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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125991021 | 12599102 | 1 | I | 20150827 | 20160727 | 20160727 | PER | US-SA-2015SA131394 | AVENTIS | 47.00 | YR | A | M | Y | 0.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125991021 | 12599102 | 1 | PS | AMBIEN CR | ZOLPIDEM TARTRATE | 1 | Oral | FH092T | 21774 | 12.5 | MG | MODIFIED-RELEASE TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125991021 | 12599102 | 1 | Sleep disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125991021 | 12599102 | Drug ineffective | |
| 125991021 | 12599102 | Dyspepsia | |
| 125991021 | 12599102 | Dysphoria | |
| 125991021 | 12599102 | Headache | |
| 125991021 | 12599102 | Malaise | |
| 125991021 | 12599102 | Muscle spasms | |
| 125991021 | 12599102 | Product odour abnormal |
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 |
|---|---|---|---|---|---|---|
| 125991021 | 12599102 | 1 | 20150813 | 0 |