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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126712611 | 12671261 | 1 | I | 20151026 | 20151102 | 20160822 | 20160822 | PER | US-TEVA-608299USA | TEVA | 18.11 | YR | M | Y | 0.00000 | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126712611 | 12671261 | 1 | PS | FEXOFENADINE | FEXOFENADINEFEXOFENADINE HYDROCHLORIDE | 1 | Oral | 180 MILLIGRAM DAILY; | 4MR0133 | 76191 | 180 | MG | TABLET | QD | |||||
| 126712611 | 12671261 | 2 | SS | FEXOFENADINE | FEXOFENADINEFEXOFENADINE HYDROCHLORIDE | 1 | 4MR0133 | 76191 | |||||||||||
| 126712611 | 12671261 | 3 | SS | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | 77255 | TABLET | ||||||||||
| 126712611 | 12671261 | 4 | SS | FAMOTIDINE. | FAMOTIDINE | 1 | Oral | N | 5FE1257 | 75311 | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126712611 | 12671261 | 1 | Nasal congestion |
| 126712611 | 12671261 | 2 | Nasal pruritus |
| 126712611 | 12671261 | 3 | Gastritis |
| 126712611 | 12671261 | 4 | Gastritis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126712611 | 12671261 | Bradycardia | |
| 126712611 | 12671261 | Cold sweat | |
| 126712611 | 12671261 | Dizziness | |
| 126712611 | 12671261 | Headache | |
| 126712611 | 12671261 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 126712611 | 12671261 | 1 | 20151026 | 20151028 | 0 | |
| 126712611 | 12671261 | 3 | 20151027 | 20151028 | 0 | |
| 126712611 | 12671261 | 4 | 20151026 | 20151028 | 0 |