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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127735121 | 12773512 | 1 | I | 20140610 | 20160909 | 20160922 | 20160922 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00588 | AMNEAL | 48.00 | YR | M | Y | 110.00000 | KG | 20160922 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127735121 | 12773512 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | UNK | Y | 75927 | ||||||||||
| 127735121 | 12773512 | 2 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | 20 MG, 1X/DAY | Y | 0 | 20 | MG | QD | ||||||
| 127735121 | 12773512 | 3 | C | ASPIRIN. | ASPIRIN | 1 | Oral | UNK | 0 | TABLET | |||||||||
| 127735121 | 12773512 | 4 | C | ZOCOR | SIMVASTATIN | 1 | Oral | UNK, 1X/DAY | 0 | TABLET | QD | ||||||||
| 127735121 | 12773512 | 5 | C | LOPRESSOR | METOPROLOL TARTRATE | 1 | Oral | UNK, 2X/DAY | 0 | TABLET | BID | ||||||||
| 127735121 | 12773512 | 6 | C | IMODIUM | LOPERAMIDE HYDROCHLORIDE | 1 | Oral | UNK AS NEEDED | 0 | CAPSULE | |||||||||
| 127735121 | 12773512 | 7 | C | DIABETA | GLYBURIDE | 1 | Oral | UNK MG, 2X/DAY | 0 | TABLET | BID | ||||||||
| 127735121 | 12773512 | 8 | C | LASIX | FUROSEMIDE | 1 | Oral | UNK UNK, 1X/DAY | 0 | TABLET | QD | ||||||||
| 127735121 | 12773512 | 9 | C | CATAPRES | CLONIDINE HYDROCHLORIDE | 1 | Oral | UNK, 2X/DAY | 0 | TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127735121 | 12773512 | 1 | Osteoarthritis |
| 127735121 | 12773512 | 2 | Prophylaxis against gastrointestinal ulcer |
| 127735121 | 12773512 | 3 | Cardiovascular event prophylaxis |
| 127735121 | 12773512 | 4 | Hyperlipidaemia |
| 127735121 | 12773512 | 5 | Hypertension |
| 127735121 | 12773512 | 6 | Irritable bowel syndrome |
| 127735121 | 12773512 | 7 | Type 2 diabetes mellitus |
| 127735121 | 12773512 | 8 | Hypertension |
| 127735121 | 12773512 | 9 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127735121 | 12773512 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127735121 | 12773512 | Angina pectoris | |
| 127735121 | 12773512 | Coronary artery disease | |
| 127735121 | 12773512 | Myocardial infarction |
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 |
|---|---|---|---|---|---|---|
| 127735121 | 12773512 | 1 | 20130425 | 20140611 | 0 | |
| 127735121 | 12773512 | 2 | 20130425 | 20140611 | 0 | |
| 127735121 | 12773512 | 3 | 1998 | 0 | ||
| 127735121 | 12773512 | 4 | 2002 | 0 | ||
| 127735121 | 12773512 | 5 | 2000 | 0 | ||
| 127735121 | 12773512 | 6 | 20121128 | 0 | ||
| 127735121 | 12773512 | 7 | 20121128 | 0 | ||
| 127735121 | 12773512 | 8 | 2002 | 0 | ||
| 127735121 | 12773512 | 9 | 2008 | 0 |