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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85476467 | 8547646 | 7 | F | 2001 | 20160726 | 20120504 | 20160729 | EXP | US-009507513-1205USA00038 | MERCK | 0.00 | M | Y | 79.14000 | KG | 20160729 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85476467 | 8547646 | 1 | PS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 35 MG, UNKNOWN | 20560 | 35 | MG | TABLET | |||||||
| 85476467 | 8547646 | 2 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 70 MG, UNKNOWN | 20560 | 70 | MG | TABLET | |||||||
| 85476467 | 8547646 | 3 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | 20560 | TABLET | |||||||||||
| 85476467 | 8547646 | 4 | SS | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | Oral | 70 MG, UNKNOWN | 20560 | 70 | MG | TABLET | |||||||
| 85476467 | 8547646 | 5 | SS | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | Oral | 70 MG, UNKNOWN | 0 | 70 | MG | TABLET | |||||||
| 85476467 | 8547646 | 6 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 70 MG, UNKNOWN | 20560 | 70 | MG | TABLET | |||||||
| 85476467 | 8547646 | 7 | SS | ACTONEL | RISEDRONATE SODIUM | 1 | Unknown | 35 MG, UNKNOWN | U | 0 | 35 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 85476467 | 8547646 | 1 | Osteoporosis |
| 85476467 | 8547646 | 2 | Osteopenia |
| 85476467 | 8547646 | 3 | Bone density abnormal |
| 85476467 | 8547646 | 4 | Bone density abnormal |
| 85476467 | 8547646 | 5 | Bone density abnormal |
| 85476467 | 8547646 | 6 | Bone density abnormal |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 85476467 | 8547646 | HO |
| 85476467 | 8547646 | OT |
| 85476467 | 8547646 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 85476467 | 8547646 | Anaemia | |
| 85476467 | 8547646 | Anaemia of chronic disease | |
| 85476467 | 8547646 | Anaemia postoperative | |
| 85476467 | 8547646 | Arthropathy | |
| 85476467 | 8547646 | Asthenia | |
| 85476467 | 8547646 | Back pain | |
| 85476467 | 8547646 | Benign prostatic hyperplasia | |
| 85476467 | 8547646 | Blood calcium decreased | |
| 85476467 | 8547646 | Bone density decreased | |
| 85476467 | 8547646 | Calcium deficiency | |
| 85476467 | 8547646 | Constipation | |
| 85476467 | 8547646 | Coronary artery disease | |
| 85476467 | 8547646 | Dental implantation | |
| 85476467 | 8547646 | Device breakage | |
| 85476467 | 8547646 | Device defective | |
| 85476467 | 8547646 | Device failure | |
| 85476467 | 8547646 | Extrasystoles | |
| 85476467 | 8547646 | Femur fracture | |
| 85476467 | 8547646 | Fracture delayed union | |
| 85476467 | 8547646 | Fracture nonunion | |
| 85476467 | 8547646 | Gastrooesophageal reflux disease | |
| 85476467 | 8547646 | Groin pain | |
| 85476467 | 8547646 | Hyperlipidaemia | |
| 85476467 | 8547646 | Inappropriate schedule of drug administration | |
| 85476467 | 8547646 | Large intestine polyp | |
| 85476467 | 8547646 | Limb asymmetry | |
| 85476467 | 8547646 | Medical device removal | |
| 85476467 | 8547646 | Open reduction of fracture | |
| 85476467 | 8547646 | Osteoarthritis | |
| 85476467 | 8547646 | Pain | |
| 85476467 | 8547646 | Periodontal disease | |
| 85476467 | 8547646 | Rhinitis allergic | |
| 85476467 | 8547646 | Rotator cuff syndrome | |
| 85476467 | 8547646 | Spinal fusion surgery | |
| 85476467 | 8547646 | Surgery | |
| 85476467 | 8547646 | Urinary retention | |
| 85476467 | 8547646 | Ventricular extrasystoles |
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 |
|---|---|---|---|---|---|---|
| 85476467 | 8547646 | 1 | 20011126 | 20060703 | 0 | |
| 85476467 | 8547646 | 2 | 20060703 | 200807 | 0 | |
| 85476467 | 8547646 | 4 | 200608 | 200804 | 0 | |
| 85476467 | 8547646 | 5 | 200807 | 201003 | 0 | |
| 85476467 | 8547646 | 6 | 200807 | 201001 | 0 | |
| 85476467 | 8547646 | 7 | 20010101 | 20060630 | 0 |