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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85263095 | 8526309 | 5 | F | 20120221 | 20160815 | 20120423 | 20160818 | EXP | JP-GLAXOSMITHKLINE-B0795407A | GLAXOSMITHKLINE | 30.79 | YR | M | Y | 0.00000 | 20160818 | PH | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85263095 | 8526309 | 1 | PS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Oral | 25 MG, QD | 20241 | 25 | MG | TABLET | QD | ||||||
| 85263095 | 8526309 | 2 | SS | VALPROATE SODIUM. | VALPROATE SODIUM | 1 | Oral | UNK | U | 0 | |||||||||
| 85263095 | 8526309 | 3 | C | Amoxan | AMOXAPINE | 1 | Oral | 25 MG, QID | 0 | 25 | MG | QID | |||||||
| 85263095 | 8526309 | 4 | C | LUVOX | FLUVOXAMINE MALEATE | 1 | 0 | ||||||||||||
| 85263095 | 8526309 | 5 | C | DESYREL | TRAZODONE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 85263095 | 8526309 | 6 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 85263095 | 8526309 | 7 | C | TEGRETOL | CARBAMAZEPINE | 1 | 300 MG, 1D | 0 | 300 | MG | QD | ||||||||
| 85263095 | 8526309 | 8 | C | ANAFRANIL | CLOMIPRAMINE HYDROCHLORIDE | 1 | 25 MG, QID | 0 | 25 | MG | QID | ||||||||
| 85263095 | 8526309 | 9 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | Oral | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 85263095 | 8526309 | 10 | C | Valerin | VALPROATE SODIUM | 1 | 100 MG, TID | 0 | 100 | MG | TID | ||||||||
| 85263095 | 8526309 | 11 | C | ROZEREM | RAMELTEON | 1 | 8 MG, QD | U | 0 | 8 | MG | QD | |||||||
| 85263095 | 8526309 | 12 | C | Tetramide | MIANSERIN | 1 | 30 MG, QD | 0 | 30 | MG | QD | ||||||||
| 85263095 | 8526309 | 13 | C | Buscopan | BUTYLSCOPOLAMINE BROMIDE | 1 | 0 | 2 | DF | QD | |||||||||
| 85263095 | 8526309 | 14 | C | CALONAL | ACETAMINOPHEN | 1 | 0 | 1 | DF | QD | |||||||||
| 85263095 | 8526309 | 15 | C | REBAMIPIDE | REBAMIPIDE | 1 | 1 DF, TID | 0 | 1 | DF | TID | ||||||||
| 85263095 | 8526309 | 16 | C | Lac-B | BIFIDOBACTERIUM SPP. | 1 | 1 G, TID | 0 | 1 | G | TID | ||||||||
| 85263095 | 8526309 | 17 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | 0 | 1 | DF | QD |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 85263095 | 8526309 | DE |
| 85263095 | 8526309 | HO |
| 85263095 | 8526309 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 85263095 | 8526309 | Abdominal pain upper | |
| 85263095 | 8526309 | Alanine aminotransferase increased | |
| 85263095 | 8526309 | Aspartate aminotransferase increased | |
| 85263095 | 8526309 | Blood alkaline phosphatase increased | |
| 85263095 | 8526309 | Blood creatine increased | |
| 85263095 | 8526309 | Blood creatine phosphokinase increased | |
| 85263095 | 8526309 | Blood lactate dehydrogenase increased | |
| 85263095 | 8526309 | Blood urea increased | |
| 85263095 | 8526309 | C-reactive protein increased | |
| 85263095 | 8526309 | Chills | |
| 85263095 | 8526309 | Conjunctival hyperaemia | |
| 85263095 | 8526309 | Diarrhoea | |
| 85263095 | 8526309 | Gamma-glutamyltransferase increased | |
| 85263095 | 8526309 | Generalised erythema | |
| 85263095 | 8526309 | Haematuria | |
| 85263095 | 8526309 | Lip erosion | |
| 85263095 | 8526309 | Multiple organ dysfunction syndrome | |
| 85263095 | 8526309 | Pyrexia | |
| 85263095 | 8526309 | Rash | |
| 85263095 | 8526309 | Rash maculo-papular | |
| 85263095 | 8526309 | Somnolence | |
| 85263095 | 8526309 | Toxic epidermal necrolysis | |
| 85263095 | 8526309 | Vomiting | |
| 85263095 | 8526309 | White blood cell count increased |
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 |
|---|---|---|---|---|---|---|
| 85263095 | 8526309 | 1 | 20120218 | 20120302 | 0 | |
| 85263095 | 8526309 | 6 | 20101109 | 0 | ||
| 85263095 | 8526309 | 7 | 20110830 | 20110921 | 0 | |
| 85263095 | 8526309 | 8 | 20110906 | 0 | ||
| 85263095 | 8526309 | 9 | 20111226 | 20120302 | 0 | |
| 85263095 | 8526309 | 10 | 20110925 | 0 | ||
| 85263095 | 8526309 | 12 | 20120218 | 20120221 | 0 |