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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125441503 | 12544150 | 3 | F | 201605 | 20160822 | 20160711 | 20160826 | EXP | US-GLENMARK PHARMACEUTICALS INC, USA.-2016GMK023537 | GLENMARK | 0.00 | Y | 0.00000 | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125441503 | 12544150 | 1 | PS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 1 DF, OD (ONE TABLET ONCE DAILY BY MOUTH) | Y | 19152478 | 91672 | 1 | DF | QD | |||||
| 125441503 | 12544150 | 2 | SS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Y | 91672 | |||||||||||
| 125441503 | 12544150 | 3 | C | ALDARA | IMIQUIMOD | 1 | Unknown | UNK | 0 | ||||||||||
| 125441503 | 12544150 | 4 | C | VITAMIN D /00107901/ | ERGOCALCIFEROL | 1 | Oral | UNK, QD | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125441503 | 12544150 | 1 | Gastrooesophageal reflux disease |
| 125441503 | 12544150 | 2 | Hernia |
| 125441503 | 12544150 | 3 | Product used for unknown indication |
| 125441503 | 12544150 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125441503 | 12544150 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125441503 | 12544150 | Dizziness | |
| 125441503 | 12544150 | Drug ineffective | |
| 125441503 | 12544150 | Mouth haemorrhage | |
| 125441503 | 12544150 | Nausea | |
| 125441503 | 12544150 | Product substitution issue | |
| 125441503 | 12544150 | Product use issue | |
| 125441503 | 12544150 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 125441503 | 12544150 | 1 | 20160501 | 20160629 | 0 |