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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126846091 | 12684609 | 1 | I | 20160816 | 20160825 | 20160825 | PER | US-GLAXOSMITHKLINE-US2016118886 | GLAXOSMITHKLINE | 0.00 | M | Y | 0.00000 | 20160825 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126846091 | 12684609 | 1 | PS | REQUIP XL | ROPINIROLE HYDROCHLORIDE | 1 | Oral | 4 MG, QD | 22008 | 4 | MG | PROLONGED-RELEASE TABLET | QD | ||||||
| 126846091 | 12684609 | 2 | SS | REQUIP XL | ROPINIROLE HYDROCHLORIDE | 1 | Oral | 8 MG, QD | 22008 | 8 | MG | PROLONGED-RELEASE TABLET | QD | ||||||
| 126846091 | 12684609 | 3 | SS | REQUIP XL | ROPINIROLE HYDROCHLORIDE | 1 | Oral | 12 MG, QD | 22008 | 12 | MG | PROLONGED-RELEASE TABLET | QD | ||||||
| 126846091 | 12684609 | 4 | SS | BELSOMRA | SUVOREXANT | 1 | U | 0 | |||||||||||
| 126846091 | 12684609 | 5 | SS | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | U | 0 | |||||||||||
| 126846091 | 12684609 | 6 | C | ANDROGEL | TESTOSTERONE | 1 | U | 0 | |||||||||||
| 126846091 | 12684609 | 7 | C | ASPIRIN. | ASPIRIN | 1 | U | 0 | |||||||||||
| 126846091 | 12684609 | 8 | C | FARXIGA | DAPAGLIFLOZIN PROPANEDIOL | 1 | U | 0 | |||||||||||
| 126846091 | 12684609 | 9 | C | FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126846091 | 12684609 | 10 | C | KLONOPIN | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 126846091 | 12684609 | 11 | C | KOMBIGLYZE XR | METFORMIN HYDROCHLORIDESAXAGLIPTIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126846091 | 12684609 | 12 | C | LYRICA | PREGABALIN | 1 | U | 0 | |||||||||||
| 126846091 | 12684609 | 13 | C | NASONEX | MOMETASONE FUROATE | 1 | U | 0 | |||||||||||
| 126846091 | 12684609 | 14 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | U | 0 | |||||||||||
| 126846091 | 12684609 | 15 | C | TRAMADOL. | TRAMADOL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126846091 | 12684609 | 1 | Restless legs syndrome |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126846091 | 12684609 | Condition aggravated | |
| 126846091 | 12684609 | Drug dose omission | |
| 126846091 | 12684609 | Drug dose titration not performed | |
| 126846091 | 12684609 | Drug ineffective | |
| 126846091 | 12684609 | Restless legs syndrome | |
| 126846091 | 12684609 | Therapeutic response unexpected | |
| 126846091 | 12684609 | Wrong technique in product usage process |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |