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
127566841 12756684 1 I 201608 20160906 20160917 20160917 PER US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-58494BP BOEHRINGER INGELHEIM 82.11 YR F Y 0.00000 20160917 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
127566841 12756684 1 PS PRADAXA DABIGATRAN ETEXILATE MESYLATE 1 Oral 300 MG 22512 150 MG CAPSULE BID
127566841 12756684 2 C Lisinopril / Hydrochlorothiazide 2 Oral DOSE PER APPLICATION: 20 MG/ 25 MG; DAILY DOSE: 20 MG / 25 MG 0 TABLET QD
127566841 12756684 3 C Lisinopril / Hydrochlorothiazide 2 0
127566841 12756684 4 C TOPROL XL METOPROLOL SUCCINATE 1 Oral 25 MG 0 25 MG TABLET QD

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127566841 12756684 1 Pulmonary embolism
127566841 12756684 2 Peripheral swelling
127566841 12756684 3 Hypertension
127566841 12756684 4 Hypertension

Outcome of event

no results found

Reactions reported

Event ID CASEID DRUG REC ACT PT
127566841 12756684 Abdominal discomfort
127566841 12756684 Abdominal pain upper
127566841 12756684 Anorectal discomfort
127566841 12756684 Asthenia
127566841 12756684 Back pain
127566841 12756684 Burning sensation
127566841 12756684 Headache
127566841 12756684 Insomnia
127566841 12756684 Migraine
127566841 12756684 Muscle spasms
127566841 12756684 Nausea
127566841 12756684 Pain in extremity
127566841 12756684 Pruritus

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
127566841 12756684 1 20160803 0
127566841 12756684 2 20160728 0
127566841 12756684 4 2015 0