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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125536511 | 12553651 | 1 | I | 2013 | 20160708 | 20160713 | 20160713 | EXP | US-JNJFOC-20160707660 | JANSSEN | 0.00 | A | F | Y | 61.24000 | KG | 20160713 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125536511 | 12553651 | 1 | SS | TOPAMAX | TOPIRAMATE | 1 | Oral | N | UNKNOWN | 0 | 80 | MG | TABLETS | ||||||
| 125536511 | 12553651 | 2 | SS | TOPAMAX | TOPIRAMATE | 1 | Oral | N | UNKNOWN | 0 | 50 | MG | TABLETS | ||||||
| 125536511 | 12553651 | 3 | SS | TOPAMAX | TOPIRAMATE | 1 | Oral | 1.5 MG TABLETS TWICE A DAY | N | UNKNOWN | 0 | 150 | MG | TABLETS | BID | ||||
| 125536511 | 12553651 | 4 | SS | TOPAMAX | TOPIRAMATE | 1 | Oral | N | UNKNOWN | 0 | TABLETS | ||||||||
| 125536511 | 12553651 | 5 | SS | TOPAMAX | TOPIRAMATE | 1 | Oral | N | UNKNOWN | 0 | 100 | MG | TABLETS | BID | |||||
| 125536511 | 12553651 | 6 | PS | TOPAMAX | TOPIRAMATE | 1 | Oral | N | UNKNOWN | 20505 | 30 | MG | TABLETS | ||||||
| 125536511 | 12553651 | 7 | C | LAMICTAL | LAMOTRIGINE | 1 | Oral | STRENGTH:100 MG | 0 | UNSPECIFIED | |||||||||
| 125536511 | 12553651 | 8 | C | LAMICTAL | LAMOTRIGINE | 1 | Oral | STRENGTH:100 MG | 0 | 300 | MG | UNSPECIFIED | BID | ||||||
| 125536511 | 12553651 | 9 | C | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | STRENGTH:75 MG | 0 | 75 | MG | UNSPECIFIED | QD | ||||||
| 125536511 | 12553651 | 10 | C | BUSPAR | BUSPIRONE HYDROCHLORIDE | 1 | Oral | 1 TIME AM??STRENGTH:15 MG | 0 | 30 | MG | UNSPECIFIED | |||||||
| 125536511 | 12553651 | 11 | C | BUSPAR | BUSPIRONE HYDROCHLORIDE | 1 | Oral | 0 | UNSPECIFIED | ||||||||||
| 125536511 | 12553651 | 12 | C | BUSPAR | BUSPIRONE HYDROCHLORIDE | 1 | Oral | 1 TIME PM??STRENGTH:15 MG | 0 | 15 | MG | UNSPECIFIED | |||||||
| 125536511 | 12553651 | 13 | C | PROPRANOL | PROPRANOLOL HYDROCHLORIDE | 1 | Oral | 0 | UNSPECIFIED | ||||||||||
| 125536511 | 12553651 | 14 | C | PROPRANOL | PROPRANOLOL HYDROCHLORIDE | 1 | Oral | STRENGTH:20 MG | 0 | 20 | MG | UNSPECIFIED | BID | ||||||
| 125536511 | 12553651 | 15 | C | BIOTIN | BIOTIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125536511 | 12553651 | 1 | Epilepsy |
| 125536511 | 12553651 | 2 | Epilepsy |
| 125536511 | 12553651 | 3 | Epilepsy |
| 125536511 | 12553651 | 4 | Epilepsy |
| 125536511 | 12553651 | 5 | Epilepsy |
| 125536511 | 12553651 | 6 | Epilepsy |
| 125536511 | 12553651 | 7 | Epilepsy |
| 125536511 | 12553651 | 8 | Epilepsy |
| 125536511 | 12553651 | 9 | Anxiety |
| 125536511 | 12553651 | 10 | Anxiety |
| 125536511 | 12553651 | 11 | Anxiety |
| 125536511 | 12553651 | 12 | Anxiety |
| 125536511 | 12553651 | 13 | Anxiety |
| 125536511 | 12553651 | 14 | Anxiety |
| 125536511 | 12553651 | 15 | Alopecia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125536511 | 12553651 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125536511 | 12553651 | Alopecia | |
| 125536511 | 12553651 | Amnesia | |
| 125536511 | 12553651 | Dysarthria | |
| 125536511 | 12553651 | Hypersomnia | |
| 125536511 | 12553651 | Language disorder | |
| 125536511 | 12553651 | Loss of consciousness | |
| 125536511 | 12553651 | Tremor | |
| 125536511 | 12553651 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 125536511 | 12553651 | 3 | 201605 | 0 | ||
| 125536511 | 12553651 | 4 | 2012 | 2013 | 0 | |
| 125536511 | 12553651 | 5 | 2013 | 201605 | 0 | |
| 125536511 | 12553651 | 15 | 2016 | 0 |