Tadalafil
Long half-life (17.5 h) PDE5 inhibitor. FDA-approved for erectile dysfunction (Cialis), benign prostatic hyperplasia (BPH), and pulmonary arterial hypertension (Adcirca).
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WHAT IS TADALAFIL?
Detailed overview
Tadalafil is a selective PDE5 inhibitor developed by Lilly (Cialis, FDA 2003). By selectively inhibiting phosphodiesterase-5, intracellular cGMP rises in smooth muscle (corpus cavernosum, prostate, lung arterioles), producing vasodilation and relaxation. The key difference from sildenafil (Viagra, 4 h half-life) vs tadalafil (17.5 h) is long duration: "weekender pill" nickname. Daily 2.5 and 5 mg dosing has been licensed since 2008, enabling an "always ready" use mode. BPH indication received FDA approval in 2011 at 5 mg daily: improvement in bladder function similar to alpha-blockers (IPSS score reduction). Adcirca (40 mg/day) for pulmonary arterial hypertension since 2009 (Galiè 2009 NEJM).
ATC code
G04BE08
Prescription
Prescription only (Rx)
Mechanism
Selective PDE5 enzyme inhibition, cGMP elevation
Half-life
17.5 h (longest among PDE5i)
Onset
30-45 min (PRN), 5-7 days (daily steady-state)
Data console
Lab data
Safety
Side effects, stop signs, contraindications
Side effects · 8
- Headache (most common, roughly 10-15%), often accompanying the vasodilatory effect.
- Facial flushing (5-10%) and nasal congestion due to vasodilation.
- Back pain and myalgia (3-8%), tadalafil-specific, likely from PDE11 cross-reactivity; usually mild and transient.
- Dyspepsia (indigestion, 4-10%) and dizziness.
- Symptomatic (orthostatic) hypotension, with increased risk when combined with alpha-blockers or other antihypertensives.
- Priapism: a painful erection lasting over 4 hours. Rare (<0.1%) but a medical EMERGENCY, risking permanent tissue damage and loss of potency; seek immediate urological care.
- NAION (non-arteritic ischemic optic neuropathy): sudden, often one-sided vision loss; stop immediately and seek ophthalmologic evaluation.
- Sudden hearing decrease or loss (rare), sometimes with tinnitus/dizziness; stop immediately and consult an ENT specialist.
Contraindications · 5
- Concomitant nitrate use (absolute, severe hypotension risk)
- Severe hypotension (SBP < 90), severe hypertension (SBP > 170, DBP > 100)
- Recent (< 90 d) MI, unstable angina, NYHA III-IV heart failure
- Stroke or life-threatening arrhythmia within 6 months
- Severe hepatic or renal impairment
Related Pharmaceuticals
Same therapeutic category
Studies
Related research and clinical findings
Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses
Brock GB, McMahon CG, Chen KK et al.
Update on the Safety of Phosphodiesterase Type 5 Inhibitors for the Treatment of Erectile Dysfunction.
Yafi FA, Sharlip ID, Becher EF
An update on new oral PDE5 inhibitors for the treatment of erectile dysfunction.
Palit V, Eardley I
Tadalafil for treatment of pulmonary arterial hypertension (PHIRST)
Galiè N, Brundage BH, Ghofrani HA et al.
Tadalafil 5 mg once daily improves lower urinary tract symptoms suggestive of BPH (long-term study)
McVary KT, Roehrborn CG, Kaminetsky JC et al.
Redefining the role of long-acting phosphodiesterase inhibitor tadalafil in the treatment of diabetic erectile dysfunction.
Bruzziches R, Greco EA, Pili M, Francomano D, Spera G, Aversa A
Direct comparison of tadalafil with sildenafil for the treatment of erectile dysfunction: a systematic review and meta-analysis.
Gong B, Ma M, Xie W, Yang X, Huang Y, Sun T, Luo Y, Huang J
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Educational drug info from official sources (PubMed, FDA, EMA). Does NOT replace medical consultation or the SmPC. Talk to your doctor!
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The information here is for educational and scientific purposes only. Medication use requires medical consultation and a prescription. The indications, dose ranges, and side effects listed here do NOT replace the official Summary of Product Characteristics (SmPC) or consultation with a physician. Do not start or stop any medication on your own. In an emergency, call your local emergency number.