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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4263713 | 4060907 | I | 4263713-0 | 20030101 | 20031218 | 20040102 | EXP | JP-JNJFOC-20031201566 | JOHNSON + JOHNSON PHARMACEUTICAL | 36 | YR | M | N | 20031231 | MD |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 4263713 | 1004492622 | PS | RISPERDAL | 1 | ORAL | DOSE=1-2 MG; 4 MG, IN 1 DAY, ORAL | D | D | 20272 | ||
| 4263713 | 1004515764 | SS | PAROXETINE HCL | 1 | ORAL | ORAL; SEE IMAGE | |||||
| 4263713 | 1004515766 | C | VEGETAMIN-B (TABLETS) VEGETAMIN A | 2 | |||||||
| 4263713 | 1004515767 | C | DIAZEPAM (UNSPECIFIED) DIAZEPAM | 2 | |||||||
| 4263713 | 1004515769 | C | BIPERIDEN HYDROCHLORIDE | 2 | |||||||
| 4263713 | 1004515771 | C | LACTATED RINGER'S SOLUTION (RINGER ^MERCK^) SOLUTION | 2 | |||||||
| 4263713 | 1004515772 | C | COLD MEDICINE (COLD CAPSULES) TABLETS | 2 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 4263713 | 1004492622 | OBSESSIVE-COMPULSIVE DISORDER |
| 4263713 | 1004515764 | OBSESSIVE-COMPULSIVE DISORDER |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 4263713 | HO |
| 4263713 | OT |
Reactions reported
| Event ID | PT |
|---|---|
| 4263713 | ASTHENIA |
| 4263713 | BLOOD CREATINE PHOSPHOKINASE INCREASED |
| 4263713 | CONDITION AGGRAVATED |
| 4263713 | DIZZINESS |
| 4263713 | GAIT DISTURBANCE |
| 4263713 | HYPOAESTHESIA |
| 4263713 | IRRITABILITY |
| 4263713 | MALAISE |
| 4263713 | MYOCLONUS |
| 4263713 | OBSESSIVE-COMPULSIVE DISORDER |
| 4263713 | PHARYNGOLARYNGEAL PAIN |
| 4263713 | PYREXIA |
| 4263713 | SEROTONIN SYNDROME |
| 4263713 | UPPER RESPIRATORY TRACT INFECTION |
| 4263713 | URINARY INCONTINENCE |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 4263713 | FGN |
| 4263713 | HP |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 4263713 | 1004492622 | 20020605 | 20030909 |