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
126693421 12669342 1 I 20160729 20160810 20160819 20160819 PER US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-52475BP BOEHRINGER INGELHEIM 57.62 YR M Y 0.00000 20160819 CN US US

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
126693421 12669342 1 PS PRADAXA DABIGATRAN ETEXILATE MESYLATE 1 Oral 300 MG 507624 22512 150 MG CAPSULE BID
126693421 12669342 2 SS PRADAXA DABIGATRAN ETEXILATE MESYLATE 1 507624 22512
126693421 12669342 3 C SIMVASTATIN. SIMVASTATIN 1 Oral 10 MG 0 10 MG TABLET QD
126693421 12669342 4 C LISINOPRIL. LISINOPRIL 1 Oral 10 MG 0 10 MG TABLET QD
126693421 12669342 5 C LISINOPRIL. LISINOPRIL 1 Oral DOSE PER APPLICATION: 5 MG; FORMULATION: TABLET 0 QD
126693421 12669342 6 C CLONAZEPAM. CLONAZEPAM 1 Oral 1 MG 0 .5 MG TABLET BID
126693421 12669342 7 C PAXIL PAROXETINE HYDROCHLORIDE 1 Oral 20 MG 0 20 MG TABLET QD

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
126693421 12669342 1 Thrombosis prophylaxis
126693421 12669342 2 Thrombosis prophylaxis
126693421 12669342 3 Product used for unknown indication
126693421 12669342 4 Hypertension
126693421 12669342 6 Anxiety
126693421 12669342 7 Depression

Outcome of event

no results found

Reactions reported

Event ID CASEID DRUG REC ACT PT
126693421 12669342 Abdominal distension
126693421 12669342 Abdominal pain upper
126693421 12669342 Dyspepsia
126693421 12669342 Flatulence

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
126693421 12669342 1 20160729 0
126693421 12669342 3 2006 0
126693421 12669342 6 2009 0
126693421 12669342 7 2009 0