Report

reporttype3Version of Safety Report ID23receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10152123serious1Date Last Updated23/12/2020receiptdateformat102companynumbCA-ROCHE-1393055occurcountryCAseriousnessother1duplicate1Date Received05/05/2014seriousnesshospitalization1transmissiondate13/01/2021primarysourcecountryCA

Primary Source

reportercountryCAqualification1

Patient

Onset Age38Unit of Onset AgeyearsSexFemale

Contents

Reaction
- 1)
- 2)
- 3)
- 4)
- 5)
- 6)
- 7)
- 8)
- 9)
- 10)
- 11)
- 12)
- 13)
- 14)
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- 21)
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- 35)
Drug
summary

Reaction

1)

reactionmeddraversionpt23.1ReactionAsthmaOutcomeRecovering/resolving

2)

reactionmeddraversionpt23.1ReactionDyspnoeaOutcomeRecovered/resolved

3)

reactionmeddraversionpt23.1ReactionPainOutcomeUnknown

4)

reactionmeddraversionpt23.1ReactionUrticariaOutcomeUnknown

5)

reactionmeddraversionpt23.1ReactionOropharyngeal painOutcomeUnknown

6)

reactionmeddraversionpt23.1ReactionWeight increasedOutcomeUnknown

7)

reactionmeddraversionpt23.1ReactionDiarrhoeaOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt23.1ReactionBody mass index increasedOutcomeUnknown

9)

reactionmeddraversionpt23.1ReactionPsoriatic arthropathyOutcomeUnknown

10)

reactionmeddraversionpt23.1ReactionMiddle insomniaOutcomeUnknown

11)

reactionmeddraversionpt23.1ReactionSwellingOutcomeUnknown

12)

reactionmeddraversionpt23.1ReactionRespiratory disorderOutcomeUnknown

13)

reactionmeddraversionpt23.1ReactionObesityOutcomeUnknown

14)

reactionmeddraversionpt23.1ReactionSensitivity to weather changeOutcomeUnknown

15)

reactionmeddraversionpt23.1ReactionSinusitisOutcomeUnknown

16)

reactionmeddraversionpt23.1ReactionAnaphylactic reactionOutcomeRecovering/resolving

17)

reactionmeddraversionpt23.1ReactionPyrexiaOutcomeNot recovered/not resolved

18)

reactionmeddraversionpt23.1ReactionBody temperature decreasedOutcomeUnknown

19)

reactionmeddraversionpt23.1ReactionAnaphylactic reactionOutcomeRecovered/resolved

20)

reactionmeddraversionpt23.1ReactionMalaiseOutcomeNot recovered/not resolved

21)

reactionmeddraversionpt23.1ReactionSwelling faceOutcomeRecovering/resolving

22)

reactionmeddraversionpt23.1ReactionBlood pressure increasedOutcomeUnknown

23)

reactionmeddraversionpt23.1ReactionPneumoniaOutcomeUnknown

24)

reactionmeddraversionpt23.1ReactionWeight decreasedOutcomeUnknown

25)

reactionmeddraversionpt23.1ReactionProduct dose omission issueOutcomeUnknown

26)

reactionmeddraversionpt23.1ReactionAsthmaOutcomeRecovered/resolved

27)

reactionmeddraversionpt23.1ReactionBlood urea decreasedOutcomeUnknown

28)

reactionmeddraversionpt23.1ReactionInfluenzaOutcomeUnknown

29)

reactionmeddraversionpt23.1ReactionGlomerular filtration rate decreasedOutcomeUnknown

30)

reactionmeddraversionpt23.1ReactionArthralgiaOutcomeUnknown

31)

reactionmeddraversionpt23.1ReactionCardiac failure congestiveOutcomeUnknown

32)

reactionmeddraversionpt23.1ReactionForced expiratory volume decreasedOutcomeNot recovered/not resolved

33)

reactionmeddraversionpt23.1ReactionReversible airways obstructionOutcomeUnknown

34)

reactionmeddraversionpt23.1ReactionTotal lung capacity decreasedOutcomeUnknown

35)

reactionmeddraversionpt23.1ReactionObstructive airways disorderOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductXOLAIRdrugbatchnumbS0060,S0004,SE068,SAD52,SEJ08,SJY86drugauthorizationnumb103976drugadministrationroute058drugstartdateformat102drugstartdate28/01/2016actiondrug4

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

2)

drugcharacterization1medicinalproductXOLAIRdrugbatchnumbS0060,S0004,SE068,SAD52,SEJ08,SJY86drugauthorizationnumb103976drugstructuredosagenumb300drugstructuredosageunit003drugadministrationroute058drugstartdateformat102drugstartdate02/05/2018actiondrug4

activesubstance

activesubstancenameOMALIZUMAB

openFDA Info on Medication

3)

activesubstance

activesubstancenameOMALIZUMAB

openFDA Info on Medication

4)

activesubstance

activesubstancenameOMALIZUMAB

openFDA Info on Medication

5)

drugcharacterization1medicinalproductXOLAIRdrugbatchnumbS0060,S0004,SE068,SAD52,SEJ08,SJY86drugauthorizationnumb103976drugstructuredosagenumb300drugstructuredosageunit003drugadministrationroute058drugindicationASTHMAdrugstartdateformat102drugstartdate03/12/2013actiondrug4

activesubstance

activesubstancenameOMALIZUMAB

openFDA Info on Medication

6)

activesubstance

activesubstancenameOMALIZUMAB

openFDA Info on Medication

7)

activesubstance

activesubstancenameOMALIZUMAB

openFDA Info on Medication

8)

activesubstance

activesubstancenameOMALIZUMAB

openFDA Info on Medication

9)

activesubstance

activesubstancenameOMALIZUMAB

openFDA Info on Medication

10)

drugcharacterization2medicinalproductADVAIR HFAdrugbatchnumbUNKNOWNdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, BIDdrugadministrationroute065actiondrug5drugadditional3

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 XINAFOATEspl_id296f1772-58d7-4742-abc6-4557165605b2spl_set_iddfaca6f9-3277-47b2-319d-1377917cb54cPackage NDC 0173-0715-20, 0173-0715-22, 0173-0716-20, 0173-0716-22, 0173-0717-20, 0173-0717- ... UNIIO2GMZ0LF5W, 6EW8Q962A5

11)

drugcharacterization2medicinalproductBENADRYLdrugbatchnumbUNKNOWNdrugstructuredosagenumb2drugstructuredosageunit032drugdosagetext2 DF, OTHERdrugadministrationroute048drugindicationCHRONIC SPONTANEOUS URTICARIAactiondrug5drugadditional3

activesubstance

activesubstancenameDIPHENHYDRAMINE HYDROCHLORIDE

openFDA Info on Medication

Application Numberpart341Brand NameCHILDRENS ALLERGY RELIEF, BENADRYLGeneric NameBENADRYL, DIPHENHYDRAMINE HYDROCHLORIDEManufacturers Rite Aid Corporation, Johnson & Johnson Consumer Inc., McNeil Consumer Healthcar ... product_ndc11822-0025, 50580-370, 50580-226Product TypeHUMAN OTC DRUGRouteORALActive IngredientsDIPHENHYDRAMINE HYDROCHLORIDERXCUI1049906, 1049630, 1049632spl_id fecb0ac3-0ede-4e4a-91c3-b6322f055b5c, ecd53790-6b06-46a1-a4ed-dd69293aa1c5, b09d ... spl_set_id 50434eaf-650c-4416-a357-d174f86d729f, 2884d2dc-2d4a-4ca6-ab73-688a80b428eb, 702f ... Package NDC 11822-0025-4, 50580-370-01, 50580-226-50, 50580-226-51, 50580-226-53, 50580-226- ... UNIITC2D6JAD40

12)

drugcharacterization2medicinalproductRABEPRAZOLEdrugstructuredosagenumb150drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048

activesubstance

activesubstancenameRABEPRAZOLE

openFDA Info on Medication

Application NumberANDA204179Brand NameRABEPRAZOLE SODIUMGeneric NameRABEPRAZOLEManufacturersAmneal Pharmaceuticals LLCproduct_ndc65162-724Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRABEPRAZOLE SODIUMRXCUI854868spl_idae04e3c4-e3fe-48bf-9648-bd298fea2cb6spl_set_id951caefe-6e18-48ff-9567-beb545b09c25Package NDC65162-724-03, 65162-724-09, 65162-724-11, 65162-724-50UNII3L36P16U4R

13)

drugcharacterization2medicinalproductADVAIR HFAdrugbatchnumbUNKNOWNdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QDdrugadministrationroute065actiondrug5drugadditional3

activesubstance

activesubstancenameFLUTICASONE PROPIONATE\SALMETEROL XINAFOATE

openFDA Info on Medication

14)

drugcharacterization2medicinalproductSINGULAIRdrugbatchnumbUNKNOWNdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, DAILYdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

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

15)

drugcharacterization2medicinalproductADVAIR HFAdrugbatchnumbUNKNOWNdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF (500/50)drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameFLUTICASONE PROPIONATE\SALMETEROL XINAFOATE

openFDA Info on Medication

16)

activesubstance

activesubstancenameOMALIZUMAB

openFDA Info on Medication

17)

drugcharacterization2medicinalproductREACTINE (CANADA)drugbatchnumbUNKNOWNdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameCETIRIZINE HYDROCHLORIDE

18)

drugcharacterization2medicinalproductZOLOFTdrugbatchnumbUNKNOWNdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, QHSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

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

19)

activesubstance

activesubstancenameOMALIZUMAB

openFDA Info on Medication

20)

drugcharacterization2medicinalproductOMNARISdrugbatchnumbUNKNOWNdrugstructuredosagenumb2drugstructuredosageunit032drugdosagetext2 DF, EACH NOSTRILdrugdosageformSPRAYdrugadministrationroute045drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameCICLESONIDE

openFDA Info on Medication

Application NumberNDA022004Brand NameOMNARISGeneric NameCICLESONIDEManufacturersCovis Pharmaproduct_ndc70515-701Product TypeHUMAN PRESCRIPTION DRUGRouteNASALActive IngredientsCICLESONIDERXCUI1797841, 1797843spl_id719d76f2-75b2-4ef7-9a83-c6ce464d9669spl_set_id15fefd46-ac7e-40d0-b635-e6c3d653c666Package NDC70515-701-01UNIIS59502J185

21)

drugcharacterization2medicinalproductRANITIDINE.

activesubstance

activesubstancenameRANITIDINE

openFDA Info on Medication

Application Number ANDA091429, NDA021698, ANDA076195, ANDA200172, ANDA207579, ANDA207578, ANDA07865 ... Brand Name COOL MINT ACID REDUCER, ZANTAC MAXIMUM STRENGTH 150 COOL MINT, HARRIS TEETER ACI ... Generic NameRANITIDINE, RANITIDINE HYDROCHLORIDEManufacturers Rite Aid Corporation, Boehringer Ingelheim Pharmaceuticals Inc., Harris Teeter, ... product_ndc 11822-0950, 0597-0120, 69256-876, 37808-303, 69842-293, 41520-609, 58602-733, 58 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsRANITIDINE HYDROCHLORIDE, RANITIDINERXCUI 198191, 827189, 312773, 198193, 1090518, 705610, 643046, 198190, 198192, 827183, ... spl_id 0ebab972-16c7-4733-b1bc-e063d53f9e87, 97cb5218-4c7e-5ae5-e053-2995a90af3f2, a43a ... spl_set_id 4784c5b2-58eb-4b7c-b6e9-13dde7610a37, 888d9feb-fc9b-49cc-8361-30b5da86ea05, a43a ... Package NDC 11822-0950-1, 11822-0950-0, 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120- ... UNIIBK76465IHM, 884KT10YB7NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]

22)

activesubstance

activesubstancenameOMALIZUMAB

openFDA Info on Medication

23)

activesubstance

activesubstancenameOMALIZUMAB

openFDA Info on Medication

24)

activesubstance

activesubstancenameOMALIZUMAB

openFDA Info on Medication

25)

drugcharacterization2medicinalproductALVESCOdrugbatchnumbUNKNOWNdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextPUFFdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameCICLESONIDE

openFDA Info on Medication

Application NumberNDA021658Brand NameALVESCOGeneric NameCICLESONIDEManufacturersCovis Pharmaproduct_ndc70515-711, 70515-712Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsCICLESONIDERXCUI799034, 799037, 799038, 799040spl_id5246fe59-7d3c-420d-b2c2-86f9a52d204aspl_set_id9f6112fb-78ef-43cf-8ae3-36370eb45468Package NDC 70515-711-01, 70515-711-02, 70515-711-03, 70515-711-04, 70515-711-05, 70515-712- ... UNIIS59502J185

summary

narrativeincludeclinicalCASE EVENT DATE: 20131205

Report Duplicate

duplicatesourceROCHEduplicatenumbCA-ROCHE-1393055

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use

Adverse Event Report

Report

Primary Source

Patient

Reaction

1)

2)

3)

4)

5)

6)

7)

8)

9)

10)

11)

12)

13)

14)

15)

16)

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35)

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

7)

activesubstance

openFDA Info on Medication

8)

activesubstance

openFDA Info on Medication

9)

activesubstance

openFDA Info on Medication

10)

activesubstance

openFDA Info on Medication

11)

activesubstance

openFDA Info on Medication

12)

activesubstance

openFDA Info on Medication

13)

activesubstance

openFDA Info on Medication