Leuprolide acetate adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Leuprolide acetate
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Gonadotropin releasing hormone receptor agonist

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 4,951 adverse event reports that name Leuprolide acetate. In these reports the drug is a suspect or interacting product.

In the same period, 1,719 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 702 reports in the 12 months to June 2026 and 517 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
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.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Leuprolide acetate is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 1 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 223 reports that name Leuprolide acetate.
In January to March 2026, FDA received 134.
In April to June 2025, FDA received 106.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 481 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for all 4,951 reports.

The site keeps a term for a year only if two or more reports of that year record it.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 481 terms.

Reaction terms in the reports that name Leuprolide acetate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,951 reports
Drug ineffectivethe medicine did not work as expected	286	5.8%
Hot flusha hot flush	243	4.9%
Fatiguetiredness	242	4.9%
Off label useused for a purpose or in a way not on the label	232	4.7%
Falla fall	231	4.7%
Deaththe patient died; cause not stated by this term	209	4.2%
Pneumonialung infection	197	4%
Prostate cancer	197	4%
Astheniaweakness or lack of energy	185	3.7%
Diabetes mellitusdiabetes	178	3.6%
Anaemialow red blood cells	136	2.7%
Prostatic specific antigen increased	136	2.7%
Dyspnoeashortness of breath	115	2.3%
Nauseafeeling sick	115	2.3%
Metastases to bone	113	2.3%
Hypertensionhigh blood pressure	109	2.2%
Arthralgiajoint pain	106	2.1%
Malignant neoplasm progression	103	2.1%
Headachehead pain	102	2.1%
Dizzinesslight-headedness or unsteadiness	100	2%
Pneumonia aspirationlung infection from breathing in material	96	1.9%
Product use in unapproved indicationused for a purpose not on the label	96	1.9%
Constipation	92	1.9%
Diarrhoealoose or frequent stools	92	1.9%
Drug dependencedependence on a medicine	91	1.8%
Malaisegeneral feeling of being unwell	87	1.8%
Painpain, site not specified	86	1.7%
Product use issuea problem in how the product was used	82	1.7%
Interstitial lung diseasescarring or inflammation of lung tissue	81	1.6%
Abdominal painstomach or belly pain	78	1.6%
Respiratory depressionslow or shallow breathing	75	1.5%
Disease progressionthe disease advanced	71	1.4%
Muscular weaknessmuscle weakness	69	1.4%
Neutropenialow neutrophils, a type of white blood cell	69	1.4%
Product prescribing error	69	1.4%
Back pain	68	1.4%
Decreased appetitereduced appetite	68	1.4%
Insomniadifficulty sleeping	65	1.3%
Depressionlow mood	63	1.3%
Urinary tract infectionbladder or urinary infection	63	1.3%
Pyrexiafever	62	1.3%
Cardiac failureheart failure	61	1.2%
Inappropriate schedule of product administrationthe product was taken at the wrong times	60	1.2%
Weight increasedweight gain	60	1.2%
Drug abusemisuse of a medicine	59	1.2%
Vomitingbeing sick	59	1.2%
Injection site induration	58	1.2%
Myocardial infarctionheart attack	58	1.2%
Pain in extremitypain in an arm or leg	58	1.2%
Condition aggravatedthe condition being treated got worse	57	1.2%

Download all 481 terms of Leuprolide acetate (CSV)

The counts add to more than 4,951 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. 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.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Leuprolide with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Leuprolide	Generic name	663
Leuprolide acetate (this page)	Generic name	4,951
Eligard	Brand name	44,385
Fensolvi	Brand name	748
Lupron Depot	Brand name	20,266
Lupron Depot-PED	Brand name	1,320

Sum of the separately reported names: 72,333. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

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.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Leuprolide acetate, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	55	53	13	8	28	4	1	11	2
2005	85	85	9	7	39	11	0	34	0
2006	66	64	12	5	43	3	1	22	2
2007	91	82	27	8	42	4	1	20	9
2008	338	309	158	19	132	13	1	64	29
2009	119	108	43	11	53	5	0	22	11
2010	183	178	79	7	74	8	1	34	5
2011	147	137	21	12	71	7	0	55	10
2012	185	177	41	9	68	9	0	85	8
2013	50	44	5	1	15	0	0	28	6
2014	31	26	2	2	20	1	0	5	5
2015	120	52	6	1	41	2	0	13	68
2016	76	53	6	0	48	0	0	7	23
2017	90	56	6	0	48	2	0	7	34
2018	94	62	10	1	42	3	0	9	32
2019	64	56	4	3	42	0	0	12	8
2020	54	33	4	0	21	0	0	11	21
2021	181	172	28	5	70	1	0	121	9
2022	432	403	76	18	151	6	0	277	29
2023	564	528	90	12	201	8	0	403	36
2024	628	567	95	21	250	13	0	412	61
2025	782	714	109	46	379	35	0	585	68
2026	516	500	82	53	224	21	0	414	16

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

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.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Leuprolide acetate, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Leuprolide acetate, by the year in which FDA received them
Year	Reports
2004	53
2005	83
2006	68
2007	88
2008	313
2009	124
2010	195
2011	153
2012	193
2013	50
2014	34
2015	119
2016	79
2017	91
2018	106
2019	120
2020	139
2021	313
2022	522
2023	597
2024	547
2025	607
2026	357

Reports that name Leuprolide acetate, 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.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Leuprolide acetate
Age	Reports	Share
Under 2	1	under 0.1%
2 to 11	148	3%
12 to 17	39	0.8%
18 to 44	396	8%
45 to 64	744	15%
65 to 74	886	17.9%
75 and over	1,280	25.9%
Age not given	1,457	29.4%

Sex of the patient in the reports that name Leuprolide acetate
Sex	Reports	Share
Female	912	18.4%
Male	3,708	74.9%
Unknown or not given	331	6.7%

Type of reporter in the reports that name Leuprolide acetate
Reporter	Reports	Share
Physician	2,016	40.7%
Pharmacist	136	2.7%
Other health professional	1,180	23.8%
Lawyer	1	under 0.1%
Consumer or non-health professional	916	18.5%
Not given	702	14.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 24% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Leuprolide acetate record
Indication as recorded (MedDRA)	Reports	Share
Prostate cancer	1,400	28.3%
Bulbospinal muscular atrophy congenital	686	13.9%
Prostate cancer stage iv	168	3.4%
Prostate cancer stage ii	143	2.9%
Prostate cancer metastatic	138	2.8%
Endometriosis	136	2.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,951 reports.

Drugs in the same reports

Other drugs that the reports of Leuprolide acetate name, in any role, in order of name
Drug	Reports that name the two
Amlodipine	141
Aspirin	212
Bicalutamide	550
Casodex	455
Docetaxel	300
Eligard	317
Enzalutamide	212
Ergocalciferol	136
Letrozole	216
Prednisone	184

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

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.

Pages near this one

Leuprolide same ingredient
Eligard same ingredient
Fensolvi same ingredient
Lupron Depot same ingredient
Lupron Depot-PED same ingredient
Supprelin same class
Goserelin same class
Zoladex same class
Leuprorelin next in the A to Z list
Leuplin next in the A to Z list
Leuprorelin acetate next in the A to Z list
Leukine next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Leuprolide acetateThe labels (prescribing information) that have this name, at the National Library of Medicine.
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. Leuprolide acetate: adverse event reports that FDA received. https://reportedreactions.com/drug/leuprolide-acetate/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Leuprolide acetate as a suspect or interacting product. The 1,719 reports that name it only as a concomitant medicine are not in the count. 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

Do these reports show that Leuprolide acetate was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
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.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Leuprolide acetate?

No. It is a count of what people reported to FDA: 4,951 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (40.7%), other health professional (23.8%) and consumer or non-health professional (18.5%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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