Prescription medication · 5-Alpha Reductase Inhibitor
dutasteride
Also sold as Avodart. This medicine treats benign prostatic hyperplasia (BPH), also known as enlarged prostate, in men.
Data updated 2026-05-15
- 20,677
- FDA reportsModerately reported
- 16
- InteractionsSeveral interactions
- 99% less
- Generic vs brandHuge savings
- $21.58
- Brand price (NADAC)
What the data shows
dutasteride (Avodart) is a prescription 5-Alpha Reductase Inhibitor, reported at a middle-of-the-pack volume (20,677 FDA reports), whose generic costs a fraction of the brand (about 99% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
dutasteride (Avodart) is a prescription 5-Alpha Reductase Inhibitor. This medicine treats benign prostatic hyperplasia (BPH), also known as enlarged prostate, in men.
Dutasteride and tamsulosin hydrochloride capsules contain two medicines to treat enlarged prostate in men. They help improve symptoms like frequent urination.
Verify with FDA → · CMS NADAC pricing →
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 →
NADAC price trail: DUTASTERIDE 0.5 MG CAPSULE
Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -13.1% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| February 21, 2024 | $0.1958/EA | - | 1 |
| December 18, 2024 | $0.1703/EA | -13.1% | 9 |
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.
The sections below are summarized in plain English from dutasteride's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 20,677 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for dutasteride, by number of reports
- Dyspnoea
Dyspnoea
1,233 reports
- Fatigue
Fatigue
1,142 reports
- Dizziness
Dizziness
985 reports
- Asthenia
Asthenia
933 reports
- Diarrhoea
Diarrhoea
896 reports
- Fall
Fall
807 reports
- Nausea
Nausea
694 reports
- Malaise
Malaise
663 reports
- Death
Death
641 reports
- Headache
Headache
616 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for dutasteride each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where dutasteride sits
dutasteride has more FDA adverse-event reports than 56% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is dutasteride; the line is the median (50th percentile).
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
Reports Mentioning Death
1,949
9.4% of reports — not proof of cause
Hospitalization Reports
6,418
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | DYSPNOEA | 1,233 |
| 3 | FATIGUE | 1,142 |
| 4 | DIZZINESS | 985 |
| 5 | ASTHENIA | 933 |
| 6 | DIARRHOEA | 896 |
| 7 | FALL | 807 |
| 9 | NAUSEA | 694 |
| 10 | MALAISE | 663 |
| 11 | DEATH | 641 |
| 12 | HEADACHE | 616 |
| 13 | PRURITUS | 611 |
| 14 | COUGH | 609 |
| 15 | ARTHRALGIA | 592 |
| 16 | INSOMNIA | 554 |
| 17 | DRUG INTERACTION | 551 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: 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.
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.
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 (...
Mechanism: There is not enough research to know exactly how these drugs interact, but they might change how your blood-thinning medicine works.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for dutasteride?
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 →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for dutasteride: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 20,677.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 9.43%.
- telmisartan Δ 0.01 pts · 33,611 reports · Angiotensin II Receptor Blocker (ARB) 9.42%death share
- fosinopril Δ 0.02 pts · 4,213 reports · ACE Inhibitor 9.45%death share
- sitagliptin Δ 0.04 pts · 70,292 reports · DPP-4 Inhibitor 9.47%death share
- gabapentin Δ 0.04 pts · 351,750 reports · Anticonvulsant / Nerve Pain Agent 9.38%death share
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
FDA bioequivalence and label-record context for narrow therapeutic index medicines
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 20,677 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: January 13, 2026
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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