The Safety Rates Drug Report

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Drug     Injury     Quarter    

Person who experienced the adverse event (patient)

Event ID CASEID CASEVERSION I F COD EVENT DT MFR DT INIT FDA DT FDA DT REPT COD AUTH NUM MFR NUM MFR SNDR LIT REF AGE AGE COD AGE GRP GNDR COD E SUB WT WT COD REPT DT TO MFR OCCP COD REPORTER COUNTRY OCCR COUNTRY
123057363 12305736 3 F 2009 20160701 20160426 20160708 EXP BR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-25316BR BOEHRINGER INGELHEIM 58.45 YR F Y 50.00000 KG 20160708 MD COUNTRY NOT SPECIFIED BR

Drug(s) used by person

Event ID CASEID DRUG SEQ ROLE COD DRUGNAME PROD AI VAL VBM ROUTE DOSE VBM CUM DOSE CHR CUM DOSE UNIT DECHAL RECHAL LOT NUM EXP DT NDA NUM DOSE AMT DOSE UNIT DOSE FORM DOSE FREQ
123057363 12305736 1 PS SPIRIVA TIOTROPIUM BROMIDE MONOHYDRATE 1 Respiratory (inhalation) 7.5 MCG 21936 2.5 UG PRESSURISED INHALATION TID
123057363 12305736 2 C SERETIDE FLUTICASONE PROPIONATESALMETEROL XINAFOATE 1 Respiratory (inhalation) 500 MG 0 250 MG CUTANEOUS POWDER BID
123057363 12305736 3 C CLENIL BECLOMETHASONE DIPROPIONATE 1 Respiratory (inhalation) 250 MG 0 250 MG QD
123057363 12305736 4 C FLUIR FORMOTEROL FUMARATE 1 Respiratory (inhalation) 48 MG 0 12 MG CUTANEOUS POWDER QID
123057363 12305736 5 C INFLUENZA VACCINE INFLUENZA VIRUS VACCINE 1 Unknown 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
123057363 12305736 1 Chronic obstructive pulmonary disease
123057363 12305736 2 Chronic obstructive pulmonary disease
123057363 12305736 3 Chronic obstructive pulmonary disease
123057363 12305736 4 Chronic obstructive pulmonary disease
123057363 12305736 5 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
123057363 12305736 OT
123057363 12305736 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
123057363 12305736 Asthma
123057363 12305736 Dizziness
123057363 12305736 Dyspnoea
123057363 12305736 Haemoptysis
123057363 12305736 Oropharyngeal pain
123057363 12305736 Overdose
123057363 12305736 Pneumonia
123057363 12305736 Pneumonitis
123057363 12305736 Pulmonary mass
123057363 12305736 Pulmonary pain
123057363 12305736 Stomatitis

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

Therapies reported

Event ID CASEID DSG DRUG SEQ START DT END DT DUR DUR COD
123057363 12305736 1 2009 0
123057363 12305736 2 2009 0
123057363 12305736 3 2009 0
123057363 12305736 4 2009 0
123057363 12305736 5 20160518 20160518 0