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
127670411 12767041 1 I 20160913 20160921 20160921 EXP DE-ACTELION-A-US2016-142581 ACTELION 0.00 F Y 0.00000 20160921 OT DE RU

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
127670411 12767041 1 PS VENTAVIS ILOPROST 1 Respiratory (inhalation) 6X/DAILY U U 21779 INHALATION VAPOUR, SOLUTION
127670411 12767041 2 SS TRACLEER BOSENTAN 1 Oral U U 21290 TABLET
127670411 12767041 3 SS SILDENAFIL. SILDENAFIL 1 Unknown U U 0
127670411 12767041 4 C OPSUMIT MACITENTAN 1 Oral U 204410 TABLET
127670411 12767041 5 C VEROSPIRON SPIRONOLACTONE 1 U 0
127670411 12767041 6 C FUROSEMIDE. FUROSEMIDE 1 U 0
127670411 12767041 7 C HYDROCHLOROTHIAZIDE. HYDROCHLOROTHIAZIDE 1 U 0
127670411 12767041 8 C BETALOC METOPROLOL TARTRATE 1 U 0
127670411 12767041 9 C OMEPRAZOLE. OMEPRAZOLE 1 U 0
127670411 12767041 10 C DIGOXIN. DIGOXIN 1 U 0
127670411 12767041 11 C DICARB 2 U 0
127670411 12767041 12 C ACETAZOLAMIDE. ACETAZOLAMIDE 1 U 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127670411 12767041 1 Pulmonary arterial hypertension
127670411 12767041 2 Pulmonary arterial hypertension
127670411 12767041 3 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
127670411 12767041 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
127670411 12767041 Cardiac failure
127670411 12767041 Chest pain
127670411 12767041 Dyspnoea exertional
127670411 12767041 Erythema
127670411 12767041 Heart rate increased
127670411 12767041 Intentional product misuse
127670411 12767041 Oedema
127670411 12767041 Oedema peripheral
127670411 12767041 Transaminases increased

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

no results found

Therapies reported

no results found