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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126301691 | 12630169 | 1 | I | 20160725 | 20160808 | 20160808 | EXP | GB-AKORN PHARMACEUTICALS-2016AKN00480 | AKORN | JOHNSON M, O^COLMAIN U, AFFLECK A. RECURRENT CORNEAL EROSION ASSOCIATED WITH ORAL ISOTRETINOIN: A CAUTIONARY TALE. CLIN EXP DERMATOL (DOI: 10.1111/CED.12825). 2016;41:564 | 38.00 | YR | F | Y | 0.00000 | 20160808 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126301691 | 12630169 | 1 | PS | ISOTRETINOIN | ISOTRETINOIN | 1 | Oral | 20 MG, 1X/DAY | Y | 76485 | 20 | MG | QD | ||||||
| 126301691 | 12630169 | 2 | SS | ISOTRETINOIN | ISOTRETINOIN | 1 | Oral | UNK | Y | 76485 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126301691 | 12630169 | 1 | Acne |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126301691 | 12630169 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126301691 | 12630169 | Corneal epithelium defect | |
| 126301691 | 12630169 | Corneal erosion |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |