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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127358561 | 12735856 | 1 | I | 20160725 | 20160913 | 20160913 | PER | US-JNJFOC-20160721997 | JANSSEN | 0.00 | E | F | Y | 49.90000 | KG | 20160913 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127358561 | 12735856 | 1 | PS | IMODIUM A-D | LOPERAMIDE HYDROCHLORIDE | 1 | Oral | U | U | 5DE1702;0045-0295-32 | 19860 | CAPLET | |||||||
| 127358561 | 12735856 | 2 | SS | IMODIUM A-D | LOPERAMIDE HYDROCHLORIDE | 1 | Oral | 1-2 CAPLETS PER ISSUE OF IBSWITH ONE THEN ONE; NO MORE THAN 4 IN 24 HRS. STARTED ON 24-JUL | U | U | 5DE1702;0045-0295-32 | 19860 | CAPLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127358561 | 12735856 | 2 | Irritable bowel syndrome |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127358561 | 12735856 | Product packaging issue | |
| 127358561 | 12735856 | Unintentional use for unapproved indication |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |