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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125452112 | 12545211 | 2 | F | 20160618 | 20160711 | 20160711 | 20160713 | EXP | FR-JNJFOC-20160706122 | JANSSEN | 91.00 | YR | E | F | Y | 0.00000 | 20160713 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125452112 | 12545211 | 1 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | U | 20588 | .25 | MG | SOLUTION | ||||||
| 125452112 | 12545211 | 2 | SS | IMOVANE | ZOPICLONE | 1 | Oral | INITIATED IN EVENING | Y | 0 | UNSPECIFIED | ||||||||
| 125452112 | 12545211 | 3 | C | CARDENSIEL | BISOPROLOL FUMARATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125452112 | 12545211 | 4 | C | LEVOTHYROX | LEVOTHYROXINE | 1 | Unknown | 0 | 125 | UG | TABLET | ||||||||
| 125452112 | 12545211 | 5 | C | MOVICOL | POLYETHYLENE GLYCOL 3350POTASSIUM CHLORIDESODIUM BICARBONATESODIUM CHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125452112 | 12545211 | 6 | C | NORMACOL | KARAYA GUM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125452112 | 12545211 | 7 | C | FLUINDIONE | FLUINDIONE | 1 | Unknown | 0 | 20 | MG | TABLET | ||||||||
| 125452112 | 12545211 | 8 | C | LAMALINE | ACETAMINOPHENCAFFEINEOPIUM | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125452112 | 12545211 | 1 | Delirium |
| 125452112 | 12545211 | 2 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125452112 | 12545211 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125452112 | 12545211 | Altered state of consciousness | |
| 125452112 | 12545211 | Cheyne-Stokes respiration | |
| 125452112 | 12545211 | Drug ineffective for unapproved indication | |
| 125452112 | 12545211 | Fall | |
| 125452112 | 12545211 | Hypotonia | |
| 125452112 | 12545211 | Off label use | |
| 125452112 | 12545211 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 125452112 | 12545211 | 1 | 20160617 | 20160619 | 0 | |
| 125452112 | 12545211 | 2 | 20160617 | 20160619 | 0 |