Dutasteride

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Dutasteride on Prescriptsy

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Dutasteride is a prescription-only medicine used to treat benign prostatic hyperplasia (BPH) in adult men.

BPH is a non-cancerous enlargement of the prostate gland that commonly develops with age, causing lower urinary tract symptoms (LUTS) such as difficulty starting urination, a weak or intermittent stream, frequent urination (especially at night), a sensation of incomplete bladder emptying, and urgency.

Dutasteride belongs to a class of medicines called 5-alpha reductase inhibitors and is available as 0.5 mg soft capsules.

It is the generic equivalent of the brand name Avodart.

In the UK, BPH affects approximately one in three men over the age of 50 and around half of all men over 60.

While it is not life-threatening, the resulting urinary symptoms can significantly affect quality of life, sleep, and daily activities.

Left untreated, BPH may progress to acute urinary retention (the sudden and painful inability to pass urine), recurrent urinary tract infections, bladder stones, or kidney damage.

Dutasteride reduces the size of the prostate gland over time, relieving symptoms and lowering the risk of these complications.

This page provides a detailed clinical overview of how dutasteride works, who it is suitable for, how to take it, expected timelines, potential side effects, important warnings, and how to obtain a prescription in the United Kingdom.

Important safety information about dutasteride

Before reading further, note the following essential safety points. Dutasteride is a prescription-only medicine (POM) and must be used under medical supervision.

• Dutasteride is for use in adult men only. Women and children must not take this medicine.
• Women who are or may become pregnant must not handle damaged or opened dutasteride capsules. The active substance can be absorbed through the skin and may harm a developing male foetus.
• Men taking dutasteride must use a condom during intercourse if their partner is pregnant or could become pregnant, as dutasteride is present in semen.
• Do not donate blood while taking dutasteride or for at least 6 months after your last dose.
• Dutasteride reduces PSA levels by approximately 50%. Always inform any doctor requesting a PSA test that you are taking this medicine.

Understanding benign prostatic hyperplasia

The prostate gland sits below the bladder and surrounds the urethra, the tube that carries urine from the bladder out of the body.

As men age, the prostate gradually enlarges under the influence of dihydrotestosterone (DHT), a potent androgen derived from testosterone by the enzyme 5-alpha reductase.

This growth can compress the urethra and obstruct normal urine flow, producing the characteristic symptoms of BPH.

BPH is assessed using a combination of symptom questionnaires (the International Prostate Symptom Score, or IPSS), physical examination including digital rectal examination, urine flow rate measurement (uroflowmetry), and blood tests including prostate-specific antigen (PSA).

NICE guideline NG45 recommends that men with bothersome LUTS suggestive of BPH should be offered lifestyle advice initially, with pharmacological treatment considered when symptoms are moderate to severe or when complications are present or likely.

Treatment options for BPH include alpha-1 adrenergic blockers (such as tamsulosin), 5-alpha reductase inhibitors (dutasteride or finasteride), combination therapy, and surgical interventions for men who do not respond to medical management.

Dutasteride is particularly suited to men with a significantly enlarged prostate (volume greater than 30 mL) and moderate to severe symptoms, as it addresses the underlying hormonal driver of prostatic growth.

How dutasteride works: mechanism of action

Testosterone is converted to DHT by the enzyme 5-alpha reductase, which exists in two isoforms.

Type I 5-alpha reductase is found predominantly in skin and liver tissue, while type II is concentrated in the prostate gland, seminal vesicles, and hair follicles.

Dutasteride is a dual inhibitor, blocking both type I and type II isoenzymes. This distinguishes it from finasteride, which inhibits only type II.

By blocking both isoforms, dutasteride reduces serum DHT levels by approximately 90 to 95% within two weeks of starting treatment.

The resulting reduction in intraprostatic DHT causes gradual involution of prostatic epithelial and stromal tissue. Prostate volume decreases by a mean of approximately 25% over 24 months.

This mechanical decompression of the urethra improves urine flow rate and reduces obstructive symptoms.

In large clinical trials (the ARIA, AVERT, and CombAT studies), dutasteride demonstrated significant improvements in maximum urinary flow rate (Qmax), IPSS scores, and prostate volume compared with placebo.

It also reduced the relative risk of acute urinary retention by approximately 57% and the risk of BPH-related surgery by approximately 48% over 4 years.

The combination of dutasteride with an alpha-blocker (tamsulosin) provided greater symptom improvement than either drug alone, particularly in men with larger prostates.

Clinical evidence and UK prescribing guidance

Dutasteride has been available in the UK since 2002.

It is recommended in NICE guideline NG45 as a treatment option for men with LUTS secondary to BPH, particularly those with prostate volume greater than 30 mL.

The guideline notes that 5-alpha reductase inhibitors take several months to achieve full effect and are most appropriate for men who are willing to commit to long-term treatment.

The British National Formulary (BNF) lists dutasteride at a dose of 500 micrograms (0.5 mg) once daily.

It is available as a single-ingredient product or in combination with tamsulosin hydrochloride 400 micrograms (branded as Combodart).

The choice between monotherapy and combination therapy depends on symptom severity, prostate size, patient preference, and tolerability.

NICE also recommends that men with LUTS should be offered an assessment of their prostate cancer risk before starting a 5-alpha reductase inhibitor, given the effect of these drugs on PSA levels.

Baseline PSA should be measured before treatment, and subsequent values should be interpreted by doubling the measured figure to estimate the true PSA level.

Dutasteride compared with finasteride

Both dutasteride and finasteride are effective treatments for BPH.

The key pharmacological difference is that dutasteride inhibits both type I and type II 5-alpha reductase, while finasteride inhibits only type II.

In clinical terms, dutasteride produces a slightly greater reduction in serum DHT (approximately 90 to 95% versus 70% for finasteride) and a modestly greater reduction in prostate volume in some studies.

Head-to-head trials (such as the EPICS study) have not demonstrated a clinically significant difference in symptom improvement between the two drugs at standard doses.

The choice between dutasteride and finasteride is typically made based on individual clinical assessment, patient preference, cost, and formulary availability.

Both drugs are available as generics in the UK at comparable prices.

Dutasteride has a substantially longer half-life (3 to 5 weeks) than finasteride (approximately 6 hours), which means its effects persist for longer after discontinuation but also means steady state takes longer to achieve.

Dosage and administration

Take one dutasteride 0.5 mg soft capsule once daily, with or without food, swallowed whole with water. Do not chew, crush, or open the capsules.

The capsule contents may irritate the lining of the mouth and throat if the gelatin shell is damaged.

Treatment with dutasteride is typically long-term.

Some symptom improvement may be noticed within the first few weeks, but meaningful clinical benefit usually requires at least 3 to 6 months of continuous treatment.

Maximum prostate volume reduction is generally achieved after 12 to 24 months. Your prescriber will review your symptoms periodically to assess whether treatment should continue.

If a dose is missed, take the next capsule at the usual time. Do not take two capsules to compensate for a missed dose.

Combination therapy with tamsulosin

For men with moderate to severe symptoms and an enlarged prostate, combination therapy with dutasteride and the alpha-blocker tamsulosin may be recommended.

This approach provides faster symptom relief (tamsulosin works within days) combined with the long-term prostate shrinkage achieved by dutasteride.

The fixed-dose combination product Combodart (dutasteride 0.5 mg / tamsulosin 0.4 mg) is available in the UK.

After 6 to 12 months, some patients may be able to discontinue the alpha-blocker and continue with dutasteride alone, depending on their response.

Side effects of dutasteride

Common side effects

The most frequently reported side effects relate to sexual function.

These include erectile dysfunction (impotence), decreased libido (reduced sex drive), ejaculation disorders (including reduced volume of ejaculate), and gynaecomastia (breast enlargement or tenderness).

In clinical trials, these effects occurred in approximately 5 to 10% of men during the first year of treatment.

They tended to diminish with continued use, and the majority resolved after stopping the drug.

Uncommon and rare side effects

Uncommon effects include dizziness and allergic reactions such as rash, pruritus (itching), and urticaria (hives).

Rare effects include angioedema (swelling of the face, lips, tongue, or throat) and alopecia (hair thinning or loss).

Post-marketing reports have described depressed mood, testicular pain, and testicular swelling, though these are uncommon.

Some men have reported that sexual side effects including erectile dysfunction, ejaculatory dysfunction, and decreased libido persisted after discontinuation of the drug.

While post-marketing surveillance has recorded these reports, randomised controlled trials have not conclusively established that dutasteride causes persistent sexual dysfunction after stopping treatment.

If you are concerned about sexual side effects, discuss this with your GP before starting treatment.

Effect on PSA and prostate cancer screening

Dutasteride reduces serum PSA by approximately 50% within 6 months. PSA is a marker used in the assessment of prostate cancer risk.

If you are undergoing PSA testing, your clinician must know that you take dutasteride so they can correctly interpret the result by doubling the measured value.

A rising PSA during dutasteride treatment, even if the absolute value appears within normal range, may warrant further investigation.

When to seek urgent medical advice

Contact your GP or NHS 111 if you experience breast lumps, nipple discharge, persistent breast pain, new or worsening mood changes, or any symptom that concerns you.

Seek emergency care (call 999 or attend A&E) if you develop sudden inability to pass urine (acute urinary retention), severe allergic reaction (swelling of face or throat, difficulty breathing), or blood in the urine with pain.

Report any suspected adverse reactions to the MHRA via the Yellow Card scheme at yellowcard.mhra.gov.uk .

Warnings and precautions

Women and children

Dutasteride is strictly for adult men. Women of childbearing potential must not handle damaged or opened capsules.

Dutasteride is a category X teratogen; it inhibits the conversion of testosterone to DHT, which is essential for normal development of the male external genitalia during pregnancy.

Even small amounts absorbed through the skin could theoretically cause genital abnormalities in a male foetus.

Intact capsules may be handled safely as the gelatin shell prevents skin contact with the active substance.

Semen exposure during pregnancy

Dutasteride is present in semen. Men whose partners are pregnant or could become pregnant should use a condom to prevent foetal exposure.

This precaution should be maintained for at least 6 months after the final dose, given the drug's long half-life.

Blood donation

Men taking dutasteride must not donate blood during treatment and for at least 6 months after the last dose. This prevents a pregnant woman from receiving dutasteride-containing blood products through transfusion.

Prostate cancer considerations

Data from large clinical trials (the REDUCE study) showed a small increase in the incidence of high-grade prostate cancer (Gleason score 8 to 10) in men treated with dutasteride compared with placebo.

However, the overall incidence of detected prostate cancer was lower in the dutasteride group.

The MHRA has issued guidance advising that the potential benefits and risks should be discussed with patients before initiating treatment.

Regular prostate monitoring, including PSA measurement (with appropriate adjustment) and digital rectal examination, should be performed during treatment.

Drug interactions

Dutasteride is metabolised primarily by the liver enzyme CYP3A4. Co-administration with potent CYP3A4 inhibitors such as ritonavir, ketoconazole, itraconazole, verapamil, and diltiazem may increase plasma levels of dutasteride.

No formal dose reduction is recommended, but your prescriber should be aware of concomitant medications.

Dutasteride does not inhibit major CYP enzymes and is not expected to affect the metabolism of other medicines significantly.

Hepatic impairment

Dutasteride is extensively metabolised by the liver. No specific dosing guidance is available for patients with hepatic impairment. Caution is advised, and patients with severe liver disease should not take dutasteride without specialist hepatology input.

How to get dutasteride in the UK

Dutasteride is a prescription-only medicine available on the NHS.

Your GP can prescribe it following a clinical assessment of your lower urinary tract symptoms, including physical examination, urine flow assessment, and blood tests (PSA, renal function).

If symptoms are severe or there is diagnostic uncertainty, referral to a urologist may be appropriate.

Authorised online prescribers registered with the General Pharmaceutical Council (GPhC) can also prescribe dutasteride following a structured clinical consultation.

The standard NHS prescription charge in England is currently 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Generic dutasteride is widely available and generally less expensive than the branded product Avodart.

Living with BPH: practical advice

While dutasteride addresses the underlying hormonal cause of prostatic enlargement, several lifestyle measures can help manage urinary symptoms alongside medical treatment.

Reducing caffeine and alcohol intake (both bladder irritants) can decrease urgency and frequency. Avoiding large fluid volumes before bedtime may reduce nocturia.

Bladder training techniques, including scheduled voiding and double voiding (waiting briefly after urination and trying again), can improve bladder emptying.

Regular physical activity and maintaining a healthy weight are associated with reduced LUTS severity.

If your symptoms worsen despite treatment, or if you develop new symptoms such as blood in the urine, recurrent infections, or complete inability to pass urine, contact your GP promptly.

These may indicate disease progression or an alternative diagnosis requiring further investigation.

When to seek medical advice

Contact your GP or NHS 111 if your urinary symptoms worsen, if you develop new symptoms, or if you experience side effects from dutasteride that are troublesome or persistent.

Seek emergency care (call 999 or attend A&E) if you experience acute urinary retention or signs of a severe allergic reaction.

Report any adverse reactions via the MHRA Yellow Card scheme at yellowcard.mhra.gov.uk .

Sources

• Dutasteride 0.5 mg Soft Capsules, Summary of Product Characteristics (EMC)
• Dutasteride, British National Formulary (BNF)
• NICE NG45: Lower urinary tract symptoms in men: management
• Benign prostate enlargement, NHS
• MHRA Yellow Card Scheme