraversionpt18.0ReactionContusionOutcomeUnknown

19)

reactionmeddraversionpt18.0ReactionInjection site swellingOutcomeNot recovered/not resolved

20)

reactionmeddraversionpt18.0ReactionOsteopeniaOutcomeUnknown

21)

reactionmeddraversionpt18.0ReactionVitamin D deficiencyOutcomeUnknown

22)

reactionmeddraversionpt18.0ReactionAnkle deformityOutcomeUnknown

23)

reactionmeddraversionpt18.0ReactionHyperkeratosisOutcomeUnknown

24)

reactionmeddraversionpt18.0ReactionTooth abscessOutcomeUnknown

25)

reactionmeddraversionpt18.0ReactionSynovitisOutcomeUnknown

26)

reactionmeddraversionpt18.0ReactionAnxietyOutcomeUnknown

27)

reactionmeddraversionpt18.0ReactionFallOutcomeUnknown

28)

reactionmeddraversionpt18.0ReactionRheumatoid arthritisOutcomeUnknown

29)

reactionmeddraversionpt18.0ReactionUrinary incontinenceOutcomeUnknown

30)

reactionmeddraversionpt18.0ReactionFatigueOutcomeUnknown

31)

reactionmeddraversionpt18.0ReactionInsomniaOutcomeUnknown

32)

reactionmeddraversionpt18.0ReactionBone deformityOutcomeUnknown

33)

reactionmeddraversionpt18.0ReactionFoot deformityOutcomeUnknown

34)

reactionmeddraversionpt18.0ReactionInjection site pruritusOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductLIPITORdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, QDdrugadministrationroute048

activesubstance

activesubstancenameATORVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA020702Brand NameLIPITORGeneric NameATORVASTATIN CALCIUMManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0155, 0071-0156, 0071-0157, 0071-0158Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATORVASTATIN CALCIUM TRIHYDRATERXCUI259255, 262095, 617310, 617311, 617312, 617314, 617318, 617320spl_idb95993d7-bc87-4d0a-9926-e3d36c5b3b4espl_set_idc6e131fe-e7df-4876-83f7-9156fc4e8228Package NDC 0071-0155-23, 0071-0155-40, 0071-0155-97, 0071-0156-23, 0071-0156-40, 0071-0156- ... UNII48A5M73Z4Q

2)

drugcharacterization2medicinalproductBENICARdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, DAILYdrugadministrationroute048drugindicationHYPERTENSION

activesubstance

activesubstancenameOLMESARTAN MEDOXOMIL

openFDA Info on Medication

Application NumberNDA021286Brand NameBENICARGeneric NameOLMESARTAN MEDOXOMILManufacturersCosette Pharmaceuticals, Inc., Daiichi Sankyo, Inc.product_ndc0713-0860, 0713-0861, 0713-0862, 65597-101, 65597-103, 65597-104Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOLMESARTAN MEDOXOMILspl_ide1e58027-cc06-6f64-e053-2995a90a9309, 9a1acd82-0655-4e72-9177-12ddf31c4b1bspl_set_id5b6f8a18-8f8a-4521-81c3-3a39c73c6646, 33770d80-754f-11de-8dba-0002a5d5c51bPackage NDC 0713-0860-30, 0713-0861-30, 0713-0862-30, 65597-101-30, 65597-103-03, 65597-103- ... UNII6M97XTV3HDRXCUI349373, 349401, 349405, 352199, 352200, 352201

3)

drugcharacterization2medicinalproductSYMBICORTdrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK UNK, BID

activesubstance

activesubstancenameBUDESONIDE\FORMOTEROL FUMARATE DIHYDRATE

openFDA Info on Medication

Application NumberNDA021929Brand NameSYMBICORTGeneric NameBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0186-0370, 0186-0372Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsBUDESONIDE, FORMOTEROL FUMARATERXCUI1246288, 1246290, 1246304, 1246306, 1246314, 1246315, 1246316, 1246317spl_id5b03fd09-2533-4975-88da-a0b9c8495d1espl_set_idfafa4cf1-99c2-43d5-73ad-51f256de3be0Package NDC 0186-0370-20, 0186-0370-28, 0186-0370-60, 0186-0372-20, 0186-0372-28, 0186-0372- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIW34SHF8J2K, Q3OKS62Q6X

4)

drugcharacterization2medicinalproductFOLIC ACID.drugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, DAILYdrugadministrationroute048

activesubstance

activesubstancenameFOLIC ACID

openFDA Info on Medication

Brand NameVENTRIXYL, FOLIC ACID, VENEXA, VITRAMYN, MULTITAM, VITREXYL, VITREXATE, VITRANOLGeneric NameFOLIC ACIDManufacturers PureTek Corporation, Leading Pharma, LLC, Amneal Pharmaceuticals of New York LLC ... product_ndc 59088-186, 69315-127, 53746-361, 10135-182, 59088-176, 71209-007, 11534-165, 586 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSActive Ingredients .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CALCIUM CARBONATE, CHOLECALCIFER ... spl_id c705632c-cd1a-0f43-e053-2995a90aa0b3, 92322e52-3179-4738-8c8a-14fef62311d4, ca64 ... spl_set_id c29dc729-93be-2a20-e053-2a95a90a8ca3, 1ba8c407-9613-4319-ac40-0a429cb0f3f4, fd85 ... Package NDC 59088-186-54, 69315-127-01, 69315-127-10, 53746-361-01, 53746-361-10, 10135-182- ... NUIN0000193618, M0001797, M0022797, N0000175952, M0022794, N0000175951Established Pharmacologic ClassVitamin C [EPC], Vitamin D [EPC], Vitamin B12 [EPC]Chemical StructureAscorbic Acid [CS], Vitamin D [CS], Vitamin B 12 [CS]UNII WR1WPI7EW8, PQ6CK8PD0R, H0G9379FGK, 1C6V77QF41, A150AY412V, P6YC3EG204, 935E97BO ... Application Number ANDA040796, ANDA040625, ANDA204418, ANDA202437, ANDA211064, ANDA202522, ANDA0911 ... RXCUI310410, 237786

5)

drugcharacterization2medicinalproductPLAQUENILdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext200 MG, BIDdrugadministrationroute048

activesubstance

activesubstancenameHYDROXYCHLOROQUINE SULFATE

openFDA Info on Medication

Application NumberNDA009768Brand NamePLAQUENILGeneric NameHYDROXYCHLOROQUINE SULFATEManufacturersConcordia Pharmaceuticals Inc.product_ndc59212-562Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROXYCHLOROQUINE SULFATERXCUI979092, 979094spl_idda37c8d1-331e-4549-aabc-68e2e4207df8spl_set_id34496b43-05a2-45fb-a769-52b12e099341Package NDC59212-562-10, 59212-562-60, 59212-562-11UNII8Q2869CNVH

6)

drugcharacterization2medicinalproductARAVAdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, BIDdrugadministrationroute048

activesubstance

activesubstancenameLEFLUNOMIDE

openFDA Info on Medication

Application NumberNDA020905Brand NameARAVAGeneric NameLEFLUNOMIDEManufacturerssanofi-aventis U.S. LLCproduct_ndc0088-2160, 0088-2161, 0088-2162Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEFLUNOMIDERXCUI205284, 205285, 205286, 213377, 213379, 213380spl_id7cce9e2d-10dd-4db0-a75a-bad58e9d1accspl_set_id320f63f2-fac3-4aee-aff8-85724e00ef52Package NDC0088-2160-30, 0088-2161-30, 0088-2162-33NUIN0000175713Established Pharmacologic ClassAntirheumatic Agent [EPC]UNIIG162GK9U4W

7)

drugcharacterization1medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition805drugdosagetext3 MG, QHSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

8)

drugcharacterization2medicinalproductVITAMIN D /00107901/drugstructuredosagenumb1000drugstructuredosageunit025drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1000 IU, DAILY

activesubstance

activesubstancenameERGOCALCIFEROL

9)

drugcharacterization1medicinalproductENBRELdrugauthorizationnumb103795drugdosagetextUNKdrugadministrationroute065drugindicationRHEUMATOID ARTHRITISdrugstartdateformat602drugstartdate//2003

activesubstance

activesubstancenameETANERCEPT

openFDA Info on Medication

Application NumberBLA103795Brand NameENBRELGeneric NameETANERCEPTManufacturersImmunex Corporationproduct_ndc 58406-010, 58406-435, 58406-445, 58406-425, 58406-455, 58406-456, 58406-446, 584 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsETANERCEPTRXCUI 253014, 261105, 727757, 802652, 809158, 809159, 1653223, 1653225, 2182338, 21823 ... spl_id39050cb4-28d1-4305-a653-e5e50098c824spl_set_ida002b40c-097d-47a5-957f-7a7b1807af7fPackage NDC 58406-435-01, 58406-435-04, 58406-445-01, 58406-445-04, 58406-425-41, 58406-425- ... NUIN0000175610, N0000175451Established Pharmacologic ClassTumor Necrosis Factor Blocker [EPC]Mechanism of ActionTumor Necrosis Factor Receptor Blocking Activity [MoA]UNIIOP401G7OJC

10)

drugcharacterization2medicinalproductDETROLdrugstructuredosagenumb4drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext4 MG, DAILYdrugadministrationroute048

activesubstance

activesubstancenameTOLTERODINE TARTRATE

openFDA Info on Medication

Application NumberNDA020771Brand NameDETROLGeneric NameTOLTERODINE TARTRATEManufacturersPharmacia & Upjohn Company LLCproduct_ndc0009-4541, 0009-4544Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOLTERODINE TARTRATERXCUI855178, 855180, 855194, 855195spl_id75d531d1-9683-4809-ab23-7f7872928085spl_set_id42f819c9-4108-4ca7-92c5-a213037dd4dbPackage NDC 0009-4541-02, 0009-4541-03, 0009-4541-01, 0009-4544-02, 0009-4544-03, 0009-4544- ... UNII5T619TQR3R

summary

narrativeincludeclinicalCASE EVENT DATE: 2003