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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
124490043 | 12449004 | 3 | F | 20160512 | 20160801 | 20160608 | 20160811 | EXP | US-MYLANLABS-2016M1023287 | MYLAN | 29.31 | YR | F | Y | 0.00000 | 20160811 | MD | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
124490043 | 12449004 | 1 | PS | AMNESTEEM | ISOTRETINOIN | 1 | Unknown | 20 MG, QD | 5500 | MG | N | 75945 | 20 | MG | CAPSULE | QD |
Indications of drugs used
no results found |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
124490043 | 12449004 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
124490043 | 12449004 | Breast tenderness | |
124490043 | 12449004 | Exposure during pregnancy | |
124490043 | 12449004 | Vaginal haemorrhage |
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 |
---|---|---|---|---|---|---|
124490043 | 12449004 | 1 | 20150812 | 20160512 | 0 |