Tamsulosin

The symptoms associated with benign prostatic hyperplasia (BPH) are related to bladder outlet obstruction, which is comprised of two underlying components: static and dynamic. The static component is related to an increase in prostate size caused, in part, by a proliferation of smooth muscle cells in the prostatic stroma.

• Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.ICD-10: I10, N40.0

• Tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. Reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see Adverse Reactions (6.2)] .contraindicated

Tamsulosin hydrochloride capsules 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. It should be administered approximately one-half hour following the same meal each day. Tamsulosin hydrochloride capsules should not be crushed, chewed or opened. For those patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing, the dose of tamsulosin hydrochloride capsules can be increased to 0.8 mg once daily. Tamsulosin hydrochloride capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [see Warnings and Precautions (5.2)]. If tamsulosin hydrochloride capsules administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the 0.4 mg once-daily dose. 0.4 mg once daily taken approximately one-half hour following the same meal each day. Tamsulosin hydrochloride capsules should not be crushed, chewed or opened. (2) Can be increased to 0.8 mg once daily for patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing (2) If discontinued or interrupted for several days, therapy should start again with the 0.4 mg once-daily dose (2)

Advise patients about the possibility of symptoms related to postural hypotension and to avoid situations where injury could result should syncope occur (5.1) Should not be used in combination with strong inhibitors of CYP3A4. Use with caution in combination with moderate inhibitors of CYP3A4, with strong or moderate inhibitors of CYP2D6, in patients known to be CYP2D6 poor metabolizers, or in combination with other cytochrome P450 inhibitors. (5.2, 7.1, 12.3) Should not be used in combination with other alpha adrenergic blocking agents (5.2, 7.2, 12.3) Exercise caution with concomitant administration of warfarin (5.2, 7.4, 12.3) Advise patients about the possibility and seriousness of priapism (5.3) Intraoperative Floppy Iris Syndrome has been observed during cataract and glaucoma surgery in some patients. Advise patients considering cataract or glaucoma surgery to tell their ophthalmologist that they have taken tamsulosin hydrochloride capsules. (5.5) Advise patients to be screened for the presence of prostate cancer prior to treatment and at regular intervals afterwards (5.4) 5.1 Orthostasis The signs and symptoms of orthostasis (postural hypotension, dizziness, and vertigo) were detected more frequently in tamsulosin hydrochloride capsule-treated patients than in placebo recipients. As with other alpha adrenergic blocking agents there is a potential risk of syncope [see Adverse Reactions (6.1)] . Patients beginning treatment with tamsulosin hydrochloride capsules should be cautioned to avoid situations in which injury could result should syncope occur.

The most common adverse events (≥2% of patients and at a higher incidence than placebo) with the 0.4 mg dose or 0.8 mg dose were headache, dizziness, rhinitis, infection, abnormal ejaculation, asthenia, back pain, diarrhea, pharyngitis, chest pain, cough increased, somnolence, nausea, sinusitis, insomnia, libido decreased, tooth disorder, and blurred vision (6.1) To report SUSPECTED ADVERSE REACTIONS, contact XLCare Pharmaceuticals, Inc. at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The incidence of treatment-emergent adverse events has been ascertained from six short-term U.S. and European placebo-controlled clinical trials in which daily doses of 0.1 to 0.8 mg tamsulosin hydrochloride capsules were used. These studies evaluated safety in 1783 patients treated with tamsulosin hydrochloride capsules and 798 patients administered placebo. Table 1 summarizes the treatment-emergent adverse events that occurred in ≥2% of patients receiving either tamsulosin hydrochloride capsules 0.4 mg or 0.8 mg and at an incidence numerically higher than that in the placebo group during two 13-week U.S. trials (US92-03A and US93-01) conducted in 1487 men.

• Pediatric Use: Not indicated for use in pediatric populations ( 8.4 , 12.3 ) • Geriatric Use: No overall differences in efficacy or safety vs. younger patients, but greater sensitivity of some older adults cannot be ruled out ( 8.5 , 12.3 ) • Renal Impairment: Has not been studied in patients with end-stage renal disease ( 8.6 , 12.3 ) • Hepatic Impairment: Has not been studied in patients with severe hepatic impairment ( 8.7 , 12.3 ) 8.1 Pregnancy Risk Summary Tamsulosin hydrochloride is not indicated for use in women. There are no adequate data on the developmental risk associated with the use of tamsulosin hydrochloride in pregnant women. No adverse developmental effects were observed in animal studies in which tamsulosin hydrochloride was administered to rats or rabbits during the period of organogenesis (GD 7 to 17 in the rat and GD 6 to 18 in the rabbit) [see Data]. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. Data Administration of tamsulosin hydrochloride to pregnant female rats during the period of organogenesis at dose levels up to approximately 50 times the human therapeutic AUC exposure (300 mg/kg/day) revealed no evidence of harm to the fetus.

Metabolism

The pharmacokinetics of tamsulosin hydrochloride have been evaluated in adult healthy volunteers and patients with BPH after single and/or multiple administration with doses ranging from 0.1 mg to 1 mg. Absorption Absorption of tamsulosin hydrochloride from tamsulosin hydrochloride capsules 0.4 mg is essentially complete (>90%) following oral administration under fasting conditions.

Should overdosage of tamsulosin hydrochloride capsules lead to hypotension [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)], support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, then administration of intravenous fluids should be considered. If necessary, vasopressors should then be used and renal function should be monitored and supported as needed. Laboratory data indicate that tamsulosin hydrochloride is 94% to 99% protein bound; therefore, dialysis is unlikely to be of benefit.

• Mar 2, 2010ANDAANDA090377Impax Labs
• Apr 27, 2010ANDAANDA078225Zydus Pharms Usa Inc
• Apr 27, 2010ANDAANDA078015Sandoz
• Apr 27, 2010ANDAANDA078801Synthon Bv
• Jun 14, 2010NDANDA022460Waylis Therap
• Jul 15, 2010ANDAANDA090931Sun Pharm Inds Ltd
• Apr 30, 2013ANDAANDA202433Aurobindo Pharma Ltd
• Feb 26, 2014ANDAANDA202509Ph Health

1. 1Fatigue1,5027.3%
2. 2Dyspnoea1,4156.9%
3. 3Dizziness1,2566.1%
4. 4Diarrhoea1,1995.9%
5. 5Off Label Use1,0295.0%
6. 6Drug Ineffective1,0285.0%
7. 7Headache9564.7%
8. 8Fall9054.4%
9. 9Asthenia8914.4%
10. 10Nausea8554.2%
11. 11Cough7723.8%
12. 12Pruritus7123.5%
13. 13Death6933.4%
14. 14Malaise6823.3%
15. 15Arthralgia6813.3%

Recent PubMed references pinned to Tamsulosin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Efficacy and safety of α1-adrenergic blockers after extracorporeal shock wave lithotripsy in pediatric kidney stones.
  Pediatric surgery international · 2026 · Kyarimov IA, Zorkin SN, Galuzinskaya AT, et al.
  PMID 41779220DOI 10.1007/s00383-026-06353-2
• The efficacy of tamsulosin 0.4 mg when tamsulosin 0.2 mg is insufficient for benign prostatic hyperplasia in Korean patients.
  Investigative and clinical urology · 2026 · Chung Y, Jeong SJ, Song SH, et al.
  PMID 41775449DOI 10.4111/icu.20250569
• Enhanced antiproliferative and anti-inflammatory effects of combined metformin, tadalafil, and tamsulosin in a rat model of testosterone-induced benign prostatic hyperplasia.
  Life sciences · 2026 · Khalaf SS, Sherif AM, Mehanna ET, et al.
  PMID 41611202DOI 10.1016/j.lfs.2026.124240
• Outcome of medical treatments combined with tamsulosin for feline ureteral obstruction.
  The Journal of veterinary medical science · 2026 · Furusawa Y, Sogawa T, Kuramoto T, et al.
  PMID 41565273DOI 10.1292/jvms.25-0247
• The Association Between Preoperative Tamsulosin Use and Intraoperative Hypotension.
  Journal of cardiothoracic and vascular anesthesia · 2026 · Plambeck CJ, Freed JK, Canales B, et al.
  PMID 41558917DOI 10.1053/j.jvca.2025.12.024
• Implementation of problem-based learning pedagogy with integration of tamsulosin management in traditional urology residency training under the multidisciplinary team model.
  Pakistan journal of pharmaceutical sciences · 2026 · Zhang C, Huang S, Jiang F, et al.
  PMID 41546587DOI 10.36721/PJPS.2026.39.2.REG.15268.1
• Cardiovascular safety of 5α-reductase inhibitors in people with benign prostatic hyperplasia and type 2 diabetes: a propensity score-matched analysis.
  European heart journal. Cardiovascular pharmacotherapy · 2026 · Tu H, Ju C, McGurnaghan SJ, et al.
  PMID 41544653DOI 10.1093/ehjcvp/pvag003
• Retrograde Intrarenal Surgery Combined with Tamsulosin Hydrochloride for Renal Calculi ≤2 cm: Single-Center Study.
  Archivos espanoles de urologia · 2025 · Sun L, Wang J, Liu Q, et al.
  PMID 41339229DOI 10.56434/j.arch.esp.urol.20257809.158

The 10 most recently updated of 287 ClinicalTrials.gov registrations naming Tamsulosin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Post-operative Urinary Retention (POUR) Following Thoracic Surgery
  Recruiting · Phase 1 · Phase 2 · Interventional · 127 enrolled · Hackensack Meridian Health
  NCT03609580updated 2026-06-11
• Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion
  Recruiting · Phase 4 · Interventional · 500 enrolled · Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
  NCT07310797updated 2026-06-08
• Tamsulosin and Intraureteral Aminophylline for Ureteral Access During RIRS
  Recruiting · Phase 2 · Interventional · 322 enrolled · Beni-Suef University
  NCT07623876updated 2026-06-03
• L-Citrulline Versus Tamsulosin for Medical Expulsive Therapy of Distal Ureteral Stones
  Recruiting · Phase 2 · Interventional · 120 enrolled · Beni-Suef University
  NCT07617909updated 2026-06-01
• A Study to Track the Safety of Vesomni in Men in South Korea Treated in Routine Clinical Practice for the Urinary Symptoms of Benign Prostatic Hyperplasia (Enlarged Prostate)
  Not yet recruiting · Observational · 600 enrolled · Astellas Pharma Korea, Inc.
  NCT07619105updated 2026-06-01
• Preoperative Tamsulosin to Prevent Postoperative Urinary Retention After Surgery For Pelvic Floor Disorders
  Completed · Early phase 1 · Interventional · 100 enrolled · The Cleveland Clinic
  NCT04232683updated 2026-05-26
• Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg
  Recruiting · Interventional · 140 enrolled · Ain Shams University
  NCT07562282updated 2026-05-01
• Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure
  Active not recruiting · Interventional · 126 enrolled · Northwestern University
  NCT05100017updated 2026-04-30
• Function of Tamsulosin in Older Males Undergoing Surgery With Indwelling Catheter
  Completed · Phase 3 · Interventional · 87 enrolled · Emory University
  NCT06257576updated 2026-04-09
• A Pilot Study of Ultra-High-Dose Hypofractionated or Single-Dose Radiotherapy for Intermediate Risk Prostate Cancer
  Active not recruiting · Phase 1 · Interventional · 31 enrolled · Albert Einstein College of Medicine
  NCT04147806updated 2026-04-03

CPIC-curated drug–gene pairs for Tamsulosin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• CYP2D6CPIC B/C (provisional)FDA label: Actionable PGx

Frequently asked questions

How does Tamsulosin work?

The symptoms associated with benign prostatic hyperplasia (BPH) are related to bladder outlet obstruction, which is comprised of two underlying components: static and dynamic. The static component is related to an increase in prostate size caused, in part, by a proliferation of smooth muscle cells in the prostatic stroma.

What is Tamsulosin used for?

According to FDA labeling, Tamsulosin carries indications including: Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Tamsulosin?

Tamsulosin is classified as Alpha-adrenoreceptor antagonists, alpha-Adrenergic Blocker, Adrenergic alpha-Antagonists, Adrenergic alpha1-Antagonists, Decreased Bladder Sphincter Tone, Decreased Urethra Smooth Muscle Tone.

What are the brand names for Tamsulosin?

Tamsulosin is marketed under brand names including Flomax, Jalyn.

What are the contraindications for Tamsulosin?

Tamsulosin labeling lists contraindications including: Tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. Reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see Adverse Reactions (6.2)] .. Always consult the full prescribing information and a clinician.