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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123302614 | 12330261 | 4 | F | 2000 | 20160905 | 20160504 | 20160920 | EXP | US-APOTEX-2016AP007856 | APOTEX | 40.00 | YR | M | Y | 0.00000 | 20160920 | CN | GB | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123302614 | 12330261 | 1 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Oral | 50 MG TWICE DAILY FOR TOTAL DOSE 100 MG | Y | U | UNKNOWN | 0 | 50 | MG | TABLET | BID | |||
| 123302614 | 12330261 | 2 | PS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | U | U | 20031 | TABLET | ||||||||
| 123302614 | 12330261 | 3 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 150 MG, BID | Y | Y | UNKNOWN | 0 | 150 | MG | BID | ||||
| 123302614 | 12330261 | 4 | SS | LAMICTAL | LAMOTRIGINE | 1 | Unknown | 350 MG, QD | Y | Y | 0 | 350 | MG | QD | |||||
| 123302614 | 12330261 | 5 | SS | LAMICTAL | LAMOTRIGINE | 1 | Unknown | 25 MG UNK | Y | Y | 0 | ||||||||
| 123302614 | 12330261 | 6 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 50 MG, BID | Y | Y | 5ZP3204 | 0 | 50 | MG | BID | ||||
| 123302614 | 12330261 | 7 | SS | LAMICTAL | LAMOTRIGINE | 1 | Unknown | 100MG UNK | Y | Y | 0 | ||||||||
| 123302614 | 12330261 | 8 | SS | KEPPRA | LEVETIRACETAM | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 123302614 | 12330261 | 9 | SS | GLUTAMATE SODIUM | MONOSODIUM GLUTAMATE | 1 | Unknown | Y | U | 0 | |||||||||
| 123302614 | 12330261 | 10 | SS | ASPARTAME | ASPARTAME | 1 | Unknown | U | U | 0 | |||||||||
| 123302614 | 12330261 | 11 | SS | MELATONIN | MELATONIN | 1 | Unknown | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123302614 | 12330261 | 1 | Seizure |
| 123302614 | 12330261 | 2 | Product used for unknown indication |
| 123302614 | 12330261 | 3 | Seizure |
| 123302614 | 12330261 | 4 | Epilepsy |
| 123302614 | 12330261 | 8 | Epilepsy |
| 123302614 | 12330261 | 9 | Product used for unknown indication |
| 123302614 | 12330261 | 10 | Product used for unknown indication |
| 123302614 | 12330261 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123302614 | 12330261 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123302614 | 12330261 | Amnesia | |
| 123302614 | 12330261 | Anuria | |
| 123302614 | 12330261 | Concussion | |
| 123302614 | 12330261 | Constipation | |
| 123302614 | 12330261 | Drug ineffective | |
| 123302614 | 12330261 | Feeling abnormal | |
| 123302614 | 12330261 | Flight of ideas | |
| 123302614 | 12330261 | Gastric disorder | |
| 123302614 | 12330261 | Generalised tonic-clonic seizure | |
| 123302614 | 12330261 | Insomnia | |
| 123302614 | 12330261 | Pain in extremity | |
| 123302614 | 12330261 | Poor quality sleep | |
| 123302614 | 12330261 | Seizure | |
| 123302614 | 12330261 | Sensory disturbance | |
| 123302614 | 12330261 | Skin texture abnormal | |
| 123302614 | 12330261 | Sleep disorder | |
| 123302614 | 12330261 | Suicidal ideation |
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 |
|---|---|---|---|---|---|---|
| 123302614 | 12330261 | 1 | 201001 | 201002 | 0 | |
| 123302614 | 12330261 | 3 | 2000 | 0 | ||
| 123302614 | 12330261 | 4 | 2012 | 0 | ||
| 123302614 | 12330261 | 5 | 201603 | 0 | ||
| 123302614 | 12330261 | 6 | 201603 | 0 | ||
| 123302614 | 12330261 | 7 | 201604 | 0 | ||
| 123302614 | 12330261 | 8 | 2004 | 0 |