Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10097479serious1Date Last Updated23/01/2015receiptdateformat102companynumbUS-AMGEN-USASP2014009902occurcountryUSseriousnessother1duplicate1Date Received23/04/2014seriousnesshospitalization1transmissiondate20/07/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age28Unit of Onset Ageyearspatientagegroup5SexFemale

Contents

Reaction
- 1)
- 2)
- 3)
- 4)
- 5)
- 6)
- 7)
- 8)
- 9)
- 10)
- 11)
- 12)
- 13)
- 14)
- 15)
- 16)
- 17)
- 18)
- 19)
- 20)
- 21)
- 22)
- 23)
- 24)
Drug
summary

Reaction

1)

reactionmeddraversionpt18.0ReactionProductive coughOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionNauseaOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.0ReactionWeight increasedOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.0ReactionSkin abrasionOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt18.0ReactionInjection site urticariaOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt18.0ReactionUrticariaOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt18.0ReactionAcneOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt18.0ReactionUpper respiratory tract infectionOutcomeRecovered/resolved

9)

reactionmeddraversionpt18.0ReactionContusionOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt18.0ReactionVomitingOutcomeRecovered/resolved

11)

reactionmeddraversionpt18.0ReactionMalaiseOutcomeRecovered/resolved

12)

reactionmeddraversionpt18.0ReactionInjection site swellingOutcomeNot recovered/not resolved

13)

reactionmeddraversionpt18.0ReactionDental cariesOutcomeRecovered/resolved

14)

reactionmeddraversionpt18.0ReactionDrug ineffectiveOutcomeUnknown

15)

reactionmeddraversionpt18.0ReactionInfection susceptibility increasedOutcomeNot recovered/not resolved

16)

reactionmeddraversionpt18.0ReactionNasopharyngitisOutcomeRecovered/resolved

17)

reactionmeddraversionpt18.0ReactionNephrolithiasisOutcomeRecovered/resolved

18)

reactionmeddraversionpt18.0ReactionMemory impairmentOutcomeNot recovered/not resolved

19)

reactionmeddraversionpt18.0ReactionStaphylococcal infectionOutcomeRecovered/resolved

20)

reactionmeddraversionpt18.0ReactionCoughOutcomeRecovered/resolved

21)

reactionmeddraversionpt18.0ReactionStressOutcomeNot recovered/not resolved

22)

reactionmeddraversionpt18.0ReactionArthralgiaOutcomeNot recovered/not resolved

23)

reactionmeddraversionpt18.0ReactionInjection site erythemaOutcomeNot recovered/not resolved

24)

reactionmeddraversionpt18.0ReactionInjection site reactionOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductATENOLOL.drugdosagetextUNK

activesubstance

activesubstancenameATENOLOL

openFDA Info on Medication

Application Number NDA018240, ANDA078512, ANDA213136, ANDA077443, ANDA076900, ANDA074052, ANDA07302 ... Brand NameTENORMIN, ATENOLOLGeneric NameATENOLOLManufacturers Almatica Pharma LLC, Aurobindo Pharma Limited, Unichem Pharmaceuticals (USA), In ... product_ndc 52427-429, 52427-430, 52427-431, 65862-168, 65862-169, 65862-170, 29300-410, 293 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATENOLOLRXCUI150750, 152414, 197379, 197380, 197381, 201322spl_id 70291313-c4f6-7c2a-cd07-04fd6a07b634, 2f8a6d3c-fbcd-4b11-aa14-d0522fa7600e, d850 ... spl_set_id 746db603-a6e1-4dc3-c2d8-92314419098c, 1b8a4689-3916-4f4b-b54a-bbb4e322d79b, 35d9 ... Package NDC 52427-429-90, 52427-430-90, 52427-431-90, 65862-168-01, 65862-168-99, 65862-169- ... NUIN0000000161, N0000175556Mechanism of ActionAdrenergic beta-Antagonists [MoA]Established Pharmacologic Classbeta-Adrenergic Blocker [EPC]UNII50VV3VW0TI

2)

drugcharacterization2medicinalproductFAMOTIDINE.drugdosagetextUNK

activesubstance

activesubstancenameFAMOTIDINE

openFDA Info on Medication

Application Number ANDA075400, ANDA077351, ANDA206531, ANDA090837, ANDA078916, ANDA090283, ANDA0755 ... Brand Name ACID CONTROLLER, HARRIS TEETER ACID REDUCER, HEARTBURN PREVENTION, FAMOTIDINE, R ... Generic NameFAMOTIDINEManufacturers H E B, Harris Teeter, LLC, Kroger Company, Wal-Mart Stores, Inc., Aurohealth LLC ... product_ndc 37808-301, 69256-141, 30142-194, 49035-589, 58602-705, 37808-042, 0536-1298, 646 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsFAMOTIDINERXCUI 199047, 310273, 284245, 204441, 1743833, 310274, 104094, 206873, 199739, 104095, ... spl_id 1f77609d-de4d-4f77-9472-a072f8d73890, f33706dc-725a-4d6d-af1e-ede3740b1674, 5445 ... spl_set_id 813d742f-8f3d-4f18-a6c5-03eea946f976, af2c0c51-ac28-4bf4-8e60-ba6e12bfc302, c978 ... Package NDC 37808-301-65, 37808-301-72, 69256-141-65, 30142-194-71, 30142-194-02, 30142-194- ... NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]UNII5QZO15J2Z8

3)

drugcharacterization2medicinalproductGABAPENTIN.drugdosagetextUNK

activesubstance

activesubstancenameGABAPENTIN

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 6e41ce47-a6cc-4c34-84f1-305747df38c2, 5fc4 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

4)

drugcharacterization1medicinalproductMETHOTREXATEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameMETHOTREXATE

openFDA Info on Medication

Application Number NDA011719, ANDA040385, ANDA040263, ANDA040632, ANDA201529, ANDA201530, NDA008085 ... Brand NameMETHOTREXATE, TREXALL, RASUVO, XATMEP, REDITREX, OTREXUPGeneric NameMETHOTREXATE, METHOTREXATE SODIUMManufacturers Hospira, Inc., Teva Women's Health, Inc., Fresenius Kabi USA, LLC, Hikma Pharmac ... product_ndc 61703-350, 51285-366, 51285-367, 51285-368, 51285-369, 63323-123, 0143-9830, 674 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRA-ARTERIAL, INTRAMUSCULAR, INTRAVENOUS, ORAL, INTRATHECAL, SUBCUTANEOUSActive IngredientsMETHOTREXATE SODIUM, METHOTREXATERXCUI 1946772, 105586, 283510, 283511, 283671, 284592, 284593, 284594, 284595, 311625, ... spl_id 60bbb387-0ce5-4c7e-a917-5bc4b4685616, 78d0abc0-9ade-4302-ada0-72fd6d67eff9, 46c4 ... spl_set_id 0d63ba29-b692-41b4-87e8-351265c8273f, 0e30eaef-5a09-4104-8a11-c32933eadeab, e942 ... Package NDC 61703-350-37, 61703-350-38, 61703-350-09, 61703-350-10, 51285-366-01, 51285-367- ... UNII3IG1E710ZN, YL5FZ2Y5U1NUIN0000175584, N0000000111Established Pharmacologic ClassFolate Analog Metabolic Inhibitor [EPC]Mechanism of ActionFolic Acid Metabolism Inhibitors [MoA]

5)

drugcharacterization2medicinalproductNYSTATIN.drugdosagetextUNK

activesubstance

activesubstancenameNYSTATIN

openFDA Info on Medication

Application Number ANDA203621, ANDA064142, ANDA211838, ANDA062124, ANDA062838, ANDA065148, ANDA0651 ... Brand NameNYSTATIN, NYAMYC, NYSTOPGeneric NameNYSTATIN, NYSTATIN ORAL SUSPENSION, NYSTATIN OINTMENT, NYSTATIN CREAMManufacturers Pharmaceutical Associates, Inc., VistaPharm, Inc., Torrent Pharmaceuticals Limit ... product_ndc 0121-0810, 0121-4810, 66689-037, 13668-534, 0168-0007, 53489-400, 80432-003, 083 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, TOPICALActive IngredientsNYSTATINRXCUI312055, 884308, 312059, 584414, 646456, 543546, 261178spl_id a9034435-e353-7bf6-e053-2995a90a4867, 91e9fe62-a1e7-46e6-8357-cdc2a93cc62f, bede ... spl_set_id 31e3da10-5a7b-4bc5-8a4f-3e786b64c13a, 41034d7b-33a1-4d6d-b425-9cfefff8d518, 4949 ... Package NDC 0121-0810-02, 0121-0810-16, 0121-4810-05, 0121-4810-40, 0121-4810-00, 0121-4810- ... NUIN0000175498, M0017172Established Pharmacologic ClassPolyene Antifungal [EPC]Chemical StructurePolyenes [CS]UNIIBDF1O1C72E

6)

drugcharacterization2medicinalproductTIZANIDINE (TIZANIDINE)drugdosagetextUNK

activesubstance

activesubstancenameTIZANIDINE

7)

drugcharacterization2medicinalproductXOPENEXdrugdosagetextUNK

activesubstance

activesubstancenameLEVALBUTEROL HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020837Brand NameXOPENEXGeneric NameLEVALBUTEROL HYDROCHLORIDEManufacturersAkorn, Inc.product_ndc17478-172, 17478-173, 17478-174, 17478-171Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsLEVALBUTEROL HYDROCHLORIDERXCUI242754, 261136, 311286, 349590, 352132, 833470, 1855389, 1855391spl_id37feff22-df96-43eb-9d66-d15edb1c6faa, 2d495cb9-f9e7-4069-9d7f-c4c664bcaf40spl_set_id7e2644e6-36c5-4988-8e52-bec90e2cd2f0, 0c47c47d-45f7-4eb4-b1f8-7d6c633a1f69Package NDC 17478-172-12, 17478-172-24, 17478-173-12, 17478-173-24, 17478-174-12, 17478-174- ... UNIIWDQ1526QJM

8)

drugcharacterization1medicinalproductREMICADEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameINFLIXIMAB

openFDA Info on Medication

Application NumberBLA103772Brand NameREMICADEGeneric NameINFLIXIMABManufacturersJanssen Biotech, Inc.product_ndc57894-030Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsINFLIXIMABRXCUI213361, 310994spl_idba599d34-1a9a-47db-8414-8e7cfcb5d49dspl_set_ida0a046c1-056d-45a9-bfd9-13b47c24f257Package NDC57894-030-01NUIN0000175610, N0000175451Established Pharmacologic ClassTumor Necrosis Factor Blocker [EPC]Mechanism of ActionTumor Necrosis Factor Receptor Blocking Activity [MoA]UNIIB72HH48FLU

9)

drugcharacterization1medicinalproductPREDNISONE.drugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePREDNISONE

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

10)

drugcharacterization2medicinalproductB12 /00056201/drugdosagetextUNKdrugdosageformINJECTION

11)

drugcharacterization2medicinalproductNEXIUMdrugdosagetextUNK

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMspl_id3797ceb7-550b-4e9a-8314-8e1e4995360b, ac4ba22b-f431-4ab4-b239-0e220ad804ddspl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43HRXCUI486501, 603536

12)

drugcharacterization2medicinalproductSERTRALINEdrugdosagetextUNK

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

13)

drugcharacterization2medicinalproductHYDROXYZINEdrugdosagetextUNK

activesubstance

activesubstancenameHYDROXYZINE\HYDROXYZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA040808Brand NameHYDROXYZINE HYDROCHLORIDEGeneric NameHYDROXYZINEManufacturersAmneal Pharmaceuticals LLCproduct_ndc65162-575, 65162-671, 65162-577Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROXYZINE HYDROCHLORIDERXCUI995218, 995258, 995281spl_id8dad3af3-9788-466a-992a-6e261a3a7600spl_set_id89901966-724b-4773-98b8-ea663ceabd53Package NDC 65162-575-10, 65162-575-11, 65162-575-50, 65162-671-10, 65162-671-11, 65162-671- ... UNII76755771U3

14)

drugcharacterization1medicinalproductENBRELdrugbatchnumb1042402drugauthorizationnumb103795drugdosagetextUNKdrugdosageformSOLUTION FOR INJECTION IN PRE-FILLED SYRINGEdrugadministrationroute058drugindicationPSORIASISactiondrug5

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_id2ba5b73d-d161-42a8-94d1-2bdd101b2e98spl_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

15)

drugcharacterization2medicinalproductOXYMORPHONEdrugdosagetextUNK

activesubstance

activesubstancenameOXYMORPHONE

16)

drugcharacterization2medicinalproductSINGULAIRdrugdosagetextUNK

activesubstance

activesubstancenameMONTELUKAST SODIUM

openFDA Info on Medication

Application NumberNDA020829, NDA020830, NDA021409Brand NameSINGULAIRGeneric NameMONTELUKAST SODIUMManufacturersMerck Sharp & Dohme Corp.product_ndc0006-9117, 0006-3841, 0006-1711, 0006-9275Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406spl_id96717981-6ea2-4720-a749-e14f1559511fspl_set_id8c166755-7711-4df9-d689-8836a1a70885Package NDC 0006-3841-30, 0006-3841-14, 0006-1711-31, 0006-1711-54, 0006-9275-31, 0006-9275- ... UNIIU1O3J18SFL

17)

drugcharacterization2medicinalproductCLONAZEPAM.drugdosagetextUNK

activesubstance

activesubstancenameCLONAZEPAM

openFDA Info on Medication

Application Number ANDA077171, ANDA074569, ANDA074869, ANDA077194, ANDA077147, ANDA074979, ANDA2110 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Par Pharmaceutical, Inc., Teva Pharmaceuticals USA, Inc., Actavis Pharma, Inc., ... product_ndc 49884-306, 49884-307, 49884-308, 49884-309, 49884-310, 0093-0832, 0093-3212, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529spl_id a95f8799-0bb3-41d6-aa27-8a291127ad54, 90dc0b61-37a3-4e54-bde3-7e4c3f7dae98, 9b58 ... spl_set_id 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069b1a0-7c06-4252-b44e-e2eef065d9b8, a58f ... Package NDC 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02, 0093-0832- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

18)

drugcharacterization2medicinalproductWARFARINdrugdosagetextUNK

activesubstance

activesubstancenameWARFARIN

openFDA Info on Medication

Application NumberANDA090935, ANDA202202Brand NameWARFARIN SODIUMGeneric NameWARFARINManufacturersExelan Pharmaceuticals Inc., Amneal Pharmaceuticals LLCproduct_ndc 76282-327, 76282-328, 76282-329, 76282-330, 76282-331, 76282-332, 76282-333, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsWARFARIN SODIUMRXCUI855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 855344spl_id45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5, f0ce7015-9133-4b90-a624-77fb776fbfa7spl_set_idc0cc4511-e656-4b6d-96cd-e02e76173b9d, 558b7a0d-5490-4c1b-802e-3ab3f1efe760Package NDC 76282-327-01, 76282-327-10, 76282-328-01, 76282-328-10, 76282-329-01, 76282-329- ... UNII6153CWM0CL

19)

drugcharacterization1medicinalproductENBRELdrugbatchnumb1036340drugauthorizationnumb103795drugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext25 MG, QWKdrugdosageformSOLUTION FOR INJECTION IN PRE-FILLED SYRINGEdrugadministrationroute065drugindicationPSORIATIC ARTHROPATHYdrugstartdateformat102drugstartdate01/01/2001drugenddateformat610drugenddate/08/2014actiondrug5

activesubstance

activesubstancenameETANERCEPT

openFDA Info on Medication

20)

drugcharacterization2medicinalproductSYMBICORTdrugdosagetextUNK

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

21)

drugcharacterization2medicinalproductSYNTHROIDdrugdosagetextUNK

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM

openFDA Info on Medication

Application NumberNDA021402Brand NameSYNTHROIDGeneric NameLEVOTHYROXINE SODIUMManufacturersAbbVie Inc.product_ndc 0074-3727, 0074-7149, 0074-4341, 0074-4552, 0074-5182, 0074-6624, 0074-6594, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, ... spl_iddb21fc0c-4a2d-9922-39bd-8128e429bebcspl_set_id1e11ad30-1041-4520-10b0-8f9d30d30fccPackage NDC 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341- ... UNII9J765S329G

22)

drugcharacterization2medicinalproductXOLAIRdrugdosagetextUNKdrugdosageformINJECTIONdrugstartdateformat610drugstartdate/06/2014

activesubstance

activesubstancenameOMALIZUMAB

openFDA Info on Medication

Application NumberBLA103976Brand NameXOLAIRGeneric NameOMALIZUMABManufacturersGenentech, Inc.product_ndc50242-040, 50242-214, 50242-215Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsOMALIZUMABRXCUI1657209, 1657212, 2058943, 2058946, 2058949, 2058950spl_id2c703552-8c5b-4c50-b673-507f12080a27spl_set_id7f6a2191-adfb-48b9-9bfa-0d9920479f0dPackage NDC 50242-040-62, 50242-040-86, 50242-214-01, 50242-214-86, 50242-215-86, 50242-215- ... NUIN0000175794, N0000175793, N0000175792Established Pharmacologic ClassAnti-IgE [EPC]Physiologic/Pharmacodynamic EffectDecreased IgE Activity [PE]Mechanism of ActionIgE-directed Antibody Interactions [MoA]UNII2P471X1Z11

23)

drugcharacterization1medicinalproductPLAQUENILdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameHYDROXYCHLOROQUINE SULFATE

openFDA Info on Medication

Application NumberNDA009768Brand NamePLAQUENILGeneric NameHYDROXYCHLOROQUINE SULFATEManufacturersConcordia Pharmaceuticals Inc.product_ndc59212-562Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROXYCHLOROQUINE SULFATERXCUI979092, 979094spl_id763bd0fa-4ae7-451d-bf90-db9237f6a009spl_set_id34496b43-05a2-45fb-a769-52b12e099341Package NDC59212-562-10, 59212-562-60, 59212-562-11UNII8Q2869CNVH

24)

drugcharacterization2medicinalproductDOXEPINdrugdosagetextUNK

activesubstance

activesubstancenameDOXEPIN

openFDA Info on Medication

Application NumberANDA201951Brand NameDOXEPINGeneric NameDOXEPINManufacturersActavis Pharma, Inc.product_ndc0228-3315, 0228-3316Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDOXEPIN HYDROCHLORIDERXCUI966787, 966793spl_idaeefed70-09dc-4efa-809e-b80fe14656a6spl_set_idc42333f8-1add-4f33-9458-6fe4436874a1Package NDC0228-3315-03, 0228-3316-03UNII3U9A0FE9N5

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drugcharacterization2medicinalproductRIZATRIPTANdrugdosagetextUNK

activesubstance

activesubstancenameRIZATRIPTAN

openFDA Info on Medication

Application NumberANDA203147Brand NameRIZATRIPTANGeneric NameRIZATRIPTANManufacturersMacleods Pharmaceuticals Limitedproduct_ndc33342-087, 33342-088Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRIZATRIPTAN BENZOATERXCUI312840, 314209spl_id56501917-d17b-4912-8a4b-6a4690115eaespl_set_id27bc2cfc-fefb-4b50-a0dc-6268c69b4902Package NDC 33342-087-07, 33342-087-46, 33342-087-12, 33342-087-52, 33342-087-50, 33342-087- ... UNIIWR978S7QHH

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drugcharacterization2medicinalproductSPIRIVAdrugdosagetextUNK

activesubstance

activesubstancenameTIOTROPIUM BROMIDE MONOHYDRATE

openFDA Info on Medication

Application NumberNDA021395Brand NameSPIRIVA HANDIHALERGeneric NameTIOTROPIUM BROMIDEManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0075Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, RESPIRATORY (INHALATION)Active IngredientsTIOTROPIUM BROMIDE MONOHYDRATERXCUI485032, 580261spl_id61e158db-bf32-4cb5-8e5e-72acd953e493spl_set_id820839ef-e53d-47e8-a3b9-d911ff92e6a9Package NDC0597-0075-41, 0597-0075-75, 0597-0075-47UNIIL64SXO195N

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drugcharacterization2medicinalproductTOPIRAMATE.drugdosagetextUNK

activesubstance

activesubstancenameTOPIRAMATE

openFDA Info on Medication

Application Number ANDA079162, ANDA078235, NDA020505, NDA020844, NDA205122, ANDA078877, ANDA207382, ... Brand NameTOPIRAMATE, TOPAMAX, QUDEXY XR, TROKENDI XRGeneric NameTOPIRAMATEManufacturers Golden State Medical Supply, Inc., Cadila Healthcare Limited, Cipla USA Inc., Zy ... product_ndc 60429-769, 60429-770, 60429-771, 60429-772, 65841-647, 65841-648, 65841-649, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOPIRAMATERXCUI 151226, 199888, 199889, 199890, 151227, 151228, 151229, 152855, 205315, 205316, ... spl_id 7b3298bf-7f7e-d7d0-e053-2a91aa0ab74b, ecd79705-832b-42c4-be26-82d93432cf7c, 6885 ... spl_set_id 5c44de38-a291-471d-8335-abc65e04387d, 57016639-89fe-43ad-89c4-5e7a756dddec, 4087 ... Package NDC 60429-769-60, 60429-769-05, 60429-769-10, 60429-770-60, 60429-770-05, 60429-770- ... NUIN0000008486, N0000185506, N0000182140Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Mechanism of ActionCytochrome P450 3A4 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNII0H73WJJ391

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drugcharacterization2medicinalproductZYRTECdrugdosagetextUNK

activesubstance

activesubstancenameCETIRIZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022429Brand NameZYRTECGeneric NameCETIRIZINE HYDROCHLORIDEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-779Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCETIRIZINE HYDROCHLORIDERXCUI1014675, 1020023spl_idd7532844-79d8-4648-ab9b-e5d3d3ad76f9spl_set_id605adf29-734f-451a-8ff3-74be7b5814a6Package NDC50580-779-12, 50580-779-25, 50580-779-40, 50580-779-65UNII64O047KTOA

summary

narrativeincludeclinicalCASE EVENT DATE: 2001

Report Duplicate

duplicatesourceAMGENduplicatenumbUS-AMGEN-USASP2014009902

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use

Adverse Event Report

Report

Primary Source

Patient

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activesubstance

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activesubstance

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activesubstance

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activesubstance

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