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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126013441 | 12601344 | 1 | I | 20070718 | 20070720 | 20160728 | 20160728 | PER | US-SUN PHARMACEUTICAL INDUSTRIES LTD-2007US-09060 | RANBAXY | 0.00 | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126013441 | 12601344 | 1 | PS | Isotretinoin | ISOTRETINOIN | 1 | Oral | 30 MG, 2 CAPSULES WITH DINNER | 540 | MG | N | 76503 | 60 | MG | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126013441 | 12601344 | 1 | Acne |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126013441 | 12601344 | Chapped lips | |
| 126013441 | 12601344 | Crying | |
| 126013441 | 12601344 | Decreased appetite | |
| 126013441 | 12601344 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 126013441 | 12601344 | 1 | 20070709 | 20070719 | 0 |