Reported Reactions

Adverse event reports that FDA received

  • Search
  • Watch list

Osteoporosis adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
thinning of the bones

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 40,569 adverse event reports that record the MedDRA preferred term Osteoporosis. In plain words, the term means: thinning of the bones. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 1,670 reports in the 12 months to June 2026 and 2,043 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 412 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, 1,670 (0.1%) record this term. Reports for patients aged 45 to 64 were 31% 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.

Plain meaning

Thinning of the bones. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

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

Drugs in these reports

The table has the 104 drug pages with 250 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 Osteoporosis name as a suspect product, in order of name
DrugClassReports with this term
AbataceptSelective T cell costimulation modulator251
Acetaminophen591
Aclasta273
ActemraInterleukin-6 receptor antagonist1,402
ActonelBisphosphonate320
AdalimumabTumor necrosis factor blocker860
Albuterolbeta2-Adrenergic agonist285
Alendronate sodiumBisphosphonate1,340
Alendronic Acid436
ApremilastPhosphodiesterase 4 inhibitor266
AravaAntirheumatic agent871
Asacol297
Atripla4,017
AvonexInterferon beta345
AzathioprinePurine antimetabolite795
Boniva332
Calcium264
Calcium carbonateBlood coagulation factor353
Calcium Glubionate297
CelebrexNonsteroidal anti-inflammatory drug447
CelecoxibNonsteroidal anti-inflammatory drug388
Certolizumab pegolTumor necrosis factor blocker429
CetirizineHistamine-1 receptor antagonist312
Cetirizine hydrochlorideHistamine-1 receptor antagonist427
Chlorhexidine280
Cholecalciferol320
CimziaTumor necrosis factor blocker849
CompleraHuman immunodeficiency virus nucleoside analog reverse transcriptase inhibitor1,379
Cortisone acetateCorticosteroid420
CosentyxInterleukin-17A antagonist640
Depo-ProveraProgestin363
DesoximetasoneCorticosteroid549
DiclofenacNonsteroidal anti-inflammatory drug452
Diclofenac potassiumNonsteroidal anti-inflammatory drug442
Diclofenac sodiumNonsteroidal anti-inflammatory drug699
Doxycycline hyclateTetracycline-class drug280
EnbrelTumor necrosis factor blocker2,105
EntyvioIntegrin receptor antagonist266
Erelzi704
ErgocalciferolProvitamin D2 compound486
Flumethasone Pivalate280
Folic acid660
ForteoParathyroid hormone analog468
FosamaxBisphosphonate2,546
Fosamax Plus D416
GolimumabTumor necrosis factor blocker410
Humira2,750
HydrocortisoneCorticosteroid368
HydroxychloroquineAntimalarial842
Hydroxychloroquine sulfateAntimalarial674
InfliximabTumor necrosis factor blocker705
Isopropyl alcoholStandardized chemical allergen287
KevzaraInterleukin-6 receptor antagonist296
LeflunomideAntirheumatic agent1,125
Lyrica445
MesalamineAminosalicylate313
MethotrexateFolate analog metabolic inhibitor1,922
Methotrexate sodiumFolate analog metabolic inhibitor372
MethylprednisoloneCorticosteroid294
Methylprednisolone sodium succinateCorticosteroid297
Minocycline hydrochlorideTetracycline-class drug267
Morphine sulfateOpioid agonist339
Mycophenolate mofetilAntimetabolite immunosuppressant743
NaproxenNonsteroidal anti-inflammatory drug397
Naproxen sodiumNonsteroidal anti-inflammatory drug564
NexiumProton pump inhibitor2,525
OmeprazoleProton pump inhibitor393
OrenciaSelective T cell costimulation modulator1,410
OtezlaPhosphodiesterase 4 inhibitor593
OxycodoneOpioid agonist357
Oxycodone hydrochlorideOpioid agonist279
PantoprazoleProton pump inhibitor580
Pantoprazole sodiumProton pump inhibitor356
Phthalylsulfathiazole511
PlaquenilAntimalarial379
PrednisoloneCorticosteroid859
PrednisoneCorticosteroid2,645
Pregabalin281
PrilosecProton pump inhibitor448
ProliaRANK ligand inhibitor613
Pseudoephedrine hydrochloridealpha-Adrenergic agonist371
Quetiapine fumarateAtypical antipsychotic288
RamiprilAngiotensin converting enzyme inhibitor367
RemicadeTumor necrosis factor blocker683
RevlimidThalidomide analog256
RinvoqJanus kinase inhibitor293
RituxanCD20-directed cytolytic antibody330
RituximabCD20-directed cytolytic antibody1,279
SimponiTumor necrosis factor blocker781
Sirukumab274
StelaraInterleukin-12 antagonist512
StribildCytochrome P450 3A inhibitor1,744
SulfasalazineAminosalicylate1,058
SymbicortCorticosteroid344
Tiotropium bromideAnticholinergic294
TocilizumabInterleukin-6 receptor antagonist707
Tramadol hydrochlorideOpioid agonist286
Triamcinolone acetonideCorticosteroid266
TruvadaHuman immunodeficiency virus nucleoside analog reverse transcriptase inhibitor7,259
UstekinumabInterleukin-12 antagonist383
VireadHepatitis B virus nucleoside analog reverse transcriptase inhibitor5,169
Vitamin cVitamin C271
XeljanzJanus kinase inhibitor1,383
Zometa344

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 58 pharmacologic classes with 250 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 Osteoporosis name, in order of name
ClassReports with this term
Alkylating drug285
alpha-Adrenergic agonist377
Aminosalicylate1,479
Angiotensin 2 receptor blocker465
Angiotensin converting enzyme inhibitor638
Anti-epileptic agent641
Anticholinergic544
Antimalarial1,895
Antimetabolite immunosuppressant852
Antirheumatic agent1,996
Aromatase inhibitor676
Atypical antipsychotic736
Benzodiazepine449
beta-Adrenergic blocker535
beta2-Adrenergic agonist607
Biguanide298
Bisphosphonate4,669
Blood coagulation factor512
Calcineurin inhibitor immunosuppressant472
Calcium channel blocker306
CD20-directed cytolytic antibody1,808
Corticosteroid8,294
Cytochrome P450 3A inhibitor2,091
Dihydrofolate reductase inhibitor antibacterial330
Estrogen273
Factor Xa inhibitor390
Folate analog metabolic inhibitor2,324
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor5,797
Histamine-1 receptor antagonist1,386
HMG-CoA reductase inhibitor527
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor9,017
Integrin receptor antagonist630
Interferon beta455
Interleukin-12 antagonist895
Interleukin-17A antagonist794
Interleukin-5 antagonist319
Interleukin-6 receptor antagonist2,458
Janus kinase inhibitor2,191
Kinase inhibitor714
l-Thyroxine259
Leukotriene receptor antagonist320
Nonsteroidal anti-inflammatory drug4,045
Opioid agonist2,144
Parathyroid hormone analog509
Phosphodiesterase 4 inhibitor882
Progestin447
Proton pump inhibitor5,093
Provitamin D2 compound541
Purine antimetabolite893
RANK ligand inhibitor729
Selective T cell costimulation modulator1,661
Serotonin reuptake inhibitor329
Standardized chemical allergen328
Substance P/Neurokinin-1 receptor antagonist282
Tetracycline-class drug969
Thalidomide analog314
Tumor necrosis factor blocker7,263
Vitamin C385

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

Reports by month

Reports that record Osteoporosis, by month, five years to June 2026
025050020222023202420252026

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 Osteoporosis
AgeReportsShareShare as a bar
Under 220under 0.1%
2 to 112200.5%
12 to 172000.5%
18 to 443,9739.8%
45 to 6412,58531%
65 to 744,63011.4%
75 and over3,1167.7%
Age not given15,82539%
Sex of the patient in the reports that record Osteoporosis
SexReportsShareShare as a bar
Female25,67963.3%
Male11,61328.6%
Unknown or not given3,2778.1%

Age and sex are as the report gives them. 65.9% 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

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

Cite this page

Embed this card on your site

Copy this code into your page. The card shows the figures above with their source. A line under the card links to this page.

How embedding works. It is free. Keep the link in the card and the link line under it.

Reported Reactions. Osteoporosis: adverse event reports that record this term. https://reportedreactions.com/reaction/osteoporosis/ 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 Osteoporosis mean in an adverse event report?

In plain words: thinning of the bones. 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 .