Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10169301serious1Date Last Updated13/05/2014receiptdateformat102companynumbUS-ASTRAZENECA-2014SE30767occurcountryUSseriousnessother1duplicate1Date Received13/05/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age69Unit of Onset AgeyearsWeight62.1SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionPneumoniaOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionSyncopeOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionLung infiltrationOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionEpistaxisOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductSYMBICORTdrugbatchnumbNOT REPORTEDdrugauthorizationnumb021929drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 PUFFS BIDdrugadministrationroute055drugindicationCHRONIC OBSTRUCTIVE PULMONARY DISEASEdrugstartdateformat610drugstartdate/02/2014actiondrug4

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

2)

drugcharacterization1medicinalproductPREDNISONEdrugstructuredosagenumb30drugstructuredosageunit003drugadministrationroute065drugstartdateformat610drugstartdate/02/2014actiondrug5

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

3)

drugcharacterization1medicinalproductPREDNISONEdrugstructuredosagenumb20drugstructuredosageunit003drugadministrationroute065actiondrug5

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

4)

drugcharacterization1medicinalproductPREDNISONEdrugstructuredosagenumb10drugstructuredosageunit003drugadministrationroute065actiondrug5

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

5)

drugcharacterization1medicinalproductPREDNISONEdrugstructuredosagenumb5drugstructuredosageunit003drugadministrationroute065actiondrug5

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

6)

drugcharacterization1medicinalproductOXYGENdrugadministrationroute065actiondrug5

openFDA Info on Medication

Brand Name OXYGEN COMPRESSED U.S.P, OXYGEN REFRIGERATED LIQUID U.S.P, OXYGEN, MEDICAL OXYGE ... Generic NameOXYGEN, 0XYGENManufacturers Apria Healthcare LLC, In Home Medical, Inc., NLR Welding Supply, Inc., AGL Inhal ... product_ndc 51319-072, 51319-073, 60941-001, 62045-4333, 17575-001, 19979-000, 23650-001, 51 ... Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION), NASAL, CUTANEOUSActive IngredientsOXYGENRXCUI 312173, 312172, 542304, 348831, 312174, 348381, 348017, 312175, 311998, 899761, ... spl_id 92e3d064-473a-4e09-bfa1-7306c4aef38f, b12e14c8-af49-4578-e053-2a95a90a6532, d595 ... spl_set_id 105a5557-c1af-42b1-859e-76cc1e83d9aa, 2260d92d-9a68-4e4f-a4bf-c6961851fdda, 49d5 ... Package NDC 51319-072-01, 51319-072-02, 51319-072-03, 51319-072-04, 51319-072-05, 51319-072- ... UNIIS88TT14065, N762921K75Application Number NDA205849, NDA205865, NDA205767, NDA206023, NDA205889, NDA212314, NDA205712, NDA ...

7)

drugcharacterization1medicinalproductCHEMOTHERAPYdrugadministrationroute065actiondrug5

8)

drugcharacterization2medicinalproductSPIRIVAdrugstructuredosagenumb18drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugstartdateformat610drugstartdate/08/2011

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

9)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationANXIETYdrugstartdateformat610drugstartdate/08/2011

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

Report Duplicate

duplicatesourceASTRAZENECAduplicatenumbUS-ASTRAZENECA-2014SE30767

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use