Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10033010serious1Date Last Updated24/03/2014receiptdateformat102companynumbUS-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-12505BPoccurcountryUSduplicate1Date Received24/03/2014seriousnesshospitalization1transmissiondate02/10/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Weight82SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionChronic obstructive pulmonary diseaseOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionLacrimation increasedOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionHeadacheOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductSPIRIVAdrugauthorizationnumb021395drugstructuredosagenumb18drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext18 MCGdrugdosageformINHALATION POWDER, HARD CAPSULEdrugadministrationroute055drugindicationCHRONIC OBSTRUCTIVE PULMONARY DISEASEactiondrug4

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

2)

drugcharacterization2medicinalproductSYMBICORTdrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065drugindicationCHRONIC OBSTRUCTIVE PULMONARY DISEASE

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]UNIIQ3OKS62Q6X, W34SHF8J2K

3)

drugcharacterization2medicinalproductALBUTEROLdrugadministrationroute065drugindicationCHRONIC OBSTRUCTIVE PULMONARY DISEASE

openFDA Info on Medication

Application Number ANDA210948, ANDA077788, ANDA213657, ANDA211397, ANDA208804, ANDA207046, ANDA0728 ... Brand NameALBUTEROL, ALBUTEROL SULFATEGeneric NameALBUTEROL SULFATE, ALBUTEROLManufacturers Nivagen Pharmaceuticals Inc, VistaPharm, Inc., Aurobindo Pharma Limited, Virtus ... product_ndc 75834-273, 75834-274, 66689-100, 59651-333, 59651-334, 69543-290, 69543-291, 692 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALBUTEROL SULFATERXCUI197316, 197318, 755497spl_id b736135f-6e13-3e29-e053-2a95a90a67f4, 737932ca-a391-48c3-96c5-14de8ae1000e, ff9b ... spl_set_id b735e92d-eb1a-6fc1-e053-2995a90afce2, c7713a63-af2a-40d3-8deb-cbb92d5f1cd3, ff9b ... Package NDC 75834-273-01, 75834-274-01, 66689-100-16, 66689-100-08, 59651-333-01, 59651-333- ... UNII021SEF3731

4)

drugcharacterization2medicinalproductTRAZODONEdrugadministrationroute065

5)

drugcharacterization2medicinalproductSERTRALINEdrugadministrationroute065

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

6)

drugcharacterization2medicinalproductZYRTECdrugadministrationroute065drugindicationSEASONAL ALLERGY

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

7)

drugcharacterization2medicinalproductLORAZEPAMdrugadministrationroute065drugindicationANXIETY

openFDA Info on Medication

Application Number ANDA076150, NDA018140, ANDA203572, ANDA074282, ANDA072755, ANDA090260, ANDA07502 ... Brand NameLORAZEPAM, ATIVANGeneric NameLORAZEPAMManufacturers International Medication Systems, Limited, West-Ward Pharmaceuticals Corp., Auro ... product_ndc 76329-8261, 0641-6207, 13107-083, 13107-084, 13107-085, 0409-6778, 0054-3532, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsLORAZEPAMRXCUI 238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 763028, 763029 ... spl_id decb713d-bc45-4bf5-8f61-c0e2f23051b0, eb500b8e-b94e-4900-bc8a-8217fc718704, e1fa ... spl_set_id 7dda070d-7809-46c4-8592-eb4e4c509707, b79b38ee-c29d-4099-964f-000031f47f5a, 5b85 ... Package NDC 76329-8261-1, 0641-6207-01, 0641-6207-25, 13107-083-10, 13107-083-01, 13107-083- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

Report Duplicate

duplicatesourceBOEHRINGER INGELHEIMduplicatenumbUS-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-12505BP

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use