{"shortAnswer":"Tadalafil is FDA-approved as Cialis for erectile dysfunction and an enlarged prostate, and as Adcirca for high blood pressure in the lungs. For those uses the evidence grade is strong-human. With nitrate heart drugs, it can drop blood pressure dangerously. FDA keeps finding it hidden in products sold as supplements.","url":"https://peptideindex.ai/compound/tadalafil","status":"fda-approved","statusCheckedAt":"2026-10-26T13:43:52.666Z","statusStale":false,"regulatoryAsOf":"2026-10-26","verified":"2026-10-26T13:43:52.703Z","primarySourceUrl":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021368","clinicallyReviewed":false,"notice":"Information, not medical advice.","id":"6de3bd98-3f36-48da-814b-1d7aae3699eb","object":"compound","slug":"tadalafil","name":"Tadalafil","attrs":{"name":"Tadalafil","class":"non-peptide","access":[{"type":"approved-product","detail":"Approved by FDA as a prescription tablet for erectile dysfunction and an enlarged prostate.","indication":"Treatment of erectile dysfunction, the signs and symptoms of benign prostatic hyperplasia, or both.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021368","brand_names":["Cialis"],"manufacturer":"Eli Lilly"},{"type":"approved-product","detail":"Approved by FDA as a prescription tablet for high blood pressure in the lungs.","indication":"Treatment of pulmonary arterial hypertension (WHO Group 1) to improve exercise ability.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022332","brand_names":["Adcirca"],"manufacturer":"Eli Lilly"},{"type":"lawful-compounding","detail":"Pharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act"}],"dosing":"From the Cialis and Adcirca labels. For erectile dysfunction as needed, most men start with 10 mg before sex, no more than once a day. The dose may go up to 20 mg or down to 5 mg. For erectile dysfunction once a day, the start is 2.5 mg daily, which may go up to 5 mg. For an enlarged prostate, with or without erectile dysfunction, the dose is 5 mg once a day at about the same time. For high blood pressure in the lungs, the dose is 40 mg, two 20 mg tablets, once a day. Kidney or liver disease and some other drugs call for lower doses. The prescriber sets the dose.","trials":[{"nct":"NCT07890285","url":"https://clinicaltrials.gov/study/NCT07890285","phase":"Not stated","title":"A Study of Opsynvi in Adults Participants With Pulmonary Arterial Hypertension in Korea","status":"not-yet-recruiting","sponsor":"Janssen Korea, Ltd., Korea","countries":[],"us_states":[]},{"nct":"NCT07882901","url":"https://clinicaltrials.gov/study/NCT07882901","phase":"Phase 2","title":"Effects of Tadalafil on Cognition and Cerebral Hemodynamics in Elderly Patients With Mild Cognitive Impairment","status":"not-yet-recruiting","sponsor":"Los Angeles Brain Science Project","countries":["United States"],"us_states":["California"]},{"nct":"NCT07537855","url":"https://clinicaltrials.gov/study/NCT07537855","phase":"Phase 2","title":"Efficacy of Intracavernosal Xeomin With Tadalafil for Mild-Moderate Erectile Dysfunction","status":"not-yet-recruiting","sponsor":"Northwestern University","countries":[],"us_states":[]},{"nct":"NCT07576335","url":"https://clinicaltrials.gov/study/NCT07576335","phase":"Phase 2","title":"Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy","status":"recruiting","sponsor":"Surgical Outcomes Research Centre (SOuRCe)","countries":["Australia"],"us_states":[]},{"nct":"NCT07773103","url":"https://clinicaltrials.gov/study/NCT07773103","phase":"Not stated","title":"Endothelial Markers and Tadalafil Response","status":"recruiting","sponsor":"Al-Azhar University","countries":["Egypt"],"us_states":[]},{"nct":"NCT07753720","url":"https://clinicaltrials.gov/study/NCT07753720","phase":"Phase 4","title":"Daily Tadalafil as Adjunctive Therapy Versus Monotherapy for PDE5 Inhibitor-Resistant Erectile Dysfunction","status":"recruiting","sponsor":"Al-Azhar University","countries":["Egypt"],"us_states":[]},{"nct":"NCT07707505","url":"https://clinicaltrials.gov/study/NCT07707505","phase":"Not applicable","title":"Intracavernosal Exosomes vs. Rectal Ozone for Post-RARP Erectile Dysfunction","status":"not-yet-recruiting","sponsor":"Medipol University","countries":["Turkey (Türkiye)"],"us_states":[]},{"nct":"NCT07722884","url":"https://clinicaltrials.gov/study/NCT07722884","phase":"Not applicable","title":"Tamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH","status":"recruiting","sponsor":"Ain Shams University","countries":["Egypt"],"us_states":[]},{"nct":"NCT07642505","url":"https://clinicaltrials.gov/study/NCT07642505","phase":"Phase 4","title":"L-Citrulline and Tadalafil for Mild to Moderate Erectile Dysfunction","status":"recruiting","sponsor":"Beni-Suef University","countries":["Egypt"],"us_states":[]},{"nct":"NCT07654413","url":"https://clinicaltrials.gov/study/NCT07654413","phase":"Phase 4","title":"Tamsulosin With or Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia","status":"recruiting","sponsor":"Beni-Suef University","countries":["Egypt"],"us_states":[]},{"nct":"NCT07245680","url":"https://clinicaltrials.gov/study/NCT07245680","phase":"Phase 3","title":"COMMODITIES Trial: Initial Dual Oral Therapy vs Monotherapy in PAH With Cardiovascular Comorbidities","status":"recruiting","sponsor":"Assistance Publique - Hôpitaux de Paris","countries":["France"],"us_states":[]},{"nct":"NCT07466030","url":"https://clinicaltrials.gov/study/NCT07466030","phase":"Phase 1","title":"Tadalafil 5 mg on Storage Lower Urinary Tract Symptoms After Anatomical Endoscopic Enucleation of the Prostate","status":"not-yet-recruiting","sponsor":"Assiut University","countries":[],"us_states":[]},{"nct":"NCT07117383","url":"https://clinicaltrials.gov/study/NCT07117383","phase":"Phase 1","title":"Hezkue®, Hezkue Turbo®, and Commercial Sildenafil Products in Fed Healthy Male Subject","status":"not-yet-recruiting","sponsor":"Aspargo Labs, Inc","countries":["United States"],"us_states":["New York"]},{"nct":"NCT07231185","url":"https://clinicaltrials.gov/study/NCT07231185","phase":"Phase 2","title":"Phase 2 Efficacy Study of Sildenafil Products in Adult Men With Erectile Dysfunction","status":"not-yet-recruiting","sponsor":"Aspargo Labs, Inc","countries":[],"us_states":[]},{"nct":"NCT07562282","url":"https://clinicaltrials.gov/study/NCT07562282","phase":"Not applicable","title":"Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg","status":"recruiting","sponsor":"Ain Shams University","countries":["Egypt"],"us_states":[]},{"nct":"NCT07391579","url":"https://clinicaltrials.gov/study/NCT07391579","phase":"Phase 4","title":"Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of Erectile Dysfunction in PDE-5I Non Responder Patients","status":"recruiting","sponsor":"Mansoura University","countries":["Egypt"],"us_states":[]},{"nct":"NCT07177326","url":"https://clinicaltrials.gov/study/NCT07177326","phase":"Phase 3","title":"Combination Therapy of Tadalafil 2.5mg Plus Sildenafil 25mg Versus Tadalafil 5 mg Monotherapy for Treatment of Erectile Dysfunction: A Randomized, Placebo-Controlled Double-Blinded Cross-Over Study","status":"not-yet-recruiting","sponsor":"Assiut University","countries":[],"us_states":[]},{"nct":"NCT07172815","url":"https://clinicaltrials.gov/study/NCT07172815","phase":"Phase 2","title":"PDE5 Inhibitor for Alzheimer's Disease","status":"not-yet-recruiting","sponsor":"Imperial College London","countries":[],"us_states":[]},{"nct":"NCT07416968","url":"https://clinicaltrials.gov/study/NCT07416968","phase":"Phase 4","title":"Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study","status":"recruiting","sponsor":"Mansoura University","countries":["Egypt"],"us_states":[]},{"nct":"NCT06968962","url":"https://clinicaltrials.gov/study/NCT06968962","phase":"Not applicable","title":"Comparison of Sequential to Initial Combination Therapy in PAH","status":"recruiting","sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","countries":["China"],"us_states":[]},{"nct":"NCT06962462","url":"https://clinicaltrials.gov/study/NCT06962462","phase":"Not applicable","title":"Daily Tadalafil in Diabetic ED Patients","status":"not-yet-recruiting","sponsor":"South Valley University","countries":[],"us_states":[]},{"nct":"NCT06753981","url":"https://clinicaltrials.gov/study/NCT06753981","phase":"Not stated","title":"Efficacy and Safety of Triple-targeted Drug Therapy in Treatment-naive Patients With Non-low-risk PAH: A Real-world, Multicenter Study","status":"recruiting","sponsor":"Qianfoshan Hospital","countries":["China"],"us_states":[]},{"nct":"NCT06583590","url":"https://clinicaltrials.gov/study/NCT06583590","phase":"Phase 2/Phase 3","title":"Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction","status":"recruiting","sponsor":"Aswan University Hospital","countries":["Egypt"],"us_states":[]},{"nct":"NCT06290713","url":"https://clinicaltrials.gov/study/NCT06290713","phase":"Phase 2","title":"Vasodilator and Exercise Study for DMD (VASO-REx)","status":"recruiting","sponsor":"University of Florida","countries":["United States"],"us_states":["Florida"]},{"nct":"NCT05937854","url":"https://clinicaltrials.gov/study/NCT05937854","phase":"Phase 2","title":"Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH","status":"recruiting","sponsor":"VA Office of Research and Development","countries":["United States"],"us_states":["Colorado","Georgia","Massachusetts","Nebraska","Rhode Island"]},{"nct":"NCT05844462","url":"https://clinicaltrials.gov/study/NCT05844462","phase":"Phase 3","title":"Tadalafil for Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease","status":"recruiting","sponsor":"Assistance Publique - Hôpitaux de Paris","countries":["France"],"us_states":[]},{"nct":"NCT06317805","url":"https://clinicaltrials.gov/study/NCT06317805","phase":"Phase 4","title":"Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients","status":"recruiting","sponsor":"AOP Orphan Pharmaceuticals AG","countries":["Austria","Czechia","France","Germany","Hungary","Italy","Poland","Portugal","Romania","Spain"],"us_states":[]},{"nct":"NCT05558007","url":"https://clinicaltrials.gov/study/NCT05558007","phase":"Phase 2","title":"Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients","status":"recruiting","sponsor":"Biozeus Biopharmaceutical S.A.","countries":["Brazil"],"us_states":[]},{"nct":"NCT07499804","url":"https://clinicaltrials.gov/study/NCT07499804","phase":"Phase 4","title":"Effect of Tadalafil on Endometrial Thickness and Frozen Embryo Transfer Outcomes","status":"recruiting","sponsor":"Beni-Suef University","countries":["Egypt"],"us_states":[]},{"nct":"NCT06717711","url":"https://clinicaltrials.gov/study/NCT06717711","phase":"Phase 3","title":"Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers","status":"recruiting","sponsor":"Regina Elena Cancer Institute","countries":["Italy"],"us_states":[]},{"nct":"NCT05955001","url":"https://clinicaltrials.gov/study/NCT05955001","phase":"Phase 2/Phase 3","title":"Efficacy of Tadalafil (5mg) For Treatment of Early Storage Symptoms and Erectile Dysfunction After Endoscopic Enucleation of Prostate","status":"recruiting","sponsor":"Mansoura University","countries":["Egypt"],"us_states":[]},{"nct":"NCT05206955","url":"https://clinicaltrials.gov/study/NCT05206955","phase":"Phase 3","title":"Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology","status":"recruiting","sponsor":"Mayo Clinic","countries":["United States"],"us_states":["Minnesota"]},{"nct":"NCT05179876","url":"https://clinicaltrials.gov/study/NCT05179876","phase":"Phase 3","title":"A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option","status":"recruiting","sponsor":"Actelion","countries":["Belarus","Belgium","Bulgaria","China","Hungary","Poland","Russia","South Africa","South Korea","Taiwan","Thailand","Ukraine","Vietnam"],"us_states":[]},{"nct":"NCT05051436","url":"https://clinicaltrials.gov/study/NCT05051436","phase":"Phase 4","title":"The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics","status":"recruiting","sponsor":"Philip Kern","countries":["United States"],"us_states":["Kentucky"]}],"aliases":["Cialis","Adcirca"],"summary":"A prescription drug for erectile dysfunction and an enlarged prostate, sold as Cialis, and for high blood pressure in the lungs, sold as Adcirca.","citations":[{"n":1,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021368s030lbl.pdf","tier":"primary","type":"label","title":"Cialis (tadalafil) tablets label, revised February 2018"},{"n":2,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022332Orig1s011lbl.pdf","tier":"primary","type":"label","title":"Adcirca (tadalafil) tablets label, revised September 2020"},{"n":3,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021368","tier":"primary","type":"regulatory","title":"Drugs@FDA: Cialis (tadalafil) tablets, application 021368"},{"n":4,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022332","tier":"primary","type":"regulatory","title":"Drugs@FDA: Adcirca (tadalafil) tablets, application 022332"},{"n":5,"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances used in compounding under section 503A"},{"n":6,"url":"https://www.fda.gov/media/94155/download","tier":"primary","type":"regulatory","title":"FDA: 503A bulk drug substances category list, updated May 2026"},{"n":7,"url":"https://www.fda.gov/drugs/medication-health-fraud/public-notification-green-lumber-contains-hidden-drug-ingredient","tier":"primary","type":"regulatory","title":"FDA public notification: sexual enhancement product with hidden tadalafil, 2019 to 2026"},{"n":8,"url":"https://www.fda.gov/consumers/health-fraud-scams/tainted-honey-based-products-hidden-active-drug-ingredients","tier":"primary","type":"regulatory","title":"FDA: tainted honey-based products with hidden drug ingredients"},{"n":9,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-662503-12202023","tier":"primary","type":"regulatory","title":"FDA warning letter on products sold as supplements or food with undeclared tadalafil, 20 December 2023"},{"n":10,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/getfitmedical-llc-dba-getfitmedical-715801-09092025","tier":"primary","type":"regulatory","title":"FDA warning letter on claims that compounded tadalafil is a generic Cialis, 9 September 2025"},{"n":11,"url":"https://pubmed.ncbi.nlm.nih.gov/12837435/","tier":"peer-reviewed","type":"rct","title":"Randomized trial: tadalafil for erectile dysfunction at 24 and 36 hours, 2003"},{"n":12,"url":"https://pubmed.ncbi.nlm.nih.gov/19470885/","tier":"peer-reviewed","type":"rct","title":"Randomized trial: tadalafil for pulmonary arterial hypertension, 2009"},{"n":13,"url":"https://pubmed.ncbi.nlm.nih.gov/26308684/","tier":"peer-reviewed","type":"rct","title":"Randomized trial: starting ambrisentan plus tadalafil in pulmonary arterial hypertension, 2015"},{"n":14,"url":"https://pubmed.ncbi.nlm.nih.gov/18722631/","tier":"peer-reviewed","type":"rct","title":"Randomized dose-finding trial: once daily tadalafil for benign prostatic hyperplasia, 2008"},{"n":15,"url":"https://pubmed.ncbi.nlm.nih.gov/28741090/","tier":"peer-reviewed","type":"systematic-review","title":"Systematic review: tadalafil compared with sildenafil for erectile dysfunction, 2017"},{"n":16,"url":"https://pubmed.ncbi.nlm.nih.gov/25358826/","tier":"peer-reviewed","type":"human-trial","title":"Case-crossover study: sudden optic nerve damage (NAION) and PDE5 inhibitor use, 2015"},{"n":17,"url":"https://pubmed.ncbi.nlm.nih.gov/30646238/","tier":"peer-reviewed","type":"reference","title":"Study: unapproved drug ingredients in dietary supplements named in FDA warnings, 2007 to 2016"},{"n":18,"url":"https://pubmed.ncbi.nlm.nih.gov/22971207/","tier":"peer-reviewed","type":"animal","title":"Rat study: tadalafil and simvastatin in pulmonary hypertension, 2012"},{"n":19,"url":"https://natlawreview.com/article/fdas-focus-returns-compounding-and-telehealth-another-wave-warning-letters","tier":"legal-analysis","type":"legal-analysis","title":"National Law Review: FDA's focus returns to compounding and telehealth"},{"n":20,"url":"https://www.nbcnews.com/health/health-news/honey-based-sexual-supplements-may-contain-cialis-viagra-ingredients-f-rcna37876","tier":"established-news","type":"reference","title":"NBC News: honey-based sexual supplements may contain Cialis and Viagra ingredients, July 2022"},{"n":21,"url":"https://clinicaltrials.gov/study/NCT05937854","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT05937854: tadalafil for shortness of breath in COPD with high lung pressure"},{"n":22,"url":"https://clinicaltrials.gov/study/NCT05206955","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT05206955: tadalafil compared with placebo in Fontan physiology"}],"known_risks":["Taken with nitrate heart drugs, such as nitroglycerin, it can drop blood pressure to dangerous levels. Both labels say never to combine them [^1] [^2].","In an emergency, the labels say at least 48 hours should pass after the last dose before a nitrate is given [^1] [^2].","Both labels also say not to take it with riociguat, a drug for high blood pressure in the lungs [^1] [^2].","Sudden loss of sight in one or both eyes has been reported. It can be a sign of damage to the nerve of the eye, called NAION [^1] [^2] [^16].","Sudden loss of hearing has been reported. The labels say to stop it and get medical care right away [^1] [^2].","An erection that lasts more than 4 hours needs emergency care [^1] [^2].","Taken with alpha-blockers, other blood pressure drugs or a lot of alcohol, it can lower blood pressure too far [^1].","Men whose heart is too weak for sex should not use it for erectile dysfunction [^1].","The Adcirca label says it is not recommended for people with a rare blockage of the small veins in the lungs [^2].","Some people have had serious allergic reactions, including a severe skin rash [^2].","In the label's studies, the most common problems were headache, upset stomach, back pain, muscle aches and flushing [^1] [^11].","Products sold as supplements may hold hidden tadalafil. A person on nitrates may take it without knowing [^7] [^9]."],"short_answer":"Tadalafil is FDA-approved as Cialis for erectile dysfunction and an enlarged prostate, and as Adcirca for high blood pressure in the lungs. For those uses the evidence grade is strong-human. With nitrate heart drugs, it can drop blood pressure dangerously. FDA keeps finding it hidden in products sold as supplements.","evidence_grade":"strong-human","open_questions":["Some men with an enlarged prostate start it with finasteride. The label says nobody knows if it adds benefit after 26 weeks [^1].","Nobody knows for sure if the drug itself causes NAION. The 2015 study was observational, so it shows a link, not proof of cause [^16].","Its use in children has not been established. A trial in boys with Duchenne muscular dystrophy found no benefit [^1].","It is not known if tadalafil eases shortness of breath in people with COPD and high lung pressure. A US trial in veterans is testing it [^21].","A 2012 rat study found tadalafil plus a cholesterol drug lowered lung pressure more than either alone. Nobody has shown this in people [^18].","Nobody can say which products sold as supplements hide tadalafil. FDA says it cannot test every such product [^7]."],"section_routes":"The legal way to get tadalafil is a prescription [^1] [^2]. Cialis is approved for erectile dysfunction and an enlarged prostate. Adcirca is approved for high blood pressure in the lungs [^3] [^4].\n\nPharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug [^5]. A compounded copy is not FDA-approved [^10].\n\nTrials of tadalafil are open, such as a US trial in veterans with COPD and high lung pressure [^21]. Another is for people who have had a Fontan palliation [^22]. The trials block on this page lists open trials with their dates.","regulatory_as_of":"2026-10-26","section_channels":"Two ways of getting tadalafil other than an approved, prescribed product show up in FDA's records [^7] [^10]. The first is products sold as supplements or foods with tadalafil hidden inside. FDA lab tests found it in such products, including honey-based products, and their labels did not list it [^7] [^8] [^9] [^20]. FDA first found it in one such product in 2019, and found it there again in 2025 and 2026 [^7]. A 2018 study of FDA warnings found hidden drugs were common in sexual enhancement supplements [^17]. FDA warns the hidden drug can react with nitrates and drop blood pressure to dangerous levels [^7] [^8].\n\nThe second is websites that sell compounded tadalafil and call it a generic Cialis [^10] [^19]. FDA says a compounded copy is not FDA-approved, and that such claims are false or misleading [^10].","section_evidence":"The evidence grade is strong-human for its three approved uses [^11] [^12] [^14]. In a 2003 trial, 348 men with erectile dysfunction took tadalafil or a dummy pill [^11]. Tried 36 hours after a dose, 59.2% of tries at sex succeeded on tadalafil [^11]. On the dummy pill, 28.3% did [^11]. A 2017 review of 16 trials found tadalafil and sildenafil gave similar results [^15].\n\nIn a 2008 trial, 1,058 men with an enlarged prostate took tadalafil or a dummy pill for 12 weeks [^14]. Urinary symptom scores improved more on tadalafil [^14]. The peak flow of urine did not change [^14].\n\nIn a 2009 trial, 405 adults with high blood pressure in the lungs took tadalafil or a dummy pill for 16 weeks [^12]. Overall, people on tadalafil walked about 33 meters farther in six minutes [^12]. Only the highest dose met the study's bar for a clear result [^12]. In a 2015 trial of 500 adults, starting it with a second drug, ambrisentan, cut the risk of getting worse by about half [^13].\n\nIn a 2012 study in rats with high blood pressure in the lungs, adding a cholesterol drug did better than tadalafil alone [^18].","regulatory_status":"fda-approved","section_what_it_is":"Tadalafil is a drug that blocks an enzyme called PDE5 [^1] [^2]. It is not a peptide.\n\nAs Cialis, it is a tablet for erectile dysfunction, which means trouble getting or keeping an erection [^1]. Cialis also treats the urinary symptoms of an enlarged prostate, called benign prostatic hyperplasia [^1]. As Adcirca, it treats high blood pressure in the arteries of the lungs, called pulmonary arterial hypertension [^2]. The Cialis label says it can help erections for up to 36 hours after a dose [^1]. FDA first approved tadalafil as Cialis in 2003 [^3] [^9].","section_is_it_legal":"Tadalafil is FDA-approved: Drugs@FDA lists Cialis and Adcirca as approved prescription drugs [^3] [^4]. The approval is for use under a prescriber's care [^9]. It does not make a product sold as a supplement legal when that product hides tadalafil [^9]. Checked 26 October 2026.\n\nFDA says a product with tadalafil cannot be a dietary supplement, because Cialis was approved first [^9]. It says a product with undeclared tadalafil is a misbranded drug [^9]. FDA also says a compounded copy is not FDA-approved. In 2025, it warned that calling a compounded copy a generic Cialis is false or misleading [^10] [^19].\n\nPharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug [^5]. Tadalafil is not on FDA's 503A category list [^6].","unofficial_channels":[{"type":"counterfeit-or-diverted","what_it_is":"Products sold as dietary supplements or foods for sexual enhancement with tadalafil hidden inside and not listed on the label.","enforcement":[{"date":"2019-09-19","text":"FDA told consumers not to buy or use a sexual enhancement product its lab found to hold tadalafil.","source_url":"https://www.fda.gov/drugs/medication-health-fraud/public-notification-green-lumber-contains-hidden-drug-ingredient"},{"date":"2023-12-20","text":"FDA warning letter to an online retailer that shipped products sold as supplements or food with undeclared tadalafil or sildenafil.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-662503-12202023"},{"date":"2026-10-23","text":"FDA said new samples of the same product again held tadalafil not listed on the label.","source_url":"https://www.fda.gov/drugs/medication-health-fraud/public-notification-green-lumber-contains-hidden-drug-ingredient"}],"legal_position":{"text":"FDA says a product with tadalafil cannot be a dietary supplement, and one with undeclared tadalafil is a misbranded drug.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-662503-12202023"},"documented_risks":[{"text":"FDA warns the hidden drug may react with nitrates, such as nitroglycerin, and lower blood pressure to dangerous levels.","source_url":"https://www.fda.gov/drugs/medication-health-fraud/public-notification-green-lumber-contains-hidden-drug-ingredient"},{"text":"FDA says it cannot test every product sold as a supplement for hidden drugs.","source_url":"https://www.fda.gov/drugs/medication-health-fraud/public-notification-green-lumber-contains-hidden-drug-ingredient"},{"text":"FDA lab tests found tadalafil, not listed on the label, in honey-based products sold for sexual enhancement.","source_url":"https://www.fda.gov/consumers/health-fraud-scams/tainted-honey-based-products-hidden-active-drug-ingredients"}]},{"type":"telehealth","what_it_is":"Websites that sell compounded tadalafil to consumers and call it a generic Cialis.","enforcement":[{"date":"2025-09-09","text":"FDA warning letter to a website that sold compounded tadalafil and called it a generic Cialis.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/getfitmedical-llc-dba-getfitmedical-715801-09092025"}],"legal_position":{"text":"FDA says a compounded drug is not FDA-approved, and a claim that it is the same as an approved drug is false or misleading.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/getfitmedical-llc-dba-getfitmedical-715801-09092025"},"documented_risks":[{"text":"FDA says such claims imply the copy is the same as the approved drug when it is 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recommendation.","sources":["https://clinicaltrials.gov/api/v2/studies?query.intr=tadalafil&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState","https://clinicaltrials.gov/study/NCT05206955","https://peptideindex.ai/methodology#evidence-grade","https://peptideindex.ai/methodology#short-answer","https://pubmed.ncbi.nlm.nih.gov/19470885/","https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021368s030lbl.pdf","https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021368","https://www.fda.gov/drugs/medication-health-fraud/public-notification-green-lumber-contains-hidden-drug-ingredient"],"verified_at":"2026-10-26T13:43:52.703Z","published_at":"2026-10-26T13:49:34.313Z","parent":null,"children":[],"snapshots":{"trials":{"snapshot_at":"2026-10-26T13:44:07.631Z","stale":false,"notice":"A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record."}}}