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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125743281 | 12574328 | 1 | I | 20160531 | 20160708 | 20160720 | 20160720 | EXP | GB-MHRA-EYC 00141966 | GB-TEVA-676645ACC | TEVA | 74.00 | YR | F | Y | 0.00000 | 20160720 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125743281 | 12574328 | 1 | I | PHENYTOIN. | PHENYTOIN | 1 | Oral | Y | U | 0 | |||||||||
| 125743281 | 12574328 | 2 | PS | TRIMETHOPRIM. | TRIMETHOPRIM | 1 | Oral | 200 MILLIGRAM DAILY; | 2600 | MG | Y | U | 18679 | 200 | MG | QD | |||
| 125743281 | 12574328 | 3 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | 20 MILLIGRAM DAILY; | 0 | 20 | MG | QD | ||||||||
| 125743281 | 12574328 | 4 | C | SOLIFENACIN | SOLIFENACIN | 1 | 0 | ||||||||||||
| 125743281 | 12574328 | 5 | C | FERROUS FUMARATE | FERROUS FUMARATE | 1 | 3 DOSAGE FORMS DAILY; | 0 | 1 | DF | TID | ||||||||
| 125743281 | 12574328 | 6 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 0 | ||||||||||||
| 125743281 | 12574328 | 7 | C | PIVMECILLINAM | PENICILLIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125743281 | 12574328 | 1 | Epilepsy |
| 125743281 | 12574328 | 2 | Urinary tract infection |
| 125743281 | 12574328 | 7 | Urinary tract infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125743281 | 12574328 | OT |
| 125743281 | 12574328 | LT |
| 125743281 | 12574328 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125743281 | 12574328 | Confusional state | |
| 125743281 | 12574328 | Drug interaction | |
| 125743281 | 12574328 | Generalised tonic-clonic seizure | |
| 125743281 | 12574328 | Hypophagia | |
| 125743281 | 12574328 | Incorrect dose administered | |
| 125743281 | 12574328 | Malaise | |
| 125743281 | 12574328 | Somnolence | |
| 125743281 | 12574328 | Toxicity to various agents |
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 |
|---|---|---|---|---|---|---|
| 125743281 | 12574328 | 2 | 20160518 | 0 |