dutasteride
Brand names: Avodart
Dutasteride and tamsulosin hydrochloride capsules contain two medicines to treat enlarged prostate in men. They help improve symptoms like frequent urination.
Drug Pricing (NADAC)
Brand Price
$21.58/unit
Generic Price
$0.17/unit
Generic Savings
99%
Generic Available
Yes (9 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats benign prostatic hyperplasia (BPH), also known as enlarged prostate, in men.
Common side effects
Problems with ejaculation, Impotence (trouble getting or keeping an erection), Decreased sex drive
Key warnings
This medicine can cause dizziness or fainting, so be careful to avoid falls or injuries.
How It Works
Dutasteride lowers a hormone called dihydrotestosterone (DHT) that causes the prostate to grow. Tamsulosin relaxes the muscles in the prostate and bladder. This combination helps urine flow more easily.
How to Take It
Take one capsule each day, about 30 minutes after the same meal. Swallow the capsule whole; do not chew or open it. If the capsule contents touch your mouth or throat, it may cause irritation. Take it at the same time every day.
Pregnancy & Breastfeeding
This medicine is not for use in women. It can cause birth defects in a male fetus if a pregnant woman is exposed to it. Pregnant women or women who may become pregnant should not handle these capsules.
Missed Dose
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. If it is almost time, skip the missed dose and continue with your regular schedule.
Storage
Store at room temperature, between 68° to 77°F (20° to 25°C).
Side Effects (from patient reports)
Based on 9,548 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 20,677 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
20,677
Death-Related Reports
1,949
Hospitalization Reports
6,418
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 1,402 |
| 2 | DYSPNOEA | 1,233 |
| 3 | FATIGUE | 1,142 |
| 4 | DIZZINESS | 985 |
| 5 | ASTHENIA | 933 |
| 6 | DIARRHOEA | 896 |
| 7 | FALL | 807 |
| 8 | OFF LABEL USE | 789 |
| 9 | NAUSEA | 694 |
| 10 | MALAISE | 663 |
| 11 | DEATH | 641 |
| 12 | HEADACHE | 616 |
| 13 | PRURITUS | 611 |
| 14 | COUGH | 609 |
| 15 | ARTHRALGIA | 592 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
This medicine can cause dizziness or fainting, so be careful to avoid falls or injuries. Do not take this medicine with other alpha-blockers, as this can lower your blood pressure too much. This medicine can affect PSA levels, which are used to screen for prostate cancer. Tell your doctor you are taking this medicine before any PSA tests. This medicine may increase the risk of high-grade prostate cancer. Pregnant women should not handle this medicine.
Known Drug Interactions
7.5 Furosemide Tamsulosin Tamsulosin had no effect on the pharmacodynamics (excretion of electrolytes) of furosemide. While furosemide produced an 11% to 12% reduction in tamsulosin hydrochloride C max and AUC, these changes are expected to be clinically insignificant and do not require adjustment of the dose of tamsulosin [see Clinical Pharmacology ( 12.3 ) ] .
Mechanism: Furosemide slightly lowers the amount of the other drug in your blood, but the effect is too small to matter.
What to do: You do not need to change your dose when taking these medications together.
7 DRUG INTERACTIONS There have been no drug interaction trials using dutasteride and tamsulosin hydrochloride capsules. Because of the potential for drug-drug interactions, use caution when prescribing a dutasteride-containing product, including dutasteride and tamsulosin hydrochloride capsules, to patients taking potent, chronic CYP3A4 enzyme inhibitors (e.g., ritonavir) [see Clinical Pharmacology ( 12.3 ) ] . Tamsulosin Strong and Moderate Inhibitors of CYP3A4 or CYP2D6: Tamsulosin is extensively metabolized, mainly by CYP3A4 or CYP2D6.
Mechanism: These drugs are processed by the same system in your liver, which could change the amount of medicine that stays in your blood.
What to do: Your doctor should use caution and monitor you closely if you are taking both of these medications.
7.2 Warfarin Dutasteride Concomitant administration of dutasteride 0.5 mg/day for 3 weeks with warfarin does not alter the steady-state pharmacokinetics of the S- or R-warfarin isomers or alter the effect of warfarin on prothrombin time [see Clinical Pharmacology ( 12.3 ) ] . Tamsulosin A definitive drug-drug interaction trial between tamsulosin hydrochloride and warfarin was not conducted. Caution should be exercised with concomitant administration of warfarin and tamsulosin-containing products, including dutasteride and tamsulosin hydrochloride capsules [see Warnings and Precautions ( 5.2...
Mechanism: There is not enough research to know exactly how these drugs interact, but they might change how your blood-thinning medicine works.
What to do: Use caution when taking these together and follow your doctor's advice for any extra blood tests.
Concomitant treatment with paroxetine (a strong inhibitor of CYP2D6) resulted in increases in the C max and area under the concentration-time curve (AUC) of tamsulosin by factors of 1.3 and 1.6, respectively.
Mechanism: Paroxetine stops the body from breaking down the medication properly, which can lead to higher amounts of the drug in your blood.
What to do: Your doctor may need to monitor you for side effects or change your dose.
7.3 Nifedipine, Atenolol, Enalapril Tamsulosin Dosage adjustments are not necessary when tamsulosin is administered concomitantly with nifedipine, atenolol, or enalapril [see Clinical Pharmacology ( 12.3 ) ] .
Mechanism: Taking these two drugs together does not change how the body handles the medication.
What to do: You do not need to change your dose when taking these two medicines together.
Common Questions
Can women take this medication?
What should I do if I feel dizzy after taking this medication?
Will this medication prevent prostate cancer?
Can I take this medication with other medications?
How long does it take for this medication to work?
What if I have cataract or glaucoma surgery?
Can this medication affect my ability to have children?
Can I donate blood while taking this medication?
What should I do if I experience painful erections?
Does this medication have any effect on my heart?
What are the common side effects of dutasteride?
Does dutasteride interact with other medications?
What drug class is dutasteride?
Is there a generic version of dutasteride?
Is dutasteride safe during pregnancy?
Related Medications in 5-Alpha Reductase Inhibitor
Other drugs grouped near dutasteride — same-class peers and common alternatives.
alfuzosin
Uroxatral
Alfuzosin is a medicine that helps men with enlarged prostate glands.
Compare with dutasteride →
bethanechol
Urecholine
Bethanechol helps you to urinate if you have trouble emptying your bladder.
Compare with dutasteride →
darifenacin
Enablex
Darifenacin (Enablex) is a medicine that helps control an overactive bladder.
Compare with dutasteride →
dutasteride/tamsulosin
Jalyn
This medicine combines two drugs to treat enlarged prostate in men.
Compare with dutasteride →
fesoterodine
Toviaz
Fesoterodine is a medicine that helps control an overactive bladder.
Compare with dutasteride →
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for dutasteride
The FDA label for dutasteride (sold under brand names such as Avodart) classifies it as a prescription-only medication in the 5-Alpha Reductase Inhibitor class. This medicine treats benign prostatic hyperplasia (BPH), also known as enlarged prostate, in men. Official labeling lists 5 commonly reported side effects, including Problems with ejaculation, Impotence (trouble getting or keeping an erection), Decreased sex drive.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 9,548 voluntary reports. The database also lists 16 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.17 versus $21.58 for the brand — a 99% generic savings.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: January 13, 2026
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages