pharmacopeia
GET
/api/v1/drug/dutasteride
2D structure
(1S,3aS,3bS,5aR,9aR,9bS,11aS)-N-[2,5-bis(trifluoromethyl)phenyl]-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxamide
SMILES C[C@]12CC[C@H]3[C@H]([C@@H]1CC[C@@H]2C(=O)NC4=C(C=CC(=C4)C(F)(F)F)C(F)(F)F)CC[C@@H]5[C@@]3(C=CC(=O)N5)C
InChIKey JWJOTENAMICLJG-QWBYCMEYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: 5-alpha Reductase Inhibitors.

5-alpha Reductase

Indications

Sourced from openFDA
  • Dutasteride is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (1.1) improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery. Dutasteride in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.ICD-10: N40.0

Contraindications

Sourced from openFDA
  • Dutasteride is contraindicated for use in: Pregnancy. Dutasteride use is contraindicated in women who are pregnant.contraindicated

Dosage & administration

Sourced from openFDA

The capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa. Dutasteride may be administered with or without food. Monotherapy: 0.5 mg once daily. (2.1) Combination with tamsulosin: 0.5 mg once daily and tamsulosin 0.4 mg once daily. (2.2) Dosing considerations: Swallow whole. May take with or without food. (2) 2.1 Monotherapy The recommended dose of dutasteride is 1 capsule (0.5 mg) taken once daily. 2.2 Combination with Alpha-adrenergic Antagonist The recommended dose of dutasteride is 1 capsule (0.5 mg) taken once daily and tamsulosin 0.4 mg taken once daily.

Warnings & precautions

Sourced from openFDA

Dutasteride reduces serum prostate-specific antigen (PSA) concentration by approximately 50%. However, any confirmed increase in PSA while on dutasteride may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for untreated men. (5.1) Dutasteride may increase the risk of high-grade prostate cancer. (5.2, 6.1) Prior to initiating treatment with dutasteride, consideration should be given to other urological conditions that may cause similar symptoms. (5.3) Women who are pregnant or may be pregnant should not handle dutasteride capsules due to potential risk to a male fetus. (5.4, 8.1) Patients should not donate blood until 6 months after their last dose of dutasteride. (5.5) 5.1 Effects on Prostate-Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection In clinical trials, dutasteride reduced serum PSA concentration by approximately 50% within 3 to 6 months of treatment. This decrease was predictable over the entire range of PSA values in subjects with symptomatic BPH, although it may vary in individuals. Dutasteride may also cause decreases in serum PSA in the presence of prostate cancer. To interpret serial PSAs in men taking dutasteride, a new PSA baseline should be established at least 3 months after starting treatment and PSA monitored periodically thereafter.

Adverse reactions

Sourced from openFDA

The most common adverse reactions, reported in ≥1% of subjects treated with dutasteride and more commonly than in subjects treated with placebo, are impotence, decreased libido, ejaculation disorders, and breast disorders. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Camber Pharmaceuticals, Inc., at 1-866-495-8330 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trial of another drug and may not reflect the rates observed in practice. From clinical trials with dutasteride as monotherapy or in combination with tamsulosin: The most common adverse reactions reported in subjects receiving dutasteride were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), and ejaculation disorders. The most common adverse reactions reported in subjects receiving combination therapy (dutasteride plus tamsulosin) were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders, and dizziness. Ejaculation disorders occurred significantly more in subjects receiving combination therapy (11%) compared with those receiving dutasteride (2%) or tamsulosin (4%) as monotherapy. Trial withdrawal due to adverse reactions occurred in 4% of subjects receiving dutasteride and 3% of subjects receiving placebo in placebo-controlled trials with dutasteride.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary Dutasteride is contraindicated for use in pregnancy because it may cause harm to the male fetus [see Contraindications (4)] . Dutasteride is not indicated for use in women. Dutasteride is a 5 alpha-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia. Abnormalities in the genitalia of male fetuses is an expected physiological consequence of inhibition of this conversion. These results are similar to observations in male infants with genetic 5 alpha-reductase deficiency. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. In animal reproduction studies, dutasteride inhibited normal development of external genitalia in male offspring when given to rats or rabbits during organogenesis at less than the maximum recommended human dose (MRHD) of 0.5 mg daily, in the absence of maternal toxicity. At 15 times the MRHD, prolonged pregnancy, decreased reproductive organ weights, and delayed puberty in male offspring were observed in rats, with no-effect levels less than the MRHD of 0.5 mg daily. Increased placental weights in rabbits were also observed, with no-effect levels less than the MRHD of 0.5 mg daily (see Data) .

Overdosage

Sourced from openFDA

In volunteer trials, single doses of dutasteride up to 40 mg (80 times the therapeutic dose) for 7 days have been administered without significant safety concerns. In a clinical trial, daily doses of 5 mg (10 times the therapeutic dose) were administered to 60 subjects for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5 mg. There is no specific antidote for dutasteride. Therefore, in cases of suspected overdosage, symptomatic and supportive treatment should be given as appropriate, taking the long half-life of dutasteride into consideration.

Approval history

Sourced from openFDA
  • Nov 20, 2001NDANDA021319Waylis Therap
  • Jun 14, 2010NDANDA022460Waylis Therap
  • Feb 26, 2014ANDAANDA202509Ph Health
  • Nov 20, 2015ANDAANDA203118Amneal Pharms
  • Nov 20, 2015ANDAANDA204705Pharmobedient
  • Nov 20, 2015ANDAANDA202660Aurobindo Pharma Ltd
  • Oct 21, 2016ANDAANDA206574Ascent Pharms Inc
  • Apr 7, 2017ANDAANDA204376Adaptis

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
21,861 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective1,4916.8%
  2. 2Dyspnoea1,2775.8%
  3. 3Fatigue1,1955.5%
  4. 4Dizziness1,0644.9%
  5. 5Asthenia9654.4%
  6. 6Diarrhoea9514.4%
  7. 7Fall8483.9%
  8. 8Off Label Use8173.7%
  9. 9Nausea7283.3%
  10. 10Malaise6813.1%
  11. 11Death6703.1%
  12. 12Headache6483.0%
  13. 13Pruritus6442.9%
  14. 14Cough6282.9%
  15. 15Arthralgia6112.8%

Literature

View JSON

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

Clinical trials

View JSON

The 10 most recently updated of 141 ClinicalTrials.gov registrations naming Dutasteride as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Dutasteride work?
Mechanism-of-action class: 5-alpha Reductase Inhibitors.
What is Dutasteride used for?
According to FDA labeling, Dutasteride carries indications including: Dutasteride is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (1.1) improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery. Dutasteride in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Dutasteride?
Dutasteride is classified as Testosterone-5-alpha reductase inhibitors, 5-alpha Reductase Inhibitor, 5-alpha Reductase Inhibitors, Decreased Dihydrotestosterone Secretion, Decreased Prostatic Size.
What are the brand names for Dutasteride?
Dutasteride is marketed under brand names including Avodart, Jalyn.
What are the contraindications for Dutasteride?
Dutasteride labeling lists contraindications including: Dutasteride is contraindicated for use in: Pregnancy. Dutasteride use is contraindicated in women who are pregnant.. Always consult the full prescribing information and a clinician.
Note. Data for dutasteride is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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