Mediclarum
Medicine guide

Tadalafil

20 mg · Tablet, Film Coated

  • Prescription only
  • Phosphodiesterase 5 Inhibitor
Active substance
Tadalafil
Made by
Lupin Pharmaceuticals, Inc.

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2023-12-14

What it is

Phosphodiesterase 5 Inhibitor

Used for
  • Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability.
The label’s usual adult dose

40 mg once daily, with or without food.

Full directions ↓
Do not take it if

Concomitant organic nitrates ( 4.1 ) Concomitant Guanylate Cyclase (GC) Stimulators ( 4.2 ) History of known serious hypersensitivity reaction to tadalafil or CIALIS.

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
189other products contain Tadalafil — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability.
  • Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).
  • ( 1.1 )
  • 1.1 Pulmonary Arterial Hypertension Tadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability.
  • Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).

From the official label · 2023-12-14 · DailyMed

How it works

From this product’s own US prescribing label.

Tadalafil is an inhibitor of phosphodiesterase type 5 (PDE5), the enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP).

Pulmonary arterial hypertension is associated with impaired release of nitric oxide by the vascular endothelium and consequent reduction of cGMP concentrations in the pulmonary vascular smooth muscle.

Half-life15 h
Mostly cleared after≈ 3 daysfive half-lives — our arithmetic
How the body breaks it down

Tadalafil is predominantly metabolized by CYP3A to a catechol metabolite.

How it leaves the body

Tadalafil is excreted predominantly as metabolites, mainly in the feces (approximately 61% of the dose) and to a lesser extent in the urine (approximately 36% of the dose).

With food

The rate and extent of absorption of tadalafil are not influenced by food; thus tadalafil may be taken with or without food.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2023-12-14

Do not take it if

  • Concomitant organic nitrates ( 4.1 ) Concomitant Guanylate Cyclase (GC) Stimulators ( 4.2 ) History of known serious hypersensitivity reaction to tadalafil or CIALIS.
  • ( 4.3 )
  • 4.1 Concomitant Organic Nitrates Tadalafil is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently.
  • Do not use nitrates within 48 hours of the last dose of Tadalafil.
  • Tadalafil potentiates the hypotensive effect of nitrates.
  • This potentiation is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway [see Clinical Pharmacology ( 12.2 )] .
  • 4.2 Concomitant Guanylate Cyclase (GC) Stimulators Coadministration of GC stimulators such as riociguat with Tadalafil is contraindicated.
  • Tadalafil may potentiate the hypotensive effects of GC stimulators.
  • 4.3 Hypersensitivity Reactions Tadalafil is contraindicated in patients with a known serious hypersensitivity to tadalafil or CIALIS.
  • Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions ( 6.2 )] .

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • 40 mg once daily, with or without food.
  • ( 2.1 ) Dividing the dose (40 mg) over the course of the day is not recommended.
  • ( 2.1 ) Use with ritonavir requires dosage adjustments.
  • ( 2.4 )
  • 2.1 Pulmonary Arterial Hypertension The recommended dose of tadalafil tablets is 40 mg (two 20 mg tablets) taken once daily with or without food.
  • Dividing the dose (40 mg) over the course of the day is not recommended.
  • 2.2 Dose Adjustment in Renal Impairment Mild (creatinine clearance 51 to 80 mL/min) or moderate (creatinine clearance 31 to 50 mL/min):
  • Start dosing at 20 mg once daily.
  • Increase to 40 mg once daily based on individual tolerability.
  • Severe (creatinine clearance <30 mL/min and on hemodialysis):
  • Avoid use of tadalafil tablets because of increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis [see Use in Specific Populations ( 8.6 )] .
  • 2.3 Dose Adjustment in Hepatic Impairment Mild or moderate (Child Pugh Class A or B):
  • Because of limited clinical experience in patients with mild to moderate hepatic cirrhosis, consider a starting dose of 20 mg once per day.
  • Severe (Child Pugh Class C):
  • Patients with severe hepatic cirrhosis have not been studied.
  • Avoid use of tadalafil tablets [see Use in Specific Populations ( 8.7 )] .
  • 2.4 Dose Adjustments for Use with Ritonavir Co-administration of Tadalafil Tablets in Patients on Ritonavir In patients receiving ritonavir for at least one week, start tadalafil tablets at 20 mg once daily.
  • Increase to 40 mg once daily based upon individual tolerability [see Drug Interactions ( 7.5 ) and Clinical Pharmacology ( 12.3 )] .
  • Co-administration of Ritonavir in Patients on Tadalafil Tablets
  • Avoid use of tadalafil tablets during the initiation of ritonavir.
  • Stop tadalafil tablets at least 24 hours prior to starting ritonavir.
  • After at least one week following the initiation of ritonavir, resume tadalafil tablets at 20 mg once daily.
  • Increase to 40 mg once daily based upon individual tolerability [see Drug Interactions ( 7.5 ) and Clinical Pharmacology ( 12.3 )] .

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • Hypotension:
  • Carefully consider whether patients with certain underlying cardiovascular disease, could be adversely affected by vasodilatory effects of tadalafil.
  • Not recommended in patients with pulmonary veno-occlusive disease.
  • ( 5.1 , 5.2 ) Effects on the eye:
  • Sudden loss of vision could be a sign of non-arteritic ischemic optic neuropathy (NAION) and may be permanent.
  • ( 5.3 ) Hearing impairment:
  • Cases of sudden decrease or loss of hearing have been reported with CIALIS.
  • ( 5.4 ) Concomitant PDE5 inhibitors: Avoid use with CIALIS or other PDE5 inhibitors.
  • ( 5.5 ) Prolonged erection:
  • Advise patients to seek emergency treatment if an erection lasts >4 hours.
  • ( 5.6 )
  • 5.1 Hypotension Tadalafil has vasodilatory properties that may result in transient decreases in blood pressure.
  • Prior to prescribing tadalafil, carefully consider whether patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects.
  • Patients with preexisting hypotension, with autonomic dysfunction, with left ventricular outflow obstruction, may be particularly sensitive to the actions of vasodilators.
  • 5.2 Worsening Pulmonary Vascular Occlusive Disease Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).
  • Since there are no clinical data on administration of tadalafil to patients with veno-occlusive disease, administration of tadalafil to such patients is not recommended.
  • Should signs of pulmonary edema occur when tadalafil is administered, the possibility of associated PVOD should be considered.
  • 5.3 Visual Loss When used to treat erectile dysfunction, non–arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including tadalafil.
  • Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to:
  • low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking.
  • Based on published literature, the annual incidence of NAION is 2.5-11.8 cases per 100,000 in males aged ≥50 in the general population.
  • An observational casecrossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, typical of erectile dysfunction treatment, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period.
  • The results suggest an approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34).
  • A similar study reported a consistent result, with a risk estimate of 2.27 (95% CI 0.99, 5.20).
  • Other risk factors for NAION, such as the presence of "crowded" optic disc, may have contributed to the occurrence of NAION in these studies.
  • Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.
  • 5.4 Hearing Impairment Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in patients taking tadalafil.
  • It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions ( 6.2 )] .
  • 5.5 Combination with Other PDE5 Inhibitors Tadalafil is also marketed for erectile dysfunction.
  • The safety and efficacy of taking tadalafil together with another PDE5 inhibitor has not been studied.
  • Inform patients taking tadalafil not to take other PDE5 inhibitors.
  • 5.6 Prolonged Erection There have been reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds.
  • Patients with conditions that might predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease) are at an increased risk.
  • Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue.
  • Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Risk Summary Limited data from case series with tadalafil use in pregnant women have not identified a drugassociated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
  • In animal reproduction studies, no adverse developmental effects were observed with oral administration of tadalafil to pregnant rats or mice during organogenesis at exposures 7 times the exposure at the maximum recommended human dose (MRHD) of 40 mg/day based on AUC (see Data) .
  • The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
  • All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
  • In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15- 20%, respectively.
  • Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death.
  • Data Animal Data Tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats.
  • Animal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when tadalafil was given to pregnant rats or mice at unbound tadalafil exposures up to 7 times the exposure at the maximum recommended human dose (MRHD) of 40 mg/day during organogenesis based on AUC.
  • In one of two perinatal/postnatal developmental studies in rats, a reduction of postnatal pup survival was observed at dose levels of 60, 200 and 1000 mg/kg.
  • The no-observed- effect-level (NOEL) for developmental toxicity was 30 mg/kg, which provided maternal exposure to unbound tadalafil concentrations approximately 5 times the exposure at the MRHD based on AUC.
  • Signs of maternal toxicity occurred at doses greater than 200 mg/kg/day, which produced AUCs greater than 8 times the exposure at the MRHD.
  • Surviving offspring had normal development and reproductive performance
  • Risk Summary There are no data on the presence of tadalafil and/or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production.
  • Tadalafil and/or its metabolites are present in the milk of lactating rats at concentrations approximately 2.4-times that found in the plasma.
  • When a drug is present in animal milk, it is likely that the drug will be present in human milk.
  • The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tadalafil and any potential adverse effects on the breastfed child from tadalafil or from the underlying maternal condition.
  • IN SPECIFIC POPULATIONS Renal Impairment ( 2.2 , 8.6 , 12.3 ) Mild or moderate:
  • Start with 20 mg once daily.
  • ( 2.2 , 8.6 ) Severe: Avoid use of tadalafil.
  • ( 2.2 , 8.6 ) Hepatic Impairment ( 2.2 , 8.7 , 12.3 ) Mild or moderate:
  • Consider starting dose of 20 mg once daily.
  • ( 2.3 , 8.7 ) Severe: Avoid use of tadalafil.
  • ( 2.3 , 8.7 )
  • 8.1 Pregnancy Risk Summary Limited data from case series with tadalafil use in pregnant women have not identified a drugassociated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
  • In animal reproduction studies, no adverse developmental effects were observed with oral administration of tadalafil to pregnant rats or mice during organogenesis at exposures 7 times the exposure at the maximum recommended human dose (MRHD) of 40 mg/day based on AUC (see Data) .
  • The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
  • All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
  • In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15- 20%, respectively.
  • Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death.
  • Data Animal Data Tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats.
  • Animal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when tadalafil was given to pregnant rats or mice at unbound tadalafil exposures up to 7 times the exposure at the maximum recommended human dose (MRHD) of 40 mg/day during organogenesis based on AUC.
  • In one of two perinatal/postnatal developmental studies in rats, a reduction of postnatal pup survival was observed at dose levels of 60, 200 and 1000 mg/kg.
  • The no-observed- effect-level (NOEL) for developmental toxicity was 30 mg/kg, which provided maternal exposure to unbound tadalafil concentrations approximately 5 times the exposure at the MRHD based on AUC.
  • Signs of maternal toxicity occurred at doses greater than 200 mg/kg/day, which produced AUCs greater than 8 times the exposure at the MRHD.
  • Surviving offspring had normal development and reproductive performance
  • 8.2 Lactation Risk Summary There are no data on the presence of tadalafil and/or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production.
  • Tadalafil and/or its metabolites are present in the milk of lactating rats at concentrations approximately 2.4-times that found in the plasma.
  • When a drug is present in animal milk, it is likely that the drug will be present in human milk.
  • The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tadalafil and any potential adverse effects on the breastfed child from tadalafil or from the underlying maternal condition.
  • 8.3 Females and Males of Reproductive Potential Infertility Males Based on the data from 3 studies in adult males, tadalafil decreased sperm concentrations in the study of 10 mg tadalafil for 6 months and the study of 20 mg tadalafil for 9 months.
  • This effect was not seen in the study of 20 mg tadalafil taken for 6 months.
  • There was no adverse effect of tadalafil 10 mg or 20 mg on mean concentrations of testosterone, luteinizing hormone or follicle stimulating hormone.
  • The clinical significance of the decreased sperm concentrations in the two studies is unknown.
  • There have been no studies evaluating the effect of tadalafil on fertility in men or women [see Clinical Pharmacology ( 12.2 )] .
  • 8.4 Pediatric Use Safety and effectiveness of tadalafil in pediatric patients have not been established.
  • 8.5 Geriatric Use Of the total number of subjects in the clinical study of tadalafil for pulmonary arterial hypertension, 28 percent were 65 and over, while 8 percent were 75 and over.
  • No overall differences in safety were observed between subjects over 65 years of age compared to younger subjects or those over 75 years of age.
  • No dose adjustment is warranted based on age alone; however, a greater sensitivity to medications in some older individuals should be considered. [See Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )] .
  • 8.6 Renal Impairment For patients with mild or moderate renal impairment, start tadalafil at 20 mg once daily.
  • Increase the dose to 40 mg once daily based upon individual tolerability [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )] .
  • In patients with severe renal impairment,
  • avoid use of tadalafil because of increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis [see Clinical Pharmacology ( 12.3 )] .
  • 8.7 Hepatic Impairment Because of limited clinical experience in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A or B), consider a starting dose of tadalafil 20 mg once daily.
  • Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied, thus
  • avoid use of tadalafil in such patients [see Dosage and Administration ( 2.3 ) and Clinical Pharmacology ( 12.3 )] .

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • 7.1 Nitrates Administration of nitrates within 48 hours after the last dose of tadalafil is contraindicated [see Contraindications ( 4.1 )] .
  • 7.2 Alpha-Blockers PDE5 inhibitors, including tadalafil, and alpha–adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects.
  • When vasodilators are used in combination, an additive effect on blood pressure may be anticipated.
  • Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin, alfuzosin or tamsulosin [see Clinical Pharmacology ( 12.2 )] .
  • 7.3 Antihypertensives PDE5 inhibitors, including tadalafil, are mild systemic vasodilators.
  • Clinical 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, bendroflumethiazide, enalapril, and metoprolol).
  • Small reductions in blood pressure occurred following coadministration of tadalafil with these agents compared with placebo [see Clinical Pharmacology ( 12.2 )] .
  • 7.4 Alcohol Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators.
  • When mild vasodilators are taken in combination, blood pressure–lowering effects of each individual compound may be increased.
  • Substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache.
  • Tadalafil (10 mg or 20 mg) did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations. [See Clinical Pharmacology ( 12.2 )] .
  • 7.5 CYP3A Inhibitors/Inducers Ritonavir Ritonavir initially inhibits and later induces CYP3A, the enzyme involved in the metabolism of tadalafil.
  • At steady state of ritonavir (about 1 week), the exposure to tadalafil is similar as in the absence of ritonavir [see Dosage and Administration ( 2.4 ) and Clinical Pharmacology ( 12.3 )] .
  • Potent Inhibitors of CYP3A Tadalafil is metabolized predominantly by CYP3A in the liver.
  • In patients taking potent inhibitors of CYP3A such as ketoconazole, and itraconazole,
  • avoid use of tadalafil [see Clinical Pharmacology ( 12.3 )] .
  • Potent Inducers of CYP3A For patients chronically taking potent inducers of CYP3A, such as rifampin,
  • avoid use of tadalafil [see Clinical Pharmacology ( 12.3 )] .

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • Single doses up to 500 mg have been given to healthy male subjects, and multiple daily doses up to 100 mg have been given to male patients with erectile dysfunction.
  • Adverse reactions were similar to those seen at lower doses.
  • Doses greater than 40 mg have not been studied in patients with pulmonary arterial hypertension.
  • In cases of overdose, standard supportive measures should be adopted as needed.
  • Hemodialysis contributes negligibly to tadalafil elimination.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness of tadalafil in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • Of the total number of subjects in the clinical study of tadalafil for pulmonary arterial hypertension, 28 percent were 65 and over, while 8 percent were 75 and over.
  • No overall differences in safety were observed between subjects over 65 years of age compared to younger subjects or those over 75 years of age.
  • No dose adjustment is warranted based on age alone; however, a greater sensitivity to medications in some older individuals should be considered. [See Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )] .

Quoted from the official label, section “Geriatric Use”.

Side effects

  • The following serious adverse reactions are discussed elsewhere in the labeling:
  • Hypotension [see Warnings and Precautions ( 5.1 )] Visual Loss [see Warnings and Precautions ( 5.3 ) and Patient Counseling Information ( 17 )] Hearing loss [see Warnings and Precautions ( 5.4 )] Priapism [see Warnings and Precautions ( 5.6 )] The most common adverse reaction is headache.
  • ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • Tadalafil was administered to 398 patients with PAH during clinical trials worldwide.
  • In trials of tadalafil, a total of 311 and 251 subjects have been treated for at least 182 days and 360 days, respectively.
  • The overall rates of discontinuation because of an adverse event (AE) in the placebo-controlled trial were 9% for tadalafil 40 mg and 15% for placebo.
  • The rates of discontinuation because of AEs, other than those related to worsening of PAH, in patients treated with tadalafil 40 mg was 4% compared to 5% in placebo-treated patients.
  • In the placebo-controlled study, the most common AEs were generally transient and mild to moderate in intensity.
  • Table 1 presents treatment-emergent adverse events reported by ≥9% of patients in the tadalafil 40 mg group and occurring more frequently than with placebo. $Table 1:
  • Treatment-Emergent Adverse Events Reported by ≥9% of Patients in Tadalafil and More Frequent than Placebo by 2% EVENT Placebo (%) (N=82) Tadalafil 20 mg (%) (N=82) Tadalafil 40 mg (%) (N=79) Headache 15 32 42 Myalgia 4 9 14 Nasopharyngitis 7 2 13 Flushing 2 6 13 Respiratory Tract Infection (Upper and Lower) 6 7 13 Pain in Extremity 2 5 11 Nausea 6 10 11 Back Pain 6 12 10 Dyspepsia 2 13 10 Nasal Congestion (Including sinus congestion) 1 0 9
  • 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of tadalafil.
  • These events have been chosen for inclusion either because of their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors.
  • Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure.
  • The list does not include adverse events that are reported from clinical trials and that are listed elsewhere in this section.
  • Cardiovascular and cerebrovascular Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported postmarketing in temporal association with the use of tadalafil [see Contraindications ( 4.1 )].
  • Most, but not all, of these patients had preexisting cardiovascular risk factors.
  • Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of tadalafil without sexual activity.
  • Others were reported to have occurred hours to days after the use of tadalafil and sexual activity.
  • It is not possible to determine whether these events are related directly to tadalafil, to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors, or to other factors.
  • Body as a whole Hypersensitivity reactions including urticaria, Stevens–Johnson syndrome, and exfoliative dermatitis Nervous Migraine, seizure and seizure recurrence, and transient global amnesia Ophthalmologic Visual field defect, retinal vein occlusion, retinal artery occlusion, and NAION [see Warnings and Precautions ( 5.3 ) and Patient Counseling Information ( 17 )].
  • Otologic Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including tadalafil.
  • In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events.
  • In many cases, medical follow-up information was limited.
  • It is not possible to determine whether these reported events are related directly to the use of tadalafil, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Warnings and Precautions ( 5.4 ) and Patient Counseling Information ( 17 )] .
  • Urogenital Priapism [see Warnings and Precautions ( 5.6 )] .

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • See FDA-Approved Patient Labeling (Patient Information) Inform patients of contraindication of tadalafil with any use of organic nitrates or GC stimulators.
  • Inform patients that tadalafil is also marketed as CIALIS for erectile dysfunction (ED) and for the signs and symptoms of benign prostatic hyperplasia (BPH).
  • Advise patients taking tadalafil not to take CIALIS or other PDE5 inhibitors.
  • Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking tadalafil.
  • Such an event may be a sign of NAION.
  • Also discuss with patients that there is an increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors.
  • Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking tadalafil.
  • These events may be accompanied by tinnitus and dizziness.
  • The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc.
  • The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.
  • Manufactured for: Lupin Pharmaceuticals, Inc.
  • Baltimore, Maryland 21202 United States Manufactured by:
  • Lupin Limited Nagpur 441 108 INDIA November 2020 ID#:
  • 266683

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

  • FORMS AND STRENGTHS Tadalafil Tablets USP, 20 mg are orange colored, round shaped, biconvex film coated tablets debossed with 'L 124' on one side and plain on other side. Tablets (not scored):
  • 20 mg ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • 16.1 How Supplied Tadalafil Tablets USP are supplied as follows:
  • 20 mg orange colored, round shaped, biconvex film coated tablets debossed with 'L 124' on one side and plain on other side.
  • Bottles of 30 NDC 68180-914-06 Bottles of 60 NDC 68180-914-07
  • Storage
  • Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
  • Keep out of reach of children.

Quoted from the official label, section “How Supplied”.

What is in it

  • Tadalafil Tablets USP, an oral treatment for pulmonary arterial hypertension, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)–specific phosphodiesterase type 5 (PDE5).
  • Tadalafil has the empirical formula C 22 H 19 N 3 O 4 representing a molecular weight of 389.41.
  • The structural formula is:
  • The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4–b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl) 2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-.
  • It is a crystalline solid that is freely soluble in dimethylsulfoxide, slightly soluble in methylene chloride and practically insoluble in water.
  • Tadalafil Tablets USP are available as orange colored, round shaped, biconvex film coated tablets debossed with 'L 124' on one side and plain on other side for oral administration.
  • Each tablet contains 20 mg of tadalafil and the following inactive ingredients:
  • croscarmellose sodium, hypromellose, iron oxide yellow, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulphate, talc, titanium dioxide, and triacetin.
  • Image-02

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.
  • Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (59)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

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Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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European UnionNo exact match for this strength and form

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France23 matching products

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Canada25 matching products

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Netherlands30 matching products

Every strength and form (99)

Details

Made byLupin Pharmaceuticals, Inc.
Active substanceTadalafil
Used inUrinary and reproductive system, hormones
Strength20 mg
FormTablet, Film Coated
RouteOral
NDC68180-914

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

180 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Adcirca20 mgPrescription onlyTablet United Therapeutics Corporation · TadalafilAlyq20 mgPrescription onlyTablet, Film Coated Teva Pharmaceuticals, Inc. · TadalafilCialis5 mgPrescription onlyTablet, Film Coated Eli Lilly and Company · TadalafilCialis10 mgPrescription onlyTablet, Film Coated Eli Lilly and Company · TadalafilCialis20 mgPrescription onlyTablet, Film Coated Eli Lilly and Company · TadalafilN/a2.5 mgPrescription onlyTablet, Film Coated Bostal LLC · Tadalafil

See every product with Tadalafil