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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127837601 | 12783760 | 1 | I | 2014 | 20160921 | 20160927 | 20160927 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-62093BP | BOEHRINGER INGELHEIM | 6.00 | DEC | F | Y | 0.00000 | 20160927 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127837601 | 12783760 | 1 | PS | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | Oral | DOSE PER APPLICATION AND DAILY DOSE: 1 TO 2 TABLETS, STRENGTH: 75MG | N | 556227 | 20520 | TABLET | |||||||
| 127837601 | 12783760 | 2 | SS | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | Oral | 75 MG | N | 556227 | 20520 | 75 | MG | TABLET | |||||
| 127837601 | 12783760 | 3 | SS | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | Oral | 37.5 MG | N | 556227 | 20520 | 37.5 | MG | TABLET | QD | ||||
| 127837601 | 12783760 | 4 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | DOSE PER APPLICATION: 80/4.5MCG | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127837601 | 12783760 | 1 | Gastrooesophageal reflux disease |
| 127837601 | 12783760 | 2 | Gastrooesophageal reflux disease |
| 127837601 | 12783760 | 4 | Asthma |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127837601 | 12783760 | Abdominal distension | |
| 127837601 | 12783760 | Diarrhoea | |
| 127837601 | 12783760 | Dyspepsia | |
| 127837601 | 12783760 | Dyspnoea | |
| 127837601 | 12783760 | Flatulence | |
| 127837601 | 12783760 | Gastrooesophageal reflux disease | |
| 127837601 | 12783760 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 127837601 | 12783760 | 1 | 2014 | 2015 | 0 | |
| 127837601 | 12783760 | 2 | 201501 | 0 | ||
| 127837601 | 12783760 | 3 | 201609 | 0 |