Reported Reactions

Adverse event reports that FDA received

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Hysterectomy 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 8,504 adverse event reports that record the MedDRA preferred term Hysterectomy. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 573 reports in the 12 months to June 2026 and 663 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 916 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, 573 (under 0.1%) record this term. Reports for female patients were 95.1% 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 78 drug pages with 25 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 Hysterectomy name as a suspect product, in order of name
DrugClassReports with this term
ActemraInterleukin-6 receptor antagonist29
ActonelBisphosphonate54
Albuterolbeta2-Adrenergic agonist27
Albuterol sulfatebeta2-Adrenergic agonist47
Alendronate sodiumBisphosphonate339
AmbrisentanEndothelin receptor antagonist85
AubagioPyrimidine synthesis inhibitor48
AvonexInterferon beta453
BenlystaB lymphocyte stimulator-specific inhibitor43
Boniva51
Breo ElliptaCorticosteroid47
CelebrexNonsteroidal anti-inflammatory drug32
Certolizumab pegolTumor necrosis factor blocker33
CimziaTumor necrosis factor blocker43
ClarithromycinMacrolide antimicrobial30
Colace43
Copaxone37
Creon52
Cymbalta35
DupixentInterleukin-4 receptor alpha antagonist152
EnbrelTumor necrosis factor blocker355
EstradiolEstrogen59
FluconazoleAzole antifungal40
Formoterol fumaratebeta2-Adrenergic agonist35
ForteoParathyroid hormone analog27
FosamaxBisphosphonate502
Fosamax Plus D115
Humira657
IbranceKinase inhibitor32
ImbruvicaKinase inhibitor27
InflectraTumor necrosis factor blocker33
InfliximabTumor necrosis factor blocker38
JanumetBiguanide27
JanuviaDipeptidyl peptidase 4 inhibitor70
LeflunomideAntirheumatic agent41
LetairisEndothelin receptor antagonist41
Lupron58
Lupron Depot251
MepolizumabInterleukin-5 antagonist26
MethotrexateFolate analog metabolic inhibitor64
Methotrexate sodiumFolate analog metabolic inhibitor27
MirenaProgestin97
MontelukastLeukotriene receptor antagonist41
Montelukast sodiumLeukotriene receptor antagonist30
NuvaringEstrogen48
Nystatin40
OpsumitEndothelin receptor antagonist54
OrilissaGonadotropin releasing hormone receptor antagonist85
OtezlaPhosphodiesterase 4 inhibitor25
OxycodoneOpioid agonist34
Oxycodone hydrochlorideOpioid agonist74
OzempicGLP-1 receptor agonist27
PantoprazoleProton pump inhibitor29
ParaGard T 380ACopper-containing intrauterine device285
PrednisoneCorticosteroid70
PremarinEstrogen48
ProliaRANK ligand inhibitor73
RebifInterferon beta81
RemicadeTumor necrosis factor blocker286
RinvoqJanus kinase inhibitor231
Risedronate sodiumBisphosphonate31
RivaroxabanFactor Xa inhibitor39
SimponiTumor necrosis factor blocker139
SkyriziInterleukin-23 antagonist244
StelaraInterleukin-12 antagonist79
SulfasalazineAminosalicylate28
SymbicortCorticosteroid32
Synthroidl-Thyroxine52
Tecfidera128
TracleerEndothelin receptor antagonist54
TysabriIntegrin receptor antagonist209
Umeclidinium bromide42
VedolizumabIntegrin receptor antagonist26
Vioxx41
XareltoFactor Xa inhibitor60
XeljanzJanus kinase inhibitor83
XyremCentral nervous system depressant263
XywavCentral nervous system depressant87

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 50 pharmacologic classes with 25 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 Hysterectomy name, in order of name
ClassReports with this term
Aminosalicylate33
Angiotensin 2 receptor blocker29
Anticholinergic30
Antimalarial43
Antirheumatic agent50
Atypical antipsychotic42
Azole antifungal40
B lymphocyte stimulator-specific inhibitor50
Benzodiazepine30
beta2-Adrenergic agonist118
Biguanide36
Bisphosphonate934
CD20-directed cytolytic antibody29
Central nervous system depressant350
Copper-containing intrauterine device285
Corticosteroid289
Dipeptidyl peptidase 4 inhibitor70
Endothelin receptor antagonist250
Estrogen209
Estrogen Agonist/Antagonist26
Factor Xa inhibitor109
Folate analog metabolic inhibitor93
GLP-1 receptor agonist87
Gonadotropin releasing hormone receptor antagonist94
Insulin analog26
Integrin receptor antagonist243
Interferon beta543
Interleukin-12 antagonist81
Interleukin-23 antagonist255
Interleukin-4 receptor alpha antagonist158
Interleukin-5 antagonist48
Interleukin-6 receptor antagonist36
Janus kinase inhibitor323
Kinase inhibitor79
l-Thyroxine56
Leukotriene receptor antagonist81
Macrolide antimicrobial30
Nonsteroidal anti-inflammatory drug75
Opioid agonist277
Parathyroid hormone analog27
Phosphodiesterase 4 inhibitor25
Progestin160
Prostacycline vasodilator29
Proton pump inhibitor65
Pyrimidine synthesis inhibitor60
RANK ligand inhibitor73
Retinoid27
Selective T cell costimulation modulator32
Serotonin reuptake inhibitor63
Tumor necrosis factor blocker952

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

Reports by month

Reports that record Hysterectomy, 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 Hysterectomy
AgeReportsShareShare as a bar
Under 21under 0.1%
2 to 111under 0.1%
12 to 1790.1%
18 to 442,12625%
45 to 642,31327.2%
65 to 744355.1%
75 and over1581.9%
Age not given3,46140.7%
Sex of the patient in the reports that record Hysterectomy
SexReportsShareShare as a bar
Female8,08895.1%
Male190.2%
Unknown or not given3974.7%

Age and sex are as the report gives them. 76.7% 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. Hysterectomy: adverse event reports that record this term. https://reportedreactions.com/reaction/hysterectomy/ 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 Hysterectomy 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 .