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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126491441 | 12649144 | 1 | I | 2016 | 20160722 | 20160812 | 20160812 | EXP | JP-JNJFOC-20160723829 | JANSSEN | 15.00 | YR | T | M | Y | 0.00000 | 20160812 | PH | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126491441 | 12649144 | 1 | SS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | Y | N | 0 | 18 | MG | SUSTAINED RELEASE TABLETS | QD | |||||
| 126491441 | 12649144 | 2 | PS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | Y | N | 21121 | 18 | MG | SUSTAINED RELEASE TABLETS | QD | |||||
| 126491441 | 12649144 | 3 | I | CLARITHROMYCIN. | CLARITHROMYCIN | 1 | Oral | U | 0 | UNSPECIFIED | |||||||||
| 126491441 | 12649144 | 4 | C | LUVOX | FLUVOXAMINE MALEATE | 1 | Oral | 0 | 25 | MG | TABLET | QD | |||||||
| 126491441 | 12649144 | 5 | C | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | Oral | 0 | 5 | MG | TABLET | QD | |||||||
| 126491441 | 12649144 | 6 | C | GASMOTIN | MOSAPRIDE CITRATE | 1 | Oral | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126491441 | 12649144 | 1 | Product used for unknown indication |
| 126491441 | 12649144 | 2 | Product used for unknown indication |
| 126491441 | 12649144 | 3 | Nasopharyngitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126491441 | 12649144 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126491441 | 12649144 | Decreased appetite | |
| 126491441 | 12649144 | Drug interaction | |
| 126491441 | 12649144 | Dysarthria | |
| 126491441 | 12649144 | Hypoaesthesia | |
| 126491441 | 12649144 | Hypoglycaemia | |
| 126491441 | 12649144 | Nasopharyngitis | |
| 126491441 | 12649144 | Seizure |
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 |
|---|---|---|---|---|---|---|
| 126491441 | 12649144 | 1 | 201606 | 20160716 | 0 | |
| 126491441 | 12649144 | 2 | 20160722 | 0 | ||
| 126491441 | 12649144 | 3 | 2016 | 0 |