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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124262392 | 12426239 | 2 | F | 20160421 | 20160712 | 20160601 | 20160715 | EXP | FI-JNJFOC-20160528447 | JANSSEN | 7.67 | YR | C | F | Y | 0.00000 | 20160715 | MD | FI | FI |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124262392 | 12426239 | 1 | PS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | Y | N | 5AE018 | 21121 | 18 | MG | SUSTAINED RELEASE TABLETS | |||||
| 124262392 | 12426239 | 2 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 0 | 5 | DF | DROPS |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124262392 | 12426239 | 1 | Attention deficit/hyperactivity disorder |
| 124262392 | 12426239 | 2 | Hypersensitivity |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124262392 | 12426239 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124262392 | 12426239 | Aggression | |
| 124262392 | 12426239 | Anger | |
| 124262392 | 12426239 | Drug ineffective | |
| 124262392 | 12426239 | Irritability | |
| 124262392 | 12426239 | Tooth injury |
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 |
|---|---|---|---|---|---|---|
| 124262392 | 12426239 | 1 | 20160421 | 20160423 | 0 |