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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127369411 | 12736941 | 1 | I | 20000410 | 20160615 | 20160912 | 20160912 | EXP | US-JNJFOC-20160627434 | JANSSEN | 10.78 | YR | C | M | Y | 0.00000 | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127369411 | 12736941 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | 0 | .25 | MG | TABLETS | BID | ||||||
| 127369411 | 12736941 | 2 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | 0.5 TABLET ONCE A DAY | U | 0 | 1 | MG | TABLETS | ||||||
| 127369411 | 12736941 | 3 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | 0.5 TABLET TWICE A DAY | U | 0 | 1 | MG | TABLETS | ||||||
| 127369411 | 12736941 | 4 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | 0.5 TABLET 3 TIMES A DAY | U | 0 | 1 | MG | TABLETS | ||||||
| 127369411 | 12736941 | 5 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | 0.5 TABLET DAILY | U | 0 | 1 | MG | TABLETS | ||||||
| 127369411 | 12736941 | 6 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | 0.5 TABLET IN THE MORNING | U | 0 | 1 | MG | TABLETS | ||||||
| 127369411 | 12736941 | 7 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | 0.5 TABLET TWICE DAILY | U | 0 | 1 | MG | TABLETS | ||||||
| 127369411 | 12736941 | 8 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | 0.25 TABLET TWICE A DAY | U | 0 | 1 | MG | TABLETS | ||||||
| 127369411 | 12736941 | 9 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | 0.25 TABLET 3 TIMES A DAY | U | 0 | 1 | MG | TABLETS | ||||||
| 127369411 | 12736941 | 10 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | 0.25 MG TWICE A DAY | U | 0 | 1 | MG | TABLETS | ||||||
| 127369411 | 12736941 | 11 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | 0.25 TABLET IN THE MORNING | U | 0 | 1 | MG | TABLETS | ||||||
| 127369411 | 12736941 | 12 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | 0 | .25 | MG | TABLETS | TID | ||||||
| 127369411 | 12736941 | 13 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | 0.5 TABLET TWICE A DAY | U | 20272 | 1 | MG | TABLETS | ||||||
| 127369411 | 12736941 | 14 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | U | 20272 | TABLETS | ||||||||
| 127369411 | 12736941 | 15 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | 0 | 1 | MG | TABLETS | |||||||
| 127369411 | 12736941 | 16 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | U | 0 | 10 | MG | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127369411 | 12736941 | 1 | Tourette's disorder |
| 127369411 | 12736941 | 2 | Tourette's disorder |
| 127369411 | 12736941 | 3 | Tourette's disorder |
| 127369411 | 12736941 | 4 | Tourette's disorder |
| 127369411 | 12736941 | 5 | Tourette's disorder |
| 127369411 | 12736941 | 6 | Tourette's disorder |
| 127369411 | 12736941 | 7 | Tourette's disorder |
| 127369411 | 12736941 | 8 | Tourette's disorder |
| 127369411 | 12736941 | 9 | Tourette's disorder |
| 127369411 | 12736941 | 10 | Tourette's disorder |
| 127369411 | 12736941 | 11 | Tourette's disorder |
| 127369411 | 12736941 | 12 | Tourette's disorder |
| 127369411 | 12736941 | 13 | Tourette's disorder |
| 127369411 | 12736941 | 14 | Product used for unknown indication |
| 127369411 | 12736941 | 15 | Product used for unknown indication |
| 127369411 | 12736941 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127369411 | 12736941 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127369411 | 12736941 | Gynaecomastia | |
| 127369411 | 12736941 | Increased appetite | |
| 127369411 | 12736941 | Obesity | |
| 127369411 | 12736941 | Off label use | |
| 127369411 | 12736941 | Product use issue | |
| 127369411 | 12736941 | Tic |
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 |
|---|---|---|---|---|---|---|
| 127369411 | 12736941 | 2 | 20000410 | 200004 | 0 | |
| 127369411 | 12736941 | 3 | 20010110 | 20010515 | 0 | |
| 127369411 | 12736941 | 4 | 20000823 | 0 | ||
| 127369411 | 12736941 | 5 | 20010515 | 0 | ||
| 127369411 | 12736941 | 6 | 20031030 | 0 | ||
| 127369411 | 12736941 | 7 | 20040708 | 0 | ||
| 127369411 | 12736941 | 8 | 20050314 | 0 | ||
| 127369411 | 12736941 | 9 | 20050803 | 0 | ||
| 127369411 | 12736941 | 12 | 20070227 | 0 | ||
| 127369411 | 12736941 | 13 | 200004 | 0 |