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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125520221 | 12552022 | 1 | I | 2014 | 20160629 | 20160713 | 20160713 | EXP | GB-AUROBINDO-AUR-APL-2016-08617 | AUROBINDO | 83.00 | YR | F | Y | 0.00000 | 20160713 | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125520221 | 12552022 | 1 | PS | TOPIRAMATE. | TOPIRAMATE | 1 | Oral | 25 MG, ONCE A DAY (25 MG AT NIGHT) | Y | U | UNKNOWN | 78462 | 25 | MG | QD | ||||
| 125520221 | 12552022 | 2 | SS | TOPIRAMATE. | TOPIRAMATE | 1 | Oral | 100 MG, TWO TIMES A DAY | Y | U | UNKNOWN | 78462 | 100 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125520221 | 12552022 | 1 | Essential tremor |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125520221 | 12552022 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125520221 | 12552022 | Abdominal pain | |
| 125520221 | 12552022 | Anal incontinence | |
| 125520221 | 12552022 | Cardiovascular disorder | |
| 125520221 | 12552022 | Communication disorder | |
| 125520221 | 12552022 | Constipation | |
| 125520221 | 12552022 | Cough | |
| 125520221 | 12552022 | Diarrhoea | |
| 125520221 | 12552022 | Dysgraphia | |
| 125520221 | 12552022 | Dysphonia | |
| 125520221 | 12552022 | Gingival bleeding | |
| 125520221 | 12552022 | Hepatic enzyme increased | |
| 125520221 | 12552022 | Hypokinesia | |
| 125520221 | 12552022 | Joint swelling | |
| 125520221 | 12552022 | Palpitations | |
| 125520221 | 12552022 | Pancreatic cyst | |
| 125520221 | 12552022 | Poor quality sleep | |
| 125520221 | 12552022 | Pruritus | |
| 125520221 | 12552022 | Renal cyst | |
| 125520221 | 12552022 | Urinary incontinence |
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 |
|---|---|---|---|---|---|---|
| 125520221 | 12552022 | 1 | 201109 | 0 | ||
| 125520221 | 12552022 | 2 | 20160204 | 0 |