Uterine leiomyoma 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 7,192 adverse event reports that record the MedDRA preferred term Uterine leiomyoma. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 313 reports in the 12 months to June 2026 and 459 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 1,215 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, 313 (under 0.1%) record this term. Reports for female patients were 96.1% 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 133 drug pages with 10 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 Uterine leiomyoma name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	35
Actemra	Interleukin-6 receptor antagonist	22
Adalimumab	Tumor necrosis factor blocker	24
Adempas	Soluble guanylate cyclase stimulator	11
Alendronate sodium	Bisphosphonate	52
Ambrisentan	Endothelin receptor antagonist	20
Ampyra	Potassium channel blocker	17
Anastrozole	Aromatase inhibitor	26
Arava	Antirheumatic agent	13
Aredia		32
Arimidex	Aromatase inhibitor	12
Aripiprazole	Atypical antipsychotic	16
Aspirin	Nonsteroidal anti-inflammatory drug	15
Avonex	Interferon beta	308
Azathioprine	Purine antimetabolite	16
Boniva		19
Byetta	GLP-1 receptor agonist	16
Capecitabine	Nucleoside metabolic inhibitor	13
Carboplatin	Platinum-based drug	18
Celebrex	Nonsteroidal anti-inflammatory drug	15
Certolizumab pegol	Tumor necrosis factor blocker	21
Climara	Estrogen	11
CombiPatch (estradiol/norethindrone acetate transdermal system)	Estrogen	14
Comirnaty		14
Copaxone		22
Cortisone	Corticosteroid	11
Cosentyx	Interleukin-17A antagonist	40
Crestor	HMG-CoA reductase inhibitor	19
Cyclophosphamide	Alkylating drug	12
Depo-Provera	Progestin	26
Desoximetasone	Corticosteroid	18
Docetaxel	Microtubule inhibitor	22
Doxepin	Tricyclic antidepressant	13
Duloxetine	Serotonin and norepinephrine reuptake inhibitor	11
Dupixent	Interleukin-4 receptor alpha antagonist	25
Eliquis	Factor Xa inhibitor	12
Enbrel	Tumor necrosis factor blocker	193
Entyvio	Integrin receptor antagonist	19
Ergocalciferol	Provitamin D2 compound	13
Estrace	Estrogen	10
Estraderm		33
Estradiol	Estrogen	18
Evista	Estrogen Agonist/Antagonist	17
Forteo	Parathyroid hormone analog	14
Fosamax	Bisphosphonate	147
Fosamax Plus D		28
Gabapentin	Anti-epileptic agent	12
Gilenya	Sphingosine 1-phosphate receptor modulator	64
Herceptin	HER2/neu receptor antagonist	18
Humira		638
Hydromorphone		11
Hydromorphone hydrochloride	Opioid agonist	11
Ibuprofen	Nonsteroidal anti-inflammatory drug	13
Implanon		11
Inflectra	Tumor necrosis factor blocker	21
Infliximab	Tumor necrosis factor blocker	21
Januvia	Dipeptidyl peptidase 4 inhibitor	21
Kesimpta	CD20-directed cytolytic antibody	18
Kisqali	Kinase inhibitor	10
Kyleena	Progestin	18
Letrozole	Aromatase inhibitor	13
Levothyroxine		10
Liletta	Progestin	26
Lupron		40
Lupron Depot		306
Medroxyprogesterone acetate	Progestin	11
Mesalamine	Aminosalicylate	10
Metformin	Biguanide	19
Methotrexate	Folate analog metabolic inhibitor	89
Methotrexate sodium	Folate analog metabolic inhibitor	15
Mirena	Progestin	658
Mirtazapine		19
Morphine	Opioid agonist	12
Mounjaro	GLP-1 receptor agonist	11
Mycophenolate mofetil	Antimetabolite immunosuppressant	14
Naltrexone hydrochloride and bupropion hydrochloride	Aminoketone	13
Nexium	Proton pump inhibitor	11
Nexplanon	Progestin	11
Nolvadex		15
Nuvaring	Estrogen	143
Ocrelizumab	CD20-directed cytolytic antibody	11
Ocrevus	CD20-directed cytolytic antibody	27
Olanzapine	Atypical antipsychotic	30
Omalizumab	Anti-IgE	20
Omeprazole	Proton pump inhibitor	21
Opsumit	Endothelin receptor antagonist	16
Oriahnn		32
Orilissa	Gonadotropin releasing hormone receptor antagonist	30
Ozempic	GLP-1 receptor agonist	13
Paclitaxel	Microtubule inhibitor	21
Palbociclib	Kinase inhibitor	12
Paragard 380a		13
ParaGard T 380A	Copper-containing intrauterine device	387
Perjeta	HER2/neu receptor antagonist	13
Prednisone	Corticosteroid	60
Premarin	Estrogen	47
Prempro	Estrogen	51
Prolia	RANK ligand inhibitor	13
Prometrium	Progesterone	10
Provera	Progestin	31
Quetiapine	Atypical antipsychotic	12
Ranitidine hydrochloride	Histamine-2 receptor antagonist	21
Rebif	Interferon beta	219
Remicade	Tumor necrosis factor blocker	78
Revlimid	Thalidomide analog	15
Rinvoq	Janus kinase inhibitor	52
Rituximab	CD20-directed cytolytic antibody	33
Seroquel	Atypical antipsychotic	25
Simponi	Tumor necrosis factor blocker	24
Skyrizi	Interleukin-23 antagonist	55
Soliris	Complement inhibitor	32
Stelara	Interleukin-12 antagonist	19
Sulfasalazine	Aminosalicylate	15
Synthroid	l-Thyroxine	28
Tamoxifen		13
Tamoxifen citrate	Estrogen Agonist/Antagonist	17
Tecfidera		80
Tozinameran		13
Tramadol hydrochloride	Opioid agonist	11
Tylenol	Expectorant	25
Tysabri	Integrin receptor antagonist	178
Valsartan	Angiotensin 2 receptor blocker	21
Vedolizumab	Integrin receptor antagonist	37
Vioxx		34
Xarelto	Factor Xa inhibitor	39
Xeljanz	Janus kinase inhibitor	39
Xolair	Anti-IgE	32
Xyrem	Central nervous system depressant	84
Yasmin		25
Yaz		24
Zofran		10
Zometa		65
Zyprexa	Atypical antipsychotic	12

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 43 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 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 Uterine leiomyoma name, in order of name
Class	Reports with this term
Aminosalicylate	25
Angiotensin 2 receptor blocker	47
Anti-IgE	52
Aromatase inhibitor	60
Atypical antipsychotic	112
Benzodiazepine	27
Biguanide	27
Bisphosphonate	208
CD20-directed cytolytic antibody	97
Central nervous system depressant	92
Complement inhibitor	37
Copper-containing intrauterine device	387
Corticosteroid	146
Endothelin receptor antagonist	50
Estrogen	312
Estrogen Agonist/Antagonist	41
Expectorant	25
Factor Xa inhibitor	56
Folate analog metabolic inhibitor	104
GLP-1 receptor agonist	73
Gonadotropin releasing hormone receptor antagonist	38
HER2/neu receptor antagonist	41
Histamine-2 receptor antagonist	28
HMG-CoA reductase inhibitor	40
Integrin receptor antagonist	234
Interferon beta	532
Interleukin-17A antagonist	40
Interleukin-23 antagonist	55
Interleukin-4 receptor alpha antagonist	27
Janus kinase inhibitor	99
Kinase inhibitor	58
l-Thyroxine	34
Microtubule inhibitor	43
Nonsteroidal anti-inflammatory drug	57
Nucleoside metabolic inhibitor	26
Opioid agonist	88
Progestin	811
Proton pump inhibitor	46
Purine antimetabolite	25
Selective T cell costimulation modulator	42
Serotonin reuptake inhibitor	28
Sphingosine 1-phosphate receptor modulator	64
Tumor necrosis factor blocker	406

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

Reports by month

Reports that record Uterine leiomyoma, 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 Uterine leiomyoma
Age	Reports	Share
Under 2	0	0%
2 to 11	0	0%
12 to 17	8	0.1%
18 to 44	2,217	30.8%
45 to 64	2,109	29.3%
65 to 74	223	3.1%
75 and over	84	1.2%
Age not given	2,551	35.5%

Sex of the patient in the reports that record Uterine leiomyoma
Sex	Reports	Share
Female	6,910	96.1%
Male	20	0.3%
Unknown or not given	262	3.6%

Age and sex are as the report gives them. 61.3% 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. Uterine leiomyoma: adverse event reports that record this term. https://reportedreactions.com/reaction/uterine-leiomyoma/ 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 Uterine leiomyoma 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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