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
119226602 11922660 2 F 20140516 20160922 20160115 20160923 PER US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-01447BI BOEHRINGER INGELHEIM 68.87 YR F Y 0.00000 20160923 MD 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
119226602 11922660 1 PS PRADAXA DABIGATRAN ETEXILATE MESYLATE 1 Oral 300 MG 22512 150 MG CAPSULE BID
119226602 11922660 2 C ASPIRIN. ASPIRIN 1 Oral FORMULATION: PACKET; DAILY DOSE: 1 PACKET DAILY AS NEEDED 0 QD
119226602 11922660 3 C CITRACAL + D CALCIUM CITRATEVITAMIN D 1 Oral DOSE PER APPLICATION: 315-200 MG; DAILY DOSE: 2 TABLETS EVERY MORNING AND 1 TABLET IN THE EVENING 0 TABLET BID
119226602 11922660 4 C TAMBOCOR FLECAINIDE ACETATE 1 Oral 100 MG 0 50 MG TABLET Q12H
119226602 11922660 5 C CLARITIN LORATADINE 1 Oral 10 MG 0 10 MG TABLET QD
119226602 11922660 6 C DILTIAZEM. DILTIAZEM 1 Oral 240 MG 0 240 MG CAPSULE QD
119226602 11922660 7 C PRILOSEC OMEPRAZOLE MAGNESIUM 1 Oral 20 MG 0 20 MG CAPSULE QD
119226602 11922660 8 C REQUIP ROPINIROLE HYDROCHLORIDE 1 Oral 2 MG 0 2 MG TABLET QD

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
119226602 11922660 1 Atrial fibrillation
119226602 11922660 2 Product used for unknown indication
119226602 11922660 3 Product used for unknown indication
119226602 11922660 4 Product used for unknown indication
119226602 11922660 5 Product used for unknown indication
119226602 11922660 6 Product used for unknown indication
119226602 11922660 7 Product used for unknown indication
119226602 11922660 8 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
119226602 11922660 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
119226602 11922660 Haemorrhagic anaemia
119226602 11922660 Lower gastrointestinal haemorrhage

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
119226602 11922660 1 20140409 20140529 0