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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126819771 | 12681977 | 1 | I | 20160818 | 20160824 | 20160824 | EXP | PL-MYLANLABS-2016M1035680 | MYLAN | HANNA K-J, AGNIESZKA K-P, MICHAL D, DARIUSZ J, IZABELA D, AGATA M, ET AL. AFFECTIVE DISORDERS AS POTENTIAL COMPLICATION OF ANTI-ACNE TREATMENT WITH ISOTRETINOIN: A CASE SERIES. J-AFFECT-DISORD 2016;204:154-158. | 0.00 | Y | 0.00000 | 20160824 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126819771 | 12681977 | 1 | PS | ISOTRETINOIN | ISOTRETINOIN | 1 | Oral | 60 MG/DAY | U | 75945 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126819771 | 12681977 | 1 | Acne |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126819771 | 12681977 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126819771 | 12681977 | Bipolar I disorder | |
| 126819771 | 12681977 | Suicidal ideation |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |