Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8016637 | 8317522 | I | 8016637-7 | 20111127 | 20111208 | 20111231 | PER | US-ROXANE LABORATORIES, INC.-2011-RO-01829RO | ROXANE LABORATORIES, INC. | 49 | YR | F | Y | 20111231 | CN | UNITED STATES |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 8016637 | 1018419965 | C | TRAMADOL HCL | 1 | |||||||
| 8016637 | 1018419964 | PS | REQUIP | 1 | ORAL | NR | 077852 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 8016637 | 1018419965 | SLEEP DISORDER |
| 8016637 | 1018419964 | RESTLESS LEGS SYNDROME |
Outcome of event
| no results found |
Reactions reported
| Event ID | PT |
|---|---|
| 8016637 | DRUG INEFFECTIVE |
| 8016637 | INSOMNIA |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 8016637 | 1018419964 | 20111115 |