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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86459968 | 8645996 | 8 | F | 2006 | 20160902 | 20120702 | 20160907 | EXP | US-009507513-1206USA04699 | MERCK | 0.00 | F | Y | 84.81000 | KG | 20160907 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86459968 | 8645996 | 1 | PS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 70 MG, QW | 20560 | 70 | MG | TABLET | /wk | ||||||
| 86459968 | 8645996 | 2 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | 20560 | TABLET | |||||||||||
| 86459968 | 8645996 | 3 | SS | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | Oral | 70 MG, UNK | 20560 | 70 | MG | TABLET | |||||||
| 86459968 | 8645996 | 4 | SS | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | Unknown | 70 MG, QW | 0 | 70 | MG | /wk | |||||||
| 86459968 | 8645996 | 5 | SS | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | Unknown | 70 MG, UNK | 0 | 70 | MG | ||||||||
| 86459968 | 8645996 | 6 | SS | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | Unknown | 70 MG, UNK | 0 | 70 | MG | ||||||||
| 86459968 | 8645996 | 7 | C | RECLAST | ZOLEDRONIC ACID | 1 | Intra-arterial | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 86459968 | 8645996 | 1 | Osteoporosis |
| 86459968 | 8645996 | 2 | Osteomalacia |
| 86459968 | 8645996 | 3 | Osteoporosis |
| 86459968 | 8645996 | 4 | Osteoporosis |
| 86459968 | 8645996 | 7 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 86459968 | 8645996 | HO |
| 86459968 | 8645996 | DS |
| 86459968 | 8645996 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 86459968 | 8645996 | Arthralgia | |
| 86459968 | 8645996 | Arthritis | |
| 86459968 | 8645996 | Arthropathy | |
| 86459968 | 8645996 | Attention deficit/hyperactivity disorder | |
| 86459968 | 8645996 | Blood creatinine increased | |
| 86459968 | 8645996 | Bone fragmentation | |
| 86459968 | 8645996 | Calcium deficiency | |
| 86459968 | 8645996 | Chronic kidney disease | |
| 86459968 | 8645996 | Colonoscopy | |
| 86459968 | 8645996 | Diabetes mellitus | |
| 86459968 | 8645996 | Fall | |
| 86459968 | 8645996 | Femoral neck fracture | |
| 86459968 | 8645996 | Femur fracture | |
| 86459968 | 8645996 | Fracture nonunion | |
| 86459968 | 8645996 | Glomerular filtration rate decreased | |
| 86459968 | 8645996 | Hip arthroplasty | |
| 86459968 | 8645996 | Hypertension | |
| 86459968 | 8645996 | Hysterectomy | |
| 86459968 | 8645996 | Internal fixation of fracture | |
| 86459968 | 8645996 | Intramedullary rod insertion | |
| 86459968 | 8645996 | Joint contracture | |
| 86459968 | 8645996 | Joint effusion | |
| 86459968 | 8645996 | Low turnover osteopathy | |
| 86459968 | 8645996 | Medical device removal | |
| 86459968 | 8645996 | Off label use | |
| 86459968 | 8645996 | Open reduction of fracture | |
| 86459968 | 8645996 | Osteopenia | |
| 86459968 | 8645996 | Osteoporosis | |
| 86459968 | 8645996 | Patella fracture | |
| 86459968 | 8645996 | Rotator cuff syndrome | |
| 86459968 | 8645996 | Stress fracture | |
| 86459968 | 8645996 | Tonsillectomy | |
| 86459968 | 8645996 | Treatment noncompliance | |
| 86459968 | 8645996 | Vitamin D deficiency |
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 |
|---|---|---|---|---|---|---|
| 86459968 | 8645996 | 1 | 200607 | 201103 | 0 | |
| 86459968 | 8645996 | 3 | 20100529 | 0 | ||
| 86459968 | 8645996 | 4 | 20081029 | 0 | ||
| 86459968 | 8645996 | 5 | 20090714 | 2009 | 0 | |
| 86459968 | 8645996 | 6 | 20091013 | 2010 | 0 | |
| 86459968 | 8645996 | 7 | 201103 | 201204 | 0 |