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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125997071 | 12599707 | 1 | I | 20160314 | 20160317 | 20160727 | 20160727 | PER | US-SA-2016SA056442 | AVENTIS | 71.00 | YR | E | F | Y | 77.11000 | KG | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125997071 | 12599707 | 1 | PS | AMBIEN | ZOLPIDEM TARTRATE | 1 | Oral | GH089 | 19908 | 20 | MG | FILM-COATED TABLET | QD | ||||||
| 125997071 | 12599707 | 2 | SS | AMBIEN | ZOLPIDEM TARTRATE | 1 | Oral | GH089 | 19908 | 20 | MG | FILM-COATED TABLET | QD | ||||||
| 125997071 | 12599707 | 3 | SS | AMBIEN | ZOLPIDEM TARTRATE | 1 | Oral | FM055 | 19908 | 20 | MG | FILM-COATED TABLET | QD | ||||||
| 125997071 | 12599707 | 4 | SS | AMBIEN | ZOLPIDEM TARTRATE | 1 | Oral | FM055 | 19908 | 20 | MG | FILM-COATED TABLET | QD | ||||||
| 125997071 | 12599707 | 5 | SS | AMBIEN | ZOLPIDEM TARTRATE | 1 | Oral | HB146 | 19908 | 20 | MG | FILM-COATED TABLET | QD | ||||||
| 125997071 | 12599707 | 6 | SS | AMBIEN | ZOLPIDEM TARTRATE | 1 | Oral | HB146 | 19908 | 20 | MG | FILM-COATED TABLET | QD | ||||||
| 125997071 | 12599707 | 7 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | START DATE-5 YEARS | 0 | 400 | MG | QID | |||||||
| 125997071 | 12599707 | 8 | C | BACLOFEN. | BACLOFEN | 1 | Unknown | START DATE- 10 YEARS | 0 | 10 | MG | TID | |||||||
| 125997071 | 12599707 | 9 | C | TERAZOSIN | TERAZOSINTERAZOSIN HYDROCHLORIDE | 1 | Unknown | START DATE- 10 YEARS | 0 | 1 | MG | BID | |||||||
| 125997071 | 12599707 | 10 | C | METOPROLOL. | METOPROLOL | 1 | Unknown | START DATE- 5 YEARS | 0 | 25 | MG | QD | |||||||
| 125997071 | 12599707 | 11 | C | OXYBUTIN | OXYBUTYNIN | 1 | Unknown | START DATE- 5 YEARS | 0 | 10 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125997071 | 12599707 | 1 | Insomnia |
| 125997071 | 12599707 | 2 | Pain in extremity |
| 125997071 | 12599707 | 3 | Insomnia |
| 125997071 | 12599707 | 4 | Pain in extremity |
| 125997071 | 12599707 | 5 | Insomnia |
| 125997071 | 12599707 | 6 | Pain in extremity |
| 125997071 | 12599707 | 7 | Neuropathy peripheral |
| 125997071 | 12599707 | 9 | Bladder disorder |
| 125997071 | 12599707 | 10 | Cardiac disorder |
| 125997071 | 12599707 | 11 | Bladder pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125997071 | 12599707 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125997071 | 12599707 | Dizziness | |
| 125997071 | 12599707 | Extra dose administered | |
| 125997071 | 12599707 | Headache | |
| 125997071 | 12599707 | Malaise | |
| 125997071 | 12599707 | Pain in extremity | |
| 125997071 | 12599707 | Product quality issue | |
| 125997071 | 12599707 | Somnolence | |
| 125997071 | 12599707 | Therapeutic response unexpected |
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 |
|---|---|---|---|---|---|---|
| 125997071 | 12599707 | 1 | 2005 | 0 | ||
| 125997071 | 12599707 | 2 | 2005 | 0 | ||
| 125997071 | 12599707 | 3 | 2005 | 0 | ||
| 125997071 | 12599707 | 4 | 2005 | 0 | ||
| 125997071 | 12599707 | 5 | 2005 | 0 | ||
| 125997071 | 12599707 | 6 | 2005 | 0 |