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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110887933 | 11088793 | 3 | F | 1995 | 20160627 | 20150504 | 20160830 | PER | US-JNJFOC-20150500402 | JANSSEN | 19.36 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110887933 | 11088793 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | U | 0 | UNSPECIFIED | ||||||||
| 110887933 | 11088793 | 2 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | U | 20272 | 4 | MG | UNSPECIFIED | ||||||
| 110887933 | 11088793 | 3 | SS | CLONIDINE. | CLONIDINE | 1 | Oral | Y | 0 | UNSPECIFIED | |||||||||
| 110887933 | 11088793 | 4 | SS | NICOTINE. | NICOTINE | 1 | Transdermal | HALF OF A 7 MG DELIVERY PATCH TO BE APPLIED BY THE DAYTIME ONLY FOR THE WEEKDAYS. | Y | 0 | PATCH |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 110887933 | 11088793 | 1 | Tic |
| 110887933 | 11088793 | 2 | Tic |
| 110887933 | 11088793 | 3 | Product used for unknown indication |
| 110887933 | 11088793 | 4 | Tic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 110887933 | 11088793 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 110887933 | 11088793 | Enuresis | |
| 110887933 | 11088793 | Gynaecomastia | |
| 110887933 | 11088793 | Obesity | |
| 110887933 | 11088793 | Off label use | |
| 110887933 | 11088793 | Palpitations | |
| 110887933 | 11088793 | Product use issue | |
| 110887933 | 11088793 | Sedation | |
| 110887933 | 11088793 | Snoring | |
| 110887933 | 11088793 | Tic |
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 |
|---|---|---|---|---|---|---|
| 110887933 | 11088793 | 1 | 1995 | 1996 | 0 | |
| 110887933 | 11088793 | 2 | 1999 | 200001 | 0 |