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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127631341 | 12763134 | 1 | I | 20140523 | 20160908 | 20160920 | 20160920 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00571 | AMNEAL | 47.00 | YR | F | Y | 0.00000 | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127631341 | 12763134 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | Y | 75927 | |||||||||||
| 127631341 | 12763134 | 2 | SS | NAPROXEN. | NAPROXEN | 1 | Y | 75927 | |||||||||||
| 127631341 | 12763134 | 3 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | 0 | |||||||||||
| 127631341 | 12763134 | 4 | C | LISINOPRIL. | LISINOPRIL | 1 | UNK | 0 | |||||||||||
| 127631341 | 12763134 | 5 | C | LANTUS | INSULIN GLARGINE | 1 | UNK | 0 | |||||||||||
| 127631341 | 12763134 | 6 | C | NOVOLOG | INSULIN ASPART | 1 | UNK | 0 | |||||||||||
| 127631341 | 12763134 | 7 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | UNK | 0 | |||||||||||
| 127631341 | 12763134 | 8 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | UNK | 0 | |||||||||||
| 127631341 | 12763134 | 9 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 127631341 | 12763134 | 10 | C | ASPIRIN. | ASPIRIN | 1 | UNK | 0 | |||||||||||
| 127631341 | 12763134 | 11 | C | RANEXA | RANOLAZINE | 1 | UNK | 0 | |||||||||||
| 127631341 | 12763134 | 12 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | UNK | U | 0 | ||||||||||
| 127631341 | 12763134 | 13 | C | METOPROLOL. | METOPROLOL | 1 | UNK | U | 0 | ||||||||||
| 127631341 | 12763134 | 14 | C | DILTIAZEM. | DILTIAZEM | 1 | UNK | U | 0 | ||||||||||
| 127631341 | 12763134 | 15 | C | BUMETANIDE. | BUMETANIDE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127631341 | 12763134 | 1 | Osteoporosis |
| 127631341 | 12763134 | 2 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127631341 | 12763134 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127631341 | 12763134 | Cardiac failure congestive | |
| 127631341 | 12763134 | Condition aggravated | |
| 127631341 | 12763134 | Coronary artery disease | |
| 127631341 | 12763134 | Dyspnoea | |
| 127631341 | 12763134 | Leukocytosis |
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 |
|---|---|---|---|---|---|---|
| 127631341 | 12763134 | 4 | 2008 | 0 | ||
| 127631341 | 12763134 | 6 | 2011 | 0 | ||
| 127631341 | 12763134 | 7 | 2006 | 0 | ||
| 127631341 | 12763134 | 8 | 2011 | 0 | ||
| 127631341 | 12763134 | 9 | 2011 | 0 | ||
| 127631341 | 12763134 | 10 | 2007 | 0 | ||
| 127631341 | 12763134 | 11 | 20140508 | 0 | ||
| 127631341 | 12763134 | 12 | 20140510 | 0 | ||
| 127631341 | 12763134 | 13 | 20140508 | 0 | ||
| 127631341 | 12763134 | 14 | 20140508 | 0 | ||
| 127631341 | 12763134 | 15 | 20140604 | 0 |