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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126128502 | 12612850 | 2 | F | 200302 | 20160720 | 20160802 | 20160804 | EXP | US-JNJFOC-20160720141 | JOHNSON AND JOHNSON | LARSON. ACETAMINOPHEN-INDUCED ACUTE LIVER FAILURE: RESULTS OF A UNITED STATES MULTICENTER, PROSPECTIVE STUDY. HEPATOLOGY 2005. | 21.00 | YR | A | F | Y | 46.00000 | KG | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126128502 | 12612850 | 1 | SS | TYLENOL PM | ACETAMINOPHENDIPHENHYDRAMINE | 1 | Unknown | AT NIGHT | U | U | 0 | UNSPECIFIED | |||||||
| 126128502 | 12612850 | 2 | SS | TYLENOL PM | ACETAMINOPHENDIPHENHYDRAMINE | 1 | Unknown | 6000 MG, TWO DAYS (HANDFUL 2 DAYS) | 12000 | MG | U | U | 0 | 6000 | MG | UNSPECIFIED | |||
| 126128502 | 12612850 | 3 | SS | TYLENOL PM | ACETAMINOPHENDIPHENHYDRAMINE | 1 | Unknown | AT NIGHT | U | U | 0 | UNSPECIFIED | |||||||
| 126128502 | 12612850 | 4 | PS | TYLENOL PM | ACETAMINOPHENDIPHENHYDRAMINE | 1 | Unknown | 6000 MG, TWO DAYS (HANDFUL 2 DAYS) | 12000 | MG | U | U | 999999 | 6000 | MG | UNSPECIFIED | |||
| 126128502 | 12612850 | 5 | SS | ETHANOL | ALCOHOL | 1 | Oral | AVERAGE GRAM OF ETHANOL PER DAY: 120 GM/DAY | U | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126128502 | 12612850 | 1 | Chest pain |
| 126128502 | 12612850 | 2 | Chest pain |
| 126128502 | 12612850 | 3 | Back pain |
| 126128502 | 12612850 | 4 | Back pain |
| 126128502 | 12612850 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126128502 | 12612850 | DE |
| 126128502 | 12612850 | HO |
| 126128502 | 12612850 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126128502 | 12612850 | Acute hepatic failure | |
| 126128502 | 12612850 | Acute kidney injury | |
| 126128502 | 12612850 | Brain oedema | |
| 126128502 | 12612850 | Drug administration error | |
| 126128502 | 12612850 | Hypothermia | |
| 126128502 | 12612850 | Intentional overdose | |
| 126128502 | 12612850 | Pleural effusion | |
| 126128502 | 12612850 | Suicide attempt |
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 |
|---|---|---|---|---|---|---|
| 126128502 | 12612850 | 2 | 200302 | 20030219 | 0 | |
| 126128502 | 12612850 | 4 | 200302 | 20030219 | 0 |