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    HomeMedication GuideTadalafil safety
    PDE5 inhibitorFDA-Approved

    Tadalafil: What to Know Before You Take It

    Also known as Cialis, Adcirca

    Other names: cialis, adcirca

    Tadalafil is an FDA-approved PDE5 inhibitor that relaxes smooth muscle in blood vessel walls, increasing blood flow. It is approved for erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension.

    FDA-approved as Cialis (erectile dysfunction, BPH) and Adcirca/Alyq (pulmonary arterial hypertension). Compounded sublingual tadalafil is not an FDA-approved dosage form and may be considered only in patient-specific circumstances.
    Reviewed by the OmniRx Health clinical team•Last reviewed Jul 4, 2026

    In plain language

    What Tadalafil is used for

    • Erectile dysfunction
    • Benign prostatic hyperplasia (BPH)
    • Pulmonary arterial hypertension

    Taking this medicine

    How it is administered

    • Oral tablet
    • Sublingual troche (compounded)

    Read before you decide

    Risks and precautions

    Risks and warnings

    • Headache, flushing
    • Nausea, dizziness
    • Back pain, muscle aches
    • Serious hypotension when combined with nitrates

    Who should not take it

    • Concurrent nitrate use (e.g., nitroglycerin, isosorbide) — potentially fatal hypotension
    • Severe cardiovascular disease or recent heart attack/stroke
    • Severe liver impairment
    • Hypersensitivity to tadalafil

    Medication review

    Tadalafil drug interactions

    Tadalafil + Isosorbide MononitrateDo not use isosorbide mononitrate in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil.Contraindicated interactionTadalafil + Nitroglycerin4 CONTRAINDICATIONS • Use of phosphodiesterase type 5 (PDE-5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulators.Contraindicated interactionTadalafil + ItraconazoleAliskiren a Riociguat Sildenafil (for pulmonary hypertension) Tadalafil (for pulmonary hypertension) Not recommended during and 2 weeks after itraconazole treatment.Major interactionTadalafil + CarbamazepineIn addition, carbamazepine causes, or would be expected to cause, decreased levels of the following drugs, for which monitoring of concentrations or dosage adjustment may be necessary: acetaminophen, albendazole, alprazolam, aprepitant, buprenorphone, bupropion, citalopram, clonazepam, clozapine, corticosteroids (e.g., prednisolone, dexamethasone), cyclosporine, dicumarol, dihydropyridine calcium channel blockers (e.g., felodipine), doxycycline, ethosuximide, everolimus, haloperidol, imatinib…Moderate interactionTadalafil + ClarithromycinPhosphodiesterase inhibitors: Sildenafil Tadalafil Vardenafil Use With Caution Sildenafil, Tadalafil, Vardenafil: Each of these phosphodiesterase inhibitors is primarily metabolized by CYP3A, and CYP3A will be inhibited by concomitant administration of clarithromycin.Moderate interactionTadalafil + AmlodipineClinical pharmacology studies were conducted to assess the effect of tadalafil on the potentiation of the blood-pressure-lowering effects of selected antihypertensive medications (amlodipine, angiotensin II receptor blockers, bendrofluazide, enalapril, and metoprolol).Minor interactionTadalafil + Aspirin7.3 Potential for Tadalafil Tablets to Affect Other Drugs Aspirin — Tadalafil did not potentiate the increase in bleeding time caused by aspirin.Minor interactionTadalafil + DigoxinDigoxin) — Coadministration of tadalafil (40 mg once per day) for 10 days did not have a significant effect on the steady-state pharmacokinetics of digoxin (0.25 mg/day) in healthy subjects.Minor interactionTadalafil + EnalaprilClinical pharmacology studies were conducted to assess the effect of tadalafil on the potentiation of the blood-pressure-lowering effects of selected antihypertensive medications (amlodipine, angiotensin II receptor blockers, bendrofluazide, enalapril, and metoprolol).Minor interactionTadalafil + Ketoconazoleketoconazole, ritonavir) increase tadalafil exposure ( 2.7 , 5.10 , 7.2 ) requiring dose adjustment: Tadalafil tablets for use as needed: no more than 10 mg every 72 hours Tadalafil tablets for once daily use: dose not to exceed 2.5 mg CYP3A4 inducers (e.g.Minor interactionTadalafil + LovastatinMidazolam or Lovastatin) — Tadalafil had no significant effect on exposure (AUC) to midazolam or lovastatin.Minor interactionTadalafil + MetoprololClinical pharmacology studies were conducted to assess the effect of tadalafil on the potentiation of the blood-pressure-lowering effects of selected antihypertensive medications (amlodipine, angiotensin II receptor blockers, bendrofluazide, enalapril, and metoprolol).Minor interactionTadalafil + PhenytoinAlthough specific interactions have not been studied, other CYP3A4 inducers, such as carbamazepine, phenytoin, and phenobarbital, would likely decrease tadalafil exposure.Minor interactionTadalafil + Rifampinrifampin) decrease tadalafil exposure ( 7.2 ).Minor interactionTadalafil + TamsulosinClinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin, tamsulosin or alfuzosin.Minor interactionTadalafil + WarfarinWarfarin) — Tadalafil had no significant effect on exposure (AUC) to S-warfarin or R-warfarin, nor did tadalafil affect changes in prothrombin time induced by warfarin.Minor interaction
    Check this against your full medication list in the Interaction Checker

    FDA safety data

    Most-reported side effects

    Based on 98,103 FAERS reports. Reports do not prove the drug caused the effect.

    dyspnoea 11,836headache 10,860diarrhoea 7,919nausea 6,608death 5,960fatigue 5,957drug ineffective 5,514dizziness 5,261cough 4,317pneumonia 4,279malaise 3,769vomiting 3,499
    Explore full FDA safety data

    Regulatory record

    FDA recalls (9)

    Class IIOngoing · Mar 23, 2023

    cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Recalling firm: Preferred Pharmaceuticals, Inc.

    Class IIOngoing · Mar 16, 2023

    CGMP Deviations

    Recalling firm: Northwind Pharmaceuticals LLC

    Class IIOngoing · Mar 16, 2023

    CGMP Deviations

    Recalling firm: Northwind Pharmaceuticals LLC

    Class IITerminated · Feb 7, 2023

    CGMP Deviations: recalling drug products following an FDA inspection.

    Recalling firm: Accord Healthcare, Inc.

    Class IITerminated · Feb 7, 2023

    CGMP Deviations: recalling drug products following an FDA inspection.

    Recalling firm: Accord Healthcare, Inc.

    Class IITerminated · Feb 7, 2023

    CGMP Deviations: recalling drug products following an FDA inspection.

    Recalling firm: Accord Healthcare, Inc.

    Class IITerminated · Feb 7, 2023

    CGMP Deviations: recalling drug products following an FDA inspection.

    Recalling firm: Accord Healthcare, Inc.

    Class IITerminated · Oct 25, 2021

    Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.

    Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC

    Class IITerminated · Oct 25, 2021

    Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.

    Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC

    Everyday context

    Food and drink interactions

    Grapefruit and grapefruit juice

    Avoid grapefruit and grapefruit juice with affected medications, or ask your pharmacist which specific statin/blood-pressure options are not affected. The effect can last a day or more, so separating by a few hours does not reliably avoid it.

    Common questions

    Patient questions

    Can I take tadalafil with nitrates?

    No. Combining tadalafil with any nitrate (including nitroglycerin, isosorbide, and recreational nitrites) can cause a severe, potentially fatal drop in blood pressure. This is an absolute contraindication. Inform all providers that you take tadalafil.

    This information is educational — not medical advice.

    This page is provided for general educational purposes and summarizes publicly available data from sources such as the U.S. Food & Drug Administration. It is not a substitute for the judgment of a licensed clinician and should not be used to start, stop, or change any medication. It may be incomplete or out of date, and individual circumstances vary. Always talk with your prescriber or pharmacist about your specific medications and health conditions. If you think you may have a medical emergency, call 911.

    Have medication questions?

    A licensed OmniRx provider can review your health history and medication list. Availability and treatment options are determined individually.

    Sources & References

    Learn more about where our data comes from and how we write and review medical content.