What the label lists and what reports show
Denosumab side effects
Denosumab's FDA label: “Most common adverse reactions (≥ 25%) were fatigue/asthenia, hypophosphatemia, and nausea.” FAERS holds 201,378 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is arthralgia (8,912 reports).
- No generic listed
Check it at the source: the denosumab FDA label on DailyMed (effective June 23, 2026, Amgen, Inc); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Prolia?Prolia may cause serious side effects. See " What is the most important information I should know about Prolia? " It is not known if the use of Prolia over a long period of time may cause slow healing of broken bones. […]
Source: FDA drug label (Prolia), Amgen, Inc, effective June 26, 2026 (SPL set 49e5afe9-a0c7-40c4-af9f-f287a80c5c88), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥ 25%) were fatigue/asthenia, hypophosphatemia, and nausea.
Table 1. Adverse Reactions Occurring in ≥ 2% of Patients with Osteoporosis and More Frequently than in Placebo-treated Patients
This table is printed in the Prolia label published by Amgen, Inc of June 26, 2026; the label quoted above does not print one.
| Preferred Term | Prolia (N = 3886) n (%) | Placebo (N = 3876) n (%) |
|---|---|---|
| Back pain | 1347 (34.7) | 1340 (34.6) |
| Pain in extremity | 453 (11.7) | 430 (11.1) |
| Musculoskeletal pain | 297 (7.6) | 291 (7.5) |
| Hypercholesterolemia | 280 (7.2) | 236 (6.1) |
| Cystitis | 228 (5.9) | 225 (5.8) |
| Vertigo | 195 (5.0) | 187 (4.8) |
| Upper respiratory tract infection | 190 (4.9) | 167 (4.3) |
| Edema peripheral | 189 (4.9) | 155 (4.0) |
| Sciatica | 178 (4.6) | 149 (3.8) |
| Bone pain | 142 (3.7) | 117 (3.0) |
| Abdominal pain upper | 129 (3.3) | 111 (2.9) |
| Anemia | 129 (3.3) | 107 (2.8) |
| Insomnia | 126 (3.2) | 122 (3.1) |
| Myalgia | 114 (2.9) | 94 (2.4) |
| Angina pectoris | 101 (2.6) | 87 (2.2) |
| Rash | 96 (2.5) | 79 (2.0) |
| Pharyngitis | 91 (2.3) | 78 (2.0) |
| Asthenia | 90 (2.3) | 73 (1.9) |
| Pruritus | 87 (2.2) | 82 (2.1) |
| Flatulence | 84 (2.2) | 53 (1.4) |
| Spinal osteoarthritis | 82 (2.1) | 64 (1.7) |
| Gastroesophageal reflux disease | 80 (2.1) | 66 (1.7) |
| Herpes zoster | 79 (2.0) | 72 (1.9) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed below and elsewhere in the labeling: • Hypersensitivity [see Warnings and Precautions ( 5.2 )] • Hypocalcemia [see Warnings and Precautions ( 5.3 ) and Use in Specific Populations ( 8.6 ) ] • Osteonecrosis of the Jaw [see Warnings and Precautions ( 5.4 )] • Atypical Subtrochanteric and Diaphyseal Femoral Fracture [see Warnings and Precautions ( 5.5 )] • Hypercalcemia following treatment discontinuation in patients with giant cell tumor of bone and in patients with growing skeletons [see Warnings and Precautions ( 5.6 ) and Use in Specific Populations ( 8.4 ) ] • Multiple vertebral fractures (MVF) following treatment discontinuation [see Warnings and Precautions ( 5.7 )] Bone Metastasis from Solid Tumors: Most common adverse reactions (≥ 25%) were fatigue/asthenia, hypophosphatemia, and nausea. ( 6.1 ) Multiple Myeloma: Most common adverse reactions (≥ 10%) were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. ( 6.1 ) Giant Cell Tumor of Bone: Most common adverse reactions (≥ 10%) were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity. …
Source: FDA drug label, Amgen, Inc, effective June 23, 2026 (SPL set 628f0998-1206-4001-aeee-18133aa9f3bf), via openFDA; the full label on DailyMed
What do FAERS reports show?
201,378 reports list denosumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 25,734 are coded as a death and 31,434 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2017 (33,838, against a median of 10,399 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 22 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Denosumab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions