Reported Reactions

Adverse event reports that FDA received

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Skeletal injury 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 10,324 adverse event reports that record the MedDRA preferred term Skeletal injury. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 88 reports in the 12 months to June 2026 and 191 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 1,373 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, 88 (under 0.1%) record this term. Reports for male patients were 57.8% of the reports that record this term and 34.6% 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 75 drug pages with 5 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 Skeletal injury name as a suspect product, in order of name
DrugClassReports with this term
Aclasta14
ActemraInterleukin-6 receptor antagonist9
ActonelBisphosphonate30
Alendronate sodiumBisphosphonate48
AmlodipineCalcium channel blocker5
AmpyraPotassium channel blocker5
AnastrozoleAromatase inhibitor12
Aredia5
Atripla4,278
AubagioPyrimidine synthesis inhibitor7
AvonexInterferon beta27
Boniva25
ChantixPartial cholinergic nicotinic agonist13
CompleraHuman immunodeficiency virus nucleoside analog reverse transcriptase inhibitor2,774
Corticotropin5
CosentyxInterleukin-17A antagonist17
CrestorHMG-CoA reductase inhibitor5
Cymbalta5
Dianeal Low Calcium10
DupixentInterleukin-4 receptor alpha antagonist6
EnbrelTumor necrosis factor blocker62
EpipenCatecholamine32
Epipen JrCatecholamine7
FaslodexEstrogen receptor antagonist10
Folic acid8
ForteoParathyroid hormone analog44
FosamaxBisphosphonate125
Fosamax Plus D34
FulvestrantEstrogen receptor antagonist21
GoserelinGonadotropin releasing hormone receptor agonist6
Humira95
HydroxychloroquineAntimalarial5
Ibandronate sodiumBisphosphonate5
IsentressHuman immunodeficiency virus integrase strand transfer inhibitor5
KaletraCytochrome P450 3A inhibitor93
KisqaliKinase inhibitor36
LeflunomideAntirheumatic agent8
LetrozoleAromatase inhibitor7
LipitorHMG-CoA reductase inhibitor6
LosartanAngiotensin 2 receptor blocker16
Lyrica27
MethotrexateFolate analog metabolic inhibitor21
NexiumProton pump inhibitor19
Oxycodone and acetaminophenOpioid agonist5
Oxycodone hydrochlorideOpioid agonist9
OxyContinOpioid agonist12
Piqray5
PrednisoneCorticosteroid17
ProliaRANK ligand inhibitor10
ReclastBisphosphonate5
RemicadeTumor necrosis factor blocker12
RevlimidThalidomide analog18
Risedronate sodiumBisphosphonate8
RituximabCD20-directed cytolytic antibody6
SeroquelAtypical antipsychotic5
SkyriziInterleukin-23 antagonist13
Somavert5
StribildCytochrome P450 3A inhibitor3,019
SulfasalazineAminosalicylate6
Sustiva7
TadalafilPhosphodiesterase 5 inhibitor7
Tecfidera9
TeriparatideParathyroid hormone analog6
TracleerEndothelin receptor antagonist11
Trizivir5
TruvadaHuman immunodeficiency virus nucleoside analog reverse transcriptase inhibitor7,170
TysabriIntegrin receptor antagonist46
Vioxx14
ViraceptProtease inhibitor5
VireadHepatitis B virus nucleoside analog reverse transcriptase inhibitor8,328
XareltoFactor Xa inhibitor6
XeljanzJanus kinase inhibitor13
XyremCentral nervous system depressant5
Zoledronic acidBisphosphonate10
Zometa31

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 46 pharmacologic classes with 5 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 Skeletal injury name, in order of name
ClassReports with this term
Aminosalicylate6
Angiotensin 2 receptor blocker20
Antimalarial5
Antirheumatic agent8
Aromatase inhibitor25
Atypical antipsychotic7
Bisphosphonate233
Calcium channel blocker5
Catecholamine41
CD20-directed cytolytic antibody8
Central nervous system depressant5
Corticosteroid17
Cytochrome P450 3A inhibitor3,115
Endothelin receptor antagonist13
Estrogen receptor antagonist31
Factor Xa inhibitor6
Folate analog metabolic inhibitor21
GLP-1 receptor agonist8
Gonadotropin releasing hormone receptor agonist8
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor8,333
HMG-CoA reductase inhibitor13
Human immunodeficiency virus integrase strand transfer inhibitor7
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor9,948
Insulin analog6
Integrin receptor antagonist46
Interferon beta31
Interleukin-17A antagonist17
Interleukin-23 antagonist13
Interleukin-4 receptor alpha antagonist6
Interleukin-6 receptor antagonist9
Janus kinase inhibitor15
Kinase inhibitor50
Nonsteroidal anti-inflammatory drug9
Opioid agonist30
Parathyroid hormone analog50
Partial cholinergic nicotinic agonist13
Phosphodiesterase 5 inhibitor7
Potassium channel blocker5
Protease inhibitor5
Proton pump inhibitor27
Pyrimidine synthesis inhibitor7
RANK ligand inhibitor10
Serotonin and norepinephrine reuptake inhibitor7
Serotonin reuptake inhibitor5
Thalidomide analog18
Tumor necrosis factor blocker82

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

Reports by month

Reports that record Skeletal injury, 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 Skeletal injury
AgeReportsShareShare as a bar
Under 22under 0.1%
2 to 11250.2%
12 to 17170.2%
18 to 441,74116.9%
45 to 643,25731.5%
65 to 744284.1%
75 and over2182.1%
Age not given4,63644.9%
Sex of the patient in the reports that record Skeletal injury
SexReportsShareShare as a bar
Female3,33532.3%
Male5,96857.8%
Unknown or not given1,0219.9%

Age and sex are as the report gives them. 94.7% 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. Skeletal injury: adverse event reports that record this term. https://reportedreactions.com/reaction/skeletal-injury/ 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 Skeletal injury 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 .