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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125221033 | 12522103 | 3 | F | 201605 | 20160728 | 20160701 | 20160803 | EXP | JP-GLAXOSMITHKLINE-JP2016JPN082563 | GLAXOSMITHKLINE | 57.70 | YR | M | Y | 0.00000 | 20160803 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125221033 | 12522103 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 25 MG, QD | 5750 | MG | Y | 20241 | 25 | MG | TABLET | QD | |||
| 125221033 | 12522103 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 50 MG, QD | 5750 | MG | Y | 20241 | 50 | MG | TABLET | QD | |||
| 125221033 | 12522103 | 3 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 75 MG, QD | 5750 | MG | Y | 20241 | 75 | MG | TABLET | QD | |||
| 125221033 | 12522103 | 4 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 50 MG, QD | 5750 | MG | Y | 20241 | 50 | MG | TABLET | QD | |||
| 125221033 | 12522103 | 5 | C | ROHYPNOL | FLUNITRAZEPAM | 1 | 2 MG, QD | 0 | 2 | MG | QD | ||||||||
| 125221033 | 12522103 | 6 | C | SOLANAX | ALPRAZOLAM | 1 | 0.4 MG, TID | 0 | .4 | MG | TID | ||||||||
| 125221033 | 12522103 | 7 | C | LITHIUM CARBONATE. | LITHIUM CARBONATE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125221033 | 12522103 | 1 | Bipolar disorder |
| 125221033 | 12522103 | 7 | Bipolar disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125221033 | 12522103 | OT |
| 125221033 | 12522103 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125221033 | 12522103 | Acute kidney injury | |
| 125221033 | 12522103 | Altered state of consciousness | |
| 125221033 | 12522103 | Anuria | |
| 125221033 | 12522103 | Blepharospasm | |
| 125221033 | 12522103 | Blood creatine phosphokinase increased | |
| 125221033 | 12522103 | Blood pressure decreased | |
| 125221033 | 12522103 | Cholelithiasis | |
| 125221033 | 12522103 | Dysarthria | |
| 125221033 | 12522103 | Fall | |
| 125221033 | 12522103 | Gait disturbance | |
| 125221033 | 12522103 | General physical health deterioration | |
| 125221033 | 12522103 | Hepatic steatosis | |
| 125221033 | 12522103 | Hyperhidrosis | |
| 125221033 | 12522103 | Liver function test increased | |
| 125221033 | 12522103 | Memory impairment | |
| 125221033 | 12522103 | Mental impairment | |
| 125221033 | 12522103 | Pneumonia | |
| 125221033 | 12522103 | Rash erythematous | |
| 125221033 | 12522103 | Restlessness | |
| 125221033 | 12522103 | Scar | |
| 125221033 | 12522103 | Seizure | |
| 125221033 | 12522103 | Skin ulcer | |
| 125221033 | 12522103 | Sputum retention | |
| 125221033 | 12522103 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125221033 | 12522103 | 1 | 20160108 | 20160204 | 0 | |
| 125221033 | 12522103 | 2 | 20160205 | 20160303 | 0 | |
| 125221033 | 12522103 | 3 | 20160304 | 20160331 | 0 | |
| 125221033 | 12522103 | 4 | 20160401 | 20160505 | 0 | |
| 125221033 | 12522103 | 7 | 201601 | 0 |