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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125882751 | 12588275 | 1 | I | 20160430 | 20160505 | 20160725 | 20160725 | PER | US-JNJFOC-20160506356 | JANSSEN | 65.00 | YR | A | F | Y | 87.09000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125882751 | 12588275 | 1 | PS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | Y | U | 464066 | 19835 | 10 | MG | TABLET | QD | ||||
| 125882751 | 12588275 | 2 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | Y | U | 464066 | 19835 | 10 | MG | TABLET | QD | ||||
| 125882751 | 12588275 | 3 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | Unknown | 0 | 5 | MG | UNSPECIFIED | ||||||||
| 125882751 | 12588275 | 4 | C | METOPROLOL TARTRATE. | METOPROLOL TARTRATE | 1 | Unknown | 0 | 25 | MG | TABLET | ||||||||
| 125882751 | 12588275 | 5 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125882751 | 12588275 | 1 | Angioedema |
| 125882751 | 12588275 | 2 | Multiple allergies |
| 125882751 | 12588275 | 3 | Hypertension |
| 125882751 | 12588275 | 4 | Hypertension |
| 125882751 | 12588275 | 5 | Hypothyroidism |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125882751 | 12588275 | Activities of daily living impaired | |
| 125882751 | 12588275 | Off label use | |
| 125882751 | 12588275 | Product use issue | |
| 125882751 | 12588275 | 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 |
|---|---|---|---|---|---|---|
| 125882751 | 12588275 | 1 | 20160430 | 20160502 | 0 | |
| 125882751 | 12588275 | 2 | 20160430 | 20160502 | 0 |