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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127724461 | 12772446 | 1 | I | 20120806 | 20160908 | 20160922 | 20160922 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00557 | AMNEAL | 63.00 | YR | F | Y | 93.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127724461 | 12772446 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | Oral | UNK, 3X/DAY | Y | 75927 | TID | ||||||||
| 127724461 | 12772446 | 2 | SS | NAPROXEN. | NAPROXEN | 1 | Y | 75927 | |||||||||||
| 127724461 | 12772446 | 3 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | 40 MG, 1X/DAY | Y | 0 | 40 | MG | QD | ||||||
| 127724461 | 12772446 | 4 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | Nasal | UNK, 2X/DAY ONE SPRAY | 0 | INHALANT | BID | ||||||||
| 127724461 | 12772446 | 5 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 40 MG, 1X/DAY | 0 | 40 | MG | QD | |||||||
| 127724461 | 12772446 | 6 | C | CLONIDINE. | CLONIDINE | 1 | Oral | 0.1 MG, 4X/DAY | 0 | .1 | MG | QID | |||||||
| 127724461 | 12772446 | 7 | C | hydrochlorothiazide/lisinopril | HYDROCHLOROTHIAZIDELISINOPRIL | 1 | Oral | UNK MG, 2X/DAY 20/12.5 MG STRENGTH | 0 | BID | |||||||||
| 127724461 | 12772446 | 8 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 40 MG, 1X/DAY | 0 | 40 | MG | QD | |||||||
| 127724461 | 12772446 | 9 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | 100 MG, 2X/DAY | 0 | 100 | MG | BID | |||||||
| 127724461 | 12772446 | 10 | C | TRAMADOL. | TRAMADOL | 1 | Oral | 50 MG, 3X/DAY | 0 | 50 | MG | TID | |||||||
| 127724461 | 12772446 | 11 | C | oxybutynin | OXYBUTYNIN | 1 | Oral | 0.5 MG, 4X/DAY | 0 | .5 | MG | QID | |||||||
| 127724461 | 12772446 | 12 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 81 MG, 1X/DAY | 0 | 81 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127724461 | 12772446 | 1 | Osteoarthritis |
| 127724461 | 12772446 | 2 | Rheumatoid arthritis |
| 127724461 | 12772446 | 3 | Prophylaxis against gastrointestinal ulcer |
| 127724461 | 12772446 | 4 | Seasonal allergy |
| 127724461 | 12772446 | 5 | Gastrooesophageal reflux disease |
| 127724461 | 12772446 | 6 | Hypertension |
| 127724461 | 12772446 | 7 | Hypertension |
| 127724461 | 12772446 | 8 | Dyslipidaemia |
| 127724461 | 12772446 | 9 | Neuropathy peripheral |
| 127724461 | 12772446 | 10 | Osteoarthritis |
| 127724461 | 12772446 | 11 | Urinary incontinence |
| 127724461 | 12772446 | 12 | Cardiovascular event prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127724461 | 12772446 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127724461 | 12772446 | Chronic obstructive pulmonary disease | |
| 127724461 | 12772446 | 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 |
|---|---|---|---|---|---|---|
| 127724461 | 12772446 | 1 | 20100413 | 20120305 | 0 | |
| 127724461 | 12772446 | 3 | 20100423 | 20120305 | 0 | |
| 127724461 | 12772446 | 4 | 20120305 | 0 | ||
| 127724461 | 12772446 | 5 | 20120313 | 0 | ||
| 127724461 | 12772446 | 6 | 20110325 | 0 | ||
| 127724461 | 12772446 | 7 | 20110325 | 0 | ||
| 127724461 | 12772446 | 8 | 2007 | 0 | ||
| 127724461 | 12772446 | 9 | 20100806 | 0 | ||
| 127724461 | 12772446 | 10 | 2008 | 0 | ||
| 127724461 | 12772446 | 11 | 2006 | 0 | ||
| 127724461 | 12772446 | 12 | 20110415 | 0 |