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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127135841 | 12713584 | 1 | I | 20160810 | 20160822 | 20160903 | 20160903 | EXP | GB-AUROBINDO-AUR-APL-2016-10877 | AUROBINDO | 43.00 | YR | F | Y | 110.67000 | KG | 20160903 | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127135841 | 12713584 | 1 | PS | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 78619 | ||||||||
| 127135841 | 12713584 | 2 | I | DAKTARIN /00310801/ | MICONAZOLE NITRATE | 1 | Oral | 2.5 ML, FOUR TIMES/DAY | 10 | ML | Y | U | GAB0Y00 | 0 | 2.5 | ML | QID | ||
| 127135841 | 12713584 | 3 | I | LORATADINE. | LORATADINE | 1 | Unknown | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127135841 | 12713584 | 1 | Anxiety |
| 127135841 | 12713584 | 2 | Oral candidiasis |
| 127135841 | 12713584 | 3 | Seasonal allergy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127135841 | 12713584 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127135841 | 12713584 | Diarrhoea | |
| 127135841 | 12713584 | Drug interaction |
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 |
|---|---|---|---|---|---|---|
| 127135841 | 12713584 | 2 | 20160810 | 20160811 | 0 |