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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86465908 | 8646590 | 8 | F | 199807 | 20160912 | 20120702 | 20160919 | EXP | US-009507513-1207USA00053 | MERCK | 0.00 | F | Y | 70.30000 | KG | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86465908 | 8646590 | 1 | PS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 10 MG, UNK | 13010.09 | MG | 20560 | 10 | MG | TABLET | |||||
| 86465908 | 8646590 | 2 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 70 MG, QW | 13010.09 | MG | 20560 | 70 | MG | TABLET | /wk | ||||
| 86465908 | 8646590 | 3 | SS | FOSAMAX PLUS D | ALENDRONATE SODIUMCHOLECALCIFEROL | 1 | Oral | UNK, UNKNOWN | U | 0 | TABLET | ||||||||
| 86465908 | 8646590 | 4 | SS | FOSAMAX PLUS D | ALENDRONATE SODIUMCHOLECALCIFEROL | 1 | U | 0 | TABLET | ||||||||||
| 86465908 | 8646590 | 5 | C | LEVOXYL | LEVOTHYROXINE SODIUM | 1 | Oral | 0.15-0.175 MG, QD | U | 0 | 1 | DF | QD | ||||||
| 86465908 | 8646590 | 6 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | UNK, UNKNOWN | U | 0 | |||||||||
| 86465908 | 8646590 | 7 | C | CALCIUM (UNSPECIFIED) | CALCIUM | 1 | Unknown | UNK UNK, UNKNOWN | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 86465908 | 8646590 | 1 | Osteopenia |
| 86465908 | 8646590 | 2 | Osteoporosis |
| 86465908 | 8646590 | 3 | Osteopenia |
| 86465908 | 8646590 | 4 | Osteoporosis |
| 86465908 | 8646590 | 5 | Hypothyroidism |
| 86465908 | 8646590 | 6 | Hypothyroidism |
| 86465908 | 8646590 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 86465908 | 8646590 | HO |
| 86465908 | 8646590 | OT |
| 86465908 | 8646590 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 86465908 | 8646590 | Accident | |
| 86465908 | 8646590 | Adenomatous polyposis coli | |
| 86465908 | 8646590 | Adverse event | |
| 86465908 | 8646590 | Anaemia postoperative | |
| 86465908 | 8646590 | Anaesthetic complication | |
| 86465908 | 8646590 | Aortic stenosis | |
| 86465908 | 8646590 | Aortic valve sclerosis | |
| 86465908 | 8646590 | Appendicectomy | |
| 86465908 | 8646590 | Arthropathy | |
| 86465908 | 8646590 | Aspiration | |
| 86465908 | 8646590 | Asthenia | |
| 86465908 | 8646590 | Back pain | |
| 86465908 | 8646590 | Blood cholesterol increased | |
| 86465908 | 8646590 | Blood immunoglobulin M | |
| 86465908 | 8646590 | Bone density decreased | |
| 86465908 | 8646590 | Bone graft | |
| 86465908 | 8646590 | Bone loss | |
| 86465908 | 8646590 | Bradycardia | |
| 86465908 | 8646590 | Bursitis | |
| 86465908 | 8646590 | Cardiac aneurysm | |
| 86465908 | 8646590 | Cardiac failure congestive | |
| 86465908 | 8646590 | Cardiac murmur | |
| 86465908 | 8646590 | Cardiac valve disease | |
| 86465908 | 8646590 | Cellulitis | |
| 86465908 | 8646590 | Chest discomfort | |
| 86465908 | 8646590 | Chest pain | |
| 86465908 | 8646590 | Chondrocalcinosis | |
| 86465908 | 8646590 | Colon cancer | |
| 86465908 | 8646590 | Constipation | |
| 86465908 | 8646590 | Depression | |
| 86465908 | 8646590 | Device failure | |
| 86465908 | 8646590 | Device loosening | |
| 86465908 | 8646590 | Diverticulitis | |
| 86465908 | 8646590 | Diverticulum | |
| 86465908 | 8646590 | Dyspnoea exertional | |
| 86465908 | 8646590 | Electrocardiogram abnormal | |
| 86465908 | 8646590 | Endodontic procedure | |
| 86465908 | 8646590 | Fatigue | |
| 86465908 | 8646590 | Femur fracture | |
| 86465908 | 8646590 | Gout | |
| 86465908 | 8646590 | Hip arthroplasty | |
| 86465908 | 8646590 | Hyperlipidaemia | |
| 86465908 | 8646590 | Hypertension | |
| 86465908 | 8646590 | Hyperthyroidism | |
| 86465908 | 8646590 | Impaired healing | |
| 86465908 | 8646590 | Insomnia | |
| 86465908 | 8646590 | International normalised ratio decreased | |
| 86465908 | 8646590 | Knee arthroplasty | |
| 86465908 | 8646590 | Left atrial enlargement | |
| 86465908 | 8646590 | Limb injury | |
| 86465908 | 8646590 | Lymphadenopathy | |
| 86465908 | 8646590 | Metastases to bone marrow | |
| 86465908 | 8646590 | Mitral valve incompetence | |
| 86465908 | 8646590 | Myalgia | |
| 86465908 | 8646590 | Nail discolouration | |
| 86465908 | 8646590 | Neuropathy peripheral | |
| 86465908 | 8646590 | Non-Hodgkin's lymphoma | |
| 86465908 | 8646590 | Oedema peripheral | |
| 86465908 | 8646590 | Open reduction of fracture | |
| 86465908 | 8646590 | Osteoarthritis | |
| 86465908 | 8646590 | Osteopetrosis | |
| 86465908 | 8646590 | Osteoporosis | |
| 86465908 | 8646590 | Pain in extremity | |
| 86465908 | 8646590 | Palpitations | |
| 86465908 | 8646590 | Pneumonia | |
| 86465908 | 8646590 | Pulmonary mass | |
| 86465908 | 8646590 | Pulmonary valve incompetence | |
| 86465908 | 8646590 | Scoliosis | |
| 86465908 | 8646590 | Seborrhoeic keratosis | |
| 86465908 | 8646590 | Spinal osteoarthritis | |
| 86465908 | 8646590 | Stress fracture | |
| 86465908 | 8646590 | Syncope | |
| 86465908 | 8646590 | Systemic lupus erythematosus | |
| 86465908 | 8646590 | Tendon disorder | |
| 86465908 | 8646590 | Tonsillectomy | |
| 86465908 | 8646590 | Tricuspid valve incompetence | |
| 86465908 | 8646590 | Upper respiratory tract infection | |
| 86465908 | 8646590 | Ventricular extrasystoles | |
| 86465908 | 8646590 | Vertebral foraminal stenosis | |
| 86465908 | 8646590 | Vitamin D decreased | |
| 86465908 | 8646590 | 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 |
|---|---|---|---|---|---|---|
| 86465908 | 8646590 | 1 | 19971110 | 20010223 | 0 | |
| 86465908 | 8646590 | 2 | 20010224 | 20080324 | 0 | |
| 86465908 | 8646590 | 7 | 1982 | 0 |