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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127686491 | 12768649 | 1 | I | 20111006 | 20160907 | 20160921 | 20160921 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00512 | AMNEAL | 83.00 | YR | M | Y | 76.64000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127686491 | 12768649 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | UNK | Y | 75927 | ||||||||||
| 127686491 | 12768649 | 2 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | 0 | |||||||||||
| 127686491 | 12768649 | 3 | C | VALTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | UNK | Y | 0 | ||||||||||
| 127686491 | 12768649 | 4 | C | KENALOG | TRIAMCINOLONE ACETONIDE | 1 | UNK | Y | N | 0 | |||||||||
| 127686491 | 12768649 | 5 | C | DELTASONE | PREDNISONE | 1 | UNK | U | 0 | ||||||||||
| 127686491 | 12768649 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | Y | 0 | ||||||||||
| 127686491 | 12768649 | 7 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | UNK | 0 | |||||||||||
| 127686491 | 12768649 | 8 | C | SIMVASTATIN. | SIMVASTATIN | 1 | UNK | 0 | |||||||||||
| 127686491 | 12768649 | 9 | C | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127686491 | 12768649 | 1 | Osteoarthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127686491 | 12768649 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127686491 | 12768649 | Dizziness | |
| 127686491 | 12768649 | Hemiparesis | |
| 127686491 | 12768649 | Transient ischaemic attack |
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 |
|---|---|---|---|---|---|---|
| 127686491 | 12768649 | 1 | 20100517 | 20111006 | 0 | |
| 127686491 | 12768649 | 2 | 20100517 | 0 | ||
| 127686491 | 12768649 | 3 | 20110928 | 20111005 | 0 | |
| 127686491 | 12768649 | 4 | 20110928 | 0 | ||
| 127686491 | 12768649 | 5 | 20110928 | 20111002 | 0 | |
| 127686491 | 12768649 | 6 | 20110928 | 20111008 | 0 | |
| 127686491 | 12768649 | 7 | 20080918 | 0 | ||
| 127686491 | 12768649 | 8 | 20090320 | 0 | ||
| 127686491 | 12768649 | 9 | 20090320 | 0 |