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Tadalafil: Drug information

Tadalafil: Drug information
(For additional information see "Tadalafil: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Adcirca;
  • Alyq;
  • Cialis;
  • Tadliq
Brand Names: Canada
  • Adcirca;
  • AG-Tadalafil;
  • APO-Tadalafil;
  • APO-Tadalafil PAH;
  • Auro-Tadalafil;
  • BIO-Tadalafil;
  • Cialis;
  • JAMP-Tadalafil;
  • M-Tadalafil;
  • Mar-Tadalafil;
  • MINT-Tadalafil;
  • MYLAN-Tadalafil;
  • NRA-Tadalafil;
  • PMS-Tadalafil;
  • Priva-Tadalafil;
  • PRZ-Tadalafil;
  • RAN-Tadalafil;
  • RIVA-Tadalafil;
  • TEVA-Tadalafil
Pharmacologic Category
  • Phosphodiesterase-5 Enzyme Inhibitor
Dosing: Adult

Note: Contraindicated in patients taking nitrates (regularly or intermittently) due to potentially severe hypotension. If a patient taking tadalafil develops chest pain, delay nitrate administration for ≥48 hours. For patients taking an alpha-1 blocker, use tadalafil with caution and consider a lower starting dose, as tadalafil can potentiate hypotensive effects (Khera 2020); some experts recommend against routine coadministration, particularly in patients with cardiovascular disease (Sauer 2020).

Benign prostatic hyperplasia

Benign prostatic hyperplasia:

Note: In patients with concomitant erectile dysfunction (ED), may use as initial monotherapy; in patients without ED, may use as an alternative to initial monotherapy with an alpha-1 blocker (eg, tamsulosin). Do not combine tadalafil with an alpha-1 blocker due to minimal added benefit and higher likelihood of adverse effects (AUA [Lerner 2021]).

Cialis: Oral: 5 mg once daily. Note: If treatment is initiated with concomitant tadalafil and finasteride, the recommended duration of tadalafil is ≤26 weeks (manufacturer’s labeling).

Erectile dysfunction

Erectile dysfunction:

As-needed dosing: Cialis: Oral: Initial: 10 mg as a single dose ≥30 minutes prior to anticipated sexual activity; do not take more than once daily. Erectile function may be improved for up to 36 hours following a single dose. Adjust dose based on effectiveness and tolerability; may decrease to 5 mg or increase to 20 mg per dose.

Once-daily dosing: Cialis: Oral: Initial: 2.5 mg once daily without regard to timing of sexual activity; may increase to 5 mg once daily based on effectiveness and tolerability.

High-altitude pulmonary edema

High-altitude pulmonary edema (adjunctive therapy) (alternative agent) (off-label use):

Prevention:

Note: May use as an adjunct to gradual ascent in high-risk individuals (eg, history of high-altitude pulmonary edema) who cannot take nifedipine (WMS [Luks 2019]).

Oral: 10 mg every 12 hours starting the day of ascent; continue for 3 to 5 days after reaching maximal altitude; can extend for up to 7 days in individuals who ascend faster than recommended (Gallagher 2022; Maggiorini 2006; WMS [Luks 2019]).

Treatment:

Note: Alternative agent when nifedipine is not available. Adjunctive to nonpharmacologic measures (eg, oxygen supplementation, portable hyperbaric chamber, gradual descent) or as monotherapy if nonpharmacologic measures are not possible (WMS [Luks 2019]).

Oral: 10 mg every 12 hours; continue until descent is complete, symptoms resolve, and oxygenation is normal for the altitude (Gallagher 2022; WMS [Luks 2019]).

Pulmonary arterial hypertension

Pulmonary arterial hypertension:

Note: A clinician with expertise in pulmonary arterial hypertension should be consulted for all management decisions. Tadalafil is contraindicated in patients taking riociguat due to potentially severe hypotension (ACCP [Klinger 2019]).

Adcirca, Alyq, Tadliq: Oral: Initial: 40 mg once daily; may also start with 20 mg once daily and increase to 40 mg after ~4 weeks (ACCP [Klinger 2019]; Galiè 2015).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function:

Tadalafil Dosing Recommendations in Altered Kidney Function

CrCl

Benign prostatic hyperplasiaa

Erectile dysfunction (as needed dosing)a

Erectile dysfunction (once-daily dosing)a

High altitude pulmonary edemab

Pulmonary arterial hypertensionc

a Dosing recommendations are based on expert opinion derived from Forgue 2007; manufacturer’s labeling.

b Dosing recommendations are based on expert opinion; has not been studied in patients with high altitude pulmonary edema with kidney impairment.

c Dosing recommendations are based on expert opinion derived from Galiè 2015; ACCP (Klinger 2019); manufacturer’s labeling.

CrCl >80 mL/minute

5 mg every 24 hours

Initial: 10 mg as a single dose ≥30 minutes prior to anticipated sexual activity; do not take more than once every 24 hours. Dose may be adjusted between 5 and 20 mg administered no more frequently than once every 24 hours based on effectiveness and tolerability.

Initial: 2.5 mg every 24 hours (not necessary to time with sexual activity); may increase to 5 mg every 24 hours based on effectiveness and tolerability.

10 mg every 12 hours

20 to 40 mg every 24 hours; if 20 mg every 24 hours is initiated, increase to 40 mg every 24 hours after ~4 weeks.

CrCl >50 to 80 mL/minute

5 mg every 24 hours; may decrease to 2.5 mg every 24 hours based on effectiveness and tolerability.

Initial: 10 mg as a single dose ≥30 minutes prior to anticipated sexual activity; may repeat no more frequently than once every 24 to 48 hours (a 48-hour interval may be preferred initially since AUC is doubled in these patients). Dose may be adjusted between 5 and 20 mg administered no more frequently than once every 24 hours based on efficacy and tolerability.

2.5 mg every 24 hours (not necessary to time with sexual activity); may increase to 5 mg every 24 hours based on effectiveness and tolerability.

10 mg every 12 hours; may reduce to 10 mg every 24 hours if intolerable adverse effects occur.

Initial: 20 mg every 24 hours; may increase to 40 mg every 24 hours based on efficacy and tolerability.

CrCl 30 to 50 mL/minute

Initial: 2.5 mg every 24 hours; may increase to 5 mg every 24 hours based on effectiveness and tolerability.

Initial: 5 mg as a single dose ≥30 minutes prior to anticipated sexual activity; do not take more than once every 24 hours. Dose may be decreased to 2.5 mg administered no more frequently than once every 24 hours or increased to 10 mg administered no more frequently than once every 48 hours based on effectiveness and tolerability.

2.5 mg every 24 hours (not necessary to time with sexual activity); may increase to 5 mg every 24 hours based on effectiveness and tolerability.

10 mg every 24 hours

Initial: 20 mg every 24 hours; may increase to 40 mg every 24 hours based on efficacy and tolerability.

CrCl <30 mL/minute

Avoid use due to increased tadalafil exposure; limited clinical experience.

5 mg as a single dose ≥30 minutes prior to anticipated sexual activity; may repeat no more frequently than once every 72 hours.

Avoid use due to increased tadalafil exposure; limited clinical experience.

Avoid use due to increased tadalafil exposure; limited clinical experience.

Avoid use due to increased tadalafil exposure; limited clinical experience.

Hemodialysis, intermittent (thrice weekly): Not significantly dialyzable (Forgue 2007):

Erectile dysfunction (as needed dosing): Oral: 5 mg as a single dose ≥30 minutes prior to anticipated sexual activity; may repeat no more frequently than once every 72 hours (Bolat 2017; Ozgur 2022; manufacturer’s labeling).

Other indications: Use not recommended (manufacturer’s labeling).

Peritoneal dialysis: Unlikely to be significantly dialyzed (highly protein bound) (expert opinion):

Erectile dysfunction (as needed dosing): Oral: 5 mg as a single dose ≥30 minutes prior to anticipated sexual activity; may repeat no more frequently than once every 72 hours (expert opinion; manufacturer’s labeling).

Other indications: Use not recommended (manufacturer’s labeling).

CRRT: Unlikely to be significantly dialyzed (highly protein bound) (expert opinion): Avoid use due to increased tadalafil exposure in patients with kidney impairment and limited clinical experience (expert opinion).

PIRRT (eg, sustained, low-efficiency diafiltration): Unlikely to be significantly dialyzed (highly protein bound) (expert opinion): Avoid use due to increased tadalafil exposure in patients with kidney impairment and limited clinical experience (expert opinion).

Dosing: Hepatic Impairment: Adult

Benign prostatic hyperplasia (Cialis):

Mild to moderate hepatic impairment (Child-Pugh class A or B): Use with caution; the use of tadalafil for once-daily use has not been extensively evaluated in patients with hepatic impairment.

Severe hepatic impairment (Child-Pugh class C): Use is not recommended.

Erectile dysfunction (Cialis):

As-needed use:

Mild to moderate impairment (Child-Pugh class A or B): Use with caution; dose should not exceed 10 mg once daily. The use of tadalafil once per day has not been evaluated extensively in patients with hepatic impairment.

Severe impairment (Child-Pugh class C): Use is not recommended.

Once-daily use:

Mild to moderate impairment (Child-Pugh class A or B): Use with caution; the use of tadalafil for once-daily use has not been extensively evaluated in patients with hepatic impairment.

Severe impairment (Child-Pugh class C): Use is not recommended.

Pulmonary arterial hypertension (Adcirca, Alyq, Tadliq):

Mild to moderate hepatic impairment (Child-Pugh class A or B): Use with caution; consider initial dose of 20 mg once daily.

Severe hepatic impairment (Child-Pugh class C): Avoid use; has not been studied in patients with severe hepatic cirrhosis.

Dosing: Older Adult

Refer to adult dosing. No dose adjustment for patients >65 years of age in the absence of kidney or hepatic impairment.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Oral:

Tadliq: 20 mg/5 mL (150 mL) [contains polysorbate 80, sodium benzoate; peppermint flavor]

Tablet, Oral:

Adcirca: 20 mg

Alyq: 20 mg

Cialis: 2.5 mg, 5 mg, 10 mg, 20 mg

Generic: 2.5 mg, 5 mg, 10 mg, 20 mg

Generic Equivalent Available: US

May be product dependent

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Adcirca: 20 mg

Cialis: 2.5 mg, 5 mg, 10 mg, 20 mg

Generic: 2.5 mg, 5 mg, 10 mg, 20 mg

Administration: Adult

Oral: May be administered with or without food.

Adcirca: Administer daily dose all at once; dividing doses throughout the day is not advised.

Cialis: Do not split tablets; the entire dose should be taken. When used on an as-needed basis, should be taken at least 30 minutes prior to sexual activity. When used on a once-daily basis, should be taken at the same time each day, without regard to timing of sexual activity.

Tadliq: Shake bottle well for 30 seconds prior to measuring dose.

Use: Labeled Indications

Benign prostatic hyperplasia (Cialis only): Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

Erectile dysfunction (Cialis only): Treatment of erectile dysfunction.

Erectile dysfunction and benign prostatic hyperplasia (Cialis only): Treatment of erectile dysfunction and the signs and symptoms of BPH.

Pulmonary arterial hypertension (Adcirca, Alyq, Tadliq): Treatment of pulmonary arterial hypertension (World Health Organization group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with New York Heart Association (NYHA) functional class II to III symptoms and etiologies of idiopathic or heritable pulmonary arterial hypertension (61%) or pulmonary arterial hypertension associated with connective tissue diseases (23%).

Use: Off-Label: Adult

High-altitude pulmonary edema

Medication Safety Issues
Sound-alike/look-alike issues:

Tadalafil may be confused with sildenafil, vardenafil

Adcirca may be confused with Advair Diskus, Advair HFA, Advicor

Adverse Reactions (Significant): Considerations
Hearing loss

Sudden auditory impairment and hearing loss have occurred with phosphodiesterase-5 (PDE-5) inhibitors, including tadalafil. Hearing changes are typically unilateral, may be accompanied by tinnitus and dizziness, and may not fully resolve. A direct relationship between therapy and hearing loss has not been determined (Ref). Hearing loss may occur at higher frequencies (Ref).

Mechanism: Unclear; several different proposed mechanisms exist. May be related to elevated middle inner ear pressure, which results from congestion of nasal erectile tissue. Intensification of effects of nitric oxide and/or activation of intracellular cyclic guanosine monophosphate (cGMP) may also contribute (Ref).

Onset: Rapid; most cases occur within 12 to 24 hours (Ref).

Hypotension

Modest decreases in blood pressure (ie, reductions of up to 7 mm Hg in systolic and 4 to 5 mm Hg in diastolic pressure) may occur with tadalafil use (Ref); reductions in diastolic pressure may last up to 12 hours (Ref). Concurrent organic nitrate or guanylate cyclase stimulator therapy may potentiate the vasodilatory effects of tadalafil and produce severe hypotension; use is contraindicated (Ref).

Mechanism: Related to the pharmacologic action; inhibition of phosphodiesterase-5 (PDE-5) activity in the vascular smooth muscle results in vasodilation, which can lead to hypotension (Ref).

Risk factors:

• Concurrent medications that potentiate the vasodilatory effects of tadalafil (eg, alpha-adrenergic antagonists)

• Concurrent antihypertensives

• Concurrent alcohol use

• Left ventricular outflow obstruction (eg, aortic stenosis, idiopathic hypertrophic subaortic stenosis)

• Resting hypotension (BP <90/50 mm Hg)

• Fluid depletion

• Autonomic dysfunction

• Hemodynamic instability

Priapism

Painful prolonged erection (priapism) lasting >4 hours in duration has been reported rarely with tadalafil (Ref).

Mechanism: Related to pharmacologic action; inhibition of phosphodiesterase-5 (PDE-5) activity, which leads to increased accumulation of cyclic guanosine monophosphate (cGMP) in response to release of nitric oxide (Ref).

Onset: Rapid; has occurred within 24 hours of use (Ref).

Risk factors:

• Conditions that predispose to priapism (eg, sickle cell anemia, multiple myeloma, leukemia)

• Anatomical deformation of the penis (eg, angulation, cavernosal fibrosis, Peyronie disease)

Visual disturbances

Visual disturbances have been reported with phosphodiesterase-5 (PDE-5) inhibitors, including tadalafil. Sudden vision loss in one or both eyes may be a sign of nonarteritic anterior ischemic optic neuropathy (NAION); however, a direct relationship has not been determined (Ref). Most cases of NAION are transient but may result in permanent vision loss (Ref). Other serious visual disturbances that have been reported with tadalafil include chorioretinitis, increased intraocular pressure, retinal artery occlusion, retinal detachment, and retinal vein occlusion (Ref).

Mechanism: NAION mechanism is not clearly established; may be due to hypoperfusion of ciliary arteries resulting from hypotension (Ref).

Onset: NAION: Varied (Ref). Risk increases within 5 days of tadalafil use and returns to baseline outside of this period (Ref).

Risk factors:

For NAION:

• Age >50 years

• Coronary artery disease

• Diabetes (Ref)

• Hypertension (Ref)

• Hyperlipidemia (Ref)

• Smoking (Ref)

• Low cup-to-disc ratio ("crowded disc") (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

>10%:

Cardiovascular: Flushing (2% to 13%)

Gastrointestinal: Dyspepsia (2% to 13%), nausea (≤11%)

Nervous system: Headache (4% to 42%)

Neuromuscular & skeletal: Back pain (2% to 12%), limb pain (1% to 11%), myalgia (1% to 14%)

Respiratory: Lower respiratory tract infection (≤13%), nasopharyngitis (6% to 13%), upper respiratory tract infection (≤13%)

1% to 10%:

Cardiovascular: Acute myocardial infarction (<2%), angina pectoris (<2%), chest pain (<2%), hypertension (1% to 3%), hypotension (<2%), orthostatic hypotension (<2%), palpitations (<2%), peripheral edema (<2%), syncope (<2%), tachycardia (<2%)

Dermatologic: Diaphoresis (<2%), pruritus (<2%), skin rash (<2%)

Gastrointestinal: Abdominal pain (1% to 2%), diarrhea (1% to 3%), dysphagia (<2%), esophagitis (<2%), gastritis (<2%), gastroenteritis (3% to 5%), gastroesophageal reflux disease (≤3%), hemorrhoidal bleeding (<2%), loose stools (<2%), rectal hemorrhage (<2%), upper abdominal pain (<2%), vomiting (<2%), xerostomia (<2%)

Genitourinary: Prolonged erection (<2%), spontaneous erections (<2%), urinary tract infection (2%)

Hepatic: Abnormal hepatic function tests (<2%), increased gamma-glutamyl transferase (<2%)

Hypersensitivity: Facial edema (<2%)

Nervous system: Asthenia (<2%), dizziness (1% (table 1)), drowsiness (<2%), fatigue (<2%), hypoesthesia (<2%), insomnia (<2%), pain (<2%), paresthesia (<2%), vertigo (<2%)

Tadalafil: Adverse Reaction: Dizziness

Drug (Tadalafil)

Placebo

Dose

Number of Patients (Tadalafil)

Number of Patients (Placebo)

1%

0.5%

5 mg once daily

581

576

Neuromuscular & skeletal: Arthralgia (<2%), neck pain (<2%)

Ophthalmic: Blurred vision (<2%), conjunctival hyperemia (<2%), conjunctivitis (<2%), eye pain (<2%), eyelid edema (<2%), increased lacrimation (<2%), vision color changes (<2%)

Otic: Hearing loss (<2%), tinnitus (<2%)

Renal: Renal insufficiency (<2%)

Respiratory: Cough (2% to 4%), dyspnea (<2%), epistaxis (<2%), nasal congestion (≤9%), paranasal sinus congestion (≤9%), pharyngitis (<2%)

<1%: Neuromuscular & skeletal: Muscle spasm

Postmarketing:

Cardiovascular: Cardiovascular toxicity

Dermatologic: Basal cell carcinoma of skin (Loeb 2015), exfoliative dermatitis, malignant melanoma (Loeb 2015), Stevens-Johnson syndrome

Genitourinary: Priapism (King 2005)

Nervous system: Amnesia (transient global) (Machado 2010), cerebrovascular accident, migraine, seizure (Calabro 2013)

Ophthalmic: Anterior ischemic optic neuropathy (nonarteritic) (Pomeranz 2017), chorioretinitis (Gordon-Bennett 2012), increased intraocular pressure (Gerometta 2010), retinal artery occlusion (Murthy 2013), retinal detachment (Gargallo-Benedicto 2022), retinal vein occlusion, vision loss (including permanent vision loss)

Contraindications

Serious hypersensitivity to tadalafil or any component of the formulation; concurrent use of organic nitrate (regularly and/or intermittently) or guanylate cyclase stimulators (eg, riociguat).

Canadian labeling: Additional contraindications (not in US labeling): Previous episode of nonarteritic anterior ischemic optic neuropathy

Warnings/Precautions

Concerns related to adverse effects:

• Anginal chest pain: Patients experiencing anginal chest pain after tadalafil administration should seek immediate medical attention.

• Color discrimination: May cause dose-related impairment of color discrimination.

Disease-related concerns:

• Anatomical penis deformation: Use with caution in patients with anatomical deformation of the penis (angulation, cavernosal fibrosis, or Peyronie disease).

• Bleeding disorders: Use with caution in patients with bleeding disorders; safety and efficacy have not been established. In vitro studies have suggested a decreased effect on platelet aggregation.

• Cardiovascular disease: Use is not recommended in patients with hypotension (<90/50 mm Hg), uncontrolled hypertension (>170/100 mm Hg), NYHA class II-IV heart failure within the last 6 months, uncontrolled arrhythmias, stroke within the last 6 months, MI within the last 3 months, unstable angina or angina during sexual intercourse; safety and efficacy have not been evaluated in these patients. Safety and efficacy in PAH have not been evaluated in patients with clinically significant aortic and/or mitral valve disease, life-threatening arrhythmias, hypotension (<90/50 mm Hg), uncontrolled hypertension, significant left ventricular dysfunction, pericardial constriction, restrictive or congestive cardiomyopathy, symptomatic coronary artery disease. There is a degree of cardiac risk associated with sexual activity; therefore, physicians may wish to consider the cardiovascular status of their patients prior to initiating any treatment for erectile dysfunction.

• Hepatic impairment: Use with caution in patients with mild to moderate hepatic impairment; dosage adjustment/limitation is needed. Use is not recommended in patients with severe hepatic impairment or cirrhosis.

• Hereditary degenerative retinal disorders (eg, retinitis pigmentosa): Use caution in patients with retinitis pigmentosa; a minority have genetic disorders of retinal phosphodiesterases. Safety has not been evaluated in patients with known hereditary degenerative retinal disorders; use is not recommended.

• Kidney impairment: Use with caution in patients with kidney impairment; dosage adjustment/limitation is needed.

• Peptic ulcer disease: Use with caution in patients with active peptic ulcer disease because of effect on platelets (bleeding); safety and efficacy have not been established.

• Pulmonary veno-occlusive disease (PVOD): Pulmonary vasodilators may exacerbate the cardiovascular status in patients with PVOD. Use is not recommended; no clinical data exists in patients with PVOD. In patients with unrecognized PVOD, signs of pulmonary edema should prompt investigation into this diagnosis.

Concurrent drug therapy issues:

• Nitrates: Concomitant use (regularly/intermittently) with all forms of nitrates is contraindicated. Nitrate-mediated vasodilation is markedly exaggerated and prolonged in the presence of PDE-5 inhibitors. When nitrate administration is medically necessary following the use of tadalafil, at least 48 hours should elapse after the tadalafil dose and before nitrate administration; close medical supervision is recommended.

Other warnings/precautions:

• Appropriate use: Potential underlying causes of erectile dysfunction or BPH should be evaluated prior to treatment.

Metabolism/Transport Effects

Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Alcohol (Ethyl): May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk C: Monitor therapy

Alpha1-Blockers (Nonselective): Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of Alpha1-Blockers (Nonselective). Management: Ensure patient is stable on one agent prior to initiating the other, and always initiate combination using the lowest possible dose of the drug being added. When tadalafil is used for treatment of BPH, concurrent alpha 1-blockers are not recommended. Risk D: Consider therapy modification

Alpha1-Blockers (Uroselective): May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk C: Monitor therapy

Alprostadil: Phosphodiesterase 5 Inhibitors may enhance the adverse/toxic effect of Alprostadil. Risk X: Avoid combination

Amyl Nitrite: Phosphodiesterase 5 Inhibitors may enhance the vasodilatory effect of Amyl Nitrite. Risk X: Avoid combination

Blood Pressure Lowering Agents: Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Bosentan: May decrease the serum concentration of Phosphodiesterase 5 Inhibitors. Phosphodiesterase 5 Inhibitors may increase the serum concentration of Bosentan. Risk C: Monitor therapy

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CYP3A4 Inducers (Moderate): May decrease the serum concentration of Tadalafil. Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of Tadalafil. Management: Erectile dysfunction or benign prostatic hypertrophy: monitor for decreased effectiveness - no standard dose adjustment is recommended. Avoid use of tadalafil for pulmonary arterial hypertension in patients receiving a strong CYP3A4 inducer. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Tadalafil. Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Tadalafil. Management: Avoid this combination in patients taking tadalafil for pulmonary arterial hypertension. In patients taking tadalafil for ED or BPH, max tadalafil dose is 2.5 mg if taking daily or 10 mg no more frequently than every 72 hours if used as needed. Risk D: Consider therapy modification

Dapoxetine: May enhance the orthostatic hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk X: Avoid combination

Etravirine: May decrease the serum concentration of Phosphodiesterase 5 Inhibitors. Risk C: Monitor therapy

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Fosamprenavir: May increase the serum concentration of Tadalafil. Management: Initiate tadalafil for pulmonary arterial hypertension at 20 mg after at least 1 week of fosamprenavir therapy. Increase to tadalafil 40 mg as tolerated. For erectile dysfunction, limit the tadalafil dose to 10 mg every 72 hours. Risk D: Consider therapy modification

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Lenacapavir: May increase the serum concentration of Tadalafil. Management: Avoid this combination in patients taking tadalafil for pulmonary arterial hypertension. In patients taking tadalafil for ED or BPH, max tadalafil dose is 2.5 mg if taking daily or 10 mg no more frequently than every 72 hours if used as needed. Risk D: Consider therapy modification

Lorcaserin (Withdrawn From US Market): May enhance the adverse/toxic effect of Phosphodiesterase 5 Inhibitors. Specifically, the risk of developing priapism may be increased. Risk C: Monitor therapy

Molsidomine: May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk X: Avoid combination

Nirmatrelvir and Ritonavir: May increase the serum concentration of Tadalafil. Management: In patients treated for pulmonary arterial hypertension avoid initiating nirmatrelvir and ritonavir in patients taking tadalafil. For ED or BPH treatment, decrease tadalafil max dose and frequency. See full monograph for details. Risk D: Consider therapy modification

Nitroprusside: Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of Nitroprusside. Risk X: Avoid combination

Phosphodiesterase 5 Inhibitors: May enhance the adverse/toxic effect of other Phosphodiesterase 5 Inhibitors. Risk X: Avoid combination

Riociguat: Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of Riociguat. Risk X: Avoid combination

Ritonavir: May increase the serum concentration of Tadalafil. Management: In patients treated for pulmonary arterial hypertension avoid initiating ritonavir in patients taking tadalafil; dose adjustments are required. For ED or BPH treatment, decrease tadalafil max dose and frequency. See full monograph for details. Risk D: Consider therapy modification

Sapropterin: May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk C: Monitor therapy

Simeprevir: May increase the serum concentration of Phosphodiesterase 5 Inhibitors. Risk C: Monitor therapy

Vasodilators (Organic Nitrates): Phosphodiesterase 5 Inhibitors may enhance the vasodilatory effect of Vasodilators (Organic Nitrates). Risk X: Avoid combination

Vericiguat: May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk X: Avoid combination

Food Interactions

Rate and extent of absorption are not affected by food. Grapefruit juice may increase serum levels/toxicity of tadalafil. Management: Monitor for increased effects/toxicity with concomitant use.

Reproductive Considerations

Tadalafil was shown to decrease sperm concentrations in some but not all studies; the clinical significance of this is not known. Less than 0.0005% is found in the semen of healthy males.

Pregnancy Considerations

Tadalafil likely crosses the placenta (Sakamoto 2016).

Information related to the use of tadalafil for pulmonary arterial hypertension in pregnant patients is limited. Untreated pulmonary arterial hypertension is associated with adverse maternal outcomes, including heart failure, preterm delivery, stroke, and maternal/fetal death. Females with pulmonary arterial hypertension are encouraged to avoid pregnancy (ACCP [Klinger 2019]; Hemnes 2015).

Breastfeeding Considerations

It is not known if tadalafil is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Monitoring Parameters

BP, response and adverse effects (including sudden auditory impairment or hearing loss, visual disturbances, priapism); International Prostate Symptom Score (baseline and 4 to 12 weeks after treatment initiation); urinalysis (baseline); objective and subjective signs of relief of benign prostatic hyperplasia and lower urinary tract symptoms (AUA [Lerner 2021]); improvement in exercise tolerance and hemodynamics.

Mechanism of Action

BPH: Exact mechanism unknown; effects likely due to PDE-5 mediated reduction in smooth muscle and endothelial cell proliferation, decreased nerve activity, and increased smooth muscle relaxation and tissue perfusion of the prostate and bladder

Erectile dysfunction: Does not directly cause penile erections, but affects the response to sexual stimulation. The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation and inflow of blood to the corpus cavernosum. Tadalafil enhances the effect of NO by inhibiting phosphodiesterase type 5 (PDE-5), which is responsible for degradation of cGMP in the corpus cavernosum; when sexual stimulation causes local release of NO, inhibition of PDE-5 by tadalafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum. At recommended doses, it has no effect in the absence of sexual stimulation.

PAH: Inhibits phosphodiesterase type 5 (PDE-5) in smooth muscle of pulmonary vasculature where PDE-5 is responsible for the degradation of cyclic guanosine monophosphate (cGMP). Increased cGMP concentration results in pulmonary vasculature relaxation; vasodilation in the pulmonary bed and the systemic circulation (to a lesser degree) may occur.

Pharmacokinetics

Onset of action: Within 1 hour

Peak effect (pulmonary artery vasodilation): 75 to 90 minutes (Ghofrani 2004)

Duration: Erectile dysfunction: Up to 36 hours

Distribution: Vd: 63 to 77 L

Protein binding: 94%

Metabolism: Hepatic, via CYP3A4 to metabolites (inactive)

Half-life elimination: 15 to 17.5 hours; Pulmonary hypertension (not receiving bosentan): 35 hours

Time to peak, plasma: ~2 hours (range: 30 minutes to 6 hours); oral suspension: median: 4 hours (range: 2 to 8 hours)

Excretion: Feces (~61%, predominantly as metabolites); urine (~36%, predominantly as metabolites)

Pharmacokinetics: Additional Considerations

Altered kidney function: Tadalafil AUC doubled in subjects with CrCl 31 to 80 mL/minute. In patients with ESRD on hemodialysis, there was a 2-fold increase in Cmax and 2.7- to 4.8-fold increase in AUC.

Hepatic function impairment: Tadalafil AUC after a 10 mg dose in patients with mild or moderate hepatic impairment (Child-Pugh class A or B) was comparable with exposure in healthy subjects. There are insufficient data for subjects with severe hepatic impairment.

Older adult: Subjects >65 years of age have a 25% higher exposure compared with subjects 19 to 45 years of age.

Diabetes mellitus: The AUC was reduced approximately 19% and Cmax was 5% lower in patients with diabetes mellitus than in healthy subjects.

Pricing: US

Suspension (Tadliq Oral)

20 mg/5 mL (per mL): $15.16

Tablets (Adcirca Oral)

20 mg (per each): $83.40

Tablets (Alyq Oral)

20 mg (per each): $76.15

Tablets (Cialis Oral)

2.5 mg (per each): $14.23

5 mg (per each): $14.23

10 mg (per each): $83.40

20 mg (per each): $83.40

Tablets (Tadalafil (PAH) Oral)

20 mg (per each): $72.14 - $76.15

Tablets (Tadalafil Oral)

2.5 mg (per each): $12.26 - $13.00

5 mg (per each): $1.29 - $13.29

10 mg (per each): $71.81 - $76.15

20 mg (per each): $3.88 - $76.15

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • 36 Horas (PY);
  • Adafil (BD);
  • Adcirca (AT, AU, BB, BE, CH, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IS, JP, LT, LU, MT, NL, NO, PL, PT, RO, SE, SI, SK);
  • Cendom (KR);
  • Cendom Orally Soluble Film (KR);
  • Cialis (AE, AR, AT, AU, BB, BE, BF, BG, BH, BJ, BR, BS, CH, CI, CL, CN, CO, CR, CY, CZ, DE, DK, DO, EE, EG, ES, ET, FI, FR, GB, GH, GM, GN, GR, GT, HK, HN, HR, HU, ID, IE, IL, IS, IT, JM, JO, JP, KE, KR, KW, LB, LR, LT, LU, LV, MA, ML, MR, MT, MU, MW, MX, MY, NE, NG, NI, NL, NO, NZ, PA, PE, PH, PL, PT, QA, RO, RU, SA, SC, SD, SE, SG, SI, SK, SL, SN, SV, TH, TN, TR, TT, TZ, UA, UG, VE, VN, ZA, ZM, ZW);
  • Ciaton (BD);
  • Clavor (ZA);
  • Dali (BR);
  • Digram (PY);
  • Duralis (LB);
  • Equitone (AR);
  • Erectalis (EG);
  • Eredys 10 (VN);
  • Erlis (PL);
  • Erotadil (VN);
  • Exerdya (GR);
  • Forzest (IN);
  • Gerocilan (CZ);
  • Glodafil (VN);
  • Glofil (LK);
  • GODN Orodispersible Film (KR);
  • Greseo Powd. (KR);
  • Gugu Chew (KR);
  • Hardcis (TR);
  • Invictus (AR);
  • Jovan T 20 (ZW);
  • Lanrextan (AT);
  • Letromax (HK);
  • Leval (AR);
  • Link (LB);
  • Longis (HK);
  • Mega Joy (BD);
  • Megafil (LK);
  • Megafort (VN);
  • Mplify (ZW);
  • Provitra (HK);
  • Quator (NL);
  • Snafi (AE, BH, EG, KW, QA, SA);
  • Spciafil (VN);
  • Sunka (KR);
  • Tadacip (LK);
  • Tadaf (LK);
  • Tadam (IL);
  • Taderect (EG);
  • Tadilecto (HR);
  • Tadis (PL);
  • Tagra (LB);
  • Talmanco (BE, FI);
  • Tedallis (RU);
  • Tyra (BH);
  • Viev (BD);
  • Yesgra (KR);
  • Zenafil (NL);
  • Zenavil (CZ, HR, MT);
  • Zyad (BR);
  • Zydalis (IN)


For country code abbreviations (show table)
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