Tamoxifen citrate adverse event reports that FDA received

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

Name type: Generic name
Class: Estrogen Agonist/Antagonist
Also reported as: Tamoxifen Citrate 10mg Tablets, Tamoxifen Citrate 20mg Tablets, Tamoxifen Citrate Tablets Usp

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.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 3,064 adverse event reports that name Tamoxifen citrate. In these reports the drug is a suspect or interacting product.

In the same period, 2,685 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 104 reports in the 12 months to June 2026 and 69 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 104 (under 0.1%) name Tamoxifen citrate. Reports for female patients were 86.6% of the reports that name Tamoxifen citrate 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. 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 Tamoxifen citrate 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 29 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.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 26 reports that name Tamoxifen citrate.
In January to March 2026, FDA received 19.
In April to June 2025, FDA received 11.

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 341 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 3,028 of the 3,064 reports (98.8%).

The reports of the other years are not in the counts.

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 341 terms.

Reaction terms in the reports that name Tamoxifen citrate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,064 reports
Malignant neoplasm progression	243	7.9%
Fatiguetiredness	175	5.7%
Nauseafeeling sick	160	5.2%
Arthralgiajoint pain	152	5%
Hot flusha hot flush	146	4.8%
Disease progressionthe disease advanced	141	4.6%
Metastases to bone	135	4.4%
Diarrhoealoose or frequent stools	129	4.2%
Breast cancer	124	4%
Neoplasm progression	109	3.6%
Breast cancer metastatic	102	3.3%
Drug ineffectivethe medicine did not work as expected	97	3.2%
Dyspnoeashortness of breath	95	3.1%
Painpain, site not specified	92	3%
Headachehead pain	91	3%
Myalgiamuscle pain	87	2.8%
Pulmonary embolisma blood clot in the lung	84	2.7%
Insomniadifficulty sleeping	83	2.7%
Vomitingbeing sick	83	2.7%
Dizzinesslight-headedness or unsteadiness	78	2.5%
Neuropathy peripheralnerve damage in hands or feet	78	2.5%
Off label useused for a purpose or in a way not on the label	77	2.5%
Astheniaweakness or lack of energy	72	2.3%
Drug interactionan interaction between medicines	72	2.3%
Weight increasedweight gain	72	2.3%
Back pain	71	2.3%
Breast cancer recurrent	71	2.3%
Pain in extremitypain in an arm or leg	70	2.3%
Weight decreasedweight loss	67	2.2%
Malaisegeneral feeling of being unwell	66	2.2%
Alopeciahair loss	64	2.1%
Depressionlow mood	64	2.1%
Paraesthesiatingling or pins and needles	63	2.1%
Bone pain	61	2%
Metastases to liver	60	2%
Rashskin rash	58	1.9%
Chest pain	56	1.8%
Muscle spasmsmuscle cramps	48	1.6%
Uterine polyp	48	1.6%
Gait disturbancedifficulty walking	46	1.5%
Deep vein thrombosisa blood clot in a deep vein	44	1.4%
Deaththe patient died; cause not stated by this term	42	1.4%
Acute myeloid leukaemia	41	1.3%
Metastases to lung	41	1.3%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	38	1.2%
Condition aggravatedthe condition being treated got worse	36	1.2%
Drug intolerancethe medicine was not tolerated	36	1.2%
Cerebrovascular accidentstroke	35	1.1%
Anaemialow red blood cells	34	1.1%
Anxiety	34	1.1%

Download all 341 terms of Tamoxifen citrate (CSV)

The counts add to more than 3,064 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.

Outcomes by year

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

Outcomes in the reports that name Tamoxifen citrate, 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	121	77	6	10	39	5	1	30	44
2005	106	72	9	5	35	5	0	36	34
2006	209	148	20	3	40	10	0	97	61
2007	189	174	13	9	41	5	7	129	15
2008	162	146	8	8	46	23	5	84	16
2009	264	259	29	18	156	8	4	96	5
2010	169	150	10	7	58	8	2	100	19
2011	215	197	38	12	54	18	0	128	18
2012	145	133	12	13	38	14	0	93	12
2013	54	43	2	2	10	3	0	32	11
2014	53	48	0	1	3	7	0	40	5
2015	74	63	5	1	10	4	0	56	11
2016	115	67	1	1	9	4	0	56	48
2017	114	62	2	2	22	5	0	44	52
2018	118	64	1	2	12	6	0	55	54
2019	133	91	8	3	7	13	0	78	42
2020	115	90	10	1	9	6	0	82	25
2021	153	128	9	2	17	4	1	117	25
2022	161	135	26	8	42	12	1	109	26
2023	159	117	19	2	25	1	1	97	42
2024	66	47	1	1	13	3	0	39	19
2025	110	87	10	7	25	0	0	78	23
2026	59	52	5	4	17	0	0	46	7

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 Tamoxifen citrate, 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 Tamoxifen citrate, by the year in which FDA received them
Year	Reports
2004	85
2005	85
2006	179
2007	265
2008	147
2009	275
2010	157
2011	218
2012	177
2013	52
2014	56
2015	81
2016	121
2017	116
2018	128
2019	146
2020	128
2021	173
2022	147
2023	130
2024	55
2025	98
2026	45

Reports that name Tamoxifen citrate, 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 Tamoxifen citrate
Age	Reports	Share
Under 2	3	0.1%
2 to 11	5	0.2%
12 to 17	1	under 0.1%
18 to 44	276	9%
45 to 64	1,015	33.1%
65 to 74	383	12.5%
75 and over	238	7.8%
Age not given	1,143	37.3%

Sex of the patient in the reports that name Tamoxifen citrate
Sex	Reports	Share
Female	2,654	86.6%
Male	99	3.2%
Unknown or not given	311	10.2%

Type of reporter in the reports that name Tamoxifen citrate
Reporter	Reports	Share
Physician	926	30.2%
Pharmacist	118	3.9%
Other health professional	723	23.6%
Lawyer	14	0.5%
Consumer or non-health professional	946	30.9%
Not given	337	11%

Age and sex are as the report gives them. The reporter is the primary source in the report. 39.2% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Tamoxifen citrate record
Indication as recorded (MedDRA)	Reports	Share
Breast cancer	1,283	41.9%
Breast cancer metastatic	159	5.2%
Breast cancer female	118	3.9%
Invasive ductal breast carcinoma	30	1%
Breast cancer in situ	28	0.9%
Her2 positive breast cancer	22	0.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,064 reports.

Drugs in the same reports

Other drugs that the reports of Tamoxifen citrate name, in any role, in order of name
Drug	Reports that name the two
Anastrozole	155
Capecitabine	184
Cyclophosphamide	327
Docetaxel	236
Exemestane	201
Fluorouracil	178
Fulvestrant	150
Letrozole	335
Paclitaxel	229
Trastuzumab	150

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

Raloxifene hydrochloride same class
Raloxifene same class
Osphena same class
Tamoxifen next in the A to Z list
Tamsulosin next in the A to Z list
Tamiflu next in the A to Z list
Tamsulosin hydrochloride next in the A to Z list
Tambocor next in the A to Z list
Tamsulosin/Tamsulosin Hydrochloride next in the A to Z list
Talzenna next in the A to Z list
Tamsulosina next in the A to Z list
Talwin 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 Tamoxifen citrateThe 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. Tamoxifen citrate: adverse event reports that FDA received. https://reportedreactions.com/drug/tamoxifen-citrate/ 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.

A report is in the count when it names Tamoxifen citrate as a suspect or interacting product. The 2,685 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 Tamoxifen citrate 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 Tamoxifen citrate?

No. It is a count of what people reported to FDA: 3,064 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?

Consumer or non-health professional (30.9%), physician (30.2%) and other health professional (23.6%). 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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