Side Effects of raloxifene: A Synthesis of Findings from 29 Studies

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Original Abstract of the Article

Major Research Findings

Raloxifene is a selective estrogen receptor modulator (SERM) used to treat postmenopausal osteoporosis. It has been shown to be effective in improving bone density and reducing the risk of fractures. Raloxifene has also been shown to inhibit alveolar bone destruction in a mouse model of periodontitis combined with systemic postmenopausal osteoporosis. 23

Raloxifene is an effective method of breast cancer prevention. In multiple randomized trials, two selective estrogen receptor modulators - tamoxifen and raloxifene, and two aromatase inhibitors - exemestane and anastrozole have reduced BC incidence by 50%-65% in high-risk women. 20

Raloxifene has been shown to enhance the efficacy of paclitaxel against pancreatic cancer. In a mouse model of pancreatic cancer, combined therapy with raloxifene and paclitaxel was more effective in inhibiting the proliferation of pancreatic cancer cells and inducing apoptosis than monotherapy. 11

Raloxifene is effective in improving lumbar spine bone density in postmenopausal women with end-stage renal disease (ESRD). 10

Raloxifene may increase the risk of osteonecrosis of the jaw (MRONJ) when used in combination with bisphosphonates. MRONJ can also occur with the isolated use of raloxifene, and the risk may be increased in patients with cemento-osseous dysplasia (FCOD). 18

Reasons for Side Effects

The side effects of raloxifene are caused by the fact that it is a selective estrogen receptor modulator (SERM), so it has both estrogen-like and antagonistic effects. Raloxifene exhibits estrogen-like effects on bone and breast tissue, but has antagonistic effects on the endometrium. Therefore, raloxifene is effective in preventing osteoporosis and breast cancer, but it may increase the risk of endometrial cancer and thromboembolic events.

Common Side Effects

Hot Flashes

Hot flashes are a common side effect of raloxifene. This occurs because raloxifene acts on estrogen receptors, causing vasodilation due to estrogen deficiency. 12 21 24

Thromboembolic Events

Raloxifene may increase the risk of thromboembolic events. This is because raloxifene has a thrombotic effect. 12 20

Endometrial Cancer

Raloxifene may increase the risk of endometrial cancer. This is because raloxifene has a stimulating effect on endometrial cell growth. 12 20

Osteonecrosis of the Jaw

Raloxifene may increase the risk of osteonecrosis of the jaw (MRONJ). This is because raloxifene affects bone metabolism. 18

Others

Other side effects of raloxifene include nausea, vomiting, constipation, abdominal pain, headache, dizziness, and fatigue. 18 24

Measures for Side Effects

Hot Flashes

Measures for hot flashes include using air conditioning, wearing light clothing, consuming cold drinks and food, and exercising. 12

Thromboembolic Events

If you are at high risk for thromboembolic events, you may need to stop taking raloxifene. 12 20

Endometrial Cancer

If you are at high risk for endometrial cancer, you may need to stop taking raloxifene. 12 20

Osteonecrosis of the Jaw

To reduce the risk of osteonecrosis of the jaw, it is important to have regular dental checkups and maintain good oral hygiene. If you are having dental surgery, be sure to tell your doctor that you are taking raloxifene. 18

Comparison of Studies

Commonalities of Studies

Multiple studies have shown that raloxifene is effective in the treatment of postmenopausal osteoporosis and the prevention of breast cancer.

Differences in Studies

The results of studies on the side effects of raloxifene may vary. For example, different results have been reported regarding the relationship between raloxifene and the risk of endometrial cancer. In addition, it has been shown that the risk of osteonecrosis of the jaw may be increased by use in combination with bisphosphonates.

Cautions Regarding Application to Real Life

Raloxifene is an effective drug for the prevention of osteoporosis and breast cancer, but there is a risk of side effects. Therefore, it is important to consult with your doctor before starting to take raloxifene and understand your risks and benefits. It is also important to have regular checkups with your doctor while taking raloxifene.

Limitations of Current Research

Research on the side effects of raloxifene is still insufficient. Further research is needed, especially regarding the relationship between raloxifene and the risk of endometrial cancer.

Future Research Directions

It is necessary to further research the side effects of raloxifene. In particular, research is needed on the relationship between raloxifene and the risk of endometrial cancer, the risk of osteonecrosis of the jaw, and other side effects.

Conclusion

Raloxifene is an effective drug for the prevention of osteoporosis and breast cancer, but there is a risk of side effects. It is important to consult with your doctor before starting to take raloxifene and understand your risks and benefits. It is also important to have regular checkups with your doctor while taking raloxifene. Research on the side effects of raloxifene is still insufficient. Future research will be needed to further assess the safety of raloxifene.

Literature analysis of 29 papers
Positive Content
24
Neutral Content
1
Negative Content
4
Article Type
0
2
3
7
28
2.

Acceptance and adherence to chemoprevention among women at increased risk of breast cancer.

Author: RoetzheimRichard G, LeeJi-Hyun, FulpWilliam, Matos GomezElizabeth, ClaytonElissa, TollinSharon, KhakpourNazanin, LarongaChristine, LeeMarie Catherine, KilukJohn V

Breast cancer prevention
Side effects

A significant percentage of women at increased risk of breast cancer declined chemoprevention, and even among those who accepted therapy, approximately 40% were unable to complete five years of therapy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

4.

Raloxifene is associated with less side effects than tamoxifen in women with early breast cancer: a questionnaire study from one physician's practice.

Author: RohatgiNitin, BlauRobbin, LowerElyse E

Breast cancer prevention
Breast cancer treatment
Antiestrogenic side effects

This study aims to compare the antiestrogenic side effects of tamoxifen and raloxifene, two selective estrogen receptor modulators used in breast cancer treatment and prevention.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

5.

Current Management Strategies in Breast Cancer by Targeting Key Altered Molecular Players.

Author: AliShazia, MondalNeelima, ChoudhryHani, RasoolMahmood, PushparajPeter N, KhanMohammad A, MahfoozMaryam, SamiGhufrana A, JarullahJummanah, AliAshraf, JamalMohammad S

Improved breast cancer treatment
Tamoxifen resistance
Thromboembolic events
Uterine cancer

Breast cancer is a major health concern for women globally. Tamoxifen and raloxifene are used for prevention, but resistance and side effects like uterine cancer and blood clots limit their use. Aromatase inhibitors are also used, and research continues to explore new drugs with fewer side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

6.

Use of tamoxifen and raloxifene for breast cancer chemoprevention in 2010.

Author: WatersErika A, McNeelTimothy S, StevensWorta McCaskill, FreedmanAndrew N

Breast cancer prevention

Tamoxifen and raloxifene, drugs used for breast cancer prevention, have relatively low usage rates in the US. In 2010, raloxifene, a more recently approved drug, was the more commonly used option. Limited awareness and concerns about potential side effects may contribute to the low usage.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

8.

Styrene maleic acid encapsulated raloxifene micelles for management of inflammatory bowel disease.

Author: GreishKhaled, TahaSafa, JasimAnfal, ElghanySara Abd, SultanAmeera, AlKhateebAli, OthmanManal, JunFang, TaurinSebastien, BakhietMoiz

IBD treatment
Side effects

Raloxifene, a selective estrogen receptor modulator, shows promise as an anti-inflammatory and immunomodulatory agent for inflammatory bowel disease (IBD). This study explores its potential through cell line studies and in vivo models of IBD.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

9.

Incorporating Biomarkers in Studies of Chemoprevention.

Author: FabianCarol J, KimlerBruce F

Reduced breast cancer risk
Incomplete efficacy
Lack of survival advantage
Side effects

Tamoxifen and raloxifene are FDA-approved for breast cancer prevention, but only 4% of eligible women use them due to side effects and lack of survival benefits. Research now focuses on better risk prediction, behavioral interventions, and new trial designs using biomarkers to identify at-risk women and predict drug effectiveness.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

10.

Raloxifene in the Treatment of Osteoporosis in Postmenopausal Women with End-Stage Renal Disease: A Systematic Review and Meta-Analysis.

Author: MaHao-Yang, ChenShuang, LuLing-Ling, GongWei, ZhangAi-Hua

raloxifene efficacy
raloxifene safety

This review assessed the safety and efficacy of raloxifene in postmenopausal women with end-stage renal disease (ESRD) or those requiring dialysis for osteoporosis treatment. Raloxifene showed efficacy in improving lumbar spine bone mineral density, but more research is needed on its long-term safety.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

11.

Targeting Interleukin-6/Glycoprotein-130 Signaling by Raloxifene or SC144 Enhances Paclitaxel Efficacy in Pancreatic Cancer.

Author: HeringNina A, GünzlerEmily, ArndtMarco, ZibellMiriam, LauscherJohannes C, KreisMartin E, BeyerKatharina, SeeligerHendrik, PoziosIoannis

Enhanced apoptosis
Reduced interleukin-6 levels
Reduced tumor growth

Combining paclitaxel with either raloxifene or SC144 enhanced anti-tumor effects in a pancreatic cancer model, suggesting potential for improved treatment strategies.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

14.

Add-back therapy with GnRH analogues for uterine fibroids.

Author: MoroniRafael M, MartinsWellington P, FerrianiRui A, VieiraCarolina S, NastriCarolina O, Candido Dos ReisFrancisco José, BritoLuiz Gustavo

Uterine fibroid treatment

Uterine fibroids are common in women and can cause bleeding and pain. GnRH analogues are the most effective medication for fibroids, but long-term use causes side effects. Adding other medications (add-back therapy) may reduce these side effects, but could also decrease the effectiveness of GnRH analogues and may not completely prevent side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

15.

Affective forecasting and medication decision making in breast-cancer prevention.

Author: HoergerMichael, SchererLaura D, FagerlinAngela

Reduced breast cancer risk
Increased health-related stress
Side effects

Many women at high risk for breast cancer avoid prevention medications like tamoxifen and raloxifene due to anticipated stress from side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

16.

Bone Mineral Density Loss and Fracture Risk After Discontinuation of Anti-osteoporotic Drug Treatment: A Narrative Review.

Author: ElbersLaura P B, RatermanHennie G, LemsWillem F

Osteoporosis treatment
Fracture risk

This review examines the effects of stopping anti-osteoporotic medications in patients with osteoporosis. Discontinuing some medications, like denosumab, can lead to rapid bone loss and increased fracture risk. However, for others, like alendronate and zoledronic acid, a 1-year or longer discontinuation may be acceptable with careful monitoring.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

17.

Denosumab, raloxifene, romosozumab and teriparatide to prevent osteoporotic fragility fractures: a systematic review and economic evaluation.

Author: DavisSarah, SimpsonEmma, HamiltonJean, JamesMarrissa Martyn-St, RawdinAndrew, WongRuth, GokaEdward, GittoesNeil, SelbyPeter

Fracture prevention
Cost-effectiveness

Non-bisphosphonate treatments for fragility fractures were found to be effective in preventing fractures, but the incremental cost-effectiveness ratios were generally higher than the commonly applied threshold of £20,000-30,000 per quality-adjusted life-year. Denosumab may be cost-effective at very high levels of risk, while raloxifene was dominated by no treatment in most risk categories.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

18.

Raloxifene-induced osteonecrosis of the jaw (MRONJ) with no exposure to bisphosphonates: clinical and radiographic findings.

Author: BindakhilMohammed, ShantiRabie M, MupparapuMel

Osteonecrosis of the jaw

Raloxifene, a drug for osteoporosis, can cause osteonecrosis of the jaw (ONJ). This case report describes a patient with florid cemento-osseous dysplasia who developed raloxifene-induced ONJ. It highlights the importance of dentists being aware of this potential complication.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

19.

Human serum albumin-based nanoparticles alter raloxifene administration and improve bioavailability.

Author: YangShu-Jyuan, ChangChih-Hao, YoungTai-Horng, WangChung-Hao, TsengTzu-Hao, WangMan-Ling

Increased bioavailability
Reduced treatment dosage

Raloxifene-loaded human serum albumin nanoparticles improved the bioavailability and half-life of raloxifene in rats, suggesting a potential nanomedicine for treating postmenopausal osteoporosis with reduced dosages and improved efficacy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

20.

Endocrine prevention of breast cancer.

Author: JahanNusrat, JonesCatherine, RahmanRakhshanda Layeequr

Prevent BC
Side effects

Breast cancer (BC) is a significant health concern for women worldwide. Endocrine therapy, like tamoxifen and raloxifene, can effectively prevent BC in high-risk women. However, underutilization of endocrine prevention is common, due to factors like infrequent risk assessment, lack of provider knowledge, concerns about side effects, and poor adherence. This review discusses the importance of endocrine prevention and explores strategies to improve its usage.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

21.

6'-Methoxy Raloxifene-analog enhances mouse bone properties with reduced estrogen receptor binding.

Author: PowellKatherine M, BrownAlexa P, SkaggsCayla G, PulliamAlexis N, BermanAlycia G, DeosthalePadmini, PlotkinLilian I, AllenMatthew R, WilliamsDavid R, WallaceJoseph M

Bone mechanical properties
ER binding reduction

A Raloxifene-Analog (RAL-A) was developed to reduce estrogen receptor binding while maintaining bone-strengthening effects. In mice with Osteogenesis Imperfecta, both RAL and RAL-A improved bone microarchitecture and toughness, suggesting potential for treating bone disorders with fewer side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

22.

Breast cancer prevention with anti-estrogens: review of the current evidence and future directions.

Author: MallickSupriya, BensonRony, JulkaP K

Reduced breast cancer risk
Side effects

Chemoprevention, particularly with anti-estrogens, can reduce breast cancer risk but needs long-term compliance and carries potential side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

23.

Raloxifene reduces the risk of local alveolar bone destruction in a mouse model of periodontitis combined with systemic postmenopausal osteoporosis.

Author: IchimaruRyota, TominariTsukasa, YoshinouchiShosei, MatsumotoChiho, WatanabeKenta, HirataMichiko, NumabeYukihiro, MurphyGillian, NagaseHideaki, MiyauraChisato, InadaMasaki

Alveolar bone mass preservation

Raloxifene, a selective estrogen receptor modulator, may have a protective effect on alveolar bone loss in a mouse model of periodontitis. This study investigates its potential role in preventing bone loss associated with estrogen deficiency and gum disease.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

24.

First Report of Erythema Multiforme Minor Caused by Raloxifene Hydrochloride.

Author: NorimatsuYurie, NorimatsuYuta

raloxifene side effects

This report describes a case of erythema multiforme minor in a woman after switching from alfacalcidol to raloxifene for osteoporosis treatment, suggesting a rare side effect of raloxifene.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

26.

Prevention of breast cancer.

Author: OlverIan N

Reduced breast cancer risk
Thromboembolism
Uterine cancer

Lifestyle choices can affect breast cancer risk. Factors like obesity, alcohol use, smoking, and hormone therapy can increase the risk. Exercise, limiting alcohol intake, and quitting smoking can help reduce the risk. Chemoprevention with tamoxifen or raloxifene can also be considered for high-risk individuals.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

28.

A combined treatment with selective androgen and estrogen receptor modulators prevents bone loss in orchiectomized rats.

Author: KomrakovaM, BüchlerG, BökerK O, LehmannW, SchillingA F, RochP J, TaudienS, HoffmannD B, SehmischS

Bone tissue improvement

A combination of enobosarm and raloxifene may improve bone health in orchiectomized rats, suggesting a potential treatment for osteoporosis.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

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