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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127249601 | 12724960 | 1 | I | 20160815 | 20160831 | 20160908 | 20160908 | EXP | GB-MHRA-EYC 00144343 | PHHY2016GB119891 | SANDOZ | 16.00 | YR | M | Y | 103.41000 | KG | 20160908 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127249601 | 12724960 | 1 | PS | CLARITHROMYCIN. | CLARITHROMYCIN | 1 | Oral | 500 MG | 65136 | 500 | MG | ||||||||
| 127249601 | 12724960 | 2 | C | MIGRALEVE | ACETAMINOPHENBUCLIZINE HYDROCHLORIDECODEINE | 1 | Unknown | Y | 0 | ||||||||||
| 127249601 | 12724960 | 3 | C | TOPIRAMATE ACTAVIS | TOPIRAMATE | 1 | Unknown | Y | 0 | 25 | MG | ||||||||
| 127249601 | 12724960 | 4 | C | AMOXICILLIN. | AMOXICILLIN | 1 | Unknown | 500 MG | Y | 0 | 500 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127249601 | 12724960 | 1 | Helicobacter infection |
| 127249601 | 12724960 | 2 | Product used for unknown indication |
| 127249601 | 12724960 | 3 | Product used for unknown indication |
| 127249601 | 12724960 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127249601 | 12724960 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127249601 | 12724960 | Confusional state | |
| 127249601 | 12724960 | Disorientation | |
| 127249601 | 12724960 | Hypersomnia | |
| 127249601 | 12724960 | Psychotic 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 |
|---|---|---|---|---|---|---|
| 127249601 | 12724960 | 1 | 20160812 | 0 | ||
| 127249601 | 12724960 | 2 | 20160812 | 20160820 | 0 | |
| 127249601 | 12724960 | 3 | 20160812 | 20160820 | 0 | |
| 127249601 | 12724960 | 4 | 20160812 | 20160820 | 0 |