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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126797851 | 12679785 | 1 | I | 20160822 | 20160824 | 20160824 | EXP | PHHY2016US115268 | NOVARTIS | KATZ J, ORDOVEZA PA. BISPHOSPHONATE-RELATED OSTEONECROSIS OF THE JAW (BRONJ) ASSOCIATED WITH A ONCE-YEARLY IV INFUSION OF ZOLEDRONIC ACID (RECLAST) 5 MG: TWO CASES AND REVIEW OF THE LITERATURE. QUINTESSENCE INTERNATIONAL. 2014;45(8):685-90 | 50.00 | YR | F | Y | 0.00000 | 20160824 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126797851 | 12679785 | 1 | PS | RECLAST | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 5 MG, Q12MO | 21817 | 5 | MG | SOLUTION FOR INJECTION | |||||||
| 126797851 | 12679785 | 2 | C | EVEROLIMUS | EVEROLIMUS | 1 | Unknown | 5 MG, QD | U | 0 | 5 | MG | QD | ||||||
| 126797851 | 12679785 | 3 | C | OCTREOTIDE. | OCTREOTIDE | 1 | Unknown | 30 MG, QD | U | 0 | 30 | MG | QD | ||||||
| 126797851 | 12679785 | 4 | C | OXYCODONE | OXYCODONE | 1 | Unknown | 30 MG, QD | U | 0 | 30 | MG | QD | ||||||
| 126797851 | 12679785 | 5 | C | PANCRELIPASE. | PANCRELIPASE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126797851 | 12679785 | 6 | C | PHENERGAN | PROMETHAZINE HYDROCHLORIDE | 1 | Unknown | 12.5 MG, QD | U | 0 | 12.5 | MG | QD | ||||||
| 126797851 | 12679785 | 7 | C | PREVACID | LANSOPRAZOLE | 1 | Unknown | 30 MG, QD | U | 0 | 30 | MG | QD | ||||||
| 126797851 | 12679785 | 8 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 50 MG, QD | U | 0 | 50 | MG | QD | ||||||
| 126797851 | 12679785 | 9 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Unknown | 25 MG, UNK | U | 0 | 25 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126797851 | 12679785 | 1 | Osteoporosis |
| 126797851 | 12679785 | 2 | Product used for unknown indication |
| 126797851 | 12679785 | 3 | Product used for unknown indication |
| 126797851 | 12679785 | 4 | Product used for unknown indication |
| 126797851 | 12679785 | 5 | Product used for unknown indication |
| 126797851 | 12679785 | 6 | Product used for unknown indication |
| 126797851 | 12679785 | 7 | Product used for unknown indication |
| 126797851 | 12679785 | 8 | Product used for unknown indication |
| 126797851 | 12679785 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126797851 | 12679785 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126797851 | 12679785 | Bone pain | |
| 126797851 | 12679785 | Exposed bone in jaw | |
| 126797851 | 12679785 | Osteonecrosis of jaw | |
| 126797851 | 12679785 | Pain in jaw |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |