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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122161503 | 12216150 | 3 | F | 20160624 | 20160329 | 20160708 | EXP | GB-AUROBINDO-AUR-APL-2016-03703 | AUROBINDO | 22.00 | YR | F | Y | 0.00000 | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122161503 | 12216150 | 1 | PS | Lamotrigine Tablet | LAMOTRIGINE | 1 | Unknown | 100 MG, UNK, 150 MILLIGRAM DAILY; ONE 100MG TABLET AND HALF 100 MG TABLET | Y | U | 78956 | TABLET | |||||||
| 122161503 | 12216150 | 2 | SS | Lamotrigine Tablet | LAMOTRIGINE | 1 | Oral | 200 MG, UNK ,200 MILLIGRAM DAILY; UNK | Y | U | 78956 | TABLET | |||||||
| 122161503 | 12216150 | 3 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 50 MG, UNK | U | U | 0 | 50 | MG | TABLET | |||||
| 122161503 | 12216150 | 4 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 100 MG, UNK | U | U | 0 | 100 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122161503 | 12216150 | 1 | Seizure |
| 122161503 | 12216150 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122161503 | 12216150 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122161503 | 12216150 | Asthma | |
| 122161503 | 12216150 | Dementia | |
| 122161503 | 12216150 | Headache | |
| 122161503 | 12216150 | Hypersensitivity | |
| 122161503 | 12216150 | Infection | |
| 122161503 | 12216150 | Nasal congestion | |
| 122161503 | 12216150 | Seizure | |
| 122161503 | 12216150 | Swelling face |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |