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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126018011 | 12601801 | 1 | I | 2011 | 20160715 | 20160728 | 20160728 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-46783BP | BOEHRINGER INGELHEIM | 77.13 | YR | F | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126018011 | 12601801 | 1 | PS | COMBIVENT | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | Respiratory (inhalation) | DOSE PER APPLICATION AND DAILY DOSE: 18 MCG / 103 MCG | 265559A,501047B | 21747 | INHALATION SOLUTION | ||||||||
| 126018011 | 12601801 | 2 | SS | COMBIVENT | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | Respiratory (inhalation) | DOSE PER APPLICATION AND DAILY DOSE : 20 MCG / 100 MCG; FORMULATION: INHALATION SPRAY | 265559A,501047B | 21747 | PRESSURISED INHALATION | QD | |||||||
| 126018011 | 12601801 | 3 | SS | STIOLTO RESPIMAT | OLODATEROL HYDROCHLORIDETIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 2.5 MCG | Y | 501877A | 206756 | 2.5 | UG | PRESSURISED INHALATION | QD | ||||
| 126018011 | 12601801 | 4 | C | Amlodipine Besalate | 2 | Oral | 5 MG | 0 | 5 | MG | TABLET | QD | |||||||
| 126018011 | 12601801 | 5 | C | RANITIDINE. | RANITIDINE | 1 | Oral | 150 MG | 0 | 150 | MG | TABLET | QD | ||||||
| 126018011 | 12601801 | 6 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 125 MG | 0 | 125 | MG | TABLET | QD | ||||||
| 126018011 | 12601801 | 7 | C | BUPROPRION | BUPROPION | 1 | Oral | 300 MG | 0 | 150 | MG | CAPSULE | BID | ||||||
| 126018011 | 12601801 | 8 | C | Atorvastatin | ATORVASTATIN | 1 | Oral | 20 MG | 0 | 20 | MG | TABLET | QD | ||||||
| 126018011 | 12601801 | 9 | C | METOPROLOL. | METOPROLOL | 1 | Oral | 50 MG | 0 | 50 | MG | TABLET | QD | ||||||
| 126018011 | 12601801 | 10 | C | LOSARTAN. | LOSARTAN | 1 | Oral | 100 MG | 0 | 100 | MG | TABLET | QD | ||||||
| 126018011 | 12601801 | 11 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 20 MG | 0 | 20 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126018011 | 12601801 | 1 | Asthma |
| 126018011 | 12601801 | 3 | Asthma |
| 126018011 | 12601801 | 4 | Hypertension |
| 126018011 | 12601801 | 5 | Gastrooesophageal reflux disease |
| 126018011 | 12601801 | 6 | Hypothyroidism |
| 126018011 | 12601801 | 7 | Depression |
| 126018011 | 12601801 | 8 | Blood cholesterol increased |
| 126018011 | 12601801 | 9 | Hypertension |
| 126018011 | 12601801 | 10 | Hypertension |
| 126018011 | 12601801 | 11 | Gastrooesophageal reflux disease |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126018011 | 12601801 | Cough | |
| 126018011 | 12601801 | Off label use | |
| 126018011 | 12601801 | Productive cough |
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 |
|---|---|---|---|---|---|---|
| 126018011 | 12601801 | 1 | 2011 | 20151230 | 0 | |
| 126018011 | 12601801 | 2 | 20151230 | 0 | ||
| 126018011 | 12601801 | 3 | 201605 | 20160711 | 0 | |
| 126018011 | 12601801 | 4 | 2016 | 0 | ||
| 126018011 | 12601801 | 5 | 2011 | 0 | ||
| 126018011 | 12601801 | 6 | 1996 | 0 | ||
| 126018011 | 12601801 | 7 | 1995 | 0 | ||
| 126018011 | 12601801 | 8 | 2015 | 0 | ||
| 126018011 | 12601801 | 9 | 2015 | 0 | ||
| 126018011 | 12601801 | 10 | 2010 | 0 | ||
| 126018011 | 12601801 | 11 | 2011 | 0 |