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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126529451 | 12652945 | 1 | I | 20150623 | 20160815 | 20160815 | PER | US-AMNEAL PHARMACEUTICALS-2016AMN00412 | AMNEAL | 24.00 | YR | M | Y | 0.00000 | 20160815 | PH | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126529451 | 12652945 | 1 | PS | TRAMADOL HYDROCHLORIDE. | TRAMADOL HYDROCHLORIDE | 1 | Oral | 50 MG, 3X/DAY | HA21215 | 76003 | 50 | MG | TABLET | TID | |||||
126529451 | 12652945 | 2 | SS | TRAMADOL HYDROCHLORIDE. | TRAMADOL HYDROCHLORIDE | 1 | Oral | 50 MG, 3X/DAY | HC07115 | 76003 | 50 | MG | TABLET | TID |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126529451 | 12652945 | 1 | Pain |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126529451 | 12652945 | Drug ineffective | |
126529451 | 12652945 | Therapeutic agent urine negative |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |