Adverse Event Report

Report

reporttype1Version of Safety Report ID8receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10174653serious1Date Last Updated06/01/2016receiptdateformat102companynumbUS-GLAXOSMITHKLINE-A1073221AoccurcountryUSseriousnessother1duplicate1Date Received15/05/2014transmissiondate25/05/2016primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age44Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt19.0ReactionHepatic neoplasmOutcomeUnknown

2)

reactionmeddraversionpt19.0ReactionNauseaOutcomeUnknown

3)

reactionmeddraversionpt19.0ReactionAsthmaOutcomeUnknown

4)

reactionmeddraversionpt19.0ReactionDrug dose omissionOutcomeUnknown

5)

reactionmeddraversionpt19.0ReactionNasopharyngitisOutcomeUnknown

6)

reactionmeddraversionpt19.0ReactionHypersensitivityOutcomeUnknown

7)

reactionmeddraversionpt19.0ReactionInfluenzaOutcomeUnknown

8)

reactionmeddraversionpt19.0ReactionAdverse eventOutcomeUnknown

9)

reactionmeddraversionpt19.0ReactionMenorrhagiaOutcomeUnknown

10)

reactionmeddraversionpt19.0ReactionStressOutcomeUnknown

11)

reactionmeddraversionpt19.0ReactionMigraineOutcomeUnknown

12)

reactionmeddraversionpt19.0ReactionEndometriosisOutcomeUnknown

13)

reactionmeddraversionpt19.0ReactionNephrolithiasisOutcomeRecovering/resolving

14)

reactionmeddraversionpt19.0ReactionHeadacheOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductCLONAZEPAM.actiondrug5

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 IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_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

2)

drugcharacterization2medicinalproductPOTASSIUM CITRATE.actiondrug5

activesubstance

activesubstancenamePOTASSIUM CITRATE

openFDA Info on Medication

Application Number ANDA212799, ANDA209758, NDA019071, ANDA203546, ANDA214420, ANDA206813, ANDA21277 ... Brand NamePOTASSIUM CITRATE, UROCIT-K, POTASSIUM CITRATE EXTENDED RELEASEGeneric NamePOTASSIUM CITRATEManufacturers Bionpharma Inc., Actavis Pharma, Inc., Upsher-Smith Laboratories, LLC, Zydus Pha ... product_ndc 69452-193, 69452-194, 0591-2682, 0591-2729, 0591-2742, 0245-0070, 0245-0071, 683 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPOTASSIUM CITRATERXCUI199381, 898490, 199376, 603281, 603282, 898517spl_id b6453fd1-9688-357d-e053-2995a90a70c6, 784c8e2d-1a63-4751-ab72-38b985b1a1d4, 44a6 ... spl_set_id ca8a9a4f-3bdf-495c-8e58-714dc3f1c125, ac173781-486b-461c-97ae-8b5c69e20792, 2215 ... Package NDC 69452-193-20, 69452-193-30, 69452-194-20, 69452-194-30, 0591-2682-01, 0591-2729- ... UNIIEE90ONI6FF

3)

drugcharacterization2medicinalproductALLERCLEAR (NOS)actiondrug5

4)

drugcharacterization2medicinalproductSERTRALINE HYDROCHLORIDE.actiondrug5

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA077206, NDA020990, NDA019839, ANDA078861, ANDA077864, ANDA077106, ANDA076934 ... Brand NameSERTRALINE HYDROCHLORIDE, SERTRALINE, ZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturers Aurobindo Pharma Limited, Greenstone LLC, Rising Pharmaceuticals, Inc., Hikma Ph ... product_ndc 65862-011, 65862-012, 65862-013, 59762-0067, 59762-4960, 59762-4900, 59762-4910, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941, 861064, 208149, 208161, 212233, 861066spl_id 80aac5d8-bb02-46f5-a8ca-5fc9f934541c, 1ef7897d-60bb-4685-820f-21c78a097642, 96aa ... spl_set_id 39a85db1-9e59-4ab0-9e18-36757f019faa, 1a58062b-e635-431a-908d-2651c6a4a21c, af2c ... Package NDC 65862-011-30, 65862-011-50, 65862-011-60, 65862-011-90, 65862-011-01, 65862-011- ... UNIIUTI8907Y6X

5)

drugcharacterization2medicinalproductFLEXERILactiondrug5

activesubstance

activesubstancenameCYCLOBENZAPRINE HYDROCHLORIDE

openFDA Info on Medication

6)

drugcharacterization1medicinalproductIMITREXdrugbatchnumbUNKNOWNdrugstructuredosagenumb5drugstructuredosageunit003drugdosagetext5MG DOSE AS NEEDEDdrugdosageformNASAL SPRAYdrugadministrationroute045drugindicationMIGRAINEdrugstartdateformat610drugstartdate/05/2010actiondrug4

activesubstance

activesubstancenameSUMATRIPTAN SUCCINATE

openFDA Info on Medication

Application NumberNDA020080, NDA020132, NDA020626Brand NameIMITREXGeneric NameSUMATRIPTANManufacturersGlaxoSmithKline LLCproduct_ndc 0173-0449, 0173-0739, 0173-0479, 0173-0478, 0173-0735, 0173-0736, 0173-0737, 017 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUS, ORAL, NASALActive IngredientsSUMATRIPTAN SUCCINATE, SUMATRIPTANRXCUI 208452, 313165, 758523, 860088, 1657160, 1657173, 208450, 209169, 284460, 313160 ... spl_id 09b593bc-1a39-4a59-83da-ff02b99aabc3, 38f8e92e-6b77-4c8d-9069-09973b45be2c, 8a09 ... spl_set_id fee7d073-0b99-48f2-7985-0d8cf970894b, 584abe73-8290-4484-ff8e-5890831c095e, cc11 ... Package NDC 0173-0739-00, 0173-0739-02, 0173-0479-00, 0173-0478-00, 0173-0449-02, 0173-0735- ... UNIIJ8BDZ68989, 8R78F6L9VONUIN0000175763, N0000175764, N0000175765Mechanism of ActionSerotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA]Established Pharmacologic ClassSerotonin-1b and Serotonin-1d Receptor Agonist [EPC]

7)

drugcharacterization1medicinalproductIMITREXdrugbatchnumbUNKNOWNdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetextVARIABLE DOSE AS REQUIRED;50 MG TABLETSFU: 50 MG AND 100MGdrugdosageformTABLETdrugadministrationroute048drugindicationMIGRAINEdrugstartdateformat610drugstartdate/05/2010actiondrug4

activesubstance

activesubstancenameSUMATRIPTAN SUCCINATE

openFDA Info on Medication

Application NumberNDA020080, NDA020132, NDA020626Brand NameIMITREXGeneric NameSUMATRIPTANManufacturersGlaxoSmithKline LLCproduct_ndc 0173-0449, 0173-0739, 0173-0479, 0173-0478, 0173-0735, 0173-0736, 0173-0737, 017 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUS, ORAL, NASALActive IngredientsSUMATRIPTAN SUCCINATE, SUMATRIPTANRXCUI 208452, 313165, 758523, 860088, 1657160, 1657173, 208450, 209169, 284460, 313160 ... spl_id 09b593bc-1a39-4a59-83da-ff02b99aabc3, 38f8e92e-6b77-4c8d-9069-09973b45be2c, 8a09 ... spl_set_id fee7d073-0b99-48f2-7985-0d8cf970894b, 584abe73-8290-4484-ff8e-5890831c095e, cc11 ... Package NDC 0173-0739-00, 0173-0739-02, 0173-0479-00, 0173-0478-00, 0173-0449-02, 0173-0735- ... UNIIJ8BDZ68989, 8R78F6L9VONUIN0000175763, N0000175764, N0000175765Mechanism of ActionSerotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA]Established Pharmacologic ClassSerotonin-1b and Serotonin-1d Receptor Agonist [EPC]

8)

drugcharacterization2medicinalproductCRESTORactiondrug5

activesubstance

activesubstancenameROSUVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA021366Brand NameCRESTORGeneric NameROSUVASTATIN CALCIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0310-0751, 0310-0755, 0310-0752, 0310-0754Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsROSUVASTATIN CALCIUMRXCUI859419, 859421, 859424, 859426, 859747, 859749, 859751, 859753spl_id0abd2d1e-ee9a-4738-ad7e-610a2caa24abspl_set_idbb0f3b5e-4bc6-41c9-66b9-6257e2513512Package NDC 0310-0755-90, 0310-0751-90, 0310-0751-39, 0310-0752-90, 0310-0752-39, 0310-0754- ... UNII83MVU38M7Q

9)

drugcharacterization2medicinalproductFLONASEactiondrug5

activesubstance

activesubstancenameFLUTICASONE PROPIONATE

openFDA Info on Medication

Application NumberNDA205434Brand NameFLONASE ALLERGY RELIEFGeneric NameFLUTICASONE PROPIONATEManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLCproduct_ndc0135-0576Product TypeHUMAN OTC DRUGRouteNASALActive IngredientsFLUTICASONE PROPIONATERXCUI1797907, 1797933spl_id746e63f3-5386-4e7b-811d-8cfd3e9120d8spl_set_idb6134ba0-b70a-4eac-9a82-cef64b242c1dPackage NDC 0135-0576-01, 0135-0576-02, 0135-0576-03, 0135-0576-04, 0135-0576-12, 0135-0576- ... UNIIO2GMZ0LF5W

10)

drugcharacterization1medicinalproductFLONASEdrugbatchnumbUNKNOWNdrugauthorizationnumb020121drugstructuredosagenumb2drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 DF, QDdrugdosageformNASAL SPRAYdrugadministrationroute045drugindicationILL-DEFINED DISORDERdrugstartdateformat102drugstartdate11/08/2010actiondrug4

activesubstance

activesubstancenameFLUTICASONE PROPIONATE

openFDA Info on Medication

Application NumberNDA205434Brand NameFLONASE ALLERGY RELIEFGeneric NameFLUTICASONE PROPIONATEManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLCproduct_ndc0135-0576Product TypeHUMAN OTC DRUGRouteNASALActive IngredientsFLUTICASONE PROPIONATERXCUI1797907, 1797933spl_id746e63f3-5386-4e7b-811d-8cfd3e9120d8spl_set_idb6134ba0-b70a-4eac-9a82-cef64b242c1dPackage NDC 0135-0576-01, 0135-0576-02, 0135-0576-03, 0135-0576-04, 0135-0576-12, 0135-0576- ... UNIIO2GMZ0LF5W

11)

drugcharacterization1medicinalproductFLONASEdrugauthorizationnumb020121drugdosageformNASAL SPRAYdrugindicationMULTIPLE ALLERGIESactiondrug4

activesubstance

activesubstancenameFLUTICASONE PROPIONATE

openFDA Info on Medication

Application NumberNDA205434Brand NameFLONASE ALLERGY RELIEFGeneric NameFLUTICASONE PROPIONATEManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLCproduct_ndc0135-0576Product TypeHUMAN OTC DRUGRouteNASALActive IngredientsFLUTICASONE PROPIONATERXCUI1797907, 1797933spl_id746e63f3-5386-4e7b-811d-8cfd3e9120d8spl_set_idb6134ba0-b70a-4eac-9a82-cef64b242c1dPackage NDC 0135-0576-01, 0135-0576-02, 0135-0576-03, 0135-0576-04, 0135-0576-12, 0135-0576- ... UNIIO2GMZ0LF5W

12)

drugcharacterization1medicinalproductLOVAZAdrugbatchnumb3ZP3567drugstructuredosagenumb2drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 UNK, BIDdrugdosageformCAPSULEdrugadministrationroute048drugindicationBLOOD CHOLESTEROLdrugstartdateformat102drugstartdate11/05/2011actiondrug2

activesubstance

activesubstancenameOMEGA-3-ACID ETHYL ESTERS

openFDA Info on Medication

Application NumberNDA021654Brand NameLOVAZAGeneric NameOMEGA-3-ACID ETHYL ESTERSManufacturersGlaxoSmithKline LLCproduct_ndc0173-0884, 0173-0783Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEGA-3-ACID ETHYL ESTERSRXCUI577208, 607044spl_ide4239cb8-fd3c-41bd-96e5-20ecfe426351spl_set_id5ada82f0-a5fd-46c9-aecc-f106f614c9f0Package NDC0173-0783-02, 0173-0884-08UNIID87YGH4Z0Q

13)

drugcharacterization2medicinalproductTRILEPTALactiondrug5

activesubstance

activesubstancenameOXCARBAZEPINE

openFDA Info on Medication

Application NumberNDA021014, NDA021285Brand NameTRILEPTALGeneric NameOXCARBAZEPINEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0337, 0078-0456, 0078-0457, 0078-0357Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXCARBAZEPINERXCUI261356, 261360, 262090, 283536, 312136, 312137, 312138, 351992spl_id7c43c549-0c47-413c-8688-f1c383022bf0spl_set_id4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691bPackage NDC 0078-0456-05, 0078-0456-61, 0078-0456-35, 0078-0337-05, 0078-0337-61, 0078-0337- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNIIVZI5B1W380

14)

drugcharacterization2medicinalproductLORATADINE.actiondrug5

activesubstance

activesubstancenameLORATADINE

openFDA Info on Medication

Application Number ANDA210722, ANDA076471, ANDA076301, ANDA202538, ANDA076805, ANDA075209, ANDA0757 ... Brand Name LORATADINE, ALLERGY RELIEF, CHILDRENS LORATADINE SUGAR FREE, COUNTERACT ALLERGY, ... Generic NameLORATADINE, LORATADINE ORALManufacturers Granules India Ltd, Geri-Care Pharmaceutical Corp, Shopko Stores Operating Co., ... product_ndc 62207-787, 57896-788, 37012-612, 69452-211, 69842-540, 54473-166, 36800-608, 036 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLORATADINE, FAMOTIDINERXCUI 311372, 828269, 692783, 1087051, 311373, 665078, 744830, 206805, 1020126, 755478 ... spl_id 9aadc2f2-d0ea-5297-e053-2995a90ac51e, 9aa07ca9-ee19-89c7-e053-2a95a90ae9b5, 105d ... spl_set_id 0dee9036-d51f-4d7f-b5e2-4f6940249eef, 41fab408-35cb-47cc-bd4e-bba4ec10f6c7, 47b0 ... Package NDC 62207-787-51, 62207-787-59, 57896-788-03, 57896-788-09, 37012-612-65, 37012-612- ... UNII7AJO3BO7QN, 5QZO15J2Z8NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]

summary

narrativeincludeclinicalCASE EVENT DATE: 201009

Report Duplicate

duplicatesourceGLAXOSMITHKLINEduplicatenumbUS-GLAXOSMITHKLINE-A1073221A

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use