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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127600441 | 12760044 | 1 | I | 20160201 | 20160907 | 20160919 | 20160919 | EXP | GB-MHRA-EYC 00134900 | GB-TEVA-692562ACC | TEVA | 79.00 | YR | M | Y | 0.00000 | 20160919 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127600441 | 12760044 | 1 | PS | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | Oral | 1 DOSAGE FORMS DAILY; | 14 | DF | Y | U | 83426 | 1 | DF | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127600441 | 12760044 | 1 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127600441 | 12760044 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127600441 | 12760044 | Asthenia | |
| 127600441 | 12760044 | Blood creatine phosphokinase increased | |
| 127600441 | 12760044 | Dysphagia | |
| 127600441 | 12760044 | Dyspnoea | |
| 127600441 | 12760044 | Myalgia |
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 |
|---|---|---|---|---|---|---|
| 127600441 | 12760044 | 1 | 20160118 | 20160201 | 0 |