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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125242182 | 12524218 | 2 | F | 2013 | 20160815 | 20160704 | 20160913 | PER | US-JNJFOC-20160520084 | JANSSEN | 0.00 | A | F | Y | 80.29000 | KG | 20160913 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125242182 | 12524218 | 1 | PS | TRAMADOL HYDROCHLORIDE. | TRAMADOL HYDROCHLORIDE | 1 | Oral | Y | N | UNKNOWN | 20281 | 300 | MG | UNSPECIFIED | TID | ||||
| 125242182 | 12524218 | 2 | SS | ULTRAM | TRAMADOL HYDROCHLORIDE | 1 | Oral | U | U | UNKNOWN | 20281 | 300 | MG | TABLETS | TID | ||||
| 125242182 | 12524218 | 3 | SS | ULTRAM ER | TRAMADOL HYDROCHLORIDE | 1 | Oral | Y | U | 14M040P;14H104P | 0 | 200 | MG | SUSTAINED RELEASE TABLETS | QD | ||||
| 125242182 | 12524218 | 4 | SS | ULTRAM ER | TRAMADOL HYDROCHLORIDE | 1 | Oral | Y | U | 14M040P;14H104P | 0 | 300 | MG | SUSTAINED RELEASE TABLETS | QD | ||||
| 125242182 | 12524218 | 5 | SS | ULTRAM ER | TRAMADOL HYDROCHLORIDE | 1 | Oral | Y | U | 14M040P;14H104P | 21692 | 200 | MG | SUSTAINED RELEASE TABLETS | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125242182 | 12524218 | 1 | Pain |
| 125242182 | 12524218 | 2 | Pain |
| 125242182 | 12524218 | 3 | Pain |
| 125242182 | 12524218 | 4 | Pain |
| 125242182 | 12524218 | 5 | Pain |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125242182 | 12524218 | Abdominal pain upper | |
| 125242182 | 12524218 | Chest pain | |
| 125242182 | 12524218 | Depression | |
| 125242182 | 12524218 | Expired product administered | |
| 125242182 | 12524218 | Feeling abnormal | |
| 125242182 | 12524218 | Product outer packaging issue | |
| 125242182 | 12524218 | Therapeutic response increased |
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 |
|---|---|---|---|---|---|---|
| 125242182 | 12524218 | 3 | 2015 | 201604 | 0 | |
| 125242182 | 12524218 | 4 | 2015 | 0 | ||
| 125242182 | 12524218 | 5 | 201604 | 0 |