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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126526571 | 12652657 | 1 | I | 20160801 | 20160815 | 20160815 | EXP | PL-AKORN PHARMACEUTICALS-2016AKN00512 | AKORN | HANNA K-J, AGNIEZKA K-P, MICHAL D, ET AL.. AFFECTIVE DISORDERS AS POTENTIAL COMPLICATION OF ANTI-ACNE TREATMENT WITH ISOTRETINOIN: A CASE SERIES.. J AFFECTIVE DISORD. (DOI: 10.1016/J.JAD.2016.06.048). 2016;204:154-158 | 23.00 | YR | M | Y | 0.00000 | 20160815 | OT | PL | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126526571 | 12652657 | 1 | PS | ISOTRETINOIN | ISOTRETINOIN | 1 | Oral | 60 MG, 1X/DAY | 76485 | 60 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126526571 | 12652657 | 1 | Acne |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126526571 | 12652657 | HO |
| 126526571 | 12652657 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126526571 | 12652657 | Bipolar I disorder | |
| 126526571 | 12652657 | Suicidal ideation |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |