Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4784850 | 5889109 | I | 4784850-8 | 20040101 | 20050921 | 20050930 | EXP | PHBS2005BR14017 | NOVARTIS PHARMACEUTICALS CORP. | 28 | YR | F | Y | 96 | KG | 20050930 | CN | BRAZIL |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 4784850 | 1006472027 | PS | TEGRETOL | 1 | ORAL | 016608 | |||||
| 4784850 | 1006472028 | SS | TEGRETOL | 1 | ORAL | 5 TAB/DAY | 016608 | ||||
| 4784850 | 1006472029 | SS | TEGRETOL | 1 | ORAL | ||||||
| 4784850 | 1006472030 | C | LITHIUM | 2 | ORAL | 300 MG, QID | |||||
| 4784850 | 1006472031 | C | EUTHYROX | 2 | ORAL | 75 UG, QD |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 4784850 | 1006472027 | BIPOLAR DISORDER |
| 4784850 | 1006472029 | BIPOLAR DISORDER |
| 4784850 | 1006472030 | AFFECTIVE DISORDER |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 4784850 | HO |
| 4784850 | OT |
Reactions reported
| Event ID | PT |
|---|---|
| 4784850 | DEPRESSION |
| 4784850 | DIZZINESS |
| 4784850 | DRY MOUTH |
| 4784850 | DYSGEUSIA |
| 4784850 | DYSPEPSIA |
| 4784850 | HYPOAESTHESIA ORAL |
| 4784850 | INSOMNIA |
| 4784850 | NAUSEA |
| 4784850 | SOMNOLENCE |
| 4784850 | TREMOR |
| 4784850 | WEIGHT INCREASED |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 4784850 | 1006472027 | 20050501 | |||
| 4784850 | 1006472028 | 20050101 | 20050920 | ||
| 4784850 | 1006472029 | 20050920 | |||
| 4784850 | 1006472030 | 20050801 |