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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127693581 | 12769358 | 1 | I | 20110603 | 20160908 | 20160921 | 20160921 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00555 | AMNEAL | 76.00 | YR | F | Y | 87.00000 | KG | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127693581 | 12769358 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | Oral | UNK, 3X/DAY | Y | 75927 | TID | ||||||||
| 127693581 | 12769358 | 2 | SS | NAPROXEN. | NAPROXEN | 1 | Y | 75927 | |||||||||||
| 127693581 | 12769358 | 3 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | UNK, 1X/DAY | Y | 0 | QD | ||||||||
| 127693581 | 12769358 | 4 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | 0 | |||||||||||
| 127693581 | 12769358 | 5 | C | BACLOFEN. | BACLOFEN | 1 | UNK | 0 | |||||||||||
| 127693581 | 12769358 | 6 | C | oxybutynin | OXYBUTYNIN | 1 | UNK | 0 | |||||||||||
| 127693581 | 12769358 | 7 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | UNK | Y | 0 | ||||||||||
| 127693581 | 12769358 | 8 | C | LISINOPRIL. | LISINOPRIL | 1 | UNK | 0 | |||||||||||
| 127693581 | 12769358 | 9 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | 0 | |||||||||||
| 127693581 | 12769358 | 10 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | UNK | 0 | |||||||||||
| 127693581 | 12769358 | 11 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | 0 | |||||||||||
| 127693581 | 12769358 | 12 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | U | 0 | |||||||||||
| 127693581 | 12769358 | 13 | C | fish oil | FISH OIL | 1 | UNK | 0 | |||||||||||
| 127693581 | 12769358 | 14 | C | baby aspirin | ASPIRIN | 1 | UNK | Y | 0 | ||||||||||
| 127693581 | 12769358 | 15 | C | CARBAMAZEPINE. | CARBAMAZEPINE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127693581 | 12769358 | 1 | Osteoarthritis |
| 127693581 | 12769358 | 2 | Rheumatoid arthritis |
| 127693581 | 12769358 | 3 | Prophylaxis against gastrointestinal ulcer |
| 127693581 | 12769358 | 4 | Trigeminal neuralgia |
| 127693581 | 12769358 | 5 | Trigeminal neuralgia |
| 127693581 | 12769358 | 6 | Hypertonic bladder |
| 127693581 | 12769358 | 7 | Hyperlipidaemia |
| 127693581 | 12769358 | 8 | Hypertension |
| 127693581 | 12769358 | 9 | Hypothyroidism |
| 127693581 | 12769358 | 10 | Abdominal discomfort |
| 127693581 | 12769358 | 11 | Vitamin supplementation |
| 127693581 | 12769358 | 12 | Vitamin supplementation |
| 127693581 | 12769358 | 13 | Supplementation therapy |
| 127693581 | 12769358 | 14 | Cardiovascular event prophylaxis |
| 127693581 | 12769358 | 15 | Trigeminal neuralgia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127693581 | 12769358 | HO |
| 127693581 | 12769358 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127693581 | 12769358 | Angina unstable | |
| 127693581 | 12769358 | Coronary artery disease |
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 |
|---|---|---|---|---|---|---|
| 127693581 | 12769358 | 1 | 20101119 | 20110602 | 0 | |
| 127693581 | 12769358 | 3 | 20101119 | 20110602 | 0 | |
| 127693581 | 12769358 | 4 | 1990 | 0 | ||
| 127693581 | 12769358 | 5 | 1990 | 0 | ||
| 127693581 | 12769358 | 6 | 2000 | 0 | ||
| 127693581 | 12769358 | 7 | 2003 | 20110602 | 0 | |
| 127693581 | 12769358 | 8 | 2000 | 0 | ||
| 127693581 | 12769358 | 9 | 2004 | 0 | ||
| 127693581 | 12769358 | 10 | 2008 | 0 | ||
| 127693581 | 12769358 | 11 | 2008 | 0 | ||
| 127693581 | 12769358 | 13 | 2008 | 0 | ||
| 127693581 | 12769358 | 14 | 2000 | 20110604 | 0 | |
| 127693581 | 12769358 | 15 | 1990 | 0 |