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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125465131 | 12546513 | 1 | I | 20151008 | 20151008 | 20160711 | 20160711 | PER | US-IGI LABORATORIES, INC.-1054871 | IGI LABORATORIES | 63.00 | YR | F | Y | 0.00000 | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125465131 | 12546513 | 1 | PS | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | Unknown | 19090 | |||||||||||
| 125465131 | 12546513 | 2 | SS | FLOVENT DISKUS | FLUTICASONE PROPIONATE | 1 | Respiratory (inhalation) | 0 | 100 | UG | INHALATION POWDER | BID | |||||||
| 125465131 | 12546513 | 3 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | 0 | ||||||||||||
| 125465131 | 12546513 | 4 | C | ALBUTEROL. | ALBUTEROL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125465131 | 12546513 | 1 | Gastrooesophageal reflux disease |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125465131 | 12546513 | Dyspnoea | |
| 125465131 | 12546513 | Hypersomnia |
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 |
|---|---|---|---|---|---|---|
| 125465131 | 12546513 | 2 | 20151007 | 0 |