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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 858116510 | 8581165 | 10 | F | 2001 | 20160630 | 20120525 | 20160706 | EXP | US-009507513-1205USA02889 | MERCK | 0.00 | F | Y | 88.18000 | KG | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 858116510 | 8581165 | 1 | PS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 10 MG, UNKNOWN | 20560 | 10 | MG | TABLET | |||||||
| 858116510 | 8581165 | 2 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 70MG, QW | 20560 | 70 | MG | TABLET | /wk | ||||||
| 858116510 | 8581165 | 3 | SS | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | Oral | 70 MG, UNKNOWN | 20560 | 70 | MG | TABLET | |||||||
| 858116510 | 8581165 | 4 | SS | ACTONEL | RISEDRONATE SODIUM | 1 | Oral | 35 MG, UNKNOWN | U | 0 | 35 | MG | |||||||
| 858116510 | 8581165 | 5 | C | FLUTICASONE | FLUTICASONEFLUTICASONE PROPIONATE | 1 | Unknown | UNK, UNKNOWN | U | U | 0 | ||||||||
| 858116510 | 8581165 | 6 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | UNK | U | U | 0 | |||||||||
| 858116510 | 8581165 | 7 | C | CLARITIN REDITABS | LORATADINE | 1 | UNK | U | U | 0 | |||||||||
| 858116510 | 8581165 | 8 | C | CALCIUM (UNSPECIFIED) | CALCIUM | 1 | UNK, BID | U | U | 0 | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 858116510 | 8581165 | 1 | Osteoporosis |
| 858116510 | 8581165 | 3 | Osteoporosis |
| 858116510 | 8581165 | 4 | Osteoporosis |
| 858116510 | 8581165 | 5 | Hypersensitivity |
| 858116510 | 8581165 | 7 | Hypersensitivity |
| 858116510 | 8581165 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 858116510 | 8581165 | HO |
| 858116510 | 8581165 | DS |
| 858116510 | 8581165 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 858116510 | 8581165 | Adjustment disorder with depressed mood | |
| 858116510 | 8581165 | Adverse event | |
| 858116510 | 8581165 | Affective disorder | |
| 858116510 | 8581165 | Anaemia | |
| 858116510 | 8581165 | Anxiety | |
| 858116510 | 8581165 | Back injury | |
| 858116510 | 8581165 | Back pain | |
| 858116510 | 8581165 | Blood alkaline phosphatase increased | |
| 858116510 | 8581165 | Cellulitis | |
| 858116510 | 8581165 | Compression fracture | |
| 858116510 | 8581165 | Constipation | |
| 858116510 | 8581165 | Cough | |
| 858116510 | 8581165 | Device failure | |
| 858116510 | 8581165 | Diverticulum | |
| 858116510 | 8581165 | Dyspnoea | |
| 858116510 | 8581165 | Endometriosis | |
| 858116510 | 8581165 | Essential hypertension | |
| 858116510 | 8581165 | Eyelid ptosis | |
| 858116510 | 8581165 | Facet joint syndrome | |
| 858116510 | 8581165 | Fall | |
| 858116510 | 8581165 | Femur fracture | |
| 858116510 | 8581165 | Foot fracture | |
| 858116510 | 8581165 | Foot operation | |
| 858116510 | 8581165 | Fractured sacrum | |
| 858116510 | 8581165 | Glucose tolerance impaired | |
| 858116510 | 8581165 | Haemoglobin decreased | |
| 858116510 | 8581165 | Haemorrhoidal haemorrhage | |
| 858116510 | 8581165 | Hip arthroplasty | |
| 858116510 | 8581165 | Hypotension | |
| 858116510 | 8581165 | Hypothyroidism | |
| 858116510 | 8581165 | Hysterectomy | |
| 858116510 | 8581165 | Impaired healing | |
| 858116510 | 8581165 | Inappropriate schedule of drug administration | |
| 858116510 | 8581165 | Intertrigo | |
| 858116510 | 8581165 | Intervertebral disc disorder | |
| 858116510 | 8581165 | Kyphoscoliosis | |
| 858116510 | 8581165 | Low turnover osteopathy | |
| 858116510 | 8581165 | Lumbar radiculopathy | |
| 858116510 | 8581165 | Lumbar spinal stenosis | |
| 858116510 | 8581165 | Medical device removal | |
| 858116510 | 8581165 | Mental status changes | |
| 858116510 | 8581165 | Musculoskeletal pain | |
| 858116510 | 8581165 | Neuropathy peripheral | |
| 858116510 | 8581165 | Obesity | |
| 858116510 | 8581165 | Oedema | |
| 858116510 | 8581165 | Oedema peripheral | |
| 858116510 | 8581165 | Onychomycosis | |
| 858116510 | 8581165 | Open reduction of fracture | |
| 858116510 | 8581165 | Osteoporosis | |
| 858116510 | 8581165 | Pain | |
| 858116510 | 8581165 | Paranoia | |
| 858116510 | 8581165 | Radius fracture | |
| 858116510 | 8581165 | Renal disorder | |
| 858116510 | 8581165 | Restless legs syndrome | |
| 858116510 | 8581165 | Rheumatoid arthritis | |
| 858116510 | 8581165 | Sinus headache | |
| 858116510 | 8581165 | Spinal compression fracture | |
| 858116510 | 8581165 | Spinal nerve stimulator implantation | |
| 858116510 | 8581165 | Stress | |
| 858116510 | 8581165 | Stress fracture | |
| 858116510 | 8581165 | Tinea pedis | |
| 858116510 | 8581165 | Varicose vein | |
| 858116510 | 8581165 | Vitamin B12 deficiency | |
| 858116510 | 8581165 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 858116510 | 8581165 | 1 | 200008 | 200312 | 0 | |
| 858116510 | 8581165 | 2 | 200404 | 2008 | 0 | |
| 858116510 | 8581165 | 3 | 2008 | 201105 | 0 | |
| 858116510 | 8581165 | 4 | 200309 | 200405 | 0 | |
| 858116510 | 8581165 | 5 | 2009 | 2011 | 0 | |
| 858116510 | 8581165 | 6 | 2008 | 2008 | 0 | |
| 858116510 | 8581165 | 7 | 2009 | 2009 | 0 | |
| 858116510 | 8581165 | 8 | 1997 | 0 |