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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123033574 | 12303357 | 4 | F | 2009 | 20160606 | 20160426 | 20160830 | PER | US-JNJFOC-20160328233 | JANSSEN | 11.26 | YR | C | M | Y | 0.00000 | 20160830 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123033574 | 12303357 | 1 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | 0.5 - 2 MG | U | 0 | TABLETS | ||||||||
| 123033574 | 12303357 | 2 | PS | RISPERIDONE. | RISPERIDONE | 1 | Oral | 0.5 - 2 MG | U | 20272 | TABLETS | ||||||||
| 123033574 | 12303357 | 3 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | TABLETS | ||||||||
| 123033574 | 12303357 | 4 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 20272 | 3 | MG | TABLETS | QD | |||||
| 123033574 | 12303357 | 5 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | 0 | TABLETS | |||||||||
| 123033574 | 12303357 | 6 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Unknown | 0 | 40 | MG | UNSPECIFIED | ||||||||
| 123033574 | 12303357 | 7 | C | PREVACID | LANSOPRAZOLE | 1 | Unknown | 0 | 30 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123033574 | 12303357 | 1 | Attention deficit/hyperactivity disorder |
| 123033574 | 12303357 | 2 | Bipolar disorder |
| 123033574 | 12303357 | 3 | Bipolar disorder |
| 123033574 | 12303357 | 4 | Bipolar disorder |
| 123033574 | 12303357 | 5 | Product used for unknown indication |
| 123033574 | 12303357 | 6 | Product used for unknown indication |
| 123033574 | 12303357 | 7 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123033574 | 12303357 | Emotional distress | |
| 123033574 | 12303357 | Gynaecomastia | |
| 123033574 | 12303357 | Obesity |
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 |
|---|---|---|---|---|---|---|
| 123033574 | 12303357 | 1 | 20090420 | 20100524 | 0 | |
| 123033574 | 12303357 | 2 | 20090420 | 20100524 | 0 | |
| 123033574 | 12303357 | 3 | 20090409 | 0 | ||
| 123033574 | 12303357 | 4 | 200011 | 0 | ||
| 123033574 | 12303357 | 6 | 2008 | 2013 | 0 | |
| 123033574 | 12303357 | 7 | 2008 | 2010 | 0 |