Tadalafil Generic Names

A person can expect to pay around $240 per month for tadalafil.

Tadalafil Mylan

This is a summary of the European public assessment report (EPAR) for Tadalafil Mylan. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Tadalafil Mylan.

For practical information about using Tadalafil Mylan, patients should read the package leaflet or contact their doctor or pharmacist.

Tadalafil Mylan is used to treat men with erectile dysfunction (sometimes called impotence) when they cannot get, or keep, a hard penis (erection) sufficient for satisfactory sexual activity. For Tadalafil Mylan to be effective in this condition, sexual stimulation is required.

Tadalafil Mylan can also be used in men to treat the signs and symptoms of benign prostatic hyperplasia (enlarged prostate gland that is not cancerous), which involve problems with the flow of urine.

Tadalafil Mylan contains the active substance tadalafil. It is a ‘generic medicine’. This means that Tadalafil Mylan is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Cialis.

For treating erectile dysfunction, the recommended dose of Tadalafil Mylan is 10 mg taken ‘on demand’ at least 30 minutes before sexual activity. The dose may be increased to 20 mg for men who do not respond to the 10 mg dose. The maximum recommended dosing frequency is once per day, but continuous daily use of 10 or 20 mg Tadalafil Mylan is not recommended. Tadalafil Mylan can be used at a lower dose once a day in men who intend to use it frequently (twice a week or more), based on the doctor’s judgment. The dose is 5 mg once a day, but can be lowered to 2.5 mg once a day depending on how well it is tolerated. The medicine should be taken around the same time every day and the appropriateness of the once-a-day dosing should be re-assessed regularly.

For treating men with benign prostatic hyperplasia, or men with both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg once a day.

Patients with severely impaired liver or kidney function should not take more than 10 mg in one dose. Once-a-day dosing is not recommended in patients with severely impaired kidney function, and should only be prescribed to patients with impaired liver function after a careful evaluation of the benefits and risks of taking the medicine.

Tadalafil Mylan can only be obtained with a prescription.

The active substance of Tadalafil Mylan, tadalafil, belongs to a group of medicines called ‘phosphodiesterase type-5 (PDE5) inhibitors’. It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the flow of blood into the corpora, producing the erection. Men with erectile dysfunction do not have enough cGMP to produce or maintain an erection. By blocking the breakdown of cGMP, Tadalafil Mylan restores erectile function. However, sexual stimulation is still needed. By blocking the phosphodiesterase enzyme and preventing the breakdown of cGMP, Tadalafil Mylan also improves the blood flow to, and relaxes the muscles of, the prostate and bladder. This may reduce the problems with the flow of urine which are symptoms of benign prostatic hyperplasia

Because Tadalafil Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Cialis. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

Because Tadalafil Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tadalafil Mylan has been shown to have comparable quality and to be bioequivalent to Cialis. Therefore, the CHMP’s view was that, as for Cialis, the benefit outweighs the identified risk. The Committee recommended that Tadalafil Mylan be approved for use in the EU.

A risk management plan has been developed to ensure that Tadalafil Mylan is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tadalafil Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan .

The European Commission granted a marketing authorisation valid throughout the European Union for Tadalafil Mylan on 21 November 2014.

For more information about treatment with Tadalafil Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Tadalafil

Tadalafil is available under the following different brand names: Adcirca, and Cialis.

Dosages of Tadalafil

Dosage Considerations – Should be Given as Follows:

As needed use: 10 mg orally initially before sexual activity, with or without food; may be increased to 20 mg or reduced to 5 mg on basis of efficacy and tolerability; in most patients, maximum dosing frequency is once daily

Once-daily use: 2.5 mg/day orally in single daily dose, without regard to timing of sexual activity, with or without food; may be increased to 5 mg/day on basis of efficacy and tolerability

As needed use: Decrease dose with concomitant use of potent CYP3A4 inhibitor (e.g., ritonavir, ketoconazole, itraconazole); not to exceed 10 mg/72 hours

Once-daily use: Decrease dose with concomitant use of potent CYP3A4 inhibitor (e.g., ritonavir, ketoconazole, itraconazole); not to exceed 2.5 mg/day

Treatment of signs and symptoms of benign prostatic hyperplasia (BPH); daily use also indicated for treatment of patients with both BPH and erectile dysfunction

BPH with erectile dysfunction: 5 mg orally once daily, taken at approximately same time each day without regard to timing of sexual activity

With finasteride for BPH: tadalafil 5 mg plus finasteride 5 mg orally once daily for up to 26 weeks

40 mg orally once daily; dividing dose for more frequent dosing is not recommended

Patients also taking ritonavir: 20 mg orally once daily initially for 1 week or more; may be increased to 40 mg/day on basis of tolerability

If possible, avoid coadministration with CYP3A4 inhibitors; if coadministration is essential, long-term therapy is indicated, or strong CYP3A4 inhibitors are required, modify or hold dose

Patients already taking strong CYP3A4 inhibitor who require tadalafil: 20 mg orally once daily; may be increased to 40 mg/day on basis of tolerability

Patients already taking tadalafil who require strong CYP3A4 inhibitor: Avoid using tadalafil while starting strong CYP3A4 inhibitor; stop tadalafil 24 hours or more before starting strong CYP3A4 inhibitor; after 1 week, resume tadalafil at 20 mg orally once daily; may be increased to 40 mg/day on basis of tolerability

Cialis: No dosage adjustment is warranted solely on basis of age; however, greater sensitivity to medications in some older individuals should be considered

Adcirca: Lower dose or reduced dosing frequency may be required in elderly because of decreased renal or hepatic clearance

Pediatric: Safety and efficacy not established

Mild (CrCl 51 mL/min or more): No dosage adjustment needed

Moderate (CrCl 30-50 mL/min): Not to exceed 5 mg orally once daily initially; maximum dosage, 10 mg orally every 48 hours

Severe (CrCl less than 30 mL/min and on hemodialysis): Not to exceed 5 mg orally every 72 hours

CrCl 30 mL/min or more: No dosage adjustment needed

CrCl less than 30 mL/min: Not recommended

Mild-to-moderate (CrCl 31-80 mL/min): 20 mg orally once daily initially; may be increased to 40 mg once daily on basis of tolerability

Severe (CrCl less than 30 mL/min and on hemodialysis): Avoid use

Mild-to-moderate (Child-Pugh class A or B): Not to exceed 10 mg orally once daily

Severe (Child-Pugh class C): Not recommended

Mild-to-moderate (Child-Pugh class A or B): Data limited; caution advised

Severe (Child-Pugh class C): Not recommended

Mild-to-moderate (Child-Pugh class A or B): Consider starting dosage of 20 mg orally once daily

QUESTION

What Are Side Effects Associated with Using Tadalafil (Zovirax)?

Common side effects or health problems may include:

  • Headache
  • Muscle pain
  • Respiratory tract infection
  • Runny or stuffy nose
  • Indigestion
  • Flushing (redness or warmth of the face, neck, or chest)
  • Back pain
  • Nausea
  • Gastroesophageal reflux disease (GERD)
  • High blood pressure (hypertension)
  • Bronchitis
  • Genitourinary tract infection
  • Stomach upset
  • Diarrhea
  • Flu-like symptoms (such as stuffy nose, sneezing, or sore throat)
  • Memory problems
  • Low blood pressure (hypotension)
  • Blurred vision
  • Abnormal ejaculation
  • Prolonged erections (priapism)

Less common side effects of tadalafil include:

Postmarketing side effects of tadalafil reported include:

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

What Other Drugs Interact with Tadalafil (Zovirax)?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of this medicine or any drug before seeking medical advice from your doctor, healthcare provider or pharmacist first. To do so may result in serious consequences or side effects.

Severe Interactions of tadalafil include:

  • boceprevir
  • isosorbide dinitrate
  • isosorbide mononitrate
  • nitroglycerin IV
  • nitroglycerin PO
  • nitroglycerin rectal
  • nitroglycerin sublingual
  • nitroglycerin topical
  • nitroglycerin transdermal
  • nitroglycerin translingual
  • riociguat
  • telaprevir

Tadalafil has serious interactions with at least 21 different drugs.

Tadalafil has moderate interactions with at least 152different drugs.

Mild Interactions of tadalafil include:

This document does not contain all possible interactions from the use of this medication. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

SLIDESHOW

What Are Warnings and Precautions for Tadalafil ( Vasostrict, ADH)?

Warnings

  • This medication contains tadalafil. Do not take Adcirca or Cialis if you are allergic to tadalafil or any ingredients contained in this drug.
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

  • Hypersensitivity, including Stevens-Johnson syndrome and exfoliative dermatitis
  • Soluble guanylate cyclase (sGC) stimulators (e.g., riociguat); concomitant use can cause hypotension
    • oadministration with nitrates
      • Coadministration with nitrates (either regularly and/or intermittently) and nitric oxide donors
      • Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates
      • A suitable time interval following PDE5 dosing for the safe administration of nitrates or nitric oxide donors has not been determined

      Effects of Drug Abuse

      Short-Term Effects

      Long-Term Effects

      Cautions

      • Use caution in patients with anatomic deformation of penis, cardiovascular disease, left ventricular outflow obstruction, myocardial infarction in preceding 90 days, unstable angina, angina occurring during sexual intercourse, NYHA class 2 or greater heart failure in preceding 6 months, uncontrolled arrhythmias, hypotension, uncontrolled hypertension, cerebrovascular accident in preceding 6 months, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, conditions predisposing to priapism, concomitant use of CYP3A4 inhibitors.
      • May cause dose-related impairment of color discrimination; use caution in patients with retinitis pigmentosa.
      • Evaluate underlying causes of erectile dysfunction or benign prostatic hyperplasia (BPH) before initiating therapy.
      • May increase risk of sudden vision loss attributed to non-arteritic ischemic optic neuropathy; if vision problems arise, discontinue, and contact physician.
      • Risk of sudden hearing loss.
      • CYP3A4 inhibitors (e.g., erythromycin, ketoconazole, itraconazole, indinavir, ritonavir) may significantly increase tadalafil serum levels.
      • CYP3A4 inducers (e.g., rifampin, St John’s wort) may decrease tadalafil serum levels.
      • Potentiates hypotensive effect of nitrates.
      • Concomitant use with alpha-blockers (other than tamsulosin 0.4 mg/day) should be stabilized before initiation of phosphodiesterase (PDE)-5 inhibitors; patients with instability on alpha-blocker therapy alone are at increased risk for symptomatic hypotension with concurrent PDE-5 inhibitor therapy.
      • Not to be taken with other PDE-5 inhibitors (e.g., sildenafil, vardenafil).
      • Not recommended in patients with pulmonary veno-occlusive disease.
      • Advise patients to seek emergency treatment if an erection lasts more than 4 hours.

      Pregnancy and Lactation

      • Tadalafil may be acceptable for use during pregnancy. Either animal studies show no risk but human studies are not available or animal studies showed minor risks and human studies were done and showed no risk.
      • Tadalafil use is not recommended in nursing women.

      Tadalafil

      Tadalafil (Cialis) is used to treat erectile dysfunction (ED, impotence; inability to get or keep an erection), and the symptoms of benign prostatic hyperplasia (BPH; an enlarged prostate) which include difficulty urinating (hesitation, dribbling, weak stream, and incomplete bladder emptying), painful urination, and urinary frequency and urgency in adult men. Tadalafil (Adcirca) is used to improve the ability to exercise in people with pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness). Tadalafil is in a class of medications called phosphodiesterase (PDE) inhibitors. It works to treat erectile dysfunction by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection. Tadalafil treats PAH by relaxing the blood vessels in the lungs to allow blood to flow more easily.

      If you are taking tadalafil to treat erectile dysfunction, you should know that it does not cure erectile dysfunction or increase sexual desire. Tadalafil does not prevent pregnancy or the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV).

      How should this medicine be used?

      Tadalafil comes as a tablet to take by mouth. It may be taken with or without food.

      If you are taking tadalafil to treat erectile dysfunction, follow your doctor’s directions and the guidelines in this paragraph. There are two different ways to take tadalafil, either daily or on an as needed basis. Talk to your doctor about which dosing schedule is right for you. Tadalafil is sometimes taken as needed, usually at least 30 minutes before sexual activity and not more often than once every 24 hours. Your doctor will help you decide the best time for you to take tadalafil before sexual activity. Tadalafil is also sometimes taken once a day every day without regard to timing of sexual activity. You may attempt sexual activity at any time between doses. If you are taking tadalafil on a regular schedule, take it at around the same time every day. If you have certain health conditions or are taking certain medications, your doctor may tell you to take tadalafil less often or may prescribe a lower dose to be taken once a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tadalafil exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

      If you are taking tadalafil to treat PAH or BPH, follow your doctor’s directions and the guidelines in this paragraph. You should take tadalafil one time a day. Take all of the tablets for your daily dose at one time each day; do not divide the tablets to take as separate doses. Take tadalafil at around the same time every day. If you are already taking medication to treat BPH, your doctor may tell you to stop taking your other medication at least one day before starting treatment with tadalafil. Follow your doctor’s directions carefully, and ask your doctor or pharmacist to explain any part you do not understand.

      If you are taking tadalafil for erectile dysfunction, your doctor will probably start you on an average dose of tadalafil and increase or decrease your dose depending on your response to the medication. Tell your doctor if tadalafil is not working well or if you are experiencing side effects.

      If you are taking tadalafil for PAH, you should know that tadalafil controls PAH but does not cure it. Continue to take tadalafil even if you feel well. Do not stop taking tadalafil without talking to your doctor.

      Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

      Other uses for this medicine

      This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

      What special precautions should I follow?

      Before taking tadalafil,

      • tell your doctor and pharmacist if you are allergic to tadalafil, any other medications, or any of the ingredients in tadalafil tablets. Ask your pharmacist for a list of the ingredients.
      • tell your doctor if you are taking or have recently taken riociguat (Adempas) or nitrates such as isosorbide dinitrate (Isordil), isosorbide mononitrate (Monoket), and nitroglycerin (Minitran, Nitro-Dur, Nitromist, Nitrostat, others). Nitrates come as tablets, sublingual (under the tongue) tablets, sprays, patches, pastes, and ointments. Ask your doctor if you are not sure whether any of your medications contain nitrates. Your doctor will probably tell you not to take tadalafil if you are taking nitrates.
      • tell your doctor if you are taking street drugs containing nitrates (‘poppers’) such as amyl nitrate, butyl nitrate, or nitrite while taking tadalafil. Your doctor will probably tell you not to take tadalafil if you are taking street drugs containing nitrates.
      • you should know that tadalafil is available under the brand names Adcirca and Cialis. You should only be treated with one of these products at a time.
      • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), dutasteride (Avodart, in Jalyn), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax, in Jalyn), and terazosin; amiodarone (Cordarone, Pacerone); certain antifungals such as fluconazole (Diflucan), griseofulvin (Grifulvin, Gris-PEG), itraconazole (Onmel, Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegel), and voriconazole (Vfend); aprepitant (Emend); bosentan (Tracleer); carbamazepine (Carbatrol, Epitol, Tegretol, Teril, others); clarithromycin (Biaxin, in Prevpac); diltiazem (Cardizem, Cartia,Tiazac, others); efavirenz (Sustiva, in Atripla); erythromycin (E.E.S., E-Mycin, Erythrocin); HIV protease inhibitors including indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra), lovastatin (Altocor, in Advicor); medications for high blood pressure; nefazodone; nevirapine (Viramune); other medications or treatments for erectile dysfunction; other medications or treatments for PAH; phenobarbital; phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); sertraline (Zoloft); telithromycin (Ketek); and verapamil (Calan, Covera,Verelan, in Tarka). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
      • tell your doctor what herbal products you are taking, especially St. John’s wort.
      • tell your doctor if you smoke; if you have ever had an erection that lasted more than 4 hours; and if you have recently had diarrhea, vomiting, not been drinking enough fluids, or sweating a lot which may have caused dehydration (loss of a large amount of body fluids. Also tell your doctor if you have or have ever had pulmonary veno-occlusive disease (PVOD; blockage of veins in the lungs); any condition that affects the shape of the penis; diabetes; high cholesterol; high or low blood pressure; irregular heartbeat; a heart attack or heart failure; angina (chest pain); a stroke; ulcers in the stomach; a bleeding disorder; blood circulation problems; blood cell problems such as sickle cell anemia (a disease of the red blood cells), multiple myeloma (cancer of the plasma cells), or leukemia (cancer of the white blood cells); or heart, kidney, or liver disease. Also tell your doctor if you or any of your family members have or have ever had an eye disease such as retinitis pigmentosa (an inherited eye condition that causes loss of vision) or if you have ever had sudden severe vision loss, especially if you were told that the vision loss was caused by a blockage of blood flow to the nerves that help you see.
      • if you are a woman and you are taking tadalafil to treat PAH, tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking tadalafil, call your doctor.
      • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tadalafil.
      • talk to your doctor about the safe use of alcoholic beverages during your treatment with tadalafil. If you drink a large amount of alcohol (more than five glasses of wine or five shots of whiskey) while you are taking tadalafil you are more likely to experience certain side effects of tadalafil such as dizziness, headache, fast heartbeat, and low blood pressure.
      • if you are taking tadalafil to treat erectile dysfunction, tell your doctor if you have ever been advised by a health care professional to avoid sexual activity for medical reasons or if you have ever experienced chest pain during sexual activity. Sexual activity may be a strain on your heart, especially if you have heart disease. If you experience chest pain, dizziness, or nausea during sexual activity, call your doctor immediately or get emergency medical treatment, and avoid sexual activity until your doctor tells you otherwise.
      • tell all your health care providers that you are taking tadalafil. If you ever need emergency medical treatment for a heart problem, the health care providers who treat you will need to know when you last took tadalafil.

      What special dietary instructions should I follow?

      Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

      What should I do if I forget a dose?

      If you are taking tadalafil for erectile dysfunction on a regular schedule, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose or more than one dose per day to make up for a missed one.

      If you are taking tadalafil for PAH or BPH, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

      What side effects can this medication cause?

      Tadalafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

      • headache
      • indigestion or heartburn
      • nausea
      • diarrhea
      • flushing
      • pain in the stomach, back, muscles, arms, or legs
      • cough

      Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

      • sudden decrease or loss of vision (see below for more information)
      • blurred vision
      • changes in color vision (seeing a blue tinge on objects or having difficulty telling the difference between blue and green)
      • sudden decrease or loss of hearing (see below for more information)
      • ringing in ears
      • erection that lasts longer than 4 hours
      • dizziness
      • chest pain
      • hives
      • rash
      • difficulty breathing or swallowing
      • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
      • blistering or peeling of skin

      Some patients experienced a sudden loss of some or all of their vision after they took tadalafil or other medications that are similar to tadalafil. The vision loss was permanent in some cases. It is not known if the vision loss was caused by the medication. If you experience a sudden loss of vision while you are taking tadalafil, call your doctor immediately or get emergency medical treatment. Do not take any more doses of tadalafil or similar medications such as sildenafil (Revatio, Viagra) or vardenafil (Levitra) until you talk to your doctor.

      Some patients experienced a sudden decrease or loss of hearing after they took tadalafil or other medications that are similar to tadalafil. The hearing loss usually involved only one ear and did not always improve when the medication was stopped. It is not known if the hearing loss was caused by the medication. If you experience a sudden loss of hearing, sometimes with ringing in the ears or dizziness, while you are taking tadalafil, call your doctor immediately. Do not take any more doses of tadalafil or similar medications such as sildenafil (Revatio, Viagra) or vardenafil (Levitra) until you talk to your doctor.

      Tadalafil may cause other side effects. Call your doctor if you have any unusual problems while taking this medication

      If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

      What should I know about storage and disposal of this medication?

      Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

      Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

      It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

      In case of emergency/overdose

      In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

      What other information should I know?

      Keep all appointments with your doctor.

      Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

      It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

      Brand names

      American Society of Health-System Pharmacists, Inc. Disclaimer

      AHFS ® Patient Medication Information™. © Copyright, 2022. The American Society of Health-System Pharmacists ® , 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

  • Tadalafil

    Tadalafil is a phosphodiesterase 5 inhibitor used to treat erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension.

    Tadalafil is a selective phosphodiesterase-5 inhibitor that is used in the treatment of erectile dysfunction (ED), pulmonary arterial hypertension (PAH), and benign prostatic hypertrophy. 8,9 It was first approved in 2003 by the FDA for use in ED and later in 2009 for PAH. In contrast to other PDE5 inhibitors like sildenafil, tadalafil has greater selectivity for PDE5 and a longer half-life which has made it a more suitable option for chronic once-daily dosing in the treatment of PAH. 2

    Type Small Molecule Groups Approved, Investigational Structure

    Structure for Tadalafil (DB00820)

    • (6R-trans)-6-(1,3-Benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-pyrazino(1′,2′:1,6)pyrido(3,4-b)indole-1,4-dione
    • (6R,12aR)-2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4-(methylenedioxy)phenyl) pyrazino(1′,2′:1,6)pyrido(3,4-b)indole-1,4-dione
    • Tadalafil
    • Tadalafilo

    Pharmacology

    Tadalafil is indicated for the treatment of erectile dysfunction (ED) and either alone or in combination with finasteride for the treatment of benign prostatic hypertrophy (BPH). 7,11 It is also indicated for the treatment of pulmonary arterial hypertension (PAH) both alone and in combination with macitentan or other endothelin-1 antagonists. 8,9

    Improve clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.

    Tadalafil exerts a therapeutic effect in ED by increasing sexual stimulation-dependant smooth muscle relaxation in the penis, allowing the corpus cavernosum to fill with blood to produce an erection. 2,3 Smooth muscle relaxation in the pulmonary vasculature helps to produce vasodilation in PAH which reduces blood pressure in the pulmonary arteries. 3 In BPH, tadalafil may contribute to decreased smooth muscle cell proliferation which may reduce the size of the prostate and relieve the anatomical obstruction which produces urinary symptoms of BPH. 4 The decreased affinity of tadalafil for PDE6 compared to other PDE5 inhibitors may explain the reduced incidence of visual side effects. 8,9,2

    Tadalafil is a selective phosphodiesterase-5 (PDE5) inhibitor that produces several downstream effects with the most common therapeutic effect being smooth muscle relaxation. 7 Patients may experience ED due to a variety of causes including psychogenic, neurogenic, vasculogenic, iatrogenic, or endocrine. 6 These causes result in dysfunction of penile smooth muscle relaxation through either disrupted neuronal signaling or direct influence on smooth muscle cells. During sexual arousal, non-adrenergic non-cholinergic (NANC) neurons release nitric oxide (NO). Nitric oxide stimulates guanylate cyclase which converts guanosine triphosphate to cyclic guanosine monophosphate (cGMP). 2,3 cGMP activates the cGMP-dependent kinase (PKG) in a signal cascade which activates K+ channels leading to inhibition of Ca2+ channels, inhibits platelet activation, and inhibits smooth muscle cell proliferation while inducing apoptosis. This signal cascade is attenuated by PDE5 which breaks the phosphodiester bond of cGMP, converting it to GMP. Inhibition of PDE5 by tadalafil increases signaling via the PKG cascade which supports penile smooth muscle relaxation during sexual arousal by decreasing Ca2+ entry into smooth muscle cells. This smooth muscle relaxation allows blood to fill the corpus cavernosum thereby producing an erection.

    In PAH, blood pressure in the pulmonary arteries is raised due to a variety of mechanisms stemming from endothelial dysfunction. 3 Decreased production of NO and prostacyclin reduce vasodilatory signaling while overproduction of endothelin-1 and thromboxane increase vasoconstriction. Inflammation, thromboses, and hypoxia later contribute to vascular remodeling which further reduces luminal size. The resultant increase in blood pressure reduces the capacity for gas exchange and increases afterload at the right ventricle, producing symptoms of dyspnea, fatigue, and dizziness as well as leading to right-sided heart failure. Tadalafil exerts its therapeutic effect in PAH through boosting NO-cGMP signaling to contribute to smooth muscle relaxation as with ED.

    Lastly, tadalafil is used to treat BPH. 7 BPH produces urinary dysfunction through hyperproliferation of the epithelial and smooth muscle layers of the prostate. 4 The increased size of the prostate blocks urine flow through the urethra resulting in higher residual volumes due to incomplete emptying. Tadalafil does not appear to exert its benefit via smooth muscle relaxation of the prostate. It may instead exert its effect through a mix of increased oxygenation and decreased inflammation, which decreases tissue remodeling, and inhibition of cell proliferation through the cGMP cascade.

    The decreased affinity for PDE6 compared to other PDE5 inhibitors may explain the decreased incidence of visual side effects as PDE6 is present in the eye and contributes to color vision. 8,9,2

    Tadalafil has a tmax of 0.5-6h with a median of 2h in healthy adults. 1,7 The tmax in adults with PAH is reported as 2-8h with a median of 4h. 8 There does not appear to be a significant effect on absorption when tadalafil is taken with food. 1

    Tadalafil has a mean apparent volume of distribution of 63L in healthy adults. 1,7 The mean apparent volume of distribution is reported as 77L in adults with PAH. 8

    Tadalafil is 94% bound to plasma proteins. 1,7,8

    Tadalafil undergoes hepatic metabolism via CYP3A4 to a catechol metabolite. 1,5,7,8 This catechol metabolite undergoes subsequent methylation and glucuronidation with the methyl-glucuronide metabolite becoming the primary metabolite in circulation. None of the known metabolites are considered to be active.

    Hover over products below to view reaction partners

    Tadalafil is primarily eliminated via hepatic metabolism. 1,7,8 These metabolites are mainly excreted in the feces (61%) and to a lesser extent in the urine (36%)

    The mean half-life of elimination of tadalafil is 15-17.5h in healthy adults. 1,7,8 The mean half-life of elimination in adults with PAH is reported as 35h. 8

    The mean apparent oral clearance of tadalafil is 2.5-3.4L/h in healthy adults. 1,7,8 The mean apparent oral clearance in adults with PAH is reported as 3.5L/h

    With structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.

    Symptoms of overdose are expected to be similar to typical adverse effects which may include headache, dyspepsia, back pain, myalgia, nasopharyngitis, and dizziness. 7,8 Standard supportive care is recommended. Hemodialysis is not expected to contribute significantly to tadalafil clearance.

    Pathways Not Available Pharmacogenomic Effects/ADRs

    Interactions

    This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

    Products

    Our datasets provide approved product information including: dosage, form, labeller, route of administration, and marketing period.

    Brand Name Prescription Products

    Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image
    Act Tadalafil Tablet 2.5 mg Oral TEVA Canada Limited 2016-07-12 Not applicable Canada
    Act Tadalafil Tablet 10 mg Oral TEVA Canada Limited 2016-07-12 Not applicable Canada
    Act Tadalafil Tablet 5 mg Oral TEVA Canada Limited 2016-07-12 Not applicable Canada
    Act Tadalafil Tablet 20 mg Oral TEVA Canada Limited 2016-07-12 Not applicable Canada
    Adcirca Tablet 20 mg/1 Oral Aphena Pharma Solutions – Tennessee, LLC 2009-05-22 Not applicable US
    Adcirca Tablet 20 mg Oral Eli Lilly & Co. Ltd. 2010-01-19 Not applicable Canada
    Adcirca Tablet 20 mg/1 Oral Avera McKennan Hospital 2015-10-28 2017-05-24 US
    Adcirca Tablet, film coated 20 mg Oral Eli Lilly Nederland B.V. 2016-09-07 Not applicable EU
    Adcirca Tablet 20 mg/1 Oral United Therapeutics Corporation 2009-05-22 Not applicable US
    Adcirca Tablet, film coated 20 mg Oral Eli Lilly Nederland B.V. 2016-09-07 Not applicable EU

    Generic Prescription Products

    Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image
    Ach-tadalafil Tablet 5 mg Oral Accord Healthcare Inc Not applicable Not applicable Canada
    Ach-tadalafil Tablet 20 mg Oral Accord Healthcare Inc Not applicable Not applicable Canada
    Ach-tadalafil Tablet 2.5 mg Oral Accord Healthcare Inc Not applicable Not applicable Canada
    Ach-tadalafil Tablet 10 mg Oral Accord Healthcare Inc Not applicable Not applicable Canada
    Ag-tadalafil Tablet 5 mg Oral Angita Pharma Inc. 2022-03-16 Not applicable Canada
    Ag-tadalafil Tablet 20 mg Oral Angita Pharma Inc. 2019-11-21 Not applicable Canada
    Ag-tadalafil Tablet 2.5 mg Oral Angita Pharma Inc. Not applicable Not applicable Canada
    Ag-tadalafil Tablet 10 mg Oral Angita Pharma Inc. Not applicable Not applicable Canada
    Alyq Tablet, film coated 20 mg/1 Oral Teva Pharmaceuticals USA, Inc. 2019-02-06 Not applicable US
    Alyq Tablet, film coated 20 mg/1 Oral AvKARE 2019-02-18 Not applicable US

    Mixture Products

    Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image
    Entadfi Tadalafil (5 mg/1) + Finasteride (5 mg/1) Capsule Oral Veru Inc. 2021-12-12 Not applicable US
    Opsynvi Tadalafil (40 mg) + Macitentan (10 mg) Tablet Oral Janssen Pharmaceuticals 2021-11-25 Not applicable Canada
    TADA PLUS 30/20 MG FILM KAPLI TABLET ,4 ADET Tadalafil (20 mg) + Dapoxetine (30 mg) Tablet, coated NEUTEC İLAÇ SAN. TİC. A.Ş. 2020-08-14 Not applicable Turkey
    TADA PLUS 30/20 MG FILM KAPLI TABLET ,8 ADET Tadalafil (20 mg) + Dapoxetine (30 mg) Tablet, coated NEUTEC İLAÇ SAN. TİC. A.Ş. 2020-08-14 Not applicable Turkey

    Categories

    • Antihypertensive Agents
    • Antihypertensives for Pulmonary Arterial Hypertension
    • Carbolines
    • Cardiovascular Agents
    • Cytochrome P-450 CYP3A Substrates
    • Cytochrome P-450 CYP3A4 Substrates
    • Cytochrome P-450 CYP3A5 Substrates
    • Cytochrome P-450 Substrates
    • Drugs that are Mainly Renally Excreted
    • Drugs Used in Benign Prostatic Hypertrophy
    • Drugs Used in Erectile Dysfunction
    • Enzyme Inhibitors
    • Genito Urinary System and Sex Hormones
    • Genitourinary Agents
    • Heterocyclic Compounds, Fused-Ring
    • Indole Alkaloids
    • Indoles
    • Phosphodiesterase 5 Inhibitors
    • Phosphodiesterase Inhibitors
    • Pyridines
    • Urological Agents
    • Urologicals
    • Vasodilating Agents

    show 8 more Substituents 1,4-diazinane / 2,5-dioxopiperazine / 3-alkylindole / Acetal / Alpha-amino acid or derivatives / Aromatic heteropolycyclic compound / Azacycle / Benzenoid / Benzodioxole / Beta-carboline / Carbonyl group / Carboxamide group / Carboxylic acid derivative / Dioxopiperazine / Heteroaromatic compound / Hydrocarbon derivative / Indole / Lactam / N-alkylpiperazine / N-methylpiperazine / Organic nitrogen compound / Organic oxide / Organic oxygen compound / Organonitrogen compound / Organooxygen compound / Organopnictogen compound / Oxacycle / Piperazine / Pyrrole / Tertiary carboxylic acid amide

    Chemical Identifiers

    References

    Ben-Zion Dolitzky, Dov Diller, “Preparation of tadalafil intermediates.” U.S. Patent US20060276652, issued December 07, 2006.

    1. Forgue ST, Patterson BE, Bedding AW, Payne CD, Phillips DL, Wrishko RE, Mitchell MI: Tadalafil pharmacokinetics in healthy subjects. Br J Clin Pharmacol. 2006 Mar;61(3):280-8. doi: 10.1111/j.1365-2125.2005.02553.x. [Article]
    2. Andersson KE: PDE5 inhibitors – pharmacology and clinical applications 20 years after sildenafil discovery. Br J Pharmacol. 2018 Jul;175(13):2554-2565. doi: 10.1111/bph.14205. Epub 2018 Apr 25. [Article]
    3. Arif SA, Poon H: Tadalafil: a long-acting phosphodiesterase-5 inhibitor for the treatment of pulmonary arterial hypertension. Clin Ther. 2011 Aug;33(8):993-1004. doi: 10.1016/j.clinthera.2011.06.008. Epub 2011 Jul 16. [Article]
    4. Monica FZ, De Nucci G: Tadalafil for the treatment of benign prostatic hyperplasia. Expert Opin Pharmacother. 2019 Jun;20(8):929-937. doi: 10.1080/14656566.2019.1589452. Epub 2019 Mar 22. [Article]
    5. Dalvie D, Obach RS, Kang P, Prakash C, Loi CM, Hurst S, Nedderman A, Goulet L, Smith E, Bu HZ, Smith DA: Assessment of three human in vitro systems in the generation of major human excretory and circulating metabolites. Chem Res Toxicol. 2009 Feb;22(2):357-68. doi: 10.1021/tx8004357. [Article]
    6. Yafi FA, Jenkins L, Albersen M, Corona G, Isidori AM, Goldfarb S, Maggi M, Nelson CJ, Parish S, Salonia A, Tan R, Mulhall JP, Hellstrom WJ: Erectile dysfunction. Nat Rev Dis Primers. 2016 Feb 4;2:16003. doi: 10.1038/nrdp.2016.3. [Article]
    7. FDA Approved Drug Products: Cialis (tadalafil) tablets [Link]
    8. FDA Approved Drug Products: Adcirca (tadalafil) tablets [Link]
    9. DPD Approved Drug Products: Opsynvi (tadalafil/macitentan) combination tablets [Link]
    10. Medisca: Tadalafil MSDS [Link]
    11. FDA Approved Drug Products: Entadfi (finasteride/tadalafil) capsules for oral use [Link]

    Clinical Trials

    Phase Status Purpose Conditions Count
    4 Active Not Recruiting Treatment Benign Prostatic Hyperplasia (BPH) / Overactive Bladder Syndrome (OABS) 1
    4 Active Not Recruiting Treatment Lower Ureteric Stones 1
    4 Completed Not Available Sexual impotency 1
    4 Completed Basic Science Becker’s Muscular Dystrophy (BMD) 1
    4 Completed Diagnostic Erectile Dysfunction / Erectile Dysfunction With Diabetes Mellitus 1
    4 Completed Treatment Becker’s Muscular Dystrophy (BMD) 1
    4 Completed Treatment Benign Prostatic Hyperplasia (BPH) 1
    4 Completed Treatment Connective Tissue Diseases / Pulmonary Arterial Hypertension (PAH) / Pulmonary Hypertension (PH) / Scleroderma Spectrum of Diseases / Systemic Sclerosis (SSc) 1
    4 Completed Treatment Diabetic Cardiomyopathies / Type 2 Diabetes Mellitus 1
    4 Completed Treatment Erectile Dysfunction 10

    Pharmacoeconomics

    • A-S Medication Solutions LLC
    • Bryant Ranch Prepack
    • Diversified Healthcare Services Inc.
    • Eli Lilly & Co.
    • Lake Erie Medical and Surgical Supply
    • Lilly Del Caribe Inc.
    • Nucare Pharmaceuticals Inc.
    • Physicians Total Care Inc.
    • Rebel Distributors Corp.
    • Redpharm Drug
    • Southwood Pharmaceuticals
    • United Therapeutics Corp.

    Dosage Forms

    Form Route Strength
    Film, soluble Oral 20 mg
    Film, soluble Oral 5 mg
    Tablet Oral 10 mg
    Tablet Oral 2.5 mg
    Tablet Oral 5 mg
    Tablet, film coated Oral 10 mg/1
    Tablet, film coated Oral 2.5 mg/1
    Tablet, film coated Oral 20 mg/1
    Tablet, film coated Oral 5 mg/1
    Tablet, coated Oral 10 mg
    Tablet, coated Oral 5 mg
    Tablet, coated Oral
    Film, soluble Oral
    Tablet, soluble Oral 10 mg
    Tablet, orally disintegrating Oral
    Capsule Oral
    Tablet, orally disintegrating Oral 10 mg
    Tablet, film coated Oral 20 mg
    Tablet, film coated Oral
    Tablet Oral
    Tablet, coated
    Tablet, film coated Oral 10.000 mg
    Tablet, film coated Oral 2.500 mg
    Tablet, film coated Oral 20.000 mg
    Tablet, film coated Oral 5.000 mg
    Tablet, chewable Oral 20 mg
    Tablet Oral 10 mg/1
    Tablet Oral 2.5 mg/1
    Tablet Oral 20 mg/1
    Tablet Oral 5 mg/1
    Tablet, coated Oral 10 mg/1
    Tablet, coated Oral 2.5 mg/1
    Tablet, coated Oral 20 mg/1
    Tablet, coated Oral 5 mg/1
    Tablet Oral
    Tablet, film coated Oral 2.5 MG
    Tablet, orally disintegrating Oral 20 mg
    Tablet, soluble Oral 5 mg
    Tablet, chewable Oral 5 mg
    Tablet Oral 20 mg
    Suspension Oral 20 mg/5mL
    Tablet, effervescent 10 mg
    Tablet, effervescent
    Film, soluble Oral 10 Mg
    Tablet, film coated Oral 10 mg
    Tablet, film coated Oral 5 mg
    Tablet, orally disintegrating Oral 5 mg
    Tablet, coated Oral 20 mg

    Prices

    Unit description Cost Unit
    Cialis 30 5 mg tablet Box 140.77USD box
    Cialis 10 mg tablet 20.92USD tablet
    Cialis 20 mg tablet 20.92USD tablet
    Cialis 2.5 mg tablet 4.76USD tablet
    Cialis 5 mg tablet 4.76USD tablet

    DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.

    Patents

    Patent Number Pediatric Extension Approved Expires (estimated) Region
    CA2379948 No 2008-03-25 2020-04-26 Canada
    CA2181377 No 2002-05-28 2015-01-19 Canada
    US6140329 No 2000-10-31 2016-07-11 US
    US6821975 Yes 2004-11-23 2021-05-19 US
    US6943166 Yes 2005-09-13 2020-10-26 US
    US7182958 Yes 2007-02-27 2020-10-26 US
    US5859006 Yes 1999-01-12 2018-05-21 US
    US11382917 No 2018-12-24 2038-12-24 US

    Properties

    State Solid Experimental Properties

    Property Value Source
    melting point (°C) 301-302 °C Medisca: Tadalafil MSDS
    water solubility Practically insoluble in water Medisca: Tadalafil MSDS
    logP 2.89 Medisca: Tadalafil MSDS

    Predicted Properties

    Property Value Source
    Water Solubility 0.25 mg/mL ALOGPS
    logP 2.36 ALOGPS
    logP 1.64 Chemaxon
    logS -3.2 ALOGPS
    pKa (Strongest Acidic) 15.17 Chemaxon
    pKa (Strongest Basic) -4.2 Chemaxon
    Physiological Charge 0 Chemaxon
    Hydrogen Acceptor Count 4 Chemaxon
    Hydrogen Donor Count 1 Chemaxon
    Polar Surface Area 74.87 Å 2 Chemaxon
    Rotatable Bond Count 1 Chemaxon
    Refractivity 104.08 m 3 ·mol -1 Chemaxon
    Polarizability 40.92 Å 3 Chemaxon
    Number of Rings 6 Chemaxon
    Bioavailability 1 Chemaxon
    Rule of Five Yes Chemaxon
    Ghose Filter Yes Chemaxon
    Veber’s Rule No Chemaxon
    MDDR-like Rule No Chemaxon

    Predicted ADMET Features

    Property Value Probability
    Human Intestinal Absorption + 0.9933
    Blood Brain Barrier + 0.7821
    Caco-2 permeable + 0.5
    P-glycoprotein substrate Substrate 0.6581
    P-glycoprotein inhibitor I Non-inhibitor 0.59
    P-glycoprotein inhibitor II Non-inhibitor 0.775
    Renal organic cation transporter Non-inhibitor 0.7165
    CYP450 2C9 substrate Non-substrate 0.8742
    CYP450 2D6 substrate Non-substrate 0.9116
    CYP450 3A4 substrate Substrate 0.7407
    CYP450 1A2 substrate Non-inhibitor 0.7447
    CYP450 2C9 inhibitor Inhibitor 0.5566
    CYP450 2D6 inhibitor Non-inhibitor 0.6788
    CYP450 2C19 inhibitor Inhibitor 0.6998
    CYP450 3A4 inhibitor Non-inhibitor 0.6981
    CYP450 inhibitory promiscuity High CYP Inhibitory Promiscuity 0.7235
    Ames test Non AMES toxic 0.6466
    Carcinogenicity Non-carcinogens 0.931
    Biodegradation Not ready biodegradable 0.8906
    Rat acute toxicity 2.6521 LD50, mol/kg Not applicable
    hERG inhibition (predictor I) Weak inhibitor 0.976
    hERG inhibition (predictor II) Non-inhibitor 0.8734

    ADMET data is predicted using admetSAR, a free tool for evaluating chemical ADMET properties. (23092397)

    Spectra

    Mass Spec (NIST) Not Available Spectra

    Spectrum Spectrum Type Splash Key
    Predicted GC-MS Spectrum – GC-MS Predicted GC-MS Not Available
    Predicted MS/MS Spectrum – 10V, Positive (Annotated) Predicted LC-MS/MS Not Available
    Predicted MS/MS Spectrum – 20V, Positive (Annotated) Predicted LC-MS/MS Not Available
    Predicted MS/MS Spectrum – 40V, Positive (Annotated) Predicted LC-MS/MS Not Available
    Predicted MS/MS Spectrum – 10V, Negative (Annotated) Predicted LC-MS/MS Not Available
    Predicted MS/MS Spectrum – 20V, Negative (Annotated) Predicted LC-MS/MS Not Available
    Predicted MS/MS Spectrum – 40V, Negative (Annotated) Predicted LC-MS/MS Not Available
    LC-MS/MS Spectrum – LC-ESI-qTof , Positive LC-MS/MS Not Available
    MS/MS Spectrum – Linear Ion Trap , negative LC-MS/MS splash10-03di-0090000000-c52485d22b5893fc60a2
    MS/MS Spectrum – Linear Ion Trap , negative LC-MS/MS splash10-03di-0090000000-2f6ad2194cd2932b0761
    MS/MS Spectrum – Linear Ion Trap , positive LC-MS/MS splash10-0i0r-0291000000-a4ae40141abccfc86710
    MS/MS Spectrum – Linear Ion Trap , positive LC-MS/MS splash10-0j59-0290000000-86095fe2d98833db9d0b
    MS/MS Spectrum – Linear Ion Trap , positive LC-MS/MS splash10-0uy0-0429200000-641774545afc89315134
    MS/MS Spectrum – Linear Ion Trap , positive LC-MS/MS splash10-0uy0-0429200000-f223c860e93cceeeacd8
    MS/MS Spectrum – , positive LC-MS/MS splash10-014i-0292000000-0563bdd5b0be8c1cfa47
    MS/MS Spectrum – , positive LC-MS/MS splash10-02t9-2890000000-0be3708ad44a8a467cc5

    Tadalafil price: Options and saving on costs

    Many online health companies offer tadalafil for people who are experiencing erectile dysfunction (ED). Doctors may also recommend this prescription-only drug for other conditions. Tadalafil is the generic version of Cialis and is typically lower in cost.

    Read on to learn about tadalafil and cost, as well as how to save money on prescriptions.

    Tadalafil is a generic prescription medication. It may be used to treat the following conditions in adults:

    Drug details

    Drug class phosphodiesterase type 5 (PDE5) inhibitor
    Drug form oral tablets
    Brand name for ED, BPH, or both: Cialis

    Below are some advantages and disadvantages of tadalafil.

    Pros

    • available in a generic form, which is cheaper than brand-name drugs
    • available in different dosages
    • some insurance companies may cover the cost of the medication

    Cons

    Tadalafil is a generic drug. Generic drugs have the same active ingredients as their brand-name equivalents. A generic drug is subject to the same safety and efficacy standards as the original, brand-name version. Typically, generic drugs cost less than brand-name drugs.

    Tadalafil is available as brand names Adcirca and Alyq, which treat PAH, and Cialis, which treats ED, BPH, or both.

    If a doctor or healthcare professional prescribes a brand-name drug and a person would prefer a generic version, they should discuss this with them during their consultation as they may have a preference for one over another.

    Individuals should also check with their insurance provider to confirm which versions of a drug their plan covers.

    As with all medications, the cost of tadalafil can vary. Factors that may affect the amount a person pays include their treatment plan, insurance coverage, and the pharmacy they use.

    To find the cost of tadalafil, a person should consult their doctor, pharmacist, or insurance provider.

    Below are some tadalafil retailers for a person to consider.

    Please note that the writer of this article has not tried these products. All information presented is purely research-based and correct at the time of publication.

    Medical News Today follows a strict product selection and vetting process. Learn more here.

    Lemonaid

    Lemonaid offers many different healthcare products and services, including a prescription of 10 tadalafil pills that a person can refill 11 times.

    However, doctors usually suggest starting with the 10 mg pills.

    Consultations cost $25, and a person can contact their health insurance provider to check whether their plan covers the costs.

    The platform requires individuals to attend an online consultation with a doctor or nurse practitioner before they receive the medication.

    All Lemonaid packages are discreet, and this product comes with free delivery.

    Roman

    Roman is an online health company that offers both generic and brand-name ED medications. It has the following tadalafil options:

    Drug name Dosage (mg) Cost
    Tadalafil 2.5, 5, 10, and 20 starting from around $11
    can increase to around $44
    Daily tadalafil 2.5 and 5 starting from around $8
    Cialis 2.5, 5, 10, and 20 starting from around $17
    can increase to around $70
    Daily Cialis 2.5 and 5 starting from around $13

    Before purchasing prescription drugs through Roman, individuals must have an online consultation. The company claims that, in most cases, the consultations are free of charge.

    Roman does not accept insurance, and a person should contact their insurer to confirm whether they are able to reclaim any out-of-pocket costs.

    Hims

    Hims offers two options for people who require tadalafil:

    • Once-a-day treatment: This is available in 2.5 and 5 mg doses.
    • As-needed treatment: Doctors can prescribe 5, 10, or 20 mg doses.

    The company explains that a person can take the 2.5 and 5 mg pills once, at the same time, each day. It does not matter how many times they engage in sexual activity.

    However, a person can take the “as-needed” pill up to 30 minutes before having sex.

    The price for tadalafil is $240 per month, while Cialis is $958.

    Hims also offers a free consultation for those who may need prescription medicines.

    Roman does not accept insurance, but the company believes its products are affordable and cheaper than other retailers.

    BlueChew

    BlueChew offers different plans for those purchasing chewable tadalafil tablets.

    They start from around $20, and individuals can choose between 6 and 9 mg pills.

    People can benefit from monthly refills, a free online consultation, and discreet shipping.

    The company does not accept insurance but states its medications are more affordable than some other options. It may also be possible for a person to use their health savings account (HSA) to purchase their prescribed drugs.

    PlushCare

    When people opt for PlushCare’s services, they can schedule a call with a board certified doctor and get a prescription for Cialis or tadalafil.

    Both treatment options are available in doses of 5, 10, and 20 mg. The costs are:

    PlushCare also works with several health insurance providers.

    Here are a few ways individuals may reduce the long-term costs of tadalafil.

    Getting a 3-month supply

    A person may be able to get a 90-day supply of tadalafil. If their insurance company approves it, a 90-day supply could reduce the number of trips to the pharmacy and help reduce costs.

    Using a mail-order pharmacy

    Tadalafil may be available through a mail-order pharmacy. Using this type of service may help lower the drug’s cost and allow a person to receive their medication without leaving home. Some Medicare plans may help cover the cost of mail-order medications.

    If an individual does not have health insurance, a doctor or pharmacist may be able to suggest online pharmacy options that could be cost-effective.

    If a person needs financial support to pay for tadalafil, they may consider looking into websites that offer cost resources and information. Two such organizations are:

    These sites can provide details on drug assistance programs, ways to make the most of insurance coverage, and links to savings cards and other services.

    A person can also visit the GoodRx website, which provides a list of companies offering coupons for tadalafil.

    People should contact a healthcare professional if they are experiencing erectile dysfunction and would like to discuss treatment options. People can either use traditional healthcare or contact a qualified professional on a website such as Lemonaid, Roman, or Hims.

    Doctors will discuss a person’s health history, including any symptoms they have, and any medications they are currently taking.

    If a healthcare professional prescribes medication, people should take note of any side effects they experience. It is important to attend any further appointments, or to discuss treatments with a doctor, to ensure a person is using the right medication for their circumstances.

    Here are answers to some common questions about tadalafil’s cost.

    Does the price of tadalafil vary by strength?

    Yes, the price of tadalafil may vary by strength. The drug comes in the following dosages:

    Factors that may affect the amount a person pays include insurance coverage, their treatment plan, and the pharmacy they use.

    Does Medicare cover tadalafil?

    Whether Medicare covers tadalafil can depend on a person’s Medicare plan.

    A Medicare Part D prescription drug plan — also called a prescription drug plan, or PDP — may help with prescription drug coverage. Certain Medicare Advantage plans also include prescription drug coverage.

    Most Medicare Part D drug plans do not cover tadalafil if prescribed to treat ED. However, plans may cover tadalafil when prescribed to treat BPH or PAH.

    How much does tadalafil cost?

    The cost can vary, depending on the company a person chooses. As with most generic medications, tadalafil is generally cheaper than the branded version Cialis.

    A person can expect to pay around $240 per month for tadalafil.

    Can I buy tadalafil without consulting a doctor?

    No. Tadalafil is only available with a prescription. Individuals who do not feel comfortable visiting a doctor in person can opt for an online service. Some telehealth companies offer free consultations and home prescription deliveries.

    Tadalafil is a generic medication for ED, and a person can expect to pay in the region of $200 each month for this drug. The brand-name version of tadalafil is Cialis, which can sometimes cost more than double. Generic and brand-name drugs have the same active ingredients and meet the same safety standards.

    If a person has questions about which version of a drug to take, they should consider discussing the options with their doctor or healthcare professional.

    Last medically reviewed on October 11, 2022

    How we reviewed this article:

    Medical News Today has strict sourcing guidelines and draws only from peer-reviewed studies, academic research institutions, and medical journals and associations. We avoid using tertiary references. We link primary sources — including studies, scientific references, and statistics — within each article and also list them in the resources section at the bottom of our articles. You can learn more about how we ensure our content is accurate and current by reading our editorial policy.

    • Alyq — tadalafil tablet, film coated. (2021).
      https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3a404db2-7a7d-476f-81cf-979a67d37f66&audience=professional
    • Cialis (tadalafil) tablets. (2018).
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021368s030lbl.pdf
    • Drug coverage (Part D). (n.d.).
      https://www.medicare.gov/drug-coverage-part-d
    • Tadalafil tablet. (2022).
      https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fceb8aaf-b4eb-4004-8ca4-f004eac6b314&audience=professional
    • Tadalafil tablet. (2022).
      https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7e4cdac1-42cc-4038-a86b-4890962ed806

    Medically reviewed by Jennie Olopaade, PharmD, RPH — By Kristina Iavarone and Faye Stewart and Stefano Iavarone — Updated on October 11, 2022

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    © 2004-2022 Healthline Media UK Ltd, Brighton, UK, a Red Ventures Company. All rights reserved. MNT is the registered trade mark of Healthline Media. Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a healthcare professional. See additional information.

    Avoid excessive or chronic alcohol consumption. Ingesting excess amounts of alcohol (more than four drinks in a short time) may potentiate the hypotension and dizziness caused by tadalafil.Avoid grapefruit products. Tadalafil is metabolized by CYP3A4, and grapefruit products are CYP3A4 inhibitors; therefore, coadministration may increase serum levels of tadalafil and result in increased hypotension.Take with or without food.