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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 91126557 | 9112655 | 7 | F | 199910 | 20160902 | 20130211 | 20160907 | EXP | US-009507513-1302USA004235 | MERCK | 0.00 | F | Y | 62.59000 | KG | 20160907 | LW | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 91126557 | 9112655 | 1 | PS | FOSAMAX | ALENDRONATE SODIUM | 1 | Unknown | 5 MG, QAM | 20560 | 5 | MG | TABLET | QD | ||||||
| 91126557 | 9112655 | 2 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 40 MG, UNK | 20560 | 40 | MG | TABLET | |||||||
| 91126557 | 9112655 | 3 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 70 MG, QW | 20560 | 70 | MG | TABLET | /wk | ||||||
| 91126557 | 9112655 | 4 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 70 MG, QW | 20560 | 70 | MG | TABLET | /wk | ||||||
| 91126557 | 9112655 | 5 | SS | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | Unknown | 70 MG, UNK | 0 | 70 | MG | ||||||||
| 91126557 | 9112655 | 6 | SS | BONIVA | IBANDRONATE SODIUM | 1 | Unknown | 150 MG, UNK | U | U | 0 | 150 | MG | ||||||
| 91126557 | 9112655 | 7 | SS | BONIVA | IBANDRONATE SODIUM | 1 | 150 MG, UNK | U | U | 0 | 150 | MG | |||||||
| 91126557 | 9112655 | 8 | C | VITAMINS (UNSPECIFIED) | VITAMINS | 1 | Oral | 1 UNK, QD | U | U | 0 | TABLET | |||||||
| 91126557 | 9112655 | 9 | C | HORMONES (UNSPECIFIED) | UNSPECIFIED INGREDIENT | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 91126557 | 9112655 | 10 | C | ESTROGEN NOS | ESTROGENS | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 91126557 | 9112655 | 1 | Osteopenia |
| 91126557 | 9112655 | 5 | Osteopenia |
| 91126557 | 9112655 | 6 | Osteopenia |
| 91126557 | 9112655 | 8 | Product used for unknown indication |
| 91126557 | 9112655 | 9 | Product used for unknown indication |
| 91126557 | 9112655 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 91126557 | 9112655 | OT |
| 91126557 | 9112655 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 91126557 | 9112655 | Arthralgia | |
| 91126557 | 9112655 | Atrophy | |
| 91126557 | 9112655 | Blood oestrogen abnormal | |
| 91126557 | 9112655 | Drug administration error | |
| 91126557 | 9112655 | Femur fracture | |
| 91126557 | 9112655 | Haematocrit abnormal | |
| 91126557 | 9112655 | Haemoglobin abnormal | |
| 91126557 | 9112655 | Hot flush | |
| 91126557 | 9112655 | Hypercholesterolaemia | |
| 91126557 | 9112655 | Intramedullary rod insertion | |
| 91126557 | 9112655 | Irritability | |
| 91126557 | 9112655 | Low turnover osteopathy | |
| 91126557 | 9112655 | Menorrhagia | |
| 91126557 | 9112655 | Mood swings | |
| 91126557 | 9112655 | Musculoskeletal pain | |
| 91126557 | 9112655 | Oedema | |
| 91126557 | 9112655 | Oedema peripheral | |
| 91126557 | 9112655 | Oral surgery | |
| 91126557 | 9112655 | Osteoporosis | |
| 91126557 | 9112655 | Postmenopausal haemorrhage | |
| 91126557 | 9112655 | Rosacea | |
| 91126557 | 9112655 | Tooth fracture | |
| 91126557 | 9112655 | Uterine atrophy | |
| 91126557 | 9112655 | Uterine dilation and curettage | |
| 91126557 | 9112655 | Vaginal discharge | |
| 91126557 | 9112655 | Vulvovaginal dryness |
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 |
|---|---|---|---|---|---|---|
| 91126557 | 9112655 | 1 | 19991011 | 0 | ||
| 91126557 | 9112655 | 2 | 199910 | 200206 | 0 | |
| 91126557 | 9112655 | 3 | 20020624 | 200610 | 0 | |
| 91126557 | 9112655 | 4 | 20070905 | 200802 | 0 | |
| 91126557 | 9112655 | 5 | 20080307 | 200904 | 0 | |
| 91126557 | 9112655 | 6 | 20061101 | 200710 | 0 | |
| 91126557 | 9112655 | 7 | 20090506 | 20100816 | 0 | |
| 91126557 | 9112655 | 8 | 1995 | 0 | ||
| 91126557 | 9112655 | 9 | 1995 | 2005 | 0 | |
| 91126557 | 9112655 | 10 | 1994 | 0 |