Nolvadextamoxifen
According to the FDA label: SOLTAMOX is an estrogen agonist/antagonist indicated: For treatment of adult patients with estrogen receptor-positive metastatic breast cancer ( 1.1 ) For adjuvant treatment of adult patients with early stage estrogen receptor- positive breast cancer ( 1.2 ) To reduce risk of invasive breast cancer following breast surgery and radiation in adult women with ductal carcinoma in situ (DCIS) ( 1.3 ) To reduce the incidence of breast cancer in adult women at high risk ( 1.4 ) 1.1 Metastatic Breast…
5,665 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Nolvadex in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Fatigue 393 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Nausea 342 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 278 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Arthralgia 276 reports
Malignant Neoplasm Progression 257 reports
A report that a cancer grew or spread. This describes the course of the illness, not necessarily an effect of the drug. Malignant neoplasm is the medical term for a cancerous growth.
Full definition in the glossary →Pain 245 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Vomiting 227 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 225 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Breast Cancer 217 reports
A cancer that forms in the tissue of the breast. It may appear in reports as a condition being treated or monitored.
Full definition in the glossary →Dizziness 213 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Headache 203 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Hot Flush 198 reports
A sudden feeling of heat, often in the face and upper body, sometimes with sweating. Often called a hot flash in American English.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 194 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Disease Progression 188 reports
A report that the underlying condition being treated got worse over time. This describes the course of the illness, not necessarily an effect of the drug.
Full definition in the glossary →Asthenia 182 reports
Physical weakness or lack of strength.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 5,029 |
| Male | 204 |
| Unknown | 6 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 24 |
| 18-34 | 117 |
| 35-49 | 790 |
| 50-64 | 1,367 |
| 65-74 | 735 |
| 75+ | 573 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Nolvadex. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 2,904 |
| Hospitalization | 1,577 |
| Non-Serious | 1,294 |
| Death | 477 |
| Disability | 361 |
| Life-Threatening | 242 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Nolvadex. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 271 |
| 2005 | 237 |
| 2006 | 486 |
| 2007 | 454 |
| 2008 | 280 |
| 2009 | 485 |
| 2010 | 355 |
| 2011 | 419 |
| 2012 | 398 |
| 2013 | 60 |
| 2014 | 62 |
| 2015 | 110 |
| 2016 | 125 |
| 2017 | 150 |
| 2018 | 223 |
| 2019 | 220 |
| 2020 | 213 |
| 2021 | 271 |
| 2022 | 242 |
| 2023 | 217 |
| 2024 | 158 |
| 2025 | 187 |
| 2026 (partial) | 42 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Nolvadex
In FDA adverse event reports that mention Nolvadex, these medications appeared most often in the same report.
- Letrozole (578 reports)
- Anastrozole (542 reports)
- Cyclophosphamide (464 reports)
- Cyclophosphamide For (464 reports)
- Trastuzumab (449 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026