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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4784848 | 5829406 | F | 4784848-X | 20050524 | 20050601 | 20050930 | EXP | PHEH2005US06209 | NOVARTIS PHARMACEUTICALS CORP. | 54 | YR | F | Y | 20050928 | MD | UNITED STATES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 4784848 | 1006472011 | PS | TRILEPTAL | 1 | ORAL | 150 MG, BID | 21014 | ||||
| 4784848 | 1006472012 | SS | LAMICTAL | 1 | UNK, BID |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 4784848 | 1006472011 | HEADACHE |
| 4784848 | 1006472012 | FIBROMYALGIA |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 4784848 | OT |
Reactions reported
| Event ID | PT |
|---|---|
| 4784848 | BLOOD CHOLESTEROL INCREASED |
| 4784848 | BLOOD GLUCOSE INCREASED |
| 4784848 | CONSTIPATION |
| 4784848 | DELUSION |
| 4784848 | DRUG INTERACTION |
| 4784848 | DRUG TOXICITY |
| 4784848 | DRY SKIN |
| 4784848 | FLUID RETENTION |
| 4784848 | HEART RATE INCREASED |
| 4784848 | LIVER FUNCTION TEST ABNORMAL |
| 4784848 | MOUTH ULCERATION |
| 4784848 | PARANOIA |
| 4784848 | RASH |
| 4784848 | SCHIZOPHRENIFORM DISORDER |
| 4784848 | SKIN FISSURES |
| 4784848 | STOMACH DISCOMFORT |
| 4784848 | WHITE BLOOD CELL COUNT 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 |
|---|---|---|---|---|---|
| 4784848 | 1006472011 | 20050513 | 20050531 | 27360 | MIN |