Report

Version of Safety Report ID1Safety Report ID10491469primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate28/05/2015reporttype1serious2receivedateformat102Date Received02/10/2014receiptdateformat102Date Last Updated02/10/2014fulfillexpeditecriteria2companynumbUS-GLAXOSMITHKLINE-A1053739Aduplicate1

Report Duplicate

duplicatesourceGLAXOSMITHKLINEduplicatenumbUS-GLAXOSMITHKLINE-A1053739A

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age65Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionRetchingOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionChoking sensationOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionNasal discomfortOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionExpired product administeredOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionBronchitisOutcomeUnknown

6)

reactionmeddraversionpt18.0ReactionNasopharyngitisOutcomeUnknown

7)

reactionmeddraversionpt18.0ReactionNervousnessOutcomeUnknown

8)

reactionmeddraversionpt18.0ReactionDyspnoeaOutcomeUnknown

9)

reactionmeddraversionpt18.0ReactionLaryngitisOutcomeUnknown

10)

reactionmeddraversionpt18.0ReactionCoughOutcomeUnknown

11)

reactionmeddraversionpt18.0ReactionVomitingOutcomeUnknown

12)

reactionmeddraversionpt18.0ReactionDrug ineffectiveOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductBACLOFEN.

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA209102, ANDA215885, ANDA209594, ANDA074584, ANDA2100 ... Brand NameBACLOFEN, BACLOFEN (INTRATHECAL), LYVISPAH, OZOBAX, FLEQSUVYGeneric NameBACLOFENManufacturers Northstar RxLLC, TruPharma LLC, Lifestar Pharma LLC, Mylan Institutional LLC, Up ... product_ndc 16714-071, 16714-072, 52817-319, 52817-320, 52817-321, 70756-085, 70756-288, 707 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 430902, 1300890, 308517, 1666613, 2586589, 2586595, 2586596, 258 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, b8da4a75-4c34-1d06-e053-2a95a90a7886, f4a6 ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 68aa591e-ea98-4438-9a4a-4f7e9ea2b285, f9dd ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 52817-319-10, 52817-320- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

2)

drugcharacterization2medicinalproductVASOTEC

activesubstance

activesubstancenameENALAPRIL MALEATE

openFDA Info on Medication

Application NumberNDA018998Brand NameVASOTECGeneric NameENALAPRIL MALEATEManufacturersBausch Health US LLCproduct_ndc0187-0140, 0187-0141, 0187-0142, 0187-0143Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsENALAPRIL MALEATERXCUI858804, 858806, 858810, 858812, 858813, 858815, 858817, 858819spl_id18a458cc-976a-4019-bd85-18f55a224f45spl_set_id39631f1f-5d19-43c1-b504-bf56d991ed97Package NDC 0187-0140-30, 0187-0140-90, 0187-0141-30, 0187-0141-90, 0187-0141-10, 0187-0142- ... UNII9O25354EPJ

3)

drugcharacterization2medicinalproductFLONASE

activesubstance

activesubstancenameFLUTICASONE PROPIONATE

openFDA Info on Medication

Application NumberNDA205434, part341Brand NameFLONASE ALLERGY RELIEF, FLONASE HEADACHE AND ALLERGY RELIEFGeneric Name FLUTICASONE PROPIONATE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE H ... ManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLCproduct_ndc0135-0576, 0135-0578Product TypeHUMAN OTC DRUGRouteNASAL, ORALActive Ingredients FLUTICASONE PROPIONATE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE H ... RXCUI1797907, 1797933, 1046781spl_id1f0c6c8a-8452-45ae-8ed6-517e855d70b9, 282c103c-3888-4a35-a5b1-d492ed6892c1spl_set_idb6134ba0-b70a-4eac-9a82-cef64b242c1d, 282c103c-3888-4a35-a5b1-d492ed6892c1Package NDC 0135-0576-01, 0135-0576-02, 0135-0576-03, 0135-0576-04, 0135-0576-12, 0135-0576- ... UNIIO2GMZ0LF5W, 362O9ITL9D, V1Q0O9OJ9Z, 04JA59TNSJ

4)

drugcharacterization1medicinalproductADVAIR HFAdrugauthorizationnumb021077drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1PUFF TWICE PER DAYdrugdosageformMulti dose powder inhalerdrugadministrationroute055drugindicationASTHMAactiondrug4

activesubstance

activesubstancenameFLUTICASONE PROPIONATE\SALMETEROL XINAFOATE

openFDA Info on Medication

Application NumberNDA021254Brand NameADVAIR HFAGeneric NameFLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0715, 0173-0716, 0173-0717Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsFLUTICASONE PROPIONATE, SALMETEROL XINAFOATERXCUI 896231, 896235, 896236, 896237, 896239, 896243, 896244, 896245, 896267, 896271, ... spl_id717071a8-e206-47f6-8e3f-c395d532ebd3spl_set_iddfaca6f9-3277-47b2-319d-1377917cb54cPackage NDC 0173-0715-20, 0173-0715-22, 0173-0716-20, 0173-0716-22, 0173-0717-20, 0173-0717- ... UNII6EW8Q962A5, O2GMZ0LF5W

5)

drugcharacterization2medicinalproductVENTOLIN

activesubstance

activesubstancenameALBUTEROL SULFATE

openFDA Info on Medication

Application NumberNDA020983Brand NameVENTOLIN HFAGeneric NameALBUTEROL SULFATEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0682Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsALBUTEROL SULFATERXCUI801092, 801095, 859088, 2123076spl_idda4f887b-f69b-4e3b-bef6-a619c6412af7spl_set_idd92c5d6b-ff10-4087-36a2-1cfc464cb967Package NDC0173-0682-20, 0173-0682-24UNII021SEF3731

6)

drugcharacterization2medicinalproductLUNESTA

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20131214

Adverse Event Report

Report

Report Duplicate

Primary Source

Sender

Receiver

Patient

Reaction

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Drug

1)

activesubstance

openFDA Info on Medication

2)

activesubstance

openFDA Info on Medication

3)

activesubstance

openFDA Info on Medication

4)

activesubstance

openFDA Info on Medication

5)

activesubstance

openFDA Info on Medication

6)

activesubstance

openFDA Info on Medication

summary

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