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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126529531 | 12652953 | 1 | I | 201512 | 20151221 | 20160815 | 20160815 | PER | US-AMNEAL PHARMACEUTICALS-2015AMN00230 | AMNEAL | 72.38 | YR | F | Y | 90.70000 | KG | 20160815 | OT | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126529531 | 12652953 | 1 | PS | TRAMADOL HYDROCHLORIDE. | TRAMADOL HYDROCHLORIDE | 1 | 50 MG, AS NEEDED | Y | HD12515 | 76003 | 50 | MG | TABLET | ||||||
| 126529531 | 12652953 | 2 | SS | TRAMADOL HYDROCHLORIDE. | TRAMADOL HYDROCHLORIDE | 1 | 100 MG, ONCE | Y | HD12515 | 76003 | 100 | MG | TABLET | ||||||
| 126529531 | 12652953 | 3 | C | NORVASC | AMLODIPINE BESYLATE | 1 | 0 | ||||||||||||
| 126529531 | 12652953 | 4 | C | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126529531 | 12652953 | 1 | Arthritis |
| 126529531 | 12652953 | 2 | Breakthrough pain |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126529531 | 12652953 | Dizziness | |
| 126529531 | 12652953 | Insomnia |
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 |
|---|---|---|---|---|---|---|
| 126529531 | 12652953 | 1 | 201512 | 0 | ||
| 126529531 | 12652953 | 2 | 201512 | 201512 | 0 |