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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122844005 | 12284400 | 5 | F | 20160729 | 20160420 | 20160811 | EXP | US-AUROBINDO-AUR-APL-2016-04747 | AUROBINDO | 0.00 | Y | 0.00000 | 20160811 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122844005 | 12284400 | 1 | PS | LOPERAMIDE HCL | LOPERAMIDE HYDROCHLORIDE | 1 | Unknown | 2 MG, (20 TO 40 TABLETS OF 2 MG LOPERAMIDE 1-2 TIMES/DAY FOR WEEKS) | U | 206548 | 2 | MG | TABLET | ||||||
| 122844005 | 12284400 | 2 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122844005 | 12284400 | 1 | Euphoric mood |
| 122844005 | 12284400 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122844005 | 12284400 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122844005 | 12284400 | Arrhythmia | |
| 122844005 | 12284400 | Asthenia | |
| 122844005 | 12284400 | Confusional state | |
| 122844005 | 12284400 | Drug abuse | |
| 122844005 | 12284400 | Dysarthria | |
| 122844005 | 12284400 | Electrocardiogram QRS complex prolonged | |
| 122844005 | 12284400 | Electrocardiogram QT prolonged | |
| 122844005 | 12284400 | Hyperkalaemia | |
| 122844005 | 12284400 | Hypotension | |
| 122844005 | 12284400 | Overdose | |
| 122844005 | 12284400 | Somnolence |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |