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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126792561 | 12679256 | 1 | I | 20160812 | 20160824 | 20160824 | EXP | TR-APOTEX-2016AP010625 | APOTEX | BERKSOY EA, YILMAZ U, CELIK T, KORKMAZ HA, YAZICI S, OZDEMIR R, ET AL.. MEDICATION RELATED DYSTONIC REACTIONS ESPECIALLY IN CHILDREN ON RISPERIDONE: A DESCRIPTION OF ELEVEN CASES AND REVIEW OF THE LITERATURE.. MED-J-BAKIRKOY. 2016;12(2):64-69 | 3.00 | YR | F | Y | 0.00000 | 20160824 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126792561 | 12679256 | 1 | PS | RISPERIDONE. | RISPERIDONE | 1 | Oral | 0.2MG/DAY | Y | U | 77953 | .2 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126792561 | 12679256 | 1 | Attention deficit/hyperactivity disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126792561 | 12679256 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126792561 | 12679256 | Dystonia | |
| 126792561 | 12679256 | Product use issue |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |