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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103423708 | 10342370 | 8 | F | 2011 | 20160727 | 20140725 | 20160804 | EXP | US-GLAXOSMITHKLINE-A1053570A | GLAXOSMITHKLINE | 64.59 | YR | F | Y | 0.00000 | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103423708 | 10342370 | 1 | PS | LAMICTAL XR | LAMOTRIGINE | 1 | Oral | 400 MG, QD | Y | 22115 | 400 | MG | PROLONGED-RELEASE TABLET | QD | |||||
| 103423708 | 10342370 | 2 | I | LAMICTAL XR | LAMOTRIGINE | 1 | Oral | 500 MG, QD | Y | 22115 | 500 | MG | PROLONGED-RELEASE TABLET | QD | |||||
| 103423708 | 10342370 | 3 | I | LAMICTAL XR | LAMOTRIGINE | 1 | Oral | 200 MG, BID | Y | 22115 | 200 | MG | PROLONGED-RELEASE TABLET | BID | |||||
| 103423708 | 10342370 | 4 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 500 MG, UNKNOWN DOSINGWAS ALSO TAKING 600 MG XR IN 2012 | Y | UNKNOWN | 22115 | 500 | MG | PROLONGED-RELEASE TABLET | |||||
| 103423708 | 10342370 | 5 | SS | LAMICTAL | LAMOTRIGINE | 1 | 600 MG, U | Y | 22115 | 600 | MG | PROLONGED-RELEASE TABLET | |||||||
| 103423708 | 10342370 | 6 | SS | LAMICTAL | LAMOTRIGINE | 1 | 400 MG, U | Y | 22115 | 400 | MG | PROLONGED-RELEASE TABLET | |||||||
| 103423708 | 10342370 | 7 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Y | 0 | |||||||||||
| 103423708 | 10342370 | 8 | SS | ASPIRIN. | ASPIRIN | 1 | U | 0 | |||||||||||
| 103423708 | 10342370 | 9 | SS | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | U | 0 | |||||||||||
| 103423708 | 10342370 | 10 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | UNK, U | U | 0 | ||||||||||
| 103423708 | 10342370 | 11 | SS | ZONEGRAN | ZONISAMIDE | 1 | 400 MG, U | Y | 0 | 400 | MG | ||||||||
| 103423708 | 10342370 | 12 | SS | LYRICA | PREGABALIN | 1 | Y | 0 | |||||||||||
| 103423708 | 10342370 | 13 | SS | DEPAKOTE | DIVALPROEX SODIUM | 1 | UNK, U | Y | UNKNOWN | 0 | |||||||||
| 103423708 | 10342370 | 14 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 103423708 | 10342370 | 15 | C | CELEXA | CITALOPRAM HYDROBROMIDE | 1 | U | 0 | |||||||||||
| 103423708 | 10342370 | 16 | C | CEREFOLIN NAC | 2 | U | 0 | ||||||||||||
| 103423708 | 10342370 | 17 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 103423708 | 10342370 | 1 | Seizure |
| 103423708 | 10342370 | 2 | Epilepsy |
| 103423708 | 10342370 | 4 | Seizure |
| 103423708 | 10342370 | 5 | Epilepsy |
| 103423708 | 10342370 | 7 | Epilepsy |
| 103423708 | 10342370 | 9 | Product used for unknown indication |
| 103423708 | 10342370 | 10 | Pruritus |
| 103423708 | 10342370 | 11 | Product used for unknown indication |
| 103423708 | 10342370 | 12 | Product used for unknown indication |
| 103423708 | 10342370 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 103423708 | 10342370 | HO |
| 103423708 | 10342370 | LT |
| 103423708 | 10342370 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 103423708 | 10342370 | Adverse drug reaction | |
| 103423708 | 10342370 | Adverse event | |
| 103423708 | 10342370 | Anticonvulsant drug level decreased | |
| 103423708 | 10342370 | Anticonvulsant drug level increased | |
| 103423708 | 10342370 | Apparent death | |
| 103423708 | 10342370 | Arthralgia | |
| 103423708 | 10342370 | Diarrhoea | |
| 103423708 | 10342370 | Drug hypersensitivity | |
| 103423708 | 10342370 | Drug ineffective | |
| 103423708 | 10342370 | Drug interaction | |
| 103423708 | 10342370 | Fall | |
| 103423708 | 10342370 | Gastrointestinal disorder | |
| 103423708 | 10342370 | Hospitalisation | |
| 103423708 | 10342370 | Joint swelling | |
| 103423708 | 10342370 | Mental disorder | |
| 103423708 | 10342370 | Nausea | |
| 103423708 | 10342370 | Overdose | |
| 103423708 | 10342370 | Pruritus | |
| 103423708 | 10342370 | Rash | |
| 103423708 | 10342370 | Scratch | |
| 103423708 | 10342370 | Seizure | |
| 103423708 | 10342370 | Suicide attempt | |
| 103423708 | 10342370 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 103423708 | 10342370 | 1 | 2001 | 0 | ||
| 103423708 | 10342370 | 2 | 2002 | 0 | ||
| 103423708 | 10342370 | 4 | 2012 | 0 | ||
| 103423708 | 10342370 | 10 | 201607 | 0 | ||
| 103423708 | 10342370 | 11 | 201312 | 0 |