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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124162503 | 12416250 | 3 | F | 201603 | 20160822 | 20160530 | 20160907 | PER | US-JNJFOC-20160522453 | JANSSEN | 0.00 | F | Y | 0.00000 | 20160907 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124162503 | 12416250 | 1 | SS | ULTRAM ER | TRAMADOL HYDROCHLORIDE | 1 | Oral | U | UNKNOWN;UNKNOWN | 0 | 300 | MG | SUSTAINED RELEASE TABLETS | QD | |||||
| 124162503 | 12416250 | 2 | SS | ULTRAM ER | TRAMADOL HYDROCHLORIDE | 1 | Oral | U | UNKNOWN;UNKNOWN | 0 | 100 | MG | SUSTAINED RELEASE TABLETS | QD | |||||
| 124162503 | 12416250 | 3 | SS | ULTRAM ER | TRAMADOL HYDROCHLORIDE | 1 | Oral | U | UNKNOWN;UNKNOWN | 0 | 300 | MG | SUSTAINED RELEASE TABLETS | ||||||
| 124162503 | 12416250 | 4 | PS | ULTRAM ER | TRAMADOL HYDROCHLORIDE | 1 | Oral | U | UNKNOWN;UNKNOWN | 21692 | 200 | MG | SUSTAINED RELEASE TABLETS | ||||||
| 124162503 | 12416250 | 5 | SS | TOPAMAX | TOPIRAMATE | 1 | Unknown | U | U | UNKNOWN | 20505 | TABLETS |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124162503 | 12416250 | 1 | Pain |
| 124162503 | 12416250 | 2 | Pain |
| 124162503 | 12416250 | 3 | Pain |
| 124162503 | 12416250 | 4 | Pain |
| 124162503 | 12416250 | 5 | Migraine prophylaxis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124162503 | 12416250 | Drug dose omission | |
| 124162503 | 12416250 | Drug ineffective | |
| 124162503 | 12416250 | Hostility | |
| 124162503 | 12416250 | Irritability | |
| 124162503 | 12416250 | Migraine | |
| 124162503 | 12416250 | Mood swings |
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 |
|---|---|---|---|---|---|---|
| 124162503 | 12416250 | 1 | 201501 | 0 | ||
| 124162503 | 12416250 | 2 | 2001 | 0 | ||
| 124162503 | 12416250 | 3 | 2016 | 2016 | 0 | |
| 124162503 | 12416250 | 4 | 2016 | 201602 | 0 |