Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
DUTASTERIDE vs CIALIS
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: July 2026 · OpiCalc Medical Review Team
Competitive inhibitor of type II and type I 5α-reductase isoenzymes, blocking conversion of testosterone to dihydrotestosterone (DHT) in prostate, hair follicles, and other tissues.
Phosphodiesterase-5 (PDE5) inhibitor; increases c GMP levels, causing smooth muscle relaxation and vasodilation in the corpus cavernosum, enhancing erectile function.
FDA: Treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate,FDA: Reduce risk of acute urinary retention,FDA: Reduce need for BPH-related surgery,Off-label: Male androgenetic alopecia
Treatment of erectile dysfunction,Treatment of benign prostatic hyperplasia,Treatment of pulmonary arterial hypertension (as Adcirca)
0.5 mg orally once daily.
Tadalafil 10 mg or 20 mg orally as needed at least 30 minutes before sexual activity; maximum dosing frequency once daily. Alternative: 2.5 mg or 5 mg once daily for daily use.
Terminal half-life approximately 3-4 weeks (21-35 days) in young adults; 5-6 weeks in elderly; supports once-daily dosing due to slow elimination.
The terminal elimination half-life of tadalafil is approximately 17.5 hours in healthy subjects, which supports once-daily dosing for erectile dysfunction and once-daily use for benign prostatic hyperplasia. This long half-life distinguishes it from other PDE5 inhibitors.
Extensively metabolized in liver via CYP3A4 and CYP1A2; minor metabolism by CYP2C8, CYP2C9, CYP2C19, and CYP2D6.
Primarily hepatic via CYP3A4; minor pathways include CYP2C9 and glucuronidation.
Primarily fecal (70%) as metabolites; renal excretion accounts for <5% unchanged drug.
Following oral administration, tadalafil is predominantly eliminated by hepatic metabolism. The metabolites are excreted mainly in feces (approximately 61% of the dose) and to a lesser extent in urine (approximately 36% of the dose). No unchanged parent drug is detected in urine.
>99% bound to albumin and alpha-1 acid glycoprotein; high affinity.
Tadalafil is 94% bound to plasma proteins, primarily to albumin. The protein binding is independent of drug concentration over a wide range.
Approximately 300-500 L (3-5 L/kg), indicating extensive tissue distribution, particularly to prostate and seminal vesicles.
The apparent volume of distribution (Vd/F) is approximately 63 L (or roughly 0.9 L/kg for a 70 kg individual), indicating distribution into tissues beyond the vascular space, including the penis and other target organs.
Oral: Approximately 60% (range 40-80%) with food; not administered parenterally.
Absolute oral bioavailability of tadalafil has not been formally determined; however, the drug is well absorbed after oral administration, with peak plasma concentrations reached in 0.5 to 6 hours (median 2 hours). Food does not affect the extent of absorption (AUC), though it may delay the rate (Tmax) by about 1–2 hours.
No dose adjustment required for renal impairment (including dialysis).
Cr Cl 30-50 m L/min: 5 mg once daily (max) for daily use; as-needed dosing: 10 mg not to exceed once every 48 hours. Cr Cl <30 m L/min: not recommended. Hemodialysis: not studied.
Contraindicated in Child-Pugh Class C; use with caution in mild to moderate impairment (Child-Pugh A/B) with no specific dose adjustment established.
Child-Pugh A and B: no dose adjustment necessary for as-needed dosing; daily use: caution, start at 5 mg once daily. Child-Pugh C: not recommended.
Not indicated in pediatric patients; safety and efficacy not established.
Not indicated for pediatric patients under 18 years.
No specific dose adjustment required; monitor for adverse effects (e.g., dizziness, orthostatic hypotension) due to age-related comorbidities.
No dose adjustment required solely based on age; consider renal function and concomitant medications.
No FDA black box warning.
None
Risk of high-grade prostate cancer in men aged 50-79 with elevated PSA and previous negative biopsy (see PLCO trial),Increased risk of sexual adverse events (impotence, decreased libido, ejaculation disorders) that may persist after discontinuation,Elevated PSA levels: use caution when interpreting PSA values; establish new baseline after 6 months of treatment
Risk of hypotension with vasodilators or alpha-blockers,Contraindicated with nitrates due to severe hypotension risk,Patients with left ventricular outflow obstruction (e.g., aortic stenosis) should avoid use,Caution in patients with hypotension, severe hepatic impairment, or end-stage renal disease,Risk of priapism: advise immediate medical attention for erections lasting >4 hours,Decreased visual or hearing ability requiring discontinuation
Women of childbearing potential (pregnancy category X; risk of fetal harm due to inhibition of 5α-reductase),History of hypersensitivity to dutasteride or other 5α-reductase inhibitors,Pediatric patients
Concomitant use of nitrates (any form) or riociguat,Hypersensitivity to tadalafil,Concomitant use with alpha-blockers (except for BPH with appropriate dosing)
No clinically significant food interactions. May be taken with or without food. Grapefruit juice does not affect dutasteride levels to a clinically relevant extent.
Avoid high-fat meals prior to dosing as they may delay absorption and reduce peak plasma concentration. Avoid large quantities of grapefruit juice (more than 1 liter per day) as it may increase tadalafil exposure via CYP3A4 inhibition.
Dutasteride is contraindicated in pregnancy. It is a 5α-reductase inhibitor that can inhibit the conversion of testosterone to dihydrotestosterone (DHT), potentially causing abnormal development of external genitalia in male fetuses. Risk extends throughout all trimesters due to potential disruption of androgen-mediated development in male fetuses during the first trimester and cumulative effects from drug accumulation in adipose tissue. No adequate human studies exist; animal studies show teratogenicity in male offspring at clinically relevant doses.
FDA Pregnancy Category B. Animal studies show no evidence of teratogenicity or embryotoxicity. No adequate, well-controlled studies in pregnant women. Risk cannot be ruled out; use only if clearly needed.
No data on dutasteride in human milk. M/P ratio unknown. Dutasteride is highly lipophilic and likely excreted in breast milk. Because of potential adverse effects on the nursing infant (e.g., interference with androgen-mediated development in male infants), breastfeeding is contraindicated during therapy and for at least 6 months after the last dose due to long half-life (approximately 5 weeks).
Excretion in human milk unknown. Not recommended for use in nursing mothers. M/P ratio not determined.
No dose adjustment studies in pregnancy because dutasteride is contraindicated. Pharmacokinetic changes in pregnancy (increased volume of distribution, altered metabolism) could affect dutasteride levels, but no adjustments are recommended as drug should not be used. If inadvertently used, discontinue immediately and monitor for adverse effects.
No specific dose adjustments studied in pregnancy. Use lowest effective dose if necessary, with caution for increased plasma volume and renal clearance potentially altering pharmacokinetics.
Monitor PSA levels cautiously, as dutasteride reduces serum PSA by approximately 50% after 6 months; double the PSA value for comparison to untreated men. Do not handle crushed or broken capsules if pregnant or planning pregnancy, as absorption through skin may cause fetal harm. Assess for signs of high-grade prostate cancer before initiating therapy, as dutasteride may increase the risk of Gleason 8-10 tumors. Onset of symptom relief may take 3-6 months; do not discontinue prematurely. Avoid concomitant use with strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole) as they increase dutasteride exposure.
Tadalafil (Cialis) has a 17.5-hour half-life allowing once-daily dosing for ED or daily for BPH/LUTS. Avoid use with nitrates; may cause prolonged erection. Onset of action is 30-60 minutes, and effect may last up to 36 hours. Use with caution in patients with left ventricular outflow obstruction or severe hepatic impairment.
Take exactly as prescribed; do not stop or change dose without consulting your doctor.,Swallow the capsule whole; do not chew or open it.,It may take 3 to 6 months to see improvement in symptoms.,Avoid handling leaking or crushed capsules if you are a woman who is or may become pregnant; wash area immediately with soap and water if skin contact occurs.,Do not donate blood for at least 6 months after your last dose to prevent exposure to a pregnant woman.,Report any breast lumps, pain, or nipple discharge promptly.,You will need regular blood tests for PSA level monitoring; inform your doctor that you are taking dutasteride.,Dutasteride can decrease sperm count and may affect fertility; discuss this with your doctor if planning to father a child.
Do not take tadalafil if you take any form of nitrate medication (e.g., nitroglycerin) for chest pain.,Seek immediate medical help if you have an erection lasting more than 4 hours.,Avoid alcohol consumption as it may increase the risk of dizziness and low blood pressure.,Take tadalafil at least 30 minutes before sexual activity; effect can last up to 36 hours.,For daily use, take at the same time each day without regard to timing of sexual activity.,Grapefruit and grapefruit juice may increase tadalafil levels; avoid large amounts.,Inform your doctor of all medications you take, especially alpha-blockers, antihypertensives, and antifungal or antibiotic drugs.
"Dutasteride, a 5α-reductase inhibitor, may inhibit cytochrome P450 enzymes, particularly CYP3A4, which is involved in the metabolism of sulfisoxazole. This inhibition can lead to decreased clearance of sulfisoxazole, resulting in elevated plasma concentrations. Increased sulfisoxazole levels may potentiate its adverse effects, including hypersensitivity reactions, crystalluria, and hematologic toxicity such as agranulocytosis."
"Concomitant use of dutasteride, a 5α-reductase inhibitor, with nelfinavir, a protease inhibitor and potent CYP3A4 inhibitor, is predicted to increase the serum concentration of nelfinavir. This occurs because dutasteride may inhibit the metabolism of nelfinavir via competition for CYP3A4, leading to elevated nelfinavir levels and an increased risk of adverse effects such as gastrointestinal disturbances, hepatotoxicity, and metabolic complications. Clinical monitoring for toxicity and dose adjustments are warranted."
"Dutasteride, a 5α-reductase inhibitor, is metabolized primarily by CYP3A4 and to a lesser extent by CYP2D6. Itraconazole is a potent inhibitor of CYP3A4 and also inhibits P-glycoprotein. Coadministration leads to significantly increased serum concentrations of dutasteride, raising the risk of adverse effects such as gynecomastia, sexual dysfunction, and depression. The effect on itraconazole levels is minimal and clinically irrelevant."
No interactions on record
Explore head-to-head clinical comparisons of other medications in the same therapeutic classes.
Common clinical questions about DUTASTERIDE vs CIALIS, answered by our medical review team.
DUTASTERIDE is a 5-alpha Reductase Inhibitor that works by Competitive inhibitor of type II and type I 5α-reductase isoenzymes, blocking conversion of testosterone to dihydrotestosterone (DHT) in prostate, hair follicles, and other tissues.. CIALIS is a PDE5 Inhibitor that works by Phosphodiesterase-5 (PDE5) inhibitor; increases c GMP levels, causing smooth muscle relaxation and vasodilation in the corpus cavernosum, enhancing erectile function.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between DUTASTERIDE and CIALIS depend on the specific clinical indication. These are agents from distinct pharmacological classes and are not directly interchangeable by dose. A physician or clinical pharmacist should guide any therapeutic switching decisions.
The standard adult dose of DUTASTERIDE is: 0.5 mg orally once daily.. The standard adult dose of CIALIS is: Tadalafil 10 mg or 20 mg orally as needed at least 30 minutes before sexual activity; maximum dosing frequency once daily. Alternative: 2.5 mg or 5 mg once daily for daily use.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.
No direct drug-drug interaction has been formally documented between DUTASTERIDE and CIALIS in current clinical databases. However, individual patient risk factors including other medications, organ function, and comorbidities should always be evaluated by a qualified healthcare provider.
The maternal-fetal safety profiles differ. DUTASTERIDE is classified as Category D/X. Dutasteride is contraindicated in pregnancy. It is a 5α-reductase inhibitor that can inhibit the conversion of testosterone to dihydrotestosterone (DHT), potentially causing abnorm. CIALIS is classified as Category C. FDA Pregnancy Category B. Animal studies show no evidence of teratogenicity or embryotoxicity. No adequate, well-controlled studies in pregnant women. Risk cannot be ruled out; use. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.