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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126850041 | 12685004 | 1 | I | 20160808 | 20160811 | 20160825 | 20160825 | PER | US-JNJFOC-20160812059 | JOHNSON AND JOHNSON | 58.00 | YR | A | F | Y | 0.00000 | 20160825 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126850041 | 12685004 | 1 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | N | 475980;475980 | 0 | 10 | MG | TABLET | BID | |||||
| 126850041 | 12685004 | 2 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | N | 475980;475980 | 0 | 10 | MG | TABLET | QD | |||||
| 126850041 | 12685004 | 3 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | N | 475980;475980 | 0 | 10 | MG | TABLET | QD | |||||
| 126850041 | 12685004 | 4 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | N | 475980;475980 | 0 | 10 | MG | TABLET | BID | |||||
| 126850041 | 12685004 | 5 | PS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | N | 475980;475980 | 19835 | 10 | MG | TABLET | QD | |||||
| 126850041 | 12685004 | 6 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | N | 475980;475980 | 19835 | 10 | MG | TABLET | BID | |||||
| 126850041 | 12685004 | 7 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 126850041 | 12685004 | 8 | C | LORAZEPAM. | LORAZEPAM | 1 | Unknown | AS NEEDED | 0 | 1 | DF | TABLET | |||||||
| 126850041 | 12685004 | 9 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | Unknown | 0 | 1000 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126850041 | 12685004 | 1 | Seasonal allergy |
| 126850041 | 12685004 | 2 | Seasonal allergy |
| 126850041 | 12685004 | 3 | Sinusitis |
| 126850041 | 12685004 | 4 | Sinusitis |
| 126850041 | 12685004 | 5 | Rhinitis |
| 126850041 | 12685004 | 6 | Rhinitis |
| 126850041 | 12685004 | 7 | Product used for unknown indication |
| 126850041 | 12685004 | 8 | Product used for unknown indication |
| 126850041 | 12685004 | 9 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126850041 | 12685004 | Confusional state | |
| 126850041 | 12685004 | Feeling drunk | |
| 126850041 | 12685004 | Off label use | |
| 126850041 | 12685004 | Product label issue | |
| 126850041 | 12685004 | Product packaging issue | |
| 126850041 | 12685004 | Product use issue | |
| 126850041 | 12685004 | Slow response to stimuli | |
| 126850041 | 12685004 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 126850041 | 12685004 | 1 | 20160809 | 0 | ||
| 126850041 | 12685004 | 2 | 20160808 | 0 | ||
| 126850041 | 12685004 | 3 | 20160808 | 0 | ||
| 126850041 | 12685004 | 4 | 20160809 | 0 | ||
| 126850041 | 12685004 | 5 | 20160808 | 0 | ||
| 126850041 | 12685004 | 6 | 20160809 | 0 |