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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126493541 | 12649354 | 1 | I | 2013 | 20160803 | 20160812 | 20160812 | EXP | TR-PRINSTON PHARMACEUTICAL INC.-2016PRN00207 | PRINSTON PHARMACEUTICAL | BERKSOY EA, YILMAZ U, CELIK T, ET AL.. MEDICATION RELATED DYSTONIC REACTIONS ESPECIALLY IN CHILDREN IN RISPERIDONE: A DESCRIPTION OF ELEVEN CASES AND REVIEW OF THE LITERATURE.. MED J BAKIRKOY (DOI: 10.5350/BTDMJB201612202). 2016;12(2):64-69 | 14.00 | YR | M | Y | 0.00000 | 20160811 | OT | TR | TR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126493541 | 12649354 | 1 | PS | RISPERIDONE. | RISPERIDONE | 1 | Oral | 1 MG, 1X/DAY | Y | 77493 | 1 | MG | QD | ||||||
| 126493541 | 12649354 | 2 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | 2 MG, 1X/DAY | Y | 77493 | 2 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126493541 | 12649354 | 1 | Autism |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126493541 | 12649354 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126493541 | 12649354 | Dystonia | |
| 126493541 | 12649354 | Oculogyric crisis | |
| 126493541 | 12649354 | Opisthotonus |
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 |
|---|---|---|---|---|---|---|
| 126493541 | 12649354 | 1 | 2013 | 0 | ||
| 126493541 | 12649354 | 2 | 2013 | 2013 | 0 |