Side Effects of nilutamide: A Synthesis of Findings from 26 Studies

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Original Abstract of the Article

Major Research Findings

Nilutamide is a medication used in the treatment of prostate cancer, particularly as a secondary hormonal therapy for androgen-independent prostate cancer. 9

Multiple studies have suggested that nilutamide is effective in treating prostate cancer when used as a single-agent therapy. 4 1 10

Nilutamide may offer subjective symptom improvement and quality of life enhancements compared to surgical castration, especially in patients with metastatic prostate cancer. 15

Reasons for Side Effects

Nilutamide is a nitroaromatic compound, and it is metabolized in the body to produce metabolites such as hydroxylamine and amine. 6 These metabolites can be toxic to tissues such as the lungs and liver, which is believed to cause side effects. 5

Common Side Effects

Visual Disturbances

Nilutamide can cause visual disturbances. 4 Specifically, it can lead to difficulty adapting to darkness, which is thought to occur because nilutamide affects the retina and reduces the ability to process visual information. 1

Gastrointestinal Symptoms

Nilutamide can cause gastrointestinal side effects. 4 7 1 Examples include nausea, vomiting, and diarrhea. 20

Liver Dysfunction

Nilutamide can affect the liver and cause liver dysfunction. 13 Elevated liver function test results may occur, particularly in patients with pre-existing liver impairment. 11

Respiratory Symptoms

Nilutamide can affect the lungs and cause respiratory symptoms such as interstitial pneumonitis. 5 Interstitial pneumonitis is a condition where inflammation occurs in the lung tissue, leading to symptoms like coughing, shortness of breath, and fever. 12

Other

In addition to the above, nilutamide can cause side effects such as fatigue, rash, and anemia. 4 20

Side Effect Management

Visual Disturbances

If visual disturbances occur, consult a doctor and consider discontinuing nilutamide as needed. 1

Gastrointestinal Symptoms

If gastrointestinal symptoms are severe, consult a doctor and consider discontinuing nilutamide or receiving medication to manage the symptoms. 7

Liver Dysfunction

If liver dysfunction is suspected, consult a doctor and consider discontinuing nilutamide or receiving medication to protect liver function. 13

Respiratory Symptoms

If respiratory symptoms occur, seek immediate medical attention. 5 12

Comparison Across Studies

Commonalities Across Studies

Multiple studies have indicated that nilutamide is effective in treating prostate cancer. 4 1 10 Additionally, all studies consistently report the potential for nilutamide to cause side effects such as visual disturbances, gastrointestinal symptoms, and liver dysfunction. 4 7 1 13

Differences Across Studies

Some studies may show variations in the effectiveness and severity of nilutamide's side effects. 15 For instance, one study reports that nilutamide may offer subjective symptom improvement and quality of life enhancements compared to surgical castration, while another study reports respiratory symptoms like interstitial pneumonitis as a side effect. 5 These differences are likely attributable to factors such as variations in participant characteristics, nilutamide dosage, and treatment duration. 20

Real-World Application Considerations

While nilutamide is an effective medication for treating prostate cancer, it carries the risk of side effects. 4 7 1 13 5 It is crucial to consult a doctor before taking nilutamide and understand the potential risks and benefits before starting treatment. 20

Limitations of Current Research

The research on nilutamide is still inadequate. 4 7 1 10 Further research is necessary to understand the long-term effects and safety of nilutamide. 20 Additionally, there are still unanswered questions about which types of patients benefit most from nilutamide, the appropriate dosage for different individuals, and so on. 9

Future Research Directions

Nilutamide research should focus on investigating the long-term effects and safety of the drug, determining optimal dosages and treatment durations. 9 It is also necessary to understand the mechanisms of action of nilutamide and develop strategies to minimize its side effects. 5

Conclusion

Nilutamide is an effective medication for treating prostate cancer but carries the risk of side effects. 4 7 1 13 5 Before taking nilutamide, it is crucial to consult a doctor and fully understand the potential risks and benefits of treatment. 20

Keywords
Benefit Keywords
Prostate cancer treatment
1
Prostate cancer treatment
Sexual function
2
Oral administration
Prostate cancer treatment
Sexual function preservation
Survival improvement
3
Maintained libido
Prostate cancer treatment
4
Safe and effective
Treats prostate cancer
7
Prostate cancer treatment
9
Prostatic cancer treatment
Retained potency
10
Improved quality of life
Prostate cancer treatment
Symptom palliation
11
Prostate cancer treatment
12
Improved quality of life
Prostate cancer treatment
Symptom relief
13
Prostate cancer treatment
14
Delayed progression
Improved quality of life
15
Prostate cancer treatment
16
Prostate cancer treatment
17
Breast cancer treatment
18
Improved quality of life
Survival advantage
19
Improved haemoglobin level
Improved sexual function
No weight gain
Reduced side effects
20
Prostatic carcinoma treatment
21
Effective hormonal treatment
Improved quality of life
Reduced diarrhea
22
Prostate cancer treatment
23
Improved quality of life
Preserves libido
Well tolerated
24
Long-term control
Prostate cancer treatment
26
Risk Keywords
Alcohol intolerance
Gastrointestinal symptoms
Nausea
Visual disturbances
1
Antiandrogen side effects
2
Breast pain
Gynecomastia
Hepatic function changes
3
Alcohol intolerance
Gastrointestinal issues
Nausea
Visual impairment
4
Crackles
Dry cough
Dyspnoea
Fever
Interstitial pneumonitis
Pulmonary fibrosis
Respiratory failure
5
Hepatotoxicity
Pneumotoxicity
6
Alcohol intolerance
Gastrointestinal problems
Night blindness
7
AR antagonist resistance
AR mutations
8
Side effects
10
Increased liver enzymes
11
Liver insufficiency
13
Decreased potency
Hot flashes
14
Side effects
15
Diarrhea
16
Medication side effects
17
Androgenic side effects
18
Increased side effects
19
Osteoporosis
20
Modest clinical advantages
Side effects of nilutamide and flutamide
22
Cardiovascular side effects
23
Drug related side effects
24
Side effects
25
Hot flashes
Lethargy
Light-dark adaptation
Nipple tenderness
26
Literature analysis of 26 papers
Positive Content
22
Neutral Content
1
Negative Content
3
Article Type
2
0
0
10
26
1.

Phase II study of the pure non-steroidal antiandrogen nilutamide in prostatic cancer. Italian Prostatic Cancer Project (PONCAP).

Author: DecensiA, GuarneriD, PaolettiM C, LalanneJ M, MerloF, BoccardoF

Prostate cancer treatment
Alcohol intolerance
Gastrointestinal symptoms
Nausea
Visual disturbances

Nilutamide, a non-steroidal antiandrogen, showed an objective response rate of 38.5% in previously untreated patients with metastatic carcinoma of the prostate. The most frequent side-effects were decreased adaptation to darkness, slight nausea, and alcohol intolerance.

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

2.

Antiandrogens as monotherapy for prostate cancer.

Author: SchröderF H

Prostate cancer treatment
Sexual function
Antiandrogen side effects

This review examines the use of antiandrogen monotherapies for prostate cancer treatment. Bicalutamide is as effective as castration in certain patient subgroups, while cyproterone acetate is as effective as estrogen therapy but with fewer side effects. Antiandrogen monotherapy may become increasingly used due to quality of life considerations.

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

3.

[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

4.

Monotherapy with nilutamide, a pure nonsteroidal antiandrogen, in untreated patients with metastatic carcinoma of the prostate. The Italian Prostatic Cancer Project.

Author: DecensiA U, BoccardoF, GuarneriD, PositanoN, PaolettiM C, CostantiniM, MartoranaG, GiulianiL

Maintained libido
Prostate cancer treatment
Alcohol intolerance
Gastrointestinal issues
Nausea
Visual impairment

Nilutamide, a non-steroidal antiandrogen, had an objective response rate of 38.5% in 26 previously untreated patients with metastatic carcinoma of the prostate. The drug was generally well tolerated, with decreased adaptation to darkness being the most frequent side effect.

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.

[Respiratory side-effects of drugs].

Author: van der DriftM A, KaajanJ Ph G

Crackles
Dry cough
Dyspnoea
Fever
Interstitial pneumonitis
Pulmonary fibrosis
Respiratory failure

Drug-induced interstitial pneumonitis can occur from within several hours up to months or years after the start of treatment, and sometimes even after the cessation of treatment. The signs and symptoms consist of a dry cough, dyspnoea, fever and crackles upon auscultation. The results of further investigations are atypical and consist of abnormalities on the X-ray or CT of the thorax and lymphocytosis in the bronchoalveolar lavage fluid. In most patients, the pulmonary abnormalities disappear after cessation of the drug treatment. Sometimes the disease progresses to pulmonary fibrosis and respiratory failure despite treatment with corticosteroids.

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

Language : Dutch

6.

Distribution of nitroreductive activity toward nilutamide in rat.

Author: AskKjetil, DécologneNathalie, AsareNana, HolmeJørn A, ArturYves, PelczarHélène, CamusPhilippe

Hepatotoxicity
Pneumotoxicity

Nilutamide, an antiandrogen used to treat prostate carcinoma, is metabolized by nitroreductases in various tissues, potentially contributing to its pneumotoxicity and hepatotoxicity.

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

7.

Anandron (RU 23908) in metastatic prostate cancer: preliminary results of a multicentric Italian study.

Author: BoccardoF, DecensiA U, GuarneriD, MartoranaG, FiorettoL, MiniE, MacalusoM P, GiulianiL, SantiL, PeritiP

Safe and effective
Treats prostate cancer
Alcohol intolerance
Gastrointestinal problems
Night blindness

A multicentric pilot study using the pure nonsteroidal antiandrogen nilutamide (Anandron--RU 23908) in 48 patients with stage D prostate carcinoma demonstrated a positive response in 43 evaluable patients. Overall, 41.6% of untreated patients achieved a partial response and 54.1% had stationary disease. In pretreated patients, 73.6% achieved stationary disease. Median progression-free survival in untreated patients was 325 days and overall survival was 696 days. The most common side effects were gastrointestinal toxicity (65%), hemeralopia (27%), and alcohol intolerance (6.2%).

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.
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

8.

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

9.

Efficacy of nilutamide as secondary hormonal therapy in androgen-independent prostate cancer.

Author: NakabayashiMari, ReganMeredith M, LifseyDeborah, KantoffPhilip W, TaplinMary-Ellen, SartorOliver, OhWilliam K

Prostate cancer treatment

Nilutamide is being evaluated as a secondary hormonal therapy for patients with androgen-independent prostate cancer. This therapy is attractive because it is orally administered, has low toxicity, and is well-accepted by patients.

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

10.

Pure antiandrogens as monotherapy in prospective studies of prostatic carcinoma.

Author: SchröderF H

Prostatic cancer treatment
Retained potency
Side effects

Flutamide is an antiandrogen that can be used to treat prostate cancer. It can cause side effects, but it is often effective in monotherapy, allowing patients to retain potency. Long-term effectiveness is still being studied.

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

Language : English

11.

Carcinoma of the prostate. Guidelines for treatment: the role of antiandrogens.

Author: Pavone-MacalusoM, CacciatoreM, DaricelloG, PavoneC, SerrettaV

Improved quality of life
Prostate cancer treatment
Symptom palliation
Increased liver enzymes

Flutamide was effective in patients with stage C or D prostate cancer, with similar response rates to 'classic' hormone therapy and fewer side 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.

Language : English

12.

Flavonoids can block PSA production by breast and prostate cancer cell lines.

Author: Rosenberg ZandRachel S, JenkinsDavid J A, BrownTheodore J, DiamandisEleftherios P

Prostate cancer treatment

This article explores the use of phytoestrogens as potential androgen-blocking agents in the treatment of prostate cancer, examining their potential for inhibiting androgen-regulated proteins.

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

Language : English

13.

Is there a role for pure antiandrogens in the treatment of advanced prostatic cancer?

Author: Pavone-MacalusoM, SerrettaV, DaricelloG, PavoneC, CacciatoreM, RomanoC, CavalloN

Improved quality of life
Prostate cancer treatment
Symptom relief
Liver insufficiency

Flutamide was found to be an effective treatment for patients with stage C and D prostate cancer. Response rates appeared to be comparable to those obtained by 'classic' hormone therapy, with minimal impact on libido and sexual potency. Side effects were generally slight or moderate.

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

Language : English

14.

Preliminary results on the clinical efficacy and safety of androgen inhibition by an LHRH agonist alone or combined with an antiandrogen in the treatment of prostatic carcinoma.

Author: FaureN, LemayA, LarocheB, RobertG, PlanteR, JeanC, ThabetM, RoyR, FazekasA T

Prostate cancer treatment
Decreased potency
Hot flashes

A combination of LHRH agonist and antiandrogen was effective in treating advanced prostatic cancer. The treatment resulted in a positive response in 97% of previously untreated patients. Side effects included hot flashes and decreased potency.

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

15.

Improved subjective responses to orchiectomy plus nilutamide (anandron) in comparison to orchiectomy plus placebo in metastatic prostate cancer. International Anandron Study Group.

Author: DijkmanG A, Fernandez del MoralP, DebruyneF M, JanknegtR A

Delayed progression
Improved quality of life
Side effects

Maximal androgen blockade improved subjective and objective outcomes for advanced prostate cancer, including delayed progression and longer median survival. This combination treatment was associated with more side effects than testicular suppression alone.

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.
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.

Language : English

17.

A controlled trial of castration with and without nilutamide in metastatic prostatic carcinoma.

Author: BélandG, ElhilaliM, FradetY, LarocheB, RamseyE W, TrachtenbergJ, VennerP M, TewariH D

Prostate cancer treatment
Medication side effects

A randomized, double-blind trial comparing nilutamide with placebo in patients with disseminated prostate cancer showed that nilutamide had a positive impact on the objective responses (46% vs 20%, P = 0.001). Progression-free survival was also initially improved in the nilutamide group. Although nilutamide increased median length of survival (from 18.9 to 24.3 months), it did not significantly increase the total survival time.

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.

Language : English

18.

Androgen receptor agonist activity of the synthetic progestin, medroxyprogesterone acetate, in human breast cancer cells.

Author: BentelJ M, BirrellS N, PickeringM A, HoldsD J, HorsfallD J, TilleyW D

Breast cancer treatment
Androgenic side effects

Medroxyprogesterone acetate (MPA) is an androgen receptor (AR) agonist, suggesting that the in vivo effects of MPA in breast cancer patients may in part be mediated by the AR.

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

19.

Combined androgen blockade: an update.

Author: KlotzLaurence

Improved quality of life
Survival advantage
Increased side effects

Combined androgen blockade therapy with bicalutamide may improve survival in prostate cancer patients compared to castration alone. However, it can increase side effects and impact quality of life.

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

20.

Long-term side-effects of intermittent androgen suppression therapy in prostate cancer: results of a phase II study.

Author: MaloneShawn, PerryGad, SegalRoanne, DahrougeSimone, CrookJuanita

Improved haemoglobin level
Improved sexual function
No weight gain
Reduced side effects
Osteoporosis

Intermittent androgen suppression therapy (IAS) showed potential for reducing side effects in patients with prostate cancer, including recovery of hemoglobin levels, sexual function, and absence of weight gain.

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.
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.
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.

Efficacy and advantages in the use of low doses of Anandron and estrogen combination in the treatment of prostate cancer.

Author: RaoB R, GeldofA A, van der WiltC L, de VoogtH J

Prostatic carcinoma treatment

A combination of Anandron and estradiol was effective in treating hormone-dependent prostatic adenocarcinoma in rats. The combination significantly retarded tumor growth.

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

23.

[New approach in the treatment of prostatic cancer: combined use of a LHRH agonist and an androgen antagonist].

Author: LabrieF, DupontA, BelangerA, LefebvreF A, RaynaudJ P

Prostate cancer treatment
Cardiovascular side effects

A combination of LHRH agonist and antiandrogen was more effective in treating advanced prostatic cancer than castration or high doses of estrogen. The treatment led to a positive response in 97% of previously untreated patients.

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 : French

25.

Maximum androgen blockade in 1996.

Author: Boccon-GibodL

Side effects

Maximal androgen blockade (MAB) with nonsteroidal antiandrogens may improve survival and progression-free survival in patients with prostate cancer, but the effect is marginal.

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

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