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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 128021711 | 12802171 | 1 | I | 20160812 | 0 | 20160930 | 20160930 | DIR | US-FDA-351974 | FDA-CTU | 42.00 | YR | F | N | 83.25000 | KG | 20160930 | N | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 128021711 | 12802171 | 1 | PS | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | Oral | OTHER DAILY ORAL | Y | D | K4964 | 20170831 | 0 | 1 | DF | COATED TABLET | QD | ||
| 128021711 | 12802171 | 3 | C | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 128021711 | 12802171 | 5 | C | RANITIDINE. | RANITIDINE | 1 | 0 | ||||||||||||
| 128021711 | 12802171 | 7 | C | CETERIZINE | 2 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 128021711 | 12802171 | 1 | Multiple allergies |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 128021711 | 12802171 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 128021711 | 12802171 | Depression | |
| 128021711 | 12802171 | Somnolence | |
| 128021711 | 12802171 | Suicidal ideation |
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 |
|---|---|---|---|---|---|---|
| 128021711 | 12802171 | 1 | 20160722 | 20160812 | 0 |