Side Effects of silodosin: A Synthesis of Findings from 27 Studies

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Original Abstract of the Article

Major Research Findings

Silodosin is a medication developed to treat benign prostatic hyperplasia (BPH). It selectively targets the α1A receptor, causing relaxation of smooth muscles in the urethra and prostate, thereby easing urination. 15

Silodosin has shown effectiveness as a treatment for BPH and ureteral stones. 17 14 19 13 24 11 12 10 20

In the treatment of ureteral stones, silodosin may be more effective than tamsulosin. 14 12

While effective for BPH and ureteral stones, silodosin has been reported to affect sexual function in some patients. 18 5 6 3 2 9

Reasons for Side Effects

Silodosin's side effects stem from its selective action on the α1A receptor. This receptor is present not only in the prostate and urethra but also in other organs like blood vessels and the heart. By blocking the α1A receptor, silodosin relaxes smooth muscles in the prostate and urethra, but it can also dilate blood vessels and increase heart rate. 15 17

The side effects of silodosin can affect organs beyond the prostate and urethra due to the selective action on the α1A receptor. 15 17

Common Side Effects

Retrograde Ejaculation

By blocking the α1A receptor, silodosin relaxes smooth muscles in the prostate and urethra, which can lead to retrograde ejaculation. 18 5 6 3 9

Erectile Dysfunction

Silodosin can cause erectile dysfunction by blocking the α1A receptor. 18 5 3

Dizziness

Silodosin can cause dizziness by blocking the α1A receptor, dilating blood vessels and lowering blood pressure. 17 23

Nasal Congestion

Silodosin can cause nasal congestion by blocking the α1A receptor, dilating blood vessels in the nasal mucosa. 17 23

Fatigue

Silodosin can cause fatigue by blocking the α1A receptor, dilating blood vessels and lowering blood pressure. 17 23

Gastrointestinal Symptoms

Silodosin can cause gastrointestinal side effects. 17 23

Frequent Urination

Silodosin can cause urinary side effects such as frequent urination due to its relaxation of smooth muscles in the urethra and prostate. 17

Rash

Silodosin can cause allergic reactions such as rash. 17

Side Effect Management

Retrograde Ejaculation

If retrograde ejaculation occurs, discontinue silodosin or consult a doctor. 18 5 6 3 9

Erectile Dysfunction

If erectile dysfunction occurs, discontinue silodosin or consult a doctor. 18 5 3

Dizziness

If dizziness occurs, discontinue silodosin or consult a doctor. 17 23

Nasal Congestion

If nasal congestion occurs, discontinue silodosin or consult a doctor. 17 23

Fatigue

If fatigue occurs, discontinue silodosin or consult a doctor. 17 23

Gastrointestinal Symptoms

If gastrointestinal side effects occur, discontinue silodosin or consult a doctor. 17 23

Frequent Urination

If urinary side effects occur, discontinue silodosin or consult a doctor. 17

Rash

If an allergic reaction occurs, discontinue silodosin and consult a doctor immediately. 17

Comparison Across Studies

Commonalities

Numerous studies have demonstrated the effectiveness of silodosin in treating BPH and ureteral stones. 17 14 19 13 24 11 12 10 20

Many studies also indicate that silodosin can affect sexual function. 18 5 6 3 2 9

Differences

The effects and side effects of silodosin can vary across different studies. 17 14 19 13 24 11 12 10 20 18 5 6 3 2 9

This variation is likely attributed to differences in factors such as the age and sex of study participants, disease severity, and concurrent medications. 17 14 19 13 24 11 12 10 20 18 5 6 3 2 9

Considerations for Real-Life Application

Silodosin is an effective medication for treating BPH and ureteral stones, but it can affect sexual function. 18 5 6 3 2 9

Before taking silodosin, consult with a doctor to determine the most appropriate dosage and method of administration based on your individual circumstances. 18 5 6 3 2 9

Limitations of Current Research

Research on silodosin is still ongoing. 17 14 19 13 24 11 12 10 20 18 5 6 3 2 9

Therefore, long-term effects and safety of silodosin still hold many unknowns. 17 14 19 13 24 11 12 10 20 18 5 6 3 2 9

Future Research Directions

Further research is needed to investigate the long-term effects and safety of silodosin. 17 14 19 13 24 11 12 10 20 18 5 6 3 2 9

Further investigation into the impact of silodosin on sexual function is also warranted. 18 5 6 3 2 9

Conclusion

Silodosin is an effective medication for treating BPH and ureteral stones, but it can have side effects related to sexual function. 18 5 6 3 2 9

When taking silodosin, consult with a doctor to determine the most appropriate dosage and method of administration for your individual circumstances. 18 5 6 3 2 9

Keywords
Benefit Keywords
LUTS treatment
3
Improved urinary symptoms
6
Alfuzosin safety
7
Improved ejaculatory control
Improved erectile function
9
Pain control
Stone expulsion
10
Faster expulsion time
Higher stone clearance
11
Ureteral stones treatment
12
Effective MET
Reduced pain episodes
13
Stone expulsion
14
Improved cardiovascular safety
Lower urinary tract symptom relief
15
Ureteral Stone Treatment
16
Early onset of efficacy
Improved LUTS
17
PE prevention
Quality of life improvement
18
Ureteral calculi treatment
19
Reduced pain
Shorter expulsion time
Stone expulsion rate
20
Improved LUTS symptoms
Improved quality of life
21
BPH treatment
22
Improved urinary flow
Reduced nocturia
23
Silodosin efficacy
Ureteral calculi treatment
24
Reduced analgesic need
Stone expulsion
25
Effective stone expulsion
Reduced analgesic requirements
Reduced expulsion time
26
Improved IPSS
Improved quality of life
Reduced nocturia episodes
27
Risk Keywords
Decreased male fertility
Hepatocyte degeneration
Mammary gland hyperplasia
Mammary gland tumors
Pituitary adenomas
Prolonged estrous cycle
Seminiferous tubular degeneration
Thyroid follicular cell carcinoma
1
Nocebo effect
Sexual dysfunction
2
Ejaculatory disorders
Erectile dysfunction
Reduced sexual desire
3
Sexual dysfunction
4
Ejaculatory dysfunction
5
Enlarged seminal vesicles
Impaired ejaculation
6
Ejaculatory disorders
Orthostatic hypotension
7
Priapism
8
Anejaculation
Erectile dysfunction
9
Side effects
10
Orthostatic hypotension
Retrograde ejaculation
11
Retrograde ejaculation
13
Orthostatic hypotension
Retrograde ejaculation
17
Side effects
18
Drug safety in younger children
20
Abnormal ejaculation
21
Cardiovascular side effects
22
Retrograde ejaculation
23
Side effects
25
Abnormal ejaculation
26
Ejaculatory disorder
27
Literature analysis of 27 papers
Positive Content
20
Neutral Content
2
Negative Content
5
Article Type
3
2
2
8
26
1.

[Toxicity profile of silodosin (KMD-3213)].

Author: MutoShin-ichi, KasaharaHiroko, YokoiRyohei, HayashiMorimichi, SoumaShinji, KobayashiKazuo, TamuraToru, MurakamiMakoto, KurodaJunji, ShibataNobuo

Decreased male fertility
Hepatocyte degeneration
Mammary gland hyperplasia
Mammary gland tumors
Pituitary adenomas
Prolonged estrous cycle
Seminiferous tubular degeneration
Thyroid follicular cell carcinoma

Silodosin, a selective alpha(1A)-adrenoceptor antagonist, showed a favorable safety profile with adequate margins between the clinically recommended dose and those associated with toxic 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.

Language : Japanese

3.

Sexual Dysfunction Related to Drugs: a Critical Review. Part V: α-Blocker and 5-ARI Drugs.

Author: La TorreA, GiupponiG, DuffyD, ConcaA, CaiT, ScardigliA

LUTS treatment
Ejaculatory disorders
Erectile dysfunction
Reduced sexual desire

This review critically examines the sexual dysfunction side effects of drugs used to treat benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS).

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

4.

[Sexual side effects of pharmacological treatments].

Author: GiulianoF, DroupyS

Sexual dysfunction

Pharmacological agents can cause sexual side effects in both men and women, including erectile dysfunction, ejaculatory disorders, orgasmic disorders, and arousal disorders. Selective serotonin reuptake inhibitors (SSRIs) are the most common culprits, followed by neuroleptics, tramadol, strong opioid agonists, and thiazide diuretics.

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

5.

Impact of medical treatments for male lower urinary tract symptoms due to benign prostatic hyperplasia on ejaculatory function: a systematic review and meta-analysis.

Author: GacciMauro, FicarraVincenzo, SebastianelliArcangelo, CoronaGiovanni, SerniSergio, ShariatShahrokh F, MaggiMario, ZattoniFiliberto, CariniMarco, NovaraGiacomo

Ejaculatory dysfunction

Alpha-blockers and 5ARIs are associated with a higher risk of ejaculatory dysfunction (EjD) than placebo. Combination therapy with both drug classes results in a 3-fold increased risk of EjD.

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.
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

6.

Silodosin causes impaired ejaculation and enlargement of seminal vesicles in sexually active men treated for lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

Author: BozkurtOzan, DemirOmer, SenVolkan, EsenAdil

Improved urinary symptoms
Enlarged seminal vesicles
Impaired ejaculation

Silodosin treatment resulted in impaired ejaculation and enlarged seminal vesicles in 90% of sexually active men. Further studies are required for better clarifying the effects of silodosin on sexual functions.

Evaluation StudyResearch that systematically evaluates the effectiveness of a particular program or policy. It measures its outcomes and provides important information for future decision-making.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

7.

Adverse events related to alpha-blockers: analysis of real-life data from Eudra-Vigilance.

Author: CicioneAntonio, NacchiaAntonio, BaldassarriValeria, TemaGiorgia, RovestiLorenzo M, ManciniElisa, GuarnottaGiorgio, VoglinoOlivia A, FrancoAntonio, D'AnnunzioSimone, LombardoRiccardo, TubaroAndrea, DE NunzioCosimo

Alfuzosin safety
Ejaculatory disorders
Orthostatic hypotension

This study analyzed real-life data on neuro-vascular and sexual adverse events (AEs) associated with alpha-blockers (ABs) reported to the Eudra-Vigilance database. The study found that silodosin had a significantly higher risk of ejaculatory disorders, while tamsulosin and silodosin had a lower risk of orthostatic hypotension compared to other ABs.

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

Language : English

8.

Priapism - A rare side effect of alpha blockers: Report of 2 cases and literature review.

Author: UnalSelman, MicoogullariUygar, OkuluEmrah, KayigilOnder

Priapism

This case report describes two patients who developed priapism, a prolonged unintended erection, after initiating treatment with alpha blockers (silodosin and tamsulosin). While this adverse effect is rare, it emphasizes the need for healthcare providers to inform patients about the potential risks of alpha blocker therapy, including priapism.

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

Language : English

11.

Silodosin vs tamsulosin in the management of distal ureteric stones: A prospective randomised study.

Author: ElgalalyHazem, SakrAhmed, FawziAmr, SalemEmad A, DesokyEsam, ShahinAshraf, KamelMostafa

Faster expulsion time
Higher stone clearance
Orthostatic hypotension
Retrograde ejaculation

Silodosin is more effective than tamsulosin in the management of distal ureteric stones for stone clearance rates and stone expulsion times.

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

Language : English

12.

Medical Expulsive Therapy for Distal Ureteral Stones: Tamsulosin Versus Silodosin in the Turkish Population.

Author: ArdaErsan, CakirogluBasri, YukselIlkan, AkdenizEsra, CetinGizem

Ureteral stones treatment

Tamsulosin and silodosin were compared in the treatment of distal ureteral stones in Turkish patients. No statistically significant superiority between the two drugs was shown in terms of stone expulsion rate.

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

Language : English

13.

Medical expulsive therapy for distal ureteric stones: tamsulosin versus silodosin.

Author: ImperatoreVittorio, FuscoFerdinando, CretaMassimiliano, Di MeoSergio, BuonopaneRoberto, LongoNicola, ImbimboCiro, MironeVincenzo

Effective MET
Reduced pain episodes
Retrograde ejaculation

Tamsulosin and silodosin are equally effective for medical expulsive therapy (MET) of distal ureteric stones sized 10 mm or smaller. Silodosin is associated with a lower incidence of side effects related to peripheral vasodilation but a higher incidence of retrograde ejaculation compared to tamsulosin.

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.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

14.

Naftopidil vs silodosin in medical expulsive therapy for ureteral stones: a randomized controlled study in Japanese male patients.

Author: TsuzakaYasuo, MatsushimaHisashi, KanekoTomoyuki, YamaguchiTsuyoshi, HommaYukio

Stone expulsion

This study compared the efficacy of naftopidil, a selective α(1D) -adrenoceptor antagonist, and silodosin, a selective α(1A) -adrenoceptor antagonist, in managing ureteral stones in Japanese male patients. The results suggest that silodosin, targeting α(1A) -adrenoceptors, was more effective in promoting stone expulsion compared to naftopidil, suggesting a potential advantage in clinical practice.

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

15.

Silodosin : a new subtype selective alpha-1 antagonist for the treatment of lower urinary tract symptoms in patients with benign prostatic hyperplasia.

Author: OsmanNadir I, ChappleChristopher R, CruzFrancisco, DesgrandchampsFrançois, LlorenteCarlos, MontorsiFrancesco

Improved cardiovascular safety
Lower urinary tract symptom relief

This review discusses silodosin, a uroselective alpha-blocker for treating lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Silodosin is effective and well-tolerated, offering similar efficacy to existing alpha-blockers with improved cardiovascular safety.

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

18.

Comparison of alpha blockers in treatment of premature ejaculation: a pilot clinical trial.

Author: AkinYigit, GulmezHakan, AtesMutlu, BozkurtAliseydi, NuhogluBaris

PE prevention
Quality of life improvement
Side effects

Silodosin seems to be more effective for preventing premature ejaculation (PE) than other alpha blockers. Silodosin may provide development in QoL than other alpha blocker agents.

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

Language : English

19.

Comparing the efficacy of tamsulosin and silodosin in the medical expulsion therapy for ureteral calculi.

Author: GuptaSandeep, LodhBijit, SinghAkoijam Kaku, SomarendraKhumukcham, MeiteiKangjam Sholay, SinghSinam Rajendra

Ureteral calculi treatment

This study compared the efficacy of tamsulosin and silodosin in the medical expulsion therapy for ureteral calculi.

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

Language : English

20.

Silodosin versus Tamsulosin as Medical Expulsive Therapy for Children with Lower-Third Ureteric Stones: Prospective Randomized Placebo-Controlled Study.

Author: SolimanMohamed G, El-GamalOsama, El-GamalSamir, Abdel RaheemAli, Abou-RamadanAhmed, El-AbdAhmed

Reduced pain
Shorter expulsion time
Stone expulsion rate
Drug safety in younger children

This prospective single-blind placebo-controlled randomized study compared the efficacy and safety of silodosin and tamsulosin as medical expulsive therapy for distal ureteric stones (DUS) in 167 children. The study found that silodosin resulted in a significantly better stone expulsion rate and shorter expulsion time compared to tamsulosin. Both medications showed good safety profiles in children.

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

21.

Silodosin, a new alpha1A-adrenoceptor-selective antagonist for treating benign prostatic hyperplasia: results of a phase III randomized, placebo-controlled, double-blind study in Japanese men.

Author: KawabeKazuki, YoshidaMasaki, HommaYukio,

Improved LUTS symptoms
Improved quality of life
Abnormal ejaculation

Silodosin was effective in treating lower urinary tract symptoms associated with benign prostatic hyperplasia, with a low incidence of side effects.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
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.

Language : English

22.

[Evaluation of the efficacy of silodosin 8 mg in comorbid patients with LUTS/BPH].

Author: ZimichevA A, GusevD O, LukyanovaD Yu

BPH treatment
Cardiovascular side effects

This study analyzed the efficiency of silodosin at a dose of 8 mg/day in treating comorbid patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Silodosin resulted in significant improvement in LUTS symptoms without any significant cardiovascular adverse events.

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.

Language : Russian

23.

Silodosin for the treatment of clinical benign prostatic hyperplasia: safety, efficacy, and patient acceptability.

Author: ChoHee Ju, YooTag Keun

Improved urinary flow
Reduced nocturia
Retrograde ejaculation

This review discusses the efficacy and safety of silodosin, a novel α1-adrenergic receptor antagonist, for the treatment of benign prostatic hyperplasia (BPH). Silodosin demonstrates significant improvement in symptoms and a favorable cardiovascular safety profile.

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

25.

Comparison of three most frequently used alpha blocker agents in medical expulsive therapy for distal ureteral calculi, result of a retrospective observational study.

Author: SentürkAykut Buğra, AydinCemil, EkiciMusa, YaytokgilMuhammet, AkkocAli, BaykamMehmet Murat

Reduced analgesic need
Stone expulsion
Side effects

Alpha blocker agents are safe and effective in medical expulsive therapy for kidney stones. Tamsulosin, alfuzosin, and silodosin were all effective in expelling stones, but silodosin was associated with a shorter time to stone expulsion.

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.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

26.

The efficacy and safety of silodosin for the treatment of ureteral stones: a systematic review and meta-analysis.

Author: YangDiandong, WuJitao, YuanHejia, CuiYuanshan

Effective stone expulsion
Reduced analgesic requirements
Reduced expulsion time
Abnormal ejaculation

Silodosin is an effective and safe treatment option for ureteral stones, with a low occurrence of 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.
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

27.

Evaluating the Efficacy and Safety of Silodosin on Nocturia in Patients With Benign Prostatic Hyperplasia: A Multicenter, Prospective, Open-label, Single-arm, Phase IV Trial.

Author: ChoKang Jun, LeeJeong Zoo, SongYun Seob, ChoiJong Bo, KimDae Kyung, KimYong Tae, KimJoon Chul

Improved IPSS
Improved quality of life
Reduced nocturia episodes
Ejaculatory disorder

Silodosin was effective and safe in treating nocturia in patients with benign prostatic hyperplasia (BPH). The number of nocturia episodes decreased significantly after 12 weeks of treatment. The most common adverse drug reaction was ejaculatory disorder.

Clinical Trial, Phase IVPost-marketing surveillance. Monitors long-term safety/efficacy after approval.
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

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