Prescription medication · RANK Ligand Inhibitor

denosumab

Also sold as Prolia, Xgeva. Stoboclo treats osteoporosis in women after menopause who are at high risk for fractures.

Data updated 2026-05-15

196,342
FDA reportsHeavily reported
$1723.69
Brand price (NADAC)

denosumab (Prolia) is a prescription RANK Ligand Inhibitor. Stoboclo treats osteoporosis in women after menopause who are at high risk for fractures.

Stoboclo is a medicine that helps to treat osteoporosis and increase bone mass. It works by blocking a protein that breaks down bone.

Drug Pricing (NADAC)

Brand Price

$1723.69/unit

Generic Available

No

Pricing data from NADAC (CMS), effective November 20, 2024. Compare all drug costs →

Compare with Another Drug → Full Side Effects Report →

What it does

Stoboclo treats osteoporosis in women after menopause who are at high risk for fractures.

Common side effects

Back pain, Pain in your arms or legs, Muscle and bone pain

Key warnings

Stoboclo can cause very low calcium levels in people with serious kidney disease, especially those on dialysis.

The sections below are summarized in plain English from denosumab's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Stoboclo blocks a protein called RANKL. RANKL tells your body to break down bone. By blocking RANKL, Stoboclo slows down bone loss and helps to increase bone mass.

Side Effects (from patient reports)

Based on 196,342 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for denosumab, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS) As of 2025

Reports over time

Adverse-event reports filed for denosumab each year to the FDA Adverse Event Reporting System (FAERS).

010,00020,00030,00040,000 2008201120142017202020232025 7,846

Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.

Where denosumab sits

denosumab has more FDA adverse-event reports than 94% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.

fewest reports most reports

Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is denosumab; the line is the median (50th percentile).

FDA Adverse Event Report Analysis

Detailed analysis of 196,342 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2008–2025.

Total Reports

196,342

Reports Mentioning Death

25,105

12.8% of reports — not proof of cause

Hospitalization Reports

30,164

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 146,088 (84%)
Male 28,091 (16%)

Age Distribution

0–17 563
18–44 3,094
45–64 29,230
65–74 38,063
75+ 49,014

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
2 DEATH 19,930
3 ARTHRALGIA 8,682
4 OSTEONECROSIS OF JAW 8,425
5 FATIGUE 7,481
6 PAIN IN EXTREMITY 6,893
7 PAIN 6,774
8 BACK PAIN 6,757
9 NAUSEA 5,301
10 DIARRHOEA 5,093
11 FALL 4,973
12 RASH 4,215
13 MYALGIA 4,163
14 BONE PAIN 3,978
15 ASTHENIA 3,959
16 PRODUCT STORAGE ERROR 3,667

Reactions in Death Reports

DEATH 19,825
FATIGUE 544
PNEUMONIA 541
MALIGNANT NEOPLASM PROGRESSION 520
DISEASE PROGRESSION 467
NAUSEA 444
DIARRHOEA 400
ASTHENIA 372
GENERAL PHYSICAL HEALTH DETERIORATION 364
DYSPNOEA 355

Reactions in Hospitalization Reports

HOSPITALISATION 2,427
FALL 2,023
FATIGUE 1,905
DIARRHOEA 1,878
NAUSEA 1,809
HYPOCALCAEMIA 1,806
PNEUMONIA 1,727
DYSPNOEA 1,531
ASTHENIA 1,396
OSTEONECROSIS OF JAW 1,392

Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Stoboclo can cause very low calcium levels in people with serious kidney disease, especially those on dialysis. This can lead to hospitalization, life-threatening problems, and even death. If you have kidney problems, your doctor should check you for mineral and bone disorders before you start Stoboclo. You should be watched closely by a doctor who knows how to treat these problems.

Common Questions

What if I have kidney problems?
Tell your doctor if you have kidney problems. Stoboclo can cause low calcium levels, especially in people with kidney disease.
Can I take Stoboclo if I'm pregnant?
No, you should not take Stoboclo if you are pregnant or plan to become pregnant.
How often do I get the Stoboclo shot?
You will get a Stoboclo shot once every 6 months.
What else should I take with Stoboclo?
You should take 1000 mg of calcium and at least 400 IU of vitamin D every day.
What are the most common side effects?
The most common side effects are back pain, pain in your arms or legs, and muscle and bone pain.
What if I have low calcium levels?
Your doctor needs to fix your low calcium levels before you start Stoboclo.
Can Stoboclo cause problems with my jaw?
Yes, Stoboclo can cause a rare but serious problem called osteonecrosis of the jaw. Tell your doctor right away if you have jaw pain, swelling, or numbness.
What happens if I stop taking Stoboclo?
Talk to your doctor before stopping Stoboclo. Stopping Stoboclo may cause you to have fractures in your spine.
Can I give myself the Stoboclo shot?
No, Stoboclo should be given by a healthcare provider.
What should I do if I have signs of an infection?
Tell your doctor right away if you have signs of an infection, such as fever, chills, or redness and swelling of the skin.
What are the common side effects of denosumab?
The registry lists Back pain, Pain in your arms or legs, Muscle and bone pain, High cholesterol, Bladder infection among the most-reported FAERS reaction terms for denosumab. The compiled record contains 196,342 FDA adverse-event reports. These counts are not an individual symptom assessment.
What drug class is denosumab?
denosumab belongs to the RANK Ligand Inhibitor drug class. It requires a prescription (Rx). Stoboclo treats osteoporosis in women after menopause who are at high risk for fractures.
What pregnancy or breastfeeding source fields are listed for denosumab?
The FDA label for denosumab contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

Other drugs grouped near denosumab - same-class peers and common alternatives.

Compare denosumab vs abaloparatide side-by-side →

Compare beyond drug class

Nationwide peers by FAERS volume & death-report share

Two PlainMeds-derived comparison paths for denosumab: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.

Medication Guides

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What the FDA Data Shows for denosumab

The FDA label for denosumab (sold under brand names such as Prolia, Xgeva) classifies it as a prescription-only medication in the RANK Ligand Inhibitor class. Stoboclo treats osteoporosis in women after menopause who are at high risk for fractures. Official labeling lists 7 commonly reported side effects, including Back pain, Pain in your arms or legs, Muscle and bone pain.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 196,342 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: October 22, 2025

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page