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Tamoxifen Side Effects

The most commonly reported side effects of tamoxifen include malignant neoplasm progression, alopecia, and fatigue, based on 23,396 FDA adverse event reports from 2004 to 2025. 3.9% of reports found the drug to be ineffective.

Tamoxifen side effects

Percentages show how often each reaction appears relative to total reports for tamoxifen.

1
Malignant Neoplasm Progression7.8%1,817
2
Alopecia6.6%1,555
3
Fatigue6.3%1,483
4
Nausea5.4%1,272
5
Metastases To Bone5.2%1,211
6
Diarrhoea4.7%1,109
7
Pain4.6%1,070
8
Breast Cancer4.0%933
9
Arthralgia4.0%931
10
Drug Ineffective3.9%905
11
Off Label Use3.7%875
12
Disease Progression3.5%820
13
Dyspnoea3.3%782
14
Metastases To Liver3.3%761
15
Headache3.2%760

These are voluntary reports and do not establish that tamoxifen caused these reactions.

Report severity

81.3%Serious19,013 reports
24.0%Hospitalizations5,607 reports
7.5%Fatal1,758 reports

Seriousness is determined by the reporter, not by OpenClaim.

Tamoxifen drug interactions

Other drugs that appear in adverse event reports alongside tamoxifen. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Docetaxel12.7%2,982
2
Letrozole10.4%2,425
3
Trastuzumab9.9%2,306
4
Paclitaxel7.8%1,817
5
Anastrozole7.8%1,815
6
Fulvestrant7.6%1,773
7
Capecitabine7.0%1,633
8
Cyclophosphamide6.9%1,615
9
Palbociclib5.7%1,332
10
Zoledronic-acid5.2%1,210
11
Exemestane5.1%1,182
12
Doxorubicin-hydrochloride4.9%1,152
13
Epirubicin-hydrochloride4.7%1,092
14
Fluorouracil4.3%997
15
Goserelin4.0%930

Taken alongside

1
Acetaminophen7.4%1,732
2
Levothyroxine-sodium6.5%1,515
3
Cyclophosphamide6.1%1,428
4
Ergocalciferol6.0%1,405
5
Omeprazole4.9%1,153
6
Aspirin4.9%1,144
7
Letrozole4.5%1,063
8
Dexamethasone4.2%974
9
Calcium4.1%964
10
Gabapentin3.7%872
11
Hydrochlorothiazide3.5%813
12
Paclitaxel3.4%791
13
Anastrozole3.4%789
14
Ondansetron3.4%789
15
Metformin3.3%771

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports tamoxifen side effects

87.1% of tamoxifen adverse event reports involve female patients and 4.2% involve male patients. The largest age group is adult at 69%. These figures reflect who reports side effects, not underlying risk.

Sex

Female87.1%
Male4.2%
Unknown8.7%

Age group

< 20.1%
2–110.1%
12–170.1%
18–6469.1%
65+30.5%

What is tamoxifen used for

Conditions and purposes for which patients were taking tamoxifen when the adverse event was reported.

Abdominal NeoplasmAbdominal Pain UpperAbortion InducedAccidental ExposureAccidental Exposure To ProductAccidental Exposure To Product By ChildAdenocarcinomaAdenomatous Polyposis ColiAdjuvant TherapyAnalgesic TherapyAnaplastic AstrocytomaAndrogen DeficiencyAngiocentric GliomaAngiosarcomaAngiosclerosis

Showing 15 of 447 indications

Tamoxifen brand names and reporting trend

Tamoxifen is sold under the brand name Nolvadex.

Brand names

Nolvadex23,608

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking tamoxifen with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.