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
116505622 11650562 2 F 2011 20160802 20151021 20160808 EXP US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2015-BI-54324PF BOEHRINGER INGELHEIM 0.00 F Y 79.38000 KG 20160808 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
116505622 11650562 1 PS SPIRIVA TIOTROPIUM BROMIDE MONOHYDRATE 1 Respiratory (inhalation) 18 MCG U 21395 18 UG INHALATION POWDER, HARD CAPSULE QD
116505622 11650562 2 SS SPIRIVA TIOTROPIUM BROMIDE MONOHYDRATE 1 Respiratory (inhalation) 36 MCG U 21395 18 UG INHALATION POWDER, HARD CAPSULE BID
116505622 11650562 3 C REVATIO SILDENAFIL CITRATE 1 Oral 60 MG 0 20 MG TABLET TID
116505622 11650562 4 C REVATIO SILDENAFIL CITRATE 1 0
116505622 11650562 5 C HYDROCODONE HYDROCODONE 1 Unknown 6 ANZ 0 Q4H
116505622 11650562 6 C HYDROCODONE HYDROCODONE 1 Unknown 120 MG 0 10 MG Q2H
116505622 11650562 7 C TYLENOL ACETAMINOPHEN 1 Unknown 6 ANZ 0 Q4H
116505622 11650562 8 C PREDNISONE. PREDNISONE 1 Oral 10 MG 0 10 MG TABLET QD
116505622 11650562 9 C PREDNISONE. PREDNISONE 1 0
116505622 11650562 10 C CYMBALTA DULOXETINE HYDROCHLORIDE 1 Oral 60 MG 0 60 MG QD
116505622 11650562 11 C CLONIDINE HCL CLONIDINE HYDROCHLORIDE 1 Oral 0.3 MG 0 .1 MG TABLET TID
116505622 11650562 12 C LIPITOR ATORVASTATIN CALCIUM 1 Oral 40 MG 0 40 MG TABLET QD
116505622 11650562 13 C PROAIR HFA ALBUTEROL SULFATE 1 Unknown 12 PUF 0 INHALATION SOLUTION Q4H
116505622 11650562 14 C LASIX FUROSEMIDE 1 Oral 80 MG 0 40 MG TABLET BID
116505622 11650562 15 C KLORCON KDUR 2 Oral 10 MEQ 0 10 MEQ TABLET QD
116505622 11650562 16 C PROCARDIA NIFEDIPINE 1 Oral 60 MG 0 60 MG TABLET QD
116505622 11650562 17 C ZELIRIS 2 Oral 500 MCG 0 500 UG TABLET QD
116505622 11650562 18 C COLACE DOCUSATE SODIUM 1 Oral 60 MG 0 60 MG CAPSULE QD
116505622 11650562 19 C COLACE DOCUSATE SODIUM 1 Unknown 200 MG 0 100 MG BID
116505622 11650562 20 C NORMODYNE LABETALOL HYDROCHLORIDE 1 Unknown 400 MG 0 100 MG TABLET
116505622 11650562 21 C ALDACTONE SPIRONOLACTONE 1 Oral 25 MG 0 25 MG TABLET QD
116505622 11650562 22 C IRON IRON 1 Oral 325 MG 0 325 MG TABLET QD
116505622 11650562 23 C ADVAIR DISKUS FLUTICASONE PROPIONATESALMETEROL XINAFOATE 1 Unknown FORMULATION: INHALER; DOSE PER APPLICATION: 250-50MCG PER DOSE INHALER 0 BID
116505622 11650562 24 C ALBUTEROL. ALBUTEROL 1 Unknown 15 MG 0 2.5 MG Q4H
116505622 11650562 25 C CALCIUM-VIT D 2 Oral 2 ANZ 0 TABLET QD
116505622 11650562 26 C CALCIUM-VIT D 2 0
116505622 11650562 27 C CALCIUM-VIT D 2 0
116505622 11650562 28 C BABY ASPIRIN ASPIRIN 1 Oral 81 MG 0 81 MG TABLET QD
116505622 11650562 29 C KLONOPIN CLONAZEPAM 1 Oral 0.5 MG 0 1 MG TABLET QOD
116505622 11650562 30 C KLONOPIN CLONAZEPAM 1 Oral 3 MG 0 1 MG TABLET TID
116505622 11650562 31 C POTASSIUM CHLORIDE. POTASSIUM CHLORIDE 1 Unknown 10 MEQ 0 10 MEQ TABLET QD
116505622 11650562 32 C DALIRESP ROFLUMILAST 1 Unknown 500 MCG 0 500 UG QD
116505622 11650562 33 C LABETALOL LABETALOLLABETALOL HYDROCHLORIDE 1 Unknown 4 ANZ 0 TABLET Q12H

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
116505622 11650562 1 Chronic obstructive pulmonary disease
116505622 11650562 3 Lung disorder
116505622 11650562 4 Pulmonary hypertension
116505622 11650562 5 Arthritis
116505622 11650562 6 Pain
116505622 11650562 7 Arthritis
116505622 11650562 8 Dyspnoea
116505622 11650562 9 Prophylaxis
116505622 11650562 10 Musculoskeletal discomfort
116505622 11650562 11 Dyspnoea
116505622 11650562 12 Blood cholesterol
116505622 11650562 13 Dyspnoea
116505622 11650562 14 Fluid retention
116505622 11650562 15 Blood potassium decreased
116505622 11650562 16 Cardiac disorder
116505622 11650562 17 Dyspnoea
116505622 11650562 18 Cardiac disorder
116505622 11650562 19 Constipation
116505622 11650562 20 Blood pressure measurement
116505622 11650562 21 Dyspnoea
116505622 11650562 22 Blood iron decreased
116505622 11650562 23 Dyspnoea
116505622 11650562 24 Dyspnoea
116505622 11650562 25 Bone disorder
116505622 11650562 26 Vitamin D decreased
116505622 11650562 27 Blood calcium decreased
116505622 11650562 28 Cardiovascular disorder
116505622 11650562 29 Nervousness
116505622 11650562 31 Blood potassium decreased
116505622 11650562 32 Renal disorder
116505622 11650562 33 Cardiac disorder

Outcome of event

Event ID CASEID OUTC COD
116505622 11650562 DE

Reactions reported

Event ID CASEID DRUG REC ACT PT
116505622 11650562 Abasia
116505622 11650562 Chronic obstructive pulmonary disease
116505622 11650562 Condition aggravated
116505622 11650562 Constipation
116505622 11650562 Dyspnoea
116505622 11650562 Malaise
116505622 11650562 Peripheral swelling

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
116505622 11650562 2 2012 0
116505622 11650562 3 201101 0
116505622 11650562 5 2012 0
116505622 11650562 7 2012 0
116505622 11650562 10 2013 0
116505622 11650562 12 2011 0
116505622 11650562 13 2012 0
116505622 11650562 14 2011 0
116505622 11650562 16 2013 0
116505622 11650562 19 2013 0
116505622 11650562 21 2014 0
116505622 11650562 22 2012 0
116505622 11650562 23 2011 0
116505622 11650562 24 2011 0
116505622 11650562 28 2008 0
116505622 11650562 29 2012 0
116505622 11650562 30 2012 0
116505622 11650562 31 2013 0
116505622 11650562 32 2014 0
116505622 11650562 33 2014 0