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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127692051 | 12769205 | 1 | I | 20160913 | 20160921 | 20160921 | EXP | JP-MYLANLABS-2016M1040347 | MYLAN | YOKOSE T, YOSHIDA M, YAMAKAA K, OONISHI M, HATANO Y, ENDOU H, ET AL. [ACUTE VALPROIC ACID OVERDOSE CAUSING ONLY SOMNOLENCE AND STAGGER DESPITE THE EXTREME HYPERAMMONEMIA: A CASE REPORT]. [JAPANESE]. CHUDOK-KENKYU 2016;29(1):30-2. | 0.00 | Y | 0.00000 | 20160921 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127692051 | 12769205 | 1 | PS | VALPROIC ACID. | VALPROIC ACID | 1 | Oral | U | U | 77567 | 200 | MG | TABLET | BID | |||||
| 127692051 | 12769205 | 2 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | Oral | 30 TABLETS OF VALPROIC ACID | U | U | 77567 | TABLET | |||||||
| 127692051 | 12769205 | 3 | C | ETHYL LOFLAZEPATE | ETHYL LOFLAZEPATE | 1 | Oral | D | 0 | 1 | MG | TABLET | QD | ||||||
| 127692051 | 12769205 | 4 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Oral | SINGLE DOSE AT 0.5 MG | D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127692051 | 12769205 | 1 | Product used for unknown indication |
| 127692051 | 12769205 | 3 | Product used for unknown indication |
| 127692051 | 12769205 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127692051 | 12769205 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127692051 | 12769205 | Balance disorder | |
| 127692051 | 12769205 | Fatigue | |
| 127692051 | 12769205 | Hyperammonaemia | |
| 127692051 | 12769205 | Intentional overdose | |
| 127692051 | 12769205 | Somnolence | |
| 127692051 | 12769205 | Toxicity to various agents |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |