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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127648121 | 12764812 | 1 | I | 20140512 | 20160921 | 20160921 | EXP | US-AUROBINDO PHARMA LTD, UK-AUR-APL-2014-05767 | AUROBINDO | KAUFMAN KR, ET AL.. AMITRIPTYLINE/CHLORDIAZEPOXIDE/ OLANZAPINE/TOPIRAMATE. REACTIONS WEEKLY. 2016;1617:20 | 75.00 | YR | M | Y | 0.00000 | 20160921 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127648121 | 12764812 | 1 | PS | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | 100 MG, TWO TIMES A DAY | Y | U | 78462 | 100 | MG | BID | |||||
| 127648121 | 12764812 | 2 | SS | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | 100 MG, AT BED TIME | Y | U | 78462 | 100 | MG | ||||||
| 127648121 | 12764812 | 3 | SS | Olanzapine 15mg | OLANZAPINE | 1 | Unknown | 15 MG NIGHTLY AT BEDTIME | Y | U | 0 | ||||||||
| 127648121 | 12764812 | 4 | SS | Sertraline 50mg | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 50 MG ONCE IN THE MORNING | Y | U | 0 | ||||||||
| 127648121 | 12764812 | 5 | SS | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Unknown | 20 MG ONCE IN THE MORNING AND 30 MG NIGHTLY AT BEDTIME | Y | U | 0 | ||||||||
| 127648121 | 12764812 | 6 | SS | CHLORDIAZEPOXIDE. | CHLORDIAZEPOXIDE | 1 | Unknown | 50 MG ONCE IN THE MORNING AND 75 MG NIGHTLY AT BEDTIME | Y | U | 0 | ||||||||
| 127648121 | 12764812 | 7 | SS | CHLORDIAZEPOXIDE. | CHLORDIAZEPOXIDE | 1 | Unknown | 25MG EVERY 6 HOURS AS NEEDED AND | Y | U | 0 | ||||||||
| 127648121 | 12764812 | 8 | SS | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Unknown | 100 MG NIGHTLY AT BEDTIME | Y | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127648121 | 12764812 | 1 | Dementia Alzheimer's type |
| 127648121 | 12764812 | 3 | Dementia Alzheimer's type |
| 127648121 | 12764812 | 4 | Dementia Alzheimer's type |
| 127648121 | 12764812 | 5 | Dementia Alzheimer's type |
| 127648121 | 12764812 | 6 | Dementia Alzheimer's type |
| 127648121 | 12764812 | 8 | Dementia Alzheimer's type |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127648121 | 12764812 | OT |
| 127648121 | 12764812 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127648121 | 12764812 | Aggression | |
| 127648121 | 12764812 | Agitation | |
| 127648121 | 12764812 | Cognitive disorder | |
| 127648121 | 12764812 | Condition aggravated | |
| 127648121 | 12764812 | Delusion of replacement | |
| 127648121 | 12764812 | Impaired quality of life | |
| 127648121 | 12764812 | Memory impairment |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |