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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125882991 | 12588299 | 1 | I | 20160410 | 20160511 | 20160725 | 20160725 | PER | US-JNJFOC-20160512236 | JANSSEN | 63.00 | YR | A | M | Y | 67.13000 | KG | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125882991 | 12588299 | 1 | PS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | N | 474651 | 19835 | TABLET | ||||||||
| 125882991 | 12588299 | 2 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 2 TABLETS, EVERY NIGHT | N | 474651 | 19835 | 2 | DF | TABLET | QD | ||||
| 125882991 | 12588299 | 3 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 10MG 3X/DAY, 2 WEEKS | 0 | 10 | MG | UNSPECIFIED | |||||||
| 125882991 | 12588299 | 4 | C | LEVOCETIRIZINE | LEVOCETIRIZINE | 1 | Unknown | 5MG 1X/DAY, 1 MONTH | 0 | 5 | MG | UNSPECIFIED | /month | ||||||
| 125882991 | 12588299 | 5 | C | CIMETIDINE | CIMETIDINE | 1 | Unknown | 400MG 2X/DAY, 1 MONTH | 0 | 400 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125882991 | 12588299 | 2 | Rash pruritic |
| 125882991 | 12588299 | 3 | Transient acantholytic dermatosis |
| 125882991 | 12588299 | 4 | Product used for unknown indication |
| 125882991 | 12588299 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125882991 | 12588299 | Diarrhoea | |
| 125882991 | 12588299 | Off label use | |
| 125882991 | 12588299 | 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 |
|---|---|---|---|---|---|---|
| 125882991 | 12588299 | 2 | 20160410 | 0 |