Side Effects of flutamide: A Synthesis of Findings from 25 Studies

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Original Abstract of the Article

Major Findings

Flutamide is an androgen receptor antagonist used to treat prostate cancer. Multiple studies have investigated its effectiveness and safety. 19 found that flutamide, when used in combination with castration, did not improve survival rates for stage D2 prostate cancer patients compared to other androgen receptor antagonists. However, 12% of the flutamide group experienced liver dysfunction. 21 found that flutamide, when used as an intermittent therapy for metastatic prostate cancer, did not show a difference in survival rates compared to continuous treatment. This study suggests that flutamide is a safe and potentially effective option for certain patients. Flutamide has also been used to treat hirsutism in women. 14 found that low doses of flutamide (125mg/day) are safe and effective in treating hirsutism in women.

Reasons for Side Effects

Flutamide’s side effects are thought to be caused by its mechanism of action: blocking the androgen receptor. Androgens are male hormones responsible for various bodily functions, including the development of male secondary sexual characteristics. By binding to androgen receptors, flutamide inhibits the effects of androgens. This allows flutamide to effectively treat conditions affected by androgens, such as hirsutism and prostate cancer. However, it also means that inhibiting the effects of androgens could lead to various side effects.

Common Side Effects

Liver Dysfunction

Flutamide can cause liver dysfunction. 19 found that 12% of the flutamide group experienced liver dysfunction. 8 notes that liver dysfunction caused by flutamide is typically temporary and resolves or improves during or after the treatment period.

Breast Pain

Flutamide can cause breast pain. 8 lists breast pain as one of the most common side effects of flutamide.

Gynecomastia

Flutamide can cause gynecomastia (enlarged breasts). 8 lists gynecomastia as one of the most common side effects of flutamide.

Gastrointestinal Symptoms

Flutamide can cause gastrointestinal symptoms. 8 mentions that flutamide, at a dosage of 750mg/day, has a higher incidence of diarrhea than a dosage of 50mg/day.

Managing Side Effects

Liver Dysfunction

If liver dysfunction is suspected, liver function tests should be performed, and flutamide administration should be stopped if necessary. 8 states that liver dysfunction is usually temporary and resolves or improves during or after flutamide treatment.

Breast Pain

If breast pain is severe, pain relievers or cold compresses can be used to alleviate the symptoms.

Gynecomastia

If gynecomastia is a concern, wearing a supportive bra can help alleviate the symptoms.

Comparison of Studies

Commonalities

Multiple studies demonstrate that flutamide is effective in treating prostate cancer. 19 , 21 , 8 Several studies also show that flutamide can cause various side effects, including liver dysfunction, breast pain, and gynecomastia. 19 , 8

Differences

The effectiveness and incidence of side effects associated with flutamide can vary across different studies. This variation may be due to differences in patient demographics, medical conditions, and treatment methods.

Real-life Application

Flutamide should be taken under the guidance of a physician. Flutamide can cause side effects, so it's important to consult with a doctor before taking it.

Limitations of Current Research

There is still a need for more research regarding flutamide. Future research is needed to gather more detailed information on flutamide’s safety and effectiveness.

Future Research

Large-scale clinical trials are needed to further investigate the safety and effectiveness of flutamide. Research focused on mitigating flutamide’s side effects is also necessary.

Conclusion

Flutamide is an effective androgen receptor antagonist used to treat prostate cancer. However, it can cause various side effects, including liver dysfunction, breast pain, and gynecomastia. If you’re considering taking flutamide, it’s essential to consult with a doctor and use it as directed.

Literature analysis of 25 papers
Positive Content
18
Neutral Content
2
Negative Content
5
Article Type
6
0
0
6
25
1.

Drug safety is a barrier to the discovery and development of new androgen receptor antagonists.

Author: FosterWilliam R, CarBruce D, ShiHong, LevesquePaul C, ObermeierMary T, GanJinping, ArezzoJoseph C, PowlinStephanie S, DinchukJoseph E, BalogAaron, SalvatiMark E, AttarRicardo M, GottardisMarco M

AR antagonist resistance
AR mutations

No new androgen receptor (AR) antagonists have been approved in over a decade despite the development of resistance to existing AR antagonists in prostate tumors. Mutations that increase AR activity and broaden ligand range contribute to treatment failure.

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

Language : English

2.

Antiandrogen monotherapy: indications and results.

Author: IversenPeter

Prostate cancer treatment
Quality of life
Sexual function
Gynecomastia
Male breast pain

Bicalutamide, a nonsteroidal antiandrogen, was as effective as castration in treating prostate cancer with fewer negative impacts on sexual function and physical capacity.

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.
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.

Language : English

3.

Combined low-dose flutamide plus finasteride vs low-dose flutamide monotherapy for recurrent prostate cancer: a comparative analysis of two phase II trials with a long-term follow-up.

Author: BañezLionel L, BlakeGary W, McLeodDavid G, CrawfordE David, MoulJudd W

PSA decrease
Metabolic effects

Low-dose flutamide alone or combined with finasteride as first-line agents in a possible graduated approach for treating PSA-only recurrent prostate cancer shows therapeutic value.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

Comparison of the clinical efficacy of flutamide and spironolactone plus ethinyloestradiol/cyproterone acetate in the treatment of hirsutism: a randomised controlled study.

Author: KarakurtFeridun, SahinIbrahim, GülerSerdar, DemirbasBerrin, CulhaCavit, SerterRustu, AralYalcin, BavbekNuket

Hirsutism treatment

This study compared the effectiveness of flutamide, spironolactone, and a combination of cyproterone acetate and ethinyloestradiol in treating hirsutism.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

5.

Metabolomics in drug intolerance.

Author: AndreuInmaculada, MayorgaCristobalina, MirandaMiguel A

Adverse drug reactions
Drug intolerance
Hepatotoxicity
Hypersensitivity reactions

Adverse drug reactions can occur with many drugs and can lead to serious health problems. This review discusses the toxicological consequences of drug biotransformation, including examples of drugs that can cause liver damage or other toxic effects.

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.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

6.

Bicalutamide monotherapy versus flutamide plus goserelin in prostate cancer patients: results of an Italian Prostate Cancer Project study.

Author: BoccardoF, RubagottiA, BarichelloM, BattagliaM, CarmignaniG, ComeriG, ContiG, CrucianiG, DamminoS, DellipontiU, DitonnoP, FerrarisV, LilliuS, MontefioreF, PortogheseF, SpanoG

Fewer side effects
Improved QOL
Erectile dysfunction
Loss of libido

Bicalutamide monotherapy yielded comparable results to maximal androgen blockade in treating advanced prostatic cancer, with fewer side effects and better quality of life.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
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.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Parenteral estrogen versus total androgen ablation in the treatment of advanced prostate carcinoma: effects on overall survival and cardiovascular mortality. The Scandinavian Prostatic Cancer Group (SPCG)-5 Trial Study.

Author: HedlundP O, HenrikssonP

Improved survival
Reduced cardiovascular mortality

Total androgen ablation is not necessarily superior to parenteral estrogen for treating prostate cancer. Parenteral estrogen may be safer than oral estrogen, as it does not have the same cardiovascular side effects.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
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.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

8.

[The role of bicalutamide in the treatment of prostate cancer].

Author: StavStav Yakov, SegalGad

Oral administration
Prostate cancer treatment
Sexual function preservation
Survival improvement
Breast pain
Gynecomastia
Hepatic function changes

This article reviews the efficacy and safety of bicalutamide, a non-steroidal antiandrogen used in prostate cancer treatment. It shows comparable effectiveness to other antiandrogens, with a lower incidence of specific side effects.

English AbstractA summary of a research paper/publication written in English for a wider audience.
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 : Hebrew

9.

Androgen receptor blockade by flutamide down-regulates renal fibrosis, inflammation, and apoptosis pathways in male rats.

Author: AllamShady, ElsakkaElsayed G E, IsmailAhmed, DoghishAhmed S, YehiaAmr Mohamed, ElkadyMohamed A, MokhlisHamada Ahmed, SayedSara M, Abd ElazizAdel I, HashishAbdullah A, AminMona M, El ShahatRehab Mohamed, MohammedOsama A

Reduced apoptosis
Reduced inflammation
Reduced renal fibrosis

This study investigated the effect of androgen receptor blockade by flutamide on renal inflammation, apoptosis, and fibrosis in male rats. The study found that AR blockade significantly reduced renal inflammation, apoptosis, and fibrosis markers. The study concluded that AR blockade may be a promising strategy for alleviating renal side effects associated with some drugs.

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

Language : English

12.

Comparison of finasteride and flutamide in the treatment of idiopathic hirsutism.

Author: FalsettiL, GamberaA

Hirsutism reduction
Hormonal changes

This study found that both finasteride and flutamide were effective in treating idiopathic hirsutism, but flutamide was more effective than finasteride.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
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.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

14.

Low-dose flutamide (125 mg/day) as maintenance therapy in the treatment of hirsutism.

Author: VenturoliS, ParadisiR, BagnoliA, ColomboF M, RavaioliB, VianelloF, ManciniF, GualerziB, PorcuE, SeracchioliR

Hirsutism treatment
Side effects

Flutamide is an effective treatment for hirsutism in women. In a study of 43 women, flutamide 250 mg/day for 12 months followed by 125 mg/day for an additional 12 months was effective in reducing hirsutism, hair diameter, and hair growth rate. The most common side effect was increased liver enzymes, which occurred in 4 patients.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

15.

Androgenetic alopecia: An update.

Author: NtshingilaSincengile, OputuOgheneochuko, ArowoloAfolake T, KhumaloNonhlanhla P

AGA treatment options
AGA psychosocial impact
Postfinasteride syndrome

Androgenetic alopecia (AGA) is a common hair loss condition with no cure. This review discusses current treatments for AGA, including finasteride and minoxidil, and the need for more effective treatments 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

17.

Treatment of hirsutism with lowest-dose flutamide (62.5 mg/day).

Author: MüderrisI I, BayramF, GüvenM

Hirsutism treatment
Side effects

The lowest dose of flutamide (62.5 mg/day) is a well-tolerated therapeutic agent for the treatment of hirsutism.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

18.

Structure toxicity relationships--how useful are they in predicting toxicities of new drugs?

Author: NelsonS D

Improved drug safety
Toxicity

This chapter discusses the association between certain structural moieties in drugs and the formation of reactive metabolites, which can lead to toxicity. The chapter provides examples of structures commonly associated with adverse effects and highlights the importance of considering benefit-risk ratios when evaluating new drugs.

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

19.

[Endocrine therapy of stage D2 prostate cancer--comparison of drugs used for total androgen blockade].

Author: TanakaM, MurakamiS, SuzukiN, HamanoS, KinsuiH, OikawaT, ShimazakiJ

Liver dysfunction
Side effects

Patients with Stage D2 prostate cancer were treated with surgical or medical castration combined with estrogen, chlormadinone acetate or flutamide. There was no difference in overall survival, cause-specific survival, or relapse-free survival among the three medications. Flutamide was associated with grade 2 liver dysfunction in 12% of patients.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
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 : Japanese

20.

Establishment of knockdown of superoxide dismutase 2 and expression of CYP3A4 cell system to evaluate drug-induced cytotoxicity.

Author: YoshikawaYukitaka, HosomiHiroko, FukamiTatsuki, NakajimaMiki, YokoiTsuyoshi

Drug development
Hepatotoxicity

This study establishes a sensitive cell system to evaluate oxidative stress and CYP3A4-mediated cytotoxicity, which could be useful in preclinical drug development. The system utilizes SOD2-knockdown cells and an adenovirus expressing CYP3A4 to assess the effects of various drugs on mitochondrial toxicity, ROS production, and lipid peroxidation.

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.

Language : English

21.

Intermittent hormonal therapy in the treatment of metastatic prostate cancer: a randomized trial.

Author: MottetNicolas, Van DammeJean, LoulidiSalim, RusselChristoph, LeitenbergerArmin, WolffJohannes M,

Prostate Cancer Treatment

Intermittent androgen deprivation therapy (ADT) is a treatment option for prostate cancer that involves cycling ADT, allowing hormonal recovery during off-treatment periods. This study of only metastatic patients found no statistical difference in either overall survival or progression-free survival between intermittent and continuous ADT, suggesting that intermittent ADT may be as safe as continuous castration. While no clear benefit in health-related quality of life was shown, intermittent ADT could be an option for highly responding and well-informed metastatic patients. This intermittent modality could be of interest in metastatic patients with significant treatment-induced side-effects.

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.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

22.

Acceptability of short term neo-adjuvant androgen deprivation in patients with locally advanced prostate cancer.

Author: LambDavid S, DenhamJames W, MameghanHedy, JosephDavid, TurnerSandra, MatthewsJohn, FranklinIan, AtkinsonChris, NorthJohn, PoulsenMichael, KovacevOlga, RobertsonRandall, FrancisLynne, ChristieDavid, SpryNigel A, TaiKeen-H, WynneChris, DuchesneGillian

Improved biochemical control
Survival increase
Liver function issues
Sexual dysfunction

Short-term neo-adjuvant maximal androgen deprivation was acceptable to patients treated with external beam radiation for locally advanced prostate cancer.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

24.

Nanomolar concentrations of anabolic-androgenic steroids amplify excitotoxic neuronal death in mixed mouse cortical cultures.

Author: OrlandoRosamaria, CarusoAlessandra, MolinaroGemma, MotoleseMarta, MatriscianoFrancesco, TognaGiuseppina, MelchiorriDaniela, NicolettiFerdinando, BrunoValeria

Excitotoxicity
Neurotoxicity

This study investigated the effects of testosterone and anabolic-androgenic steroids (AASs) on excitotoxic neuronal death induced by NMDA in primary cultures of mouse cortical cells. AASs were found to amplify NMDA toxicity, suggesting that they may increase neuronal vulnerability to excitotoxic insults.

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.

Language : English

25.

Effect of flutamide and two novel synthetic steroids on GABA, glutamine and some oxidative stress markers in rat brain and prostate.

Author: Calderón GuzmánD, BratoeffE, Ramírez LópezE, Hernández GarcíaE, Pierdant RiojaF, Osnaya BrizuelaN, Trujillo JiménezF, Barragán MejíaG, Juárez OlguínH, Santamaría Del ÁngelD

Antioxidant effect
Side effects

This study assayed the effects of flutamide and two novel synthetic steroids on GABA, glutamine, and oxidative stress markers in rats. 16β-methyl-17α-benzoyloxypregnen-4-en-3,20-dione showed an antioxidant effect and seemed to impair the GABAergic and serotonergic metabolism, making it a promising treatment for androgen-dependent diseases and epilepsy.

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

Language : English

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