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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86459999 | 8645999 | 9 | F | 200211 | 20160727 | 20120702 | 20160802 | EXP | US-009507513-1206USA04951 | MERCK | 0.00 | F | Y | 84.81000 | KG | 20160802 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86459999 | 8645999 | 1 | PS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 70 MG, QW | U | 20560 | 70 | MG | TABLET | /wk | |||||
| 86459999 | 8645999 | 2 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | U | 20560 | TABLET | ||||||||||
| 86459999 | 8645999 | 3 | SS | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | Unknown | 70 MG, UNK | 0 | 70 | MG | ||||||||
| 86459999 | 8645999 | 4 | SS | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | 0 | ||||||||||||
| 86459999 | 8645999 | 5 | C | calcium (unspecified) (+) vitamin D (unspecified) | CALCIUM CARBONATEVITAMIN D | 1 | Unknown | UNK, BID | U | 0 | BID | ||||||||
| 86459999 | 8645999 | 6 | C | calcium (unspecified) (+) vitamin D (unspecified) | CALCIUM CARBONATEVITAMIN D | 1 | U | 0 | |||||||||||
| 86459999 | 8645999 | 7 | C | MIACALCIN | CALCITONIN SALMON | 1 | Unknown | U | 0 | ||||||||||
| 86459999 | 8645999 | 8 | C | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 86459999 | 8645999 | 9 | C | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 86459999 | 8645999 | 10 | C | DITROPAN XL | OXYBUTYNIN CHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 86459999 | 8645999 | 11 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 800 IU, QD | U | 0 | 800 | IU | QD | ||||||
| 86459999 | 8645999 | 12 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 86459999 | 8645999 | 13 | C | CALCIUM (UNSPECIFIED) | CALCIUM | 1 | Unknown | 1500 MG, UNK | U | 0 | 1500 | MG | QD | ||||||
| 86459999 | 8645999 | 14 | C | CALCIUM (UNSPECIFIED) | CALCIUM | 1 | U | 0 | |||||||||||
| 86459999 | 8645999 | 15 | C | MAGNESIUM (UNSPECIFIED) | MAGNESIUM | 1 | Unknown | 400 MG, QD | U | 0 | 400 | MG | QD | ||||||
| 86459999 | 8645999 | 16 | C | MAGNESIUM (UNSPECIFIED) | MAGNESIUM | 1 | U | 0 | |||||||||||
| 86459999 | 8645999 | 17 | C | VITAMINS (UNSPECIFIED) | VITAMINS | 1 | Unknown | UNK | U | 0 | |||||||||
| 86459999 | 8645999 | 18 | C | BONIVA | IBANDRONATE SODIUM | 1 | Unknown | 150 MG, UNK | U | 0 | 150 | MG | |||||||
| 86459999 | 8645999 | 19 | C | BONIVA | IBANDRONATE SODIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 86459999 | 8645999 | 1 | Osteoporosis |
| 86459999 | 8645999 | 2 | Osteopenia |
| 86459999 | 8645999 | 3 | Osteoporosis |
| 86459999 | 8645999 | 4 | Osteopenia |
| 86459999 | 8645999 | 5 | Osteoporosis |
| 86459999 | 8645999 | 6 | Osteopenia |
| 86459999 | 8645999 | 7 | Osteoporosis |
| 86459999 | 8645999 | 8 | Restless legs syndrome |
| 86459999 | 8645999 | 9 | Periodic limb movement disorder |
| 86459999 | 8645999 | 10 | Product used for unknown indication |
| 86459999 | 8645999 | 11 | Osteoporosis |
| 86459999 | 8645999 | 12 | Osteopenia |
| 86459999 | 8645999 | 13 | Osteoporosis |
| 86459999 | 8645999 | 14 | Osteopenia |
| 86459999 | 8645999 | 15 | Osteoporosis |
| 86459999 | 8645999 | 16 | Osteopenia |
| 86459999 | 8645999 | 17 | Product used for unknown indication |
| 86459999 | 8645999 | 18 | Osteopenia |
| 86459999 | 8645999 | 19 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 86459999 | 8645999 | HO |
| 86459999 | 8645999 | OT |
| 86459999 | 8645999 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 86459999 | 8645999 | Amnesia | |
| 86459999 | 8645999 | Animal bite | |
| 86459999 | 8645999 | Anxiety | |
| 86459999 | 8645999 | Back pain | |
| 86459999 | 8645999 | Blindness | |
| 86459999 | 8645999 | Blood pressure increased | |
| 86459999 | 8645999 | Carpal tunnel syndrome | |
| 86459999 | 8645999 | Cerebrovascular disorder | |
| 86459999 | 8645999 | Depression | |
| 86459999 | 8645999 | Device dislocation | |
| 86459999 | 8645999 | Device failure | |
| 86459999 | 8645999 | Device loosening | |
| 86459999 | 8645999 | Drug ineffective | |
| 86459999 | 8645999 | Electrocardiogram abnormal | |
| 86459999 | 8645999 | Feeling jittery | |
| 86459999 | 8645999 | Femur fracture | |
| 86459999 | 8645999 | Flushing | |
| 86459999 | 8645999 | Gait disturbance | |
| 86459999 | 8645999 | Hip arthroplasty | |
| 86459999 | 8645999 | Holmes-Adie pupil | |
| 86459999 | 8645999 | Hypercholesterolaemia | |
| 86459999 | 8645999 | Hypotension | |
| 86459999 | 8645999 | Hypothyroidism | |
| 86459999 | 8645999 | Intervertebral disc operation | |
| 86459999 | 8645999 | Intervertebral disc protrusion | |
| 86459999 | 8645999 | Joint arthroplasty | |
| 86459999 | 8645999 | Low turnover osteopathy | |
| 86459999 | 8645999 | Lumbar spinal stenosis | |
| 86459999 | 8645999 | Macular cyst | |
| 86459999 | 8645999 | Macular hole | |
| 86459999 | 8645999 | Macular pseudohole | |
| 86459999 | 8645999 | Maculopathy | |
| 86459999 | 8645999 | Malaise | |
| 86459999 | 8645999 | Muscle twitching | |
| 86459999 | 8645999 | Nuclear magnetic resonance imaging brain abnormal | |
| 86459999 | 8645999 | Osteoporosis | |
| 86459999 | 8645999 | Pain in extremity | |
| 86459999 | 8645999 | Poor quality sleep | |
| 86459999 | 8645999 | Spinal laminectomy | |
| 86459999 | 8645999 | Stress fracture | |
| 86459999 | 8645999 | Surgery | |
| 86459999 | 8645999 | Transient ischaemic attack | |
| 86459999 | 8645999 | Tremor | |
| 86459999 | 8645999 | Viral infection | |
| 86459999 | 8645999 | Vitrectomy | |
| 86459999 | 8645999 | Vitreous disorder |
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 |
|---|---|---|---|---|---|---|
| 86459999 | 8645999 | 1 | 200210 | 201004 | 0 | |
| 86459999 | 8645999 | 3 | 20090421 | 0 | ||
| 86459999 | 8645999 | 17 | 19800101 | 0 | ||
| 86459999 | 8645999 | 18 | 200803 | 200807 | 0 |