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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126135933 | 12613593 | 3 | F | 20160825 | 20160802 | 20160908 | EXP | PL-SUN PHARMACEUTICAL INDUSTRIES LTD-2016RR-121304 | RANBAXY | 19.00 | YR | F | Y | 0.00000 | 20160908 | OT | GB | PL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126135933 | 12613593 | 1 | PS | Isotretinoin | ISOTRETINOIN | 1 | Oral | (APPROXIMATE TOTAL DOSE RECEIVED 18 G) | U | 76041 | 50 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126135933 | 12613593 | 1 | Acne |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126135933 | 12613593 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126135933 | 12613593 | Bipolar I disorder |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |