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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125166453 | 12516645 | 3 | F | 2007 | 20160728 | 20160630 | 20160809 | EXP | US-JNJFOC-20160623520 | JANSSEN | 4.40 | YR | C | M | Y | 0.00000 | 20160809 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125166453 | 12516645 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | UNKNOWN | 0 | UNSPECIFIED | |||||||
| 125166453 | 12516645 | 2 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | UNKNOWN | 0 | .5 | MG | UNSPECIFIED | |||||
| 125166453 | 12516645 | 3 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | UNKNOWN | 0 | UNSPECIFIED | |||||||
| 125166453 | 12516645 | 4 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | UNKNOWN | 20272 | .5 | MG | UNSPECIFIED | |||||
| 125166453 | 12516645 | 5 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | IN VARYING DOSES FROM 0.25 TO 0.5 MG | Y | U | 20272 | UNSPECIFIED | |||||||
| 125166453 | 12516645 | 6 | SS | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Unknown | U | 0 | 40 | MG | UNSPECIFIED | |||||||
| 125166453 | 12516645 | 7 | SS | CLONIDINE. | CLONIDINE | 1 | Unknown | U | 0 | 1.5 | MG | UNSPECIFIED | |||||||
| 125166453 | 12516645 | 8 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | IN VARYING DOSES FROM 0.25 TO 0.5 MG | U | 0 | TABLETS |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125166453 | 12516645 | 1 | Affective disorder |
| 125166453 | 12516645 | 2 | Affective disorder |
| 125166453 | 12516645 | 3 | Attention deficit/hyperactivity disorder |
| 125166453 | 12516645 | 4 | Attention deficit/hyperactivity disorder |
| 125166453 | 12516645 | 5 | Attention deficit/hyperactivity disorder |
| 125166453 | 12516645 | 6 | Attention deficit/hyperactivity disorder |
| 125166453 | 12516645 | 7 | Attention deficit/hyperactivity disorder |
| 125166453 | 12516645 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125166453 | 12516645 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125166453 | 12516645 | Drug ineffective for unapproved indication | |
| 125166453 | 12516645 | Emotional distress | |
| 125166453 | 12516645 | Gynaecomastia | |
| 125166453 | 12516645 | Off label use | |
| 125166453 | 12516645 | Product use issue | |
| 125166453 | 12516645 | Suicidal ideation | |
| 125166453 | 12516645 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 125166453 | 12516645 | 1 | 20150204 | 0 | ||
| 125166453 | 12516645 | 2 | 2007 | 2008 | 0 | |
| 125166453 | 12516645 | 3 | 20150204 | 0 | ||
| 125166453 | 12516645 | 4 | 2007 | 2008 | 0 | |
| 125166453 | 12516645 | 5 | 2008 | 2015 | 0 | |
| 125166453 | 12516645 | 6 | 2007 | 0 | ||
| 125166453 | 12516645 | 7 | 2008 | 0 |