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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126552671 | 12655267 | 1 | I | 201510 | 20160120 | 20160816 | 20160816 | PER | GXBR2016US000561 | SANDOZ | 61.92 | YR | F | Y | 63.49000 | KG | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126552671 | 12655267 | 1 | PS | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, QD | 75049 | 20 | MG | CAPSULE | QD | ||||||
| 126552671 | 12655267 | 2 | SS | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 40 MG, QD | 75049 | 40 | MG | CAPSULE | QD | ||||||
| 126552671 | 12655267 | 3 | SS | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Oral | UNK DF, UNK | 75049 | CAPSULE | |||||||||
| 126552671 | 12655267 | 4 | C | ZEGERID | OMEPRAZOLESODIUM BICARBONATE | 1 | Unknown | UNK DF, UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126552671 | 12655267 | 1 | Anxiety |
| 126552671 | 12655267 | 4 | Dyspepsia |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126552671 | 12655267 | Feeling abnormal | |
| 126552671 | 12655267 | Impaired quality of life | |
| 126552671 | 12655267 | Pruritus generalised | |
| 126552671 | 12655267 | Sleep disorder |
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 |
|---|---|---|---|---|---|---|
| 126552671 | 12655267 | 2 | 201509 | 0 |