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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125011572 | 12501157 | 2 | F | 20160629 | 20160627 | 20160705 | EXP | US-JNJFOC-20160623420 | JANSSEN | POPE S, ZARAA S. EFFICACY OF LONG-ACTING INJECTABLE ANTIPSYCHOTICS IN ADOLESCENTS. JOURNAL OF CHILD ADOLESCENT PSYCHOPHARMACOLOGY 01-MAY-2016;26/4:391-394. | 17.00 | YR | T | M | Y | 0.00000 | 20160705 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125011572 | 12501157 | 1 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | N | 0 | UNSPECIFIED | |||||||||
| 125011572 | 12501157 | 2 | PS | RISPERIDONE. | RISPERIDONE | 1 | Oral | INCREASED DOSE | N | 20272 | UNSPECIFIED | ||||||||
| 125011572 | 12501157 | 3 | SS | RISPERIDONE. | RISPERIDONE | 1 | Other | U | U | 21346 | 25 | MG | MICROSPHERES | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125011572 | 12501157 | 1 | Affective disorder |
| 125011572 | 12501157 | 2 | Affective disorder |
| 125011572 | 12501157 | 3 | Affective disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125011572 | 12501157 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125011572 | 12501157 | Aggression | |
| 125011572 | 12501157 | Extrapyramidal disorder | |
| 125011572 | 12501157 | Irritability | |
| 125011572 | 12501157 | Off label use | |
| 125011572 | 12501157 | Product use issue | |
| 125011572 | 12501157 | Treatment noncompliance |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |