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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125243702 | 12524370 | 2 | F | 20160711 | 20160704 | 20160726 | EXP | US-AUROBINDO-AUR-APL-2016-08411 | AUROBINDO | 51.00 | YR | M | Y | 0.00000 | 20160725 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125243702 | 12524370 | 1 | PS | Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/325 mg | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Unknown | 10/325 MG, 2 TABLETS 3 TIMES DAILY | U | 201013 | TABLET | ||||||||
| 125243702 | 12524370 | 2 | SS | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | U | 0 | ||||||||||
| 125243702 | 12524370 | 3 | C | METOPROLOL TARTRATE. | METOPROLOL TARTRATE | 1 | Unknown | 25 MG, TWO TIMES A DAY | U | 0 | 25 | MG | BID | ||||||
| 125243702 | 12524370 | 4 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 40 MG, DAILY | U | 0 | 40 | MG | |||||||
| 125243702 | 12524370 | 5 | C | BACLOFEN. | BACLOFEN | 1 | Unknown | 15 MG, TWO TIMES A DAY | U | 0 | 15 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125243702 | 12524370 | 1 | Back pain |
| 125243702 | 12524370 | 2 | Back pain |
| 125243702 | 12524370 | 3 | Product used for unknown indication |
| 125243702 | 12524370 | 4 | Product used for unknown indication |
| 125243702 | 12524370 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125243702 | 12524370 | DE |
| 125243702 | 12524370 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125243702 | 12524370 | Acidosis | |
| 125243702 | 12524370 | Cardiac arrest | |
| 125243702 | 12524370 | Confusional state | |
| 125243702 | 12524370 | Dyspnoea | |
| 125243702 | 12524370 | Hallucination, visual | |
| 125243702 | 12524370 | Mental status changes | |
| 125243702 | 12524370 | Metabolic acidosis | |
| 125243702 | 12524370 | Pyroglutamate increased | |
| 125243702 | 12524370 | Respiratory alkalosis | |
| 125243702 | 12524370 | Respiratory distress | |
| 125243702 | 12524370 | Respiratory failure | |
| 125243702 | 12524370 | Somnolence | |
| 125243702 | 12524370 | Tachycardia | |
| 125243702 | 12524370 | Tachypnoea |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |