Pharmacologic class (EPC) · 9 drug pages

Bisphosphonate: adverse event reports filed with FDA

97,060 reports list a drug in this class as a suspect or interacting product, 2004–2026.

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.

97,060
reports across the class: 0.5% of all reports; 5,999
reports, 12 months to June 2026: 7,123 in the 12 months before; 90.3%
marked serious by the reporter: 57.4% across all reports; 9
drugs with a page: brand and generic names counted separately

Bisphosphonate is a pharmacologic class (an FDA Established Pharmacologic Class) with 9 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 97,060 adverse event reports received by FDA, 0.5% of the database, from January 2004 to June 2026.

5,999 reports arrived in the 12 months to June 2026, down 16% from 7,123 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 90.3% of the class's reports are marked serious, 13.8% record death among the outcomes and 36.9% record hospitalisation, as reported.

Across the class the reactions recorded most often are pain (18.5%), femur fracture (17.5%) and arthralgia (15.5%). 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
FosamaxAlendronate sodium	brand	34,844	1,311	92.2%	Femur fracture
Alendronate sodium	generic	18,082	1,528	90.4%	Pain
Zoledronic acid	generic	16,682	1,868	97.1%	Osteonecrosis of jaw
ReclastZoledronic acid	brand	10,382	402	81%	Arthralgia
ActonelRisedronate sodium	brand	6,039	33	84.3%	Femur fracture
AlendronateAlendronate sodium	brand	4,045	213	79.6%	Arthralgia
Risedronate sodium	generic	3,512	552	92.5%	Asthma
Pamidronate disodium	generic	2,136	32	96.9%	Osteonecrosis
Ibandronate sodium	generic	1,338	60	71.5%	Femur fracture

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

Painpain, site not specified18.5%17,931
Femur fracture17.5%16,984
Arthralgiajoint pain15.5%15,076
Fatiguetiredness14.6%14,218
Drug ineffectivethe medicine did not work as expected13.6%13,227
Abdominal discomfortstomach discomfort12.2%11,829
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease12.2%11,815
Alopeciahair loss11.9%11,584
Systemic lupus erythematosuslupus, an autoimmune disease11.4%11,069
Pemphigus11.1%10,788
Arthropathy10.6%10,244
Rashskin rash10.4%10,141
Glossodynia10.3%9,994
Hypertensionhigh blood pressure10.2%9,921
Swellingswelling9.9%9,609
Nauseafeeling sick9.4%9,104
Falla fall9.3%9,002
Hand deformity9.2%8,905
Headachehead pain9%8,727
Dyspnoeashortness of breath9%8,709
Off label useused for a purpose or in a way not on the label8.9%8,642
Joint swellinga swollen joint8.9%8,636
Infusion related reactiona reaction during or soon after an infusion8.7%8,468
Pain in extremitypain in an arm or leg8.7%8,419
Contraindicated product administered8.7%8,410

Solid bar: share of all class reports. Hollow bar: the median share across the 9 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death13.8%13,385

Life-threatening10.9%10,537

Hospitalisation (initial or prolonged)36.9%35,781

Disability22.6%21,900

Congenital anomaly4.2%4,122

Other serious70.5%68,427

Not serious9.7%9,387

Patient age

Under 20.1%69

2 to 110.4%411

12 to 170.3%268

18 to 449.4%9,085

45 to 6417.8%17,301

65 to 7414.3%13,857

75 and over14.1%13,728

Age not given43.6%42,341

Who reported

Physician24.5%23,805

Pharmacist2.9%2,799

Other health professional34.4%33,429

Lawyer4.7%4,548

Consumer or non-health professional28%27,147

Not given5.5%5,332

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 Bisphosphonate reports

Which drugs are in the Bisphosphonate class on this site?

Fosamax, Alendronate sodium, Zoledronic acid, Reclast, Actonel and Alendronate and 3 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

97,060 reports through June 2026, 5,999 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?

pain (18.5%), femur fracture (17.5%), arthralgia (15.5%), fatigue (14.6%) and drug ineffective (13.6%).

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.