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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127758541 | 12775854 | 1 | I | 20160912 | 20160923 | 20160923 | EXP | MY-AKORN PHARMACEUTICALS-2016AKN00626 | AKORN | YAP FBB. SAFETY AND EFFICACY OF FOXED-DOSE 10 MG DAILY ISOTRETINION TREATMENT FOR ACNE VULGARIS IN MALAYSIA. J COSMET DERMATOL. 2016 | 0.00 | Y | 0.00000 | 20160923 | MD | MY | MY |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127758541 | 12775854 | 1 | PS | ISOTRETINOIN | ISOTRETINOIN | 1 | Oral | 10 MG, 1X/DAY | 76485 | 10 | MG | QD | |||||||
| 127758541 | 12775854 | 2 | C | CLINDAMYCIN | CLINDAMYCINCLINDAMYCIN PHOSPHATE | 1 | Topical | 0 | GEL |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127758541 | 12775854 | 1 | Acne |
| 127758541 | 12775854 | 2 | Acne |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127758541 | 12775854 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127758541 | 12775854 | Lip dry | |
| 127758541 | 12775854 | Mood altered |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |