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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125627601 | 12562760 | 1 | I | 2014 | 20160701 | 20160715 | 20160715 | EXP | US-SUNOVION-2016SUN001721 | SUNOVION | 57.39 | YR | F | Y | 72.57000 | KG | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125627601 | 12562760 | 1 | PS | LUNESTA | ESZOPICLONE | 1 | Oral | U | 21476 | TABLET | |||||||||
| 125627601 | 12562760 | 2 | C | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 11 MG, QD | 0 | 11 | MG | QD | |||||||
| 125627601 | 12562760 | 3 | C | METHOTREXATE. | METHOTREXATE | 1 | UNK | 0 | |||||||||||
| 125627601 | 12562760 | 4 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 125627601 | 12562760 | 5 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | Oral | 10 MG, HS | 0 | 10 | MG | QD | |||||||
| 125627601 | 12562760 | 6 | C | CARISOPRODOL. | CARISOPRODOL | 1 | Oral | 350 MG, QD | 0 | 350 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125627601 | 12562760 | 1 | Insomnia |
| 125627601 | 12562760 | 2 | Rheumatoid arthritis |
| 125627601 | 12562760 | 3 | Rheumatoid arthritis |
| 125627601 | 12562760 | 4 | Pain |
| 125627601 | 12562760 | 5 | Insomnia |
| 125627601 | 12562760 | 6 | Muscle relaxant therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125627601 | 12562760 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125627601 | 12562760 | Abnormal behaviour | |
| 125627601 | 12562760 | Drug ineffective | |
| 125627601 | 12562760 | Dry mouth | |
| 125627601 | 12562760 | Dysgeusia | |
| 125627601 | 12562760 | Insomnia | |
| 125627601 | 12562760 | Rib fracture | |
| 125627601 | 12562760 | Sinus headache | |
| 125627601 | 12562760 | Spinal fracture | |
| 125627601 | 12562760 | Upper limb fracture | |
| 125627601 | 12562760 | Visual impairment | |
| 125627601 | 12562760 | Vomiting | |
| 125627601 | 12562760 | Weight 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 |
|---|---|---|---|---|---|---|
| 125627601 | 12562760 | 2 | 2016 | 0 | ||
| 125627601 | 12562760 | 3 | 2015 | 201604 | 0 | |
| 125627601 | 12562760 | 5 | 2014 | 0 |