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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126969231 | 12696923 | 1 | I | 20160817 | 20160830 | 20160830 | EXP | AU-MACLEODS PHARMACEUTICALS US LTD-MAC2016003058 | MACLEODS | 0.00 | Y | 0.00000 | 20160830 | OT | GB | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126969231 | 12696923 | 1 | PS | TRAMADOL HYDROCHLORIDE. | TRAMADOL HYDROCHLORIDE | 1 | Unknown | 150 MG, QD | Y | U | 0 | 150 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126969231 | 12696923 | 1 | Back pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126969231 | 12696923 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126969231 | 12696923 | Anxiety | |
| 126969231 | 12696923 | Circumstantiality | |
| 126969231 | 12696923 | Euphoric mood | |
| 126969231 | 12696923 | Grandiosity | |
| 126969231 | 12696923 | Insomnia | |
| 126969231 | 12696923 | Mania | |
| 126969231 | 12696923 | Muscle twitching | |
| 126969231 | 12696923 | Paranoia | |
| 126969231 | 12696923 | Pressure of speech | |
| 126969231 | 12696923 | Psychomotor hyperactivity | |
| 126969231 | 12696923 | Pyrexia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |