Stress fracture 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 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

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 2 Oct 2026.

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 2 Oct 2026.

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 5,355 adverse event reports that record the MedDRA preferred term Stress fracture. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 172 reports in the 12 months to June 2026 and 168 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 1,342 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, 172 (under 0.1%) record this term. Reports for female patients were 80% of the reports that record this term and 52.7% 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 130 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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

Drugs that the reports with the term Stress fracture name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	16
Aclasta		20
Actemra	Interleukin-6 receptor antagonist	60
Actonel	Bisphosphonate	375
Actos	Peroxisome proliferator receptor alpha agonist	6
Adalimumab	Tumor necrosis factor blocker	13
Afinitor	Kinase inhibitor	5
Alendronate	Bisphosphonate	85
Alendronate sodium	Bisphosphonate	930
Alendronic Acid		94
Apo Leflunomide		9
Apo Prednisone		6
Apo-Leflunomide		15
Apo-Prednisone		16
Aredia		34
Atripla		29
Avandia		9
Avelox		5
Avonex	Interferon beta	6
Boniva		480
Bonviva		5
Budesonide	Corticosteroid	7
Budesonide Formoterol Fumarate Dihydrate		6
Calcitriol	Vitamin D3 analog	8
Calcium acetate	Blood coagulation factor	7
Cannabidiol		5
Capecitabine	Nucleoside metabolic inhibitor	7
Carboplatin	Platinum-based drug	5
Certolizumab pegol	Tumor necrosis factor blocker	10
Cimzia	Tumor necrosis factor blocker	11
Cinacalcet hydrochloride	Calcium-sensing receptor agonist	5
Citalopram	Serotonin reuptake inhibitor	5
Complera	Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	8
Cortisone	Corticosteroid	5
Cosentyx	Interleukin-17A antagonist	11
Crysvita		5
Cymbalta		5
Depo-Provera	Progestin	9
Dexamethasone	Corticosteroid	11
Dianeal Low Calcium Peritoneal Dialysis Solution with Dextrose		8
Dupixent	Interleukin-4 receptor alpha antagonist	24
Eliquis	Factor Xa inhibitor	17
Enbrel	Tumor necrosis factor blocker	145
Entresto	Angiotensin 2 receptor blocker	11
Etanercept	Tumor necrosis factor blocker	5
Evenity		10
Evista	Estrogen Agonist/Antagonist	18
Ferinject		5
Ferric carboxymaltose	Parenteral iron replacement	7
Flecaine		5
Flecainide		6
Fludarabine	Nucleoside metabolic inhibitor	7
Forteo	Parathyroid hormone analog	159
Fosamax	Bisphosphonate	1,763
Fosamax Plus D		322
Fosavance		6
Gleevec	Kinase inhibitor	6
Humalog	Insulin analog	6
Human immunoglobulin g	Human immunoglobulin G	5
Humira		195
Hydroxychloroquine	Antimalarial	22
Hydroxychloroquine sulfate	Antimalarial	16
Ibandronate sodium	Bisphosphonate	42
Ibandronic Acid		17
Ibrance	Kinase inhibitor	6
Ibuprofen	Nonsteroidal anti-inflammatory drug	9
Imbruvica	Kinase inhibitor	19
Jakafi	Janus kinase inhibitor	19
Kesimpta	CD20-directed cytolytic antibody	5
Lamictal	Anti-epileptic agent	5
Lamivudine	Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	8
Leflunomide	Antirheumatic agent	42
Levothyroxine sodium	l-Thyroxine	6
Losartan	Angiotensin 2 receptor blocker	9
Lyrica		9
Melphalan	Alkylating drug	6
Methotrexate	Folate analog metabolic inhibitor	190
Methotrexate sodium	Folate analog metabolic inhibitor	59
Methylprednisolone	Corticosteroid	7
Nexium	Proton pump inhibitor	35
Nuvaring	Estrogen	7
Ocrevus	CD20-directed cytolytic antibody	19
Olmesartan		5
Omeprazole	Proton pump inhibitor	12
Opsumit	Endothelin receptor antagonist	10
Orencia	Selective T cell costimulation modulator	48
Otezla	Phosphodiesterase 4 inhibitor	15
Pamidronate		9
Pamidronate disodium	Bisphosphonate	22
Plaquenil	Antimalarial	14
Pomalyst	Thalidomide analog	10
Potassium chloride	Osmotic laxative	6
Prednisolone	Corticosteroid	56
Prednisone	Corticosteroid	110
Prolia	RANK ligand inhibitor	281
Reclast	Bisphosphonate	66
Remicade	Tumor necrosis factor blocker	51
Revlimid	Thalidomide analog	49
Rinvoq	Janus kinase inhibitor	49
Risedronate sodium	Bisphosphonate	35
Rituxan	CD20-directed cytolytic antibody	7
Rituximab	CD20-directed cytolytic antibody	33
Simponi	Tumor necrosis factor blocker	36
Simvastatin	HMG-CoA reductase inhibitor	10
Skyrizi	Interleukin-23 antagonist	22
Somatropin	Recombinant human growth hormone	7
Stelara	Interleukin-12 antagonist	14
Strensiq		32
Stribild	Cytochrome P450 3A inhibitor	14
Tacrolimus	Calcineurin inhibitor immunosuppressant	5
Tenofovir		6
Tocilizumab	Interleukin-6 receptor antagonist	5
Trimeprazine		6
Truvada	Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	40
Tymlos		26
Tysabri	Integrin receptor antagonist	9
Vedolizumab	Integrin receptor antagonist	7
Vioxx		8
Viread	Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	26
Xarelto	Factor Xa inhibitor	5
Xeljanz	Janus kinase inhibitor	77
Xgeva	RANK ligand inhibitor	27
Xolair	Anti-IgE	21
Xyrem	Central nervous system depressant	18
Xywav	Central nervous system depressant	6
Zanidip		11
Zidovudine	Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	7
Zoledronic acid	Bisphosphonate	38
Zoledronoc Acid		12
Zometa		62

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 56 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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

Pharmacologic classes of the drugs that the reports with the term Stress fracture name, in order of name
Class	Reports with this term
Alkylating drug	11
Angiotensin 2 receptor blocker	23
Anti-epileptic agent	7
Anti-IgE	25
Antimalarial	52
Antirheumatic agent	42
Aromatase inhibitor	8
beta2-Adrenergic agonist	6
Bisphosphonate	3,356
Calcineurin inhibitor immunosuppressant	7
Calcium-sensing receptor agonist	5
CD20-directed cytolytic antibody	66
Central nervous system depressant	24
Corticosteroid	210
Cytochrome P450 3A inhibitor	18
Endothelin receptor antagonist	12
Estrogen	11
Estrogen Agonist/Antagonist	20
Factor Xa inhibitor	22
Folate analog metabolic inhibitor	249
Gonadotropin releasing hormone receptor agonist	6
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	37
HMG-CoA reductase inhibitor	16
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	57
Human immunoglobulin G	9
Insulin analog	6
Integrin receptor antagonist	19
Interferon beta	10
Interleukin-12 antagonist	14
Interleukin-17A antagonist	13
Interleukin-23 antagonist	22
Interleukin-4 receptor alpha antagonist	24
Interleukin-6 receptor antagonist	65
Janus kinase inhibitor	147
Kinase inhibitor	51
l-Thyroxine	9
Leukotriene receptor antagonist	6
Nonsteroidal anti-inflammatory drug	13
Nucleoside metabolic inhibitor	18
Osmotic laxative	6
Parathyroid hormone analog	159
Parenteral iron replacement	9
Peroxisome proliferator receptor alpha agonist	6
Phosphodiesterase 4 inhibitor	15
Platinum-based drug	7
Progestin	9
Programmed death Receptor-1 blocking antibody	5
Proton pump inhibitor	61
RANK ligand inhibitor	310
Recombinant human growth hormone	7
Selective T cell costimulation modulator	64
Serotonin reuptake inhibitor	7
Sphingosine 1-phosphate receptor modulator	6
Thalidomide analog	61
Tumor necrosis factor blocker	278
Vitamin D3 analog	8

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

Reports by month

Reports that record Stress fracture, by month, five years to June 2026

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 Stress fracture
Age	Reports	Share
Under 2	3	0.1%
2 to 11	42	0.8%
12 to 17	34	0.6%
18 to 44	254	4.7%
45 to 64	1,272	23.8%
65 to 74	795	14.8%
75 and over	518	9.7%
Age not given	2,437	45.5%

Sex of the patient in the reports that record Stress fracture
Sex	Reports	Share
Female	4,286	80%
Male	631	11.8%
Unknown or not given	438	8.2%

Age and sex are as the report gives them. 74.6% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Stress fracture: adverse event reports that record this term. https://reportedreactions.com/reaction/stress-fracture/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

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 Stress fracture 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 2 Oct 2026.

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 2 Oct 2026.

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 2 Oct 2026.

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