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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105816833 | 10581683 | 3 | F | 20160322 | 20141113 | 20160331 | EXP | GB-MHRA-EYC 00116066 | GB-MYLANLABS-2014M1009228 | MYLAN | 0.00 | Y | 0.00000 | 20160331 | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105816833 | 10581683 | 1 | PS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 1 DF, BID | 16 | DF | 75876 | 1 | DF | BID | |||||
| 105816833 | 10581683 | 2 | SS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 20 MG, QD | 16 | DF | 75876 | 20 | MG | QD | |||||
| 105816833 | 10581683 | 3 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 150 MG, UNK | U | 0 | 150 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 105816833 | 10581683 | 1 | Hiatus hernia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 105816833 | 10581683 | DS |
| 105816833 | 10581683 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 105816833 | 10581683 | Arthralgia | |
| 105816833 | 10581683 | Confusional state | |
| 105816833 | 10581683 | Dizziness | |
| 105816833 | 10581683 | Fatigue | |
| 105816833 | 10581683 | Feeling abnormal | |
| 105816833 | 10581683 | Flatulence | |
| 105816833 | 10581683 | Insomnia | |
| 105816833 | 10581683 | Joint crepitation | |
| 105816833 | 10581683 | Muscle twitching | |
| 105816833 | 10581683 | Myalgia | |
| 105816833 | 10581683 | Oropharyngeal pain | |
| 105816833 | 10581683 | 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 |
|---|---|---|---|---|---|---|
| 105816833 | 10581683 | 1 | 20140915 | 20141018 | 0 | |
| 105816833 | 10581683 | 2 | 20140204 | 201403 | 0 |