Pharmacologic class (EPC) · 3 drug pages

RANK ligand inhibitor: adverse event reports filed with FDA

168,671 reports list a drug in this class as a suspect or interacting product, 2009–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

168,671
reports across the class: 0.8% of all reports; 5,532
reports, 12 months to June 2026: 5,650 in the 12 months before; 51.1%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

RANK ligand inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 168,671 adverse event reports received by FDA, 0.8% of the database, from November 2009 to June 2026.

5,532 reports arrived in the 12 months to June 2026, close to the 5,650 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 51.1% of the class's reports are marked serious, 13.2% record death among the outcomes and 12.3% record hospitalisation, as reported.

Across the class the reactions recorded most often are off label use (20.7%), death (11.2%) and osteonecrosis of jaw (5.1%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
ProliaDenosumab	brand	137,683	3,532	43.6%	Off label use
XgevaDenosumab	brand	22,746	756	79.6%	Osteonecrosis of jaw
Denosumab	generic	8,242	1,244	98%	Osteonecrosis of jaw

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Off label useused for a purpose or in a way not on the label20.7%34,866
Deaththe patient died; cause not stated by this term11.2%18,859
Osteonecrosis of jawdeath of jaw bone tissue5.1%8,612
Arthralgiajoint pain4.3%7,280
Pain in extremitypain in an arm or leg3.5%5,924
Back painback pain3.4%5,761
Painpain, site not specified3.1%5,235
Falla fall2.3%3,953
Product storage errorthe product was stored wrongly2.2%3,721
Fatiguetiredness2.2%3,707
Myalgiamuscle pain2.2%3,696
Bone painbone pain2.1%3,566
Hypocalcaemialow blood calcium1.9%3,187
Rashskin rash1.8%3,117
Tooth disordera dental problem1.8%3,082
Spinal fracturea broken bone in the spine1.6%2,763
Nauseafeeling sick1.6%2,722
Malaisegeneral feeling of being unwell1.5%2,582
Pain in jaw1.5%2,553
Astheniaweakness or lack of energy1.4%2,439
Hospitalisationadmission to hospital1.3%2,274
Headachehead pain1.3%2,250
Diarrhoealoose or frequent stools1.3%2,231
Pruritusitching1.3%2,164
Circumstance or information capable of leading to medication errora situation that could lead to a medication error1.3%2,119

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death13.2%22,257

Life-threatening0.8%1,409

Hospitalisation (initial or prolonged)12.3%20,747

Disability1.6%2,702

Congenital anomaly0%75

Other serious39.4%66,526

Not serious48.9%82,471

Patient age

Under 20%22

2 to 110.1%136

12 to 170.1%158

18 to 441.3%2,224

45 to 6413.6%22,975

65 to 7418.5%31,220

75 and over25.6%43,115

Age not given40.8%68,821

Who reported

Physician41.1%69,337

Pharmacist3.6%6,117

Other health professional21.6%36,451

Lawyer0%43

Consumer or non-health professional32.6%55,017

Not given1%1,706

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about RANK ligand inhibitor reports

Which drugs are in the RANK ligand inhibitor class on this site?

Prolia, Xgeva and Denosumab. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

168,671 reports through June 2026, 5,532 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

off label use (20.7%), death (11.2%), osteonecrosis of jaw (5.1%), arthralgia (4.3%) and pain in extremity (3.5%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.