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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125378022 | 12537802 | 2 | F | 2016 | 20160823 | 20160707 | 20160906 | EXP | US-AKORN PHARMACEUTICALS-2016AKN00415 | AKORN | 0.00 | M | Y | 0.00000 | 20160906 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125378022 | 12537802 | 1 | PS | MYORISAN | ISOTRETINOIN | 1 | UNK | Y | 76485 | CAPSULE | |||||||||
| 125378022 | 12537802 | 2 | SS | AMNESTEEM | ISOTRETINOIN | 1 | UNK | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125378022 | 12537802 | 1 | Acne |
| 125378022 | 12537802 | 2 | Acne |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125378022 | 12537802 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125378022 | 12537802 | Depression | |
| 125378022 | 12537802 | Epistaxis |
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 |
|---|---|---|---|---|---|---|
| 125378022 | 12537802 | 1 | 20160318 | 2016 | 0 | |
| 125378022 | 12537802 | 2 | 20160426 | 2016 | 0 |