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
127171281 12717128 1 I 20160829 20160906 20160906 EXP TW-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-56663BI BOEHRINGER INGELHEIM LAI C,TSENG T,JOU Y,LU T,LEE W,SUNG S. REVERSIBLE ACUTE RENAL FAILURE IN A PATIENT WITH ACQUIRED AORTIC COARCTATION. INTERNATIONAL JOURNAL OF CARDIOLOGY 2016;222:683-685. 57.00 YR F Y 0.00000 20160906 OT COUNTRY NOT SPECIFIED TW

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
127171281 12717128 1 PS CATAPRES CLONIDINE HYDROCHLORIDE 1 Unknown U 17407 .15 MG
127171281 12717128 2 C LEVOTHYROXINE SODIUM. LEVOTHYROXINE SODIUM 1 Unknown 0 100 UG
127171281 12717128 3 C FENOFIBRATE. FENOFIBRATE 1 Unknown 0 100 MG
127171281 12717128 4 C NIFEDIPINE. NIFEDIPINE 1 Unknown 0 20 MG
127171281 12717128 5 C LOSARTAN. LOSARTAN 1 Unknown 0 50 MG
127171281 12717128 6 C DOXAZOSIN DOXAZOSINDOXAZOSIN MESYLATE 1 Unknown 0 4 MG
127171281 12717128 7 C SIMVASTATIN. SIMVASTATIN 1 Unknown 20 MG 0 20 MG QD
127171281 12717128 8 C DUAL RAAS BLOCKER (LOSARTAN) 2 Unknown 0
127171281 12717128 9 C SPIRONOLACTONE. SPIRONOLACTONE 1 Unknown 0
127171281 12717128 10 C CARVEDILOL. CARVEDILOL 1 Unknown 0
127171281 12717128 11 C AMLODIPINE AMLODIPINE BESYLATE 1 Unknown 0
127171281 12717128 12 C HYDRALAZINE HYDRALAZINE HYDROCHLORIDE 1 Unknown 0
127171281 12717128 13 C DUAL RAAS BLOCKER (ALISKIREN) 2 Unknown 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127171281 12717128 1 Hypertension
127171281 12717128 2 Product used for unknown indication
127171281 12717128 3 Product used for unknown indication
127171281 12717128 4 Product used for unknown indication
127171281 12717128 5 Product used for unknown indication
127171281 12717128 6 Hypertension
127171281 12717128 7 Product used for unknown indication
127171281 12717128 8 Hypertension
127171281 12717128 9 Hypertension
127171281 12717128 10 Hypertension
127171281 12717128 11 Hypertension
127171281 12717128 12 Hypertension
127171281 12717128 13 Hypertension

Outcome of event

Event ID CASEID OUTC COD
127171281 12717128 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
127171281 12717128 Acute kidney injury
127171281 12717128 Coarctation of the aorta
127171281 12717128 Ejection fraction decreased
127171281 12717128 Left ventricular hypertrophy
127171281 12717128 Oliguria
127171281 12717128 Pneumothorax
127171281 12717128 Renal impairment
127171281 12717128 Respiratory acidosis

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

no results found

Therapies reported

no results found