Denosumab vs Zoledronic Acid: side effects in FDA adverse event reports
At a glance
| Denosumab | Zoledronic Acid | |
|---|---|---|
| Drug class | RANK Ligand Inhibitor | – |
| Brand names | Jubbonti | – |
| FAERS reports | 201,340 | 39,894 |
| Serious | 54% | 87% |
| Death outcome | 25,732 | 5,134 |
| Boxed warning | Yes SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE • Patients with advanced chronic kidney disease (eGFR < 30 mL/min/1.73 m 2 ), including dialysis-de | No |
Signals both drugs share
| Reaction | Denosumab | Zoledronic Acid | Label screen (A / B) |
|---|---|---|---|
| Osteonecrosis of jaw | 8,645 · PRR 55.2 | 2,708 · PRR 64.0 | Labeled — boxed warning / Labeled (related wording) |
| Atypical femur fracture | 881 · PRR 46.7 | 247 · PRR 50.1 | Labeled adverse reaction / Labeled adverse reaction |
| Exposed bone in jaw | 436 · PRR 25.7 | 247 · PRR 66.7 | Labeled (related wording) / Labeled (related wording) |
| Atypical fracture | 225 · PRR 60.3 | 51 · PRR 47.6 | Labeled adverse reaction / Labeled adverse reaction |
| Metastases to bone | 1,763 · PRR 12.5 | 927 · PRR 31.5 | Not in label — unassessed / Not in label — unassessed |
| Sequestrectomy | 73 · PRR 12.6 | 73 · PRR 63.9 | Not in label — unassessed / Not in label — unassessed |
| Osteonecrosis of external auditory canal | 90 · PRR 95.4 | 24 · PRR 76.7 | Not in label — unassessed / Not in label — unassessed |
| Pik3ca-activated mutation | 75 · PRR 30.9 | 33 · PRR 59.1 | Not in label — unassessed / Not in label — unassessed |
| Dental fistula | 62 · PRR 18.0 | 23 · PRR 30.5 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Denosumab
- Tooth disorder — n=3,234, PRR 17.5 Labeled (related wording)
- Spinal fracture — n=2,930, PRR 17.8 Labeled (related wording)
- Tooth extraction — n=1,574, PRR 14.9 Labeled adverse reaction
- Intercepted product administration error — n=1,212, PRR 19.3 Labeled (related wording)
- Thoracic vertebral fracture — n=648, PRR 29.2 Labeled (related wording)
- Lumbar vertebral fracture — n=639, PRR 16.9 Labeled (related wording)
- Dental care — n=566, PRR 45.7 Labeled (related wording)
Labeled signals distinctive to Zoledronic Acid
- Iridocyclitis — n=161, PRR 28.5 Labeled adverse reaction
- Acute phase reaction — n=129, PRR 278.2 Labeled adverse reaction
- Idiopathic orbital inflammation — n=46, PRR 167.6 Labeled (related wording)
- Respiratory tract infection bacterial — n=27, PRR 29.9 Labeled (related wording)
Common questions
Which has more reported side effects, Denosumab or Zoledronic Acid?
Denosumab has 201,340 FAERS reports and Zoledronic Acid 39,894. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (54% vs 87%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Denosumab and Zoledronic Acid share?
Both drugs carry disproportionality signals for osteonecrosis of jaw, atypical femur fracture, exposed bone in jaw, atypical fracture, metastases to bone. Shared signals often reflect a shared drug class or the condition both are used for.
Is Denosumab or Zoledronic Acid safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.