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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127743481 | 12774348 | 1 | I | 20160912 | 20160923 | 20160923 | EXP | DE-SUN PHARMACEUTICAL INDUSTRIES LTD-2016RR-124257 | RANBAXY | 0.00 | M | Y | 0.00000 | 20160923 | OT | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127743481 | 12774348 | 1 | PS | Isotretinoin | ISOTRETINOIN | 1 | Unknown | HIGH DOSE | U | 76041 | |||||||||
| 127743481 | 12774348 | 2 | SS | Isotretinoin | ISOTRETINOIN | 1 | Unknown | 10 MG, DAILY | U | 76041 | 10 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127743481 | 12774348 | 1 | Rosacea |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127743481 | 12774348 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127743481 | 12774348 | Back pain | |
| 127743481 | 12774348 | Hydromyelia | |
| 127743481 | 12774348 | Muscle spasms | |
| 127743481 | 12774348 | Musculoskeletal stiffness | |
| 127743481 | 12774348 | Spinal osteoarthritis |
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 |
|---|---|---|---|---|---|---|
| 127743481 | 12774348 | 1 | 2010 | 0 | ||
| 127743481 | 12774348 | 2 | 2010 | 0 |