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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127492631 | 12749263 | 1 | I | 20120604 | 20160915 | 20160915 | EXP | JP-WARNER CHILCOTT 2012-002108 | WARNER CHILCOTT | 60.00 | YR | F | Y | 0.00000 | 20160915 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127492631 | 12749263 | 1 | PS | ACTONEL | RISEDRONATE SODIUM | 1 | 20835 | 5 | MG | TABLET | |||||||||
| 127492631 | 12749263 | 2 | SS | ACTONEL | RISEDRONATE SODIUM | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 3 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 4 | C | TESTOSTERONE. | TESTOSTERONE | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 5 | C | TAMOXIFEN | TAMOXIFEN | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 6 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 7 | C | AZMACORT | TRIAMCINOLONE ACETONIDE | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 8 | C | NASACORT | TRIAMCINOLONE ACETONIDE | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 9 | C | PULMICORT TURBUHALER | BUDESONIDE | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 10 | C | RHINOCORT AQUA | BUDESONIDE | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 11 | C | SEREVENT DISKUS | SALMETEROL XINAFOATE | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 12 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 13 | C | ULTRAM | TRAMADOL HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 14 | C | BEXTRA | VALDECOXIB | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 15 | C | MOBIC | MELOXICAM | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 16 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 17 | C | PREVACID | LANSOPRAZOLE | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 18 | C | DITROPAN XL | OXYBUTYNIN CHLORIDE | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 19 | C | DOXEPIN | DOXEPIN | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 20 | C | EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 21 | C | VERAPAMIL | VERAPAMIL HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 22 | C | CLONIDINE. | CLONIDINE | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 23 | C | CALCIUM | CALCIUM | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 24 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 25 | C | GLUCOSAMINE | GLUCOSAMINE | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 26 | C | ECHINACEA | ECHINACEA, UNSPECIFIED | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 27 | C | MULTIVITAMIN | VITAMINS | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 28 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 29 | C | OMEGA 3 | OMEGA-3 FATTY ACIDS | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 30 | C | TUMS | CALCIUM CARBONATE | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 31 | C | CENTRUM SILVER | MINERALSVITAMINS | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 32 | C | MAGNESIUM | MAGNESIUM | 1 | 0 | ||||||||||||
| 127492631 | 12749263 | 33 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127492631 | 12749263 | 1 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127492631 | 12749263 | OT |
| 127492631 | 12749263 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127492631 | 12749263 | Arthralgia | |
| 127492631 | 12749263 | Bone disorder | |
| 127492631 | 12749263 | Bone marrow oedema syndrome | |
| 127492631 | 12749263 | Femur fracture | |
| 127492631 | 12749263 | Low turnover osteopathy | |
| 127492631 | 12749263 | Pain | |
| 127492631 | 12749263 | Pain in extremity | |
| 127492631 | 12749263 | Pathological fracture | |
| 127492631 | 12749263 | Stress fracture |
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 |
|---|---|---|---|---|---|---|
| 127492631 | 12749263 | 1 | 200402 | 200602 | 0 | |
| 127492631 | 12749263 | 2 | 200208 | 0 | ||
| 127492631 | 12749263 | 5 | 2000 | 2005 | 0 |