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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127504251 | 12750425 | 1 | I | 20120717 | 20160907 | 20160916 | 20160916 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00535 | AMNEAL | 62.00 | YR | M | Y | 75.11000 | KG | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127504251 | 12750425 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | UNK | Y | 75927 | ||||||||||
| 127504251 | 12750425 | 2 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | Y | 0 | ||||||||||
| 127504251 | 12750425 | 3 | C | TEMAZEPAM. | TEMAZEPAM | 1 | UNK | Y | 0 | ||||||||||
| 127504251 | 12750425 | 4 | C | oral digoxin | 2 | UNK | 0 | ||||||||||||
| 127504251 | 12750425 | 5 | C | CARVEDILOL. | CARVEDILOL | 1 | UNK | 0 | |||||||||||
| 127504251 | 12750425 | 6 | C | COLACE | DOCUSATE SODIUM | 1 | UNK | Y | 0 | ||||||||||
| 127504251 | 12750425 | 7 | C | GLIPIZIDE. | GLIPIZIDE | 1 | UNK | 0 | |||||||||||
| 127504251 | 12750425 | 8 | C | magnessium citrate | 2 | UNK | Y | 0 | |||||||||||
| 127504251 | 12750425 | 9 | C | amitriptyline | AMITRIPTYLINE | 1 | UNK | Y | 0 | ||||||||||
| 127504251 | 12750425 | 10 | C | METHADONE | METHADONE HYDROCHLORIDE | 1 | UNK | Y | 0 | ||||||||||
| 127504251 | 12750425 | 11 | C | SENOKOT-S | DOCUSATE SODIUMSENNOSIDES | 1 | UNK | Y | 0 | ||||||||||
| 127504251 | 12750425 | 12 | C | PAROXETINE. | PAROXETINE | 1 | UNK | 0 | |||||||||||
| 127504251 | 12750425 | 13 | C | CLOPIDOGREL | CLOPIDOGREL BISULFATE | 1 | UNK | 0 | |||||||||||
| 127504251 | 12750425 | 14 | C | LISINOPRIL. | LISINOPRIL | 1 | UNK | Y | 0 | ||||||||||
| 127504251 | 12750425 | 15 | C | LOVASTATIN. | LOVASTATIN | 1 | UNK | 0 | |||||||||||
| 127504251 | 12750425 | 16 | C | ATENOLOL. | ATENOLOL | 1 | UNK | 0 | |||||||||||
| 127504251 | 12750425 | 17 | C | EZETIMIBE. | EZETIMIBE | 1 | UNK | 0 | |||||||||||
| 127504251 | 12750425 | 18 | C | sitagliptin | SITAGLIPTIN | 1 | UNK | 0 | |||||||||||
| 127504251 | 12750425 | 19 | C | ASA | ASPIRIN | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127504251 | 12750425 | 1 | Osteoarthritis |
| 127504251 | 12750425 | 3 | Insomnia |
| 127504251 | 12750425 | 4 | Atrial fibrillation |
| 127504251 | 12750425 | 5 | Coronary artery disease |
| 127504251 | 12750425 | 6 | Constipation |
| 127504251 | 12750425 | 7 | Diabetes mellitus |
| 127504251 | 12750425 | 9 | Insomnia |
| 127504251 | 12750425 | 13 | Coronary artery disease |
| 127504251 | 12750425 | 14 | Hypertension |
| 127504251 | 12750425 | 15 | Dyslipidaemia |
| 127504251 | 12750425 | 16 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127504251 | 12750425 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127504251 | 12750425 | Chest pain | |
| 127504251 | 12750425 | Oesophagitis |
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 |
|---|---|---|---|---|---|---|
| 127504251 | 12750425 | 1 | 20101130 | 20130106 | 0 | |
| 127504251 | 12750425 | 2 | 20110131 | 20130612 | 0 | |
| 127504251 | 12750425 | 3 | 2011 | 20130606 | 0 | |
| 127504251 | 12750425 | 4 | 20120427 | 0 | ||
| 127504251 | 12750425 | 5 | 2007 | 0 | ||
| 127504251 | 12750425 | 6 | 20120413 | 201306 | 0 | |
| 127504251 | 12750425 | 7 | 201011 | 0 | ||
| 127504251 | 12750425 | 8 | 20120319 | 20130605 | 0 | |
| 127504251 | 12750425 | 9 | 20111130 | 20130606 | 0 | |
| 127504251 | 12750425 | 10 | 20120319 | 20130510 | 0 | |
| 127504251 | 12750425 | 11 | 20120319 | 20130606 | 0 | |
| 127504251 | 12750425 | 12 | 2009 | 0 | ||
| 127504251 | 12750425 | 13 | 2003 | 0 | ||
| 127504251 | 12750425 | 14 | 2000 | 20130108 | 0 | |
| 127504251 | 12750425 | 15 | 2005 | 0 | ||
| 127504251 | 12750425 | 16 | 2003 | 0 | ||
| 127504251 | 12750425 | 17 | 2010 | 0 | ||
| 127504251 | 12750425 | 18 | 2010 | 0 | ||
| 127504251 | 12750425 | 19 | 2003 | 0 |