Nolvadex adverse event reports that FDA received

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

Name type: Product name as reported
Also reported as: Nolvadex /00388701/

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 1,152 adverse event reports that name Nolvadex. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 513 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 18 reports in the 12 months to June 2026 and 40 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, 18 (under 0.1%) name Nolvadex. Reports for female patients were 93.8% of the reports that name Nolvadex 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 Nolvadex 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 7 reports that name Nolvadex.
In January to March 2026, FDA received 3.
In April to June 2025, FDA received 4.

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 108 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 1,126 of the 1,152 reports (97.7%).

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 108 terms.

Reaction terms in the reports that name Nolvadex, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,152 reports
Malignant neoplasm progression	52	4.5%
Nauseafeeling sick	41	3.6%
Diarrhoealoose or frequent stools	39	3.4%
Uterine polyp	38	3.3%
Dyspnoeashortness of breath	37	3.2%
Arthralgiajoint pain	33	2.9%
Metastases to bone	33	2.9%
Hot flusha hot flush	27	2.3%
Metastases to liver	27	2.3%
Pain in extremitypain in an arm or leg	27	2.3%
Abdominal painstomach or belly pain	26	2.3%
Endometrial hyperplasia	25	2.2%
Falla fall	25	2.2%
Neutropenialow neutrophils, a type of white blood cell	24	2.1%
Fatiguetiredness	22	1.9%
Vomitingbeing sick	22	1.9%
Disease progressionthe disease advanced	21	1.8%
Weight increasedweight gain	21	1.8%
Astheniaweakness or lack of energy	20	1.7%
Headachehead pain	19	1.6%
Pulmonary embolisma blood clot in the lung	19	1.6%
Rashskin rash	19	1.6%
Breast cancer recurrent	18	1.6%
Pleural effusionfluid around the lung	18	1.6%
Small intestinal obstruction	17	1.5%
Vaginal haemorrhagevaginal bleeding	17	1.5%
Anaemialow red blood cells	16	1.4%
Depressionlow mood	16	1.4%
Back pain	15	1.3%
Blood pressure increaseda raised blood pressure reading	15	1.3%
Breast cancer	15	1.3%
Drug ineffectivethe medicine did not work as expected	15	1.3%
Ovarian cysta cyst on an ovary	15	1.3%
Uterine leiomyoma	15	1.3%
Breast cancer metastatic	14	1.2%
Cataractclouding of the eye lens	14	1.2%
Dizzinesslight-headedness or unsteadiness	14	1.2%
Muscle spasmsmuscle cramps	14	1.2%
Pelvic pain	14	1.2%
Uterine cancer	14	1.2%
Cerebral infarction	13	1.1%
Hepatic steatosisfatty liver	13	1.1%
Myalgiamuscle pain	13	1.1%
Pyrexiafever	13	1.1%
Cardiac failureheart failure	12	1%
Cervical polyp	12	1%
Alopeciahair loss	11	1%
Hypoaesthesianumbness	11	1%
Metastases to lung	11	1%
Off label useused for a purpose or in a way not on the label	11	1%

Download all 108 terms of Nolvadex (CSV)

The counts add to more than 1,152 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 Nolvadex, 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	Other Serious (Important Medical Events)	Not serious
2004	144	96	5	11	75	17	7	48
2005	128	108	5	9	69	19	44	20
2006	109	81	2	2	42	9	48	28
2007	99	95	4	4	49	10	53	4
2008	72	71	4	8	28	14	39	1
2009	87	77	4	16	43	10	37	10
2010	46	45	2	3	18	8	21	1
2011	32	27	0	0	13	0	17	5
2012	18	16	1	1	8	0	9	2
2013	13	13	1	1	6	2	7	0
2014	18	16	0	0	8	0	10	2
2015	44	40	6	2	25	2	19	4
2016	27	25	2	0	12	1	13	2
2017	43	42	0	0	12	0	33	1
2018	48	46	1	1	17	0	29	2
2019	39	39	9	1	15	2	23	0
2020	25	23	1	1	7	1	18	2
2021	20	20	1	0	8	0	14	0
2022	12	12	1	0	1	0	11	0
2023	22	22	0	0	15	1	9	0
2024	61	40	3	0	15	0	26	21
2025	28	28	4	1	11	0	27	0
2026	17	16	4	2	7	0	13	1

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 Nolvadex, 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 Nolvadex, by the year in which FDA received them
Year	Reports
2004	119
2005	105
2006	125
2007	127
2008	73
2009	87
2010	51
2011	31
2012	22
2013	13
2014	17
2015	41
2016	30
2017	44
2018	56
2019	38
2020	25
2021	23
2022	14
2023	35
2024	48
2025	18
2026	10

Reports that name Nolvadex, 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 Nolvadex
Age	Reports	Share
Under 2	0	0%
2 to 11	2	0.2%
12 to 17	0	0%
18 to 44	161	14%
45 to 64	427	37.1%
65 to 74	151	13.1%
75 and over	132	11.5%
Age not given	279	24.2%

Sex of the patient in the reports that name Nolvadex
Sex	Reports	Share
Female	1,080	93.8%
Male	26	2.3%
Unknown or not given	46	4%

Type of reporter in the reports that name Nolvadex
Reporter	Reports	Share
Physician	601	52.2%
Pharmacist	60	5.2%
Other health professional	143	12.4%
Lawyer	4	0.3%
Consumer or non-health professional	120	10.4%
Not given	224	19.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 20.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Nolvadex record
Indication as recorded (MedDRA)	Reports	Share
Breast cancer	596	51.7%
Breast cancer female	82	7.1%
Her2 positive breast cancer	57	4.9%
Breast cancer metastatic	39	3.4%
Invasive lobular breast carcinoma	7	0.6%
Hormone therapy	5	0.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,152 reports.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for NolvadexThe 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. Nolvadex: adverse event reports that FDA received. https://reportedreactions.com/drug/nolvadex/ 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 Nolvadex as a suspect or interacting product. The 513 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 Nolvadex 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 Nolvadex?

No. It is a count of what people reported to FDA: 1,152 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 (52.2%), other health professional (12.4%) and consumer or non-health professional (10.4%). 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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