Reported Reactions

Adverse event reports that FDA received

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Osteomyelitis adverse event reports that record this term

Kind of term
MedDRA preferred term

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.

Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

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.

Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .

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

Reports on file

From January 2004 to June 2026, FDA received 17,813 adverse event reports that record the MedDRA preferred term Osteomyelitis. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 725 reports in the 12 months to June 2026 and 697 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 775 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 725 (0.1%) record this term. Reports for patients aged 45 to 64 were 33.5% of the reports that record this term and 20% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 90 drug pages with 50 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

FDA says:

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.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.

Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .

Drugs that the reports with the term Osteomyelitis name as a suspect product, in order of name
DrugClassReports with this term
AbataceptSelective T cell costimulation modulator103
Aclasta53
ActemraInterleukin-6 receptor antagonist371
ActonelBisphosphonate133
AdalimumabTumor necrosis factor blocker212
Alendronate sodiumBisphosphonate198
Alendronic Acid91
AnakinraInterleukin-1 receptor antagonist84
AravaAntirheumatic agent148
Aredia635
AvonexInterferon beta131
AzathioprinePurine antimetabolite122
Boniva125
Bonviva60
CeftriaxoneCephalosporin antibacterial71
CelebrexNonsteroidal anti-inflammatory drug99
Certolizumab pegolTumor necrosis factor blocker82
CimziaTumor necrosis factor blocker144
CiprofloxacinFluoroquinolone antibacterial83
Codeine54
CosentyxInterleukin-17A antagonist194
Cubicin60
CyclophosphamideAlkylating drug143
CyclosporineCalcineurin inhibitor immunosuppressant121
CytarabineNucleoside metabolic inhibitor51
DenosumabRANK ligand inhibitor165
DexamethasoneCorticosteroid178
Dianeal Low Calcium83
Dianeal Low Calcium Peritoneal Dialysis Solution with Dextrose111
DupixentInterleukin-4 receptor alpha antagonist69
EnbrelTumor necrosis factor blocker639
Erelzi66
EtanerceptTumor necrosis factor blocker94
ExtranealOsmotic laxative73
ForteoParathyroid hormone analog83
FosamaxBisphosphonate1,228
Fosamax Plus D105
GoldStandardized chemical allergen65
HumalogInsulin analog107
Human immunoglobulin gHuman immunoglobulin G79
Humira733
HydroxychloroquineAntimalarial133
Hydroxychloroquine sulfateAntimalarial92
IbranceKinase inhibitor58
IbuprofenNonsteroidal anti-inflammatory drug76
InfliximabTumor necrosis factor blocker131
InvokametBiguanide193
InvokanaSodium-Glucose cotransporter 2 inhibitor2,132
JardianceSodium-Glucose cotransporter 2 inhibitor60
LantusInsulin analog55
LeflunomideAntirheumatic agent219
LenalidomideThalidomide analog54
Lyrica66
MetforminBiguanide88
MethotrexateFolate analog metabolic inhibitor624
Methotrexate sodiumFolate analog metabolic inhibitor102
MethylprednisoloneCorticosteroid111
Mycophenolate mofetilAntimetabolite immunosuppressant222
OcrevusCD20-directed cytolytic antibody109
OrenciaSelective T cell costimulation modulator249
OtezlaPhosphodiesterase 4 inhibitor88
Pamidronate disodiumBisphosphonate72
PlaquenilAntimalarial74
PomalystThalidomide analog86
Pralia105
PrednisoloneCorticosteroid200
PrednisoneCorticosteroid454
ProliaRANK ligand inhibitor359
Ranmark75
Regranex161
RemicadeTumor necrosis factor blocker312
RevlimidThalidomide analog342
RinvoqJanus kinase inhibitor102
RituxanCD20-directed cytolytic antibody112
RituximabCD20-directed cytolytic antibody295
SimponiTumor necrosis factor blocker276
SkyriziInterleukin-23 antagonist69
StelaraInterleukin-12 antagonist136
SulfasalazineAminosalicylate136
TacrolimusCalcineurin inhibitor immunosuppressant242
Tecfidera65
TocilizumabInterleukin-6 receptor antagonist87
TysabriIntegrin receptor antagonist204
VancomycinGlycopeptide antibacterial111
VedolizumabIntegrin receptor antagonist66
XeljanzJanus kinase inhibitor208
XgevaRANK ligand inhibitor130
Zoledronate56
Zoledronic acidBisphosphonate177
Zometa1,636

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 36 pharmacologic classes with 100 or more reports that record this term. The rows are in order of name.

FDA says:

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.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.

Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .

Pharmacologic classes of the drugs that the reports with the term Osteomyelitis name, in order of name
ClassReports with this term
Alkylating drug177
Aminosalicylate136
Antimalarial299
Antimetabolite immunosuppressant273
Antirheumatic agent367
Biguanide317
Bisphosphonate1,896
Calcineurin inhibitor immunosuppressant409
CD20-directed cytolytic antibody549
Cephalosporin antibacterial121
Corticosteroid1,035
Endothelin receptor antagonist119
Fluoroquinolone antibacterial132
Folate analog metabolic inhibitor726
Glycopeptide antibacterial126
Human immunoglobulin G119
Insulin analog331
Integrin receptor antagonist288
Interferon beta182
Interleukin-12 antagonist169
Interleukin-17A antagonist225
Interleukin-6 receptor antagonist470
Janus kinase inhibitor369
Kinase inhibitor424
Nonsteroidal anti-inflammatory drug397
Nucleoside metabolic inhibitor155
Opioid agonist377
Phosphodiesterase 4 inhibitor130
Programmed death Receptor-1 blocking antibody104
Proton pump inhibitor103
Purine antimetabolite149
RANK ligand inhibitor654
Selective T cell costimulation modulator352
Sodium-Glucose cotransporter 2 inhibitor2,235
Thalidomide analog492
Tumor necrosis factor blocker1,980

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Osteomyelitis, by month, five years to June 2026
05010020222023202420252026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Patients in these reports

Age of the patient in the reports that record Osteomyelitis
AgeReportsShareShare as a bar
Under 2190.1%
2 to 111741%
12 to 171170.7%
18 to 441,4468.1%
45 to 645,96633.5%
65 to 743,01116.9%
75 and over1,99511.2%
Age not given5,08528.5%
Sex of the patient in the reports that record Osteomyelitis
SexReportsShareShare as a bar
Female9,20051.6%
Male7,58842.6%
Unknown or not given1,0255.8%

Age and sex are as the report gives them. 61.6% of these reports give the United States as the country.

Terms near this one

Official pages

The site checked these addresses on . The links open in a new tab.

Cite this page

Reported Reactions. Osteomyelitis: adverse event reports that record this term. https://reportedreactions.com/reaction/osteomyelitis/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

The count has the reports with each spelling of one MedDRA preferred term. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

What does Osteomyelitis mean in an adverse event report?

It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.

Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on .