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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 81546867 | 8154686 | 7 | F | 201108 | 20160712 | 20110923 | 20160713 | EXP | US-GLAXOSMITHKLINE-A0944789A | GLAXOSMITHKLINE | 58.08 | YR | F | Y | 0.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 81546867 | 8154686 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 100 MG, UNK | 20241 | 100 | MG | TABLET | BID | ||||||
| 81546867 | 8154686 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | 100 MG, 2 QAM 2QPM | UNKNOWN | 20241 | 100 | MG | TABLET | |||||||
| 81546867 | 8154686 | 3 | SS | LAMICTAL | LAMOTRIGINE | 1 | 100 MG, 2QAM 3QPM | UNKNOWN | 20241 | 100 | MG | TABLET | |||||||
| 81546867 | 8154686 | 4 | SS | PHENOBARBITAL. | PHENOBARBITAL | 1 | Unknown | 0 | QD | ||||||||||
| 81546867 | 8154686 | 5 | SS | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | U | 0 | 500 | MG | TABLET | QD | ||||||
| 81546867 | 8154686 | 6 | SS | DILANTIN | PHENYTOIN | 1 | Oral | 100 MG CAPSULES | V120725 | 0 | BID | ||||||||
| 81546867 | 8154686 | 7 | SS | LYRICA | PREGABALIN | 1 | Oral | 0 | 75 | MG | QD | ||||||||
| 81546867 | 8154686 | 8 | SS | LYRICA | PREGABALIN | 1 | 0 | ||||||||||||
| 81546867 | 8154686 | 9 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | 0 | 100 | UG | QD | |||||||||
| 81546867 | 8154686 | 10 | C | LISINOPRIL. | LISINOPRIL | 1 | 0 | 1 | DF | TABLET | QD | ||||||||
| 81546867 | 8154686 | 11 | C | PRAVASTATIN. | PRAVASTATIN | 1 | U | 0 | 200 | MG | QD | ||||||||
| 81546867 | 8154686 | 12 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | U | 0 | 1 | DF | QD | ||||||||
| 81546867 | 8154686 | 13 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 81546867 | 8154686 | 14 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 81546867 | 8154686 | 15 | C | PHENYTOIN. | PHENYTOIN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 81546867 | 8154686 | 1 | Seizure |
| 81546867 | 8154686 | 4 | Seizure |
| 81546867 | 8154686 | 5 | Diabetes mellitus |
| 81546867 | 8154686 | 6 | Seizure |
| 81546867 | 8154686 | 7 | Seizure |
| 81546867 | 8154686 | 8 | Neuropathy peripheral |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 81546867 | 8154686 | LT |
| 81546867 | 8154686 | HO |
| 81546867 | 8154686 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 81546867 | 8154686 | Drug dose omission | |
| 81546867 | 8154686 | Drug ineffective | |
| 81546867 | 8154686 | Fatigue | |
| 81546867 | 8154686 | Hospitalisation | |
| 81546867 | 8154686 | Intentional underdose | |
| 81546867 | 8154686 | Seizure | |
| 81546867 | 8154686 | Speech disorder | |
| 81546867 | 8154686 | Treatment noncompliance |
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 |
|---|---|---|---|---|---|---|
| 81546867 | 8154686 | 1 | 200707 | 0 | ||
| 81546867 | 8154686 | 3 | 2015 | 0 | ||
| 81546867 | 8154686 | 5 | 201112 | 0 | ||
| 81546867 | 8154686 | 6 | 200707 | 0 | ||
| 81546867 | 8154686 | 7 | 200906 | 0 |