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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127759491 | 12775949 | 1 | I | 2016 | 20160917 | 20160923 | 20160923 | EXP | US-OTSUKA-2016_022505 | OTSUKA | 47.79 | YR | F | Y | 0.00000 | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127759491 | 12775949 | 1 | PS | REXULTI | BREXPIPRAZOLE | 1 | Unknown | 1 MG, QD | 205422 | 1 | MG | TABLET | QD | ||||||
| 127759491 | 12775949 | 2 | SS | REXULTI | BREXPIPRAZOLE | 1 | Unknown | UNK | 205422 | TABLET | |||||||||
| 127759491 | 12775949 | 3 | SS | LITHIUM. | LITHIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 127759491 | 12775949 | 4 | SS | LITHIUM. | LITHIUM | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127759491 | 12775949 | 1 | Bipolar I disorder |
| 127759491 | 12775949 | 3 | Bipolar I disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127759491 | 12775949 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127759491 | 12775949 | Abdominal discomfort | |
| 127759491 | 12775949 | Erythema | |
| 127759491 | 12775949 | Eye swelling | |
| 127759491 | 12775949 | Formication | |
| 127759491 | 12775949 | Heart rate decreased | |
| 127759491 | 12775949 | Hot flush | |
| 127759491 | 12775949 | Irritability | |
| 127759491 | 12775949 | Lip swelling | |
| 127759491 | 12775949 | Muscular weakness | |
| 127759491 | 12775949 | Off label use | |
| 127759491 | 12775949 | Pruritus | |
| 127759491 | 12775949 | Sleep disorder | |
| 127759491 | 12775949 | Staphylococcal infection | |
| 127759491 | 12775949 | Thyroid hormones decreased | |
| 127759491 | 12775949 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 127759491 | 12775949 | 1 | 2016 | 2016 | 0 | |
| 127759491 | 12775949 | 2 | 201609 | 0 |