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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126674601 | 12667460 | 1 | I | 20160812 | 20160819 | 20160819 | EXP | TR-MYLANLABS-2016M1034843 | MYLAN | 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. | 0.00 | Y | 0.00000 | 20160819 | MD | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126674601 | 12667460 | 1 | PS | RISPERIDONE. | RISPERIDONE | 1 | Oral | Y | U | 76288 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126674601 | 12667460 | 1 | Product used for unknown indication |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126674601 | 12667460 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126674601 | 12667460 | Accidental exposure to product | |
126674601 | 12667460 | Dystonia |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |