Prescription medicine
Tadalafil Brand names: Cialis, Tadliq, Adcirca, Alyq
Tadalafil (Cialis) is a prescription medicine with an FDA approval on record since 2003. FDA's NDC Directory lists it from 49 generic labelers, and pharmacies paid $0.167 per tadalafil 20 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the tadalafil FDA label on DailyMed (effective June 3, 2026, Eli Lilly and Company); the NDA 21368 record on Drugs@FDA; every tadalafil label on DailyMed.
Highlights of the record
FDA label of June 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCIALIS ® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) ( 1.1 ) the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2 ) ED and the signs and symptoms of BPH (ED/BPH) ( 1.3 ) If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ).
Forms and strengths
- 2.5 mg
- 5 mg
- 10 mg
- 20 mg
- 20 mg/5ml
Film-coated tablet; tablet; coated tablet; suspension.
On the market
- Earliest approval on file
- November 21, 2003 Cialis, Lilly; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 44 first May 22, 2018; 39 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 52 of which 49 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- December 24, 2038 Tadliq oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.167 per tablet Tadalafil 20 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 12 since 2018 0 Class I among all firms' recalls; latest March 23, 2023; 11 more by firms not listed as its makers
- FAERS reports
- 99,551 through July 30, 2026
What is tadalafil used for?
From the label: indications and usageCIALIS ® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) ( 1.1 ) the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2 ) ED and the signs and symptoms of BPH (ED/BPH) ( 1.3 ) If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 Erectile Dysfunction CIALIS ® is indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia CIALIS is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia CIALIS is indicated for the treatment of ED and the […]
Conditions named in the indications of tadalafil's FDA labels, with every medicine labeled for each:
From other tadalafil labelsPulmonary arterial hypertension: Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability.
FDA pharmacologic class: Phosphodiesterase 5 Inhibitor.
Source: FDA drug label (Cialis), Eli Lilly and Company, effective June 3, 2026 (SPL set bcd8f8ab-81a2-4891-83db-24a0b0e25895), via openFDA; the full label on DailyMed
Is there a generic for tadalafil (Cialis)?
The FDA approved the first generic tadalafil on May 22, 2018. 44 generic applications are approved; 39 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists tadalafil from 49 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Cialis tablets; a patent listed only for Tadliq oral suspension runs to December 24, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2003 earliest approval on file
- 2018 first generic approved
- 2038 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tadalafil (Cialis)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.167 per Tadalafil 20 mg tablet, down 19% from $0.206 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tadalafil 20 mg tablet (generic)
- Cialis 5 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Alyq 20 mg tablet | Generic | $0.146 per tablet | $4.39 | -30% |
| Tadalafil 10 mg tablet | Generic | $0.153 per tablet | $4.60 | -2% |
| Tadalafil 2.5 mg tablet | Generic | $0.113 per tablet | $3.38 | -11% |
| Tadalafil 20 mg tablet | Generic | $0.167 per tablet | $5.01 | -19% |
| Tadalafil 5 mg tablet | Generic | $0.103 per tablet | $3.10 | -16% |
| Cialis 10 mg tablet | Brand | $53.69 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,610.62 | no change |
| Cialis 20 mg tablet | Brand | $53.83 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,614.76 | +0.1% |
| Cialis 5 mg tablet | Brand | $9.20 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $276.13 | -0.2% |
| Tadliq 20 mg/5 mL suspension | Brand | $13.59 per mL | n/a | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has tadalafil been recalled?
The FDA's Enforcement Report lists 23 recalls naming tadalafil since 2018: 0 Class I (the most serious), 21 Class II, 2 Class III; 6 still ongoing. 11 of them are by firms that FDA's NDC Directory does not list as a maker of tadalafil and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 3, 2026 | Class II | Shoolin Pharma Chem LLP not a listed maker | CGMP Deviations:Noted during FDA inspection |
| March 23, 2023 | Class II | Preferred Pharmaceuticals, Inc. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. |
| March 20, 2023 | Class II | RemedyRepack Inc. | cGMP Deviations |
| March 16, 2023 | Class II | Northwind Pharmaceuticals LLC | CGMP Deviations |
| February 7, 2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
| October 25, 2021 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product. |
| July 2, 2020 | Class II | MasterPharm LLC not a listed maker | Lack of Processing Controls (lack of assurance of conformity to specifications). |
| December 18, 2019 | Class II | MPRX, Inc. dba Medical Park Pharmacy not a listed maker | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the tadalafil label say about other medicines?
The tadalafil label names 25 other medicines in its interaction, contraindication or warning sections. The labels of 29 other medicines name tadalafil. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Alfuzosin | drug interactions | Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin, tamsulosin or alfuzosin. [see Dosage and Administration ( 2.7 ), Warnings and Precautions ( 5.6 ), and Clinical Pharmacology ( 12.2 )]. |
| Amlodipine | drug interactions | 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, bendrofluazide, enalapril, and metoprolol). |
| Aspirin | drug interactions | Potential for CIALIS to Affect Other Drugs Aspirin – Tadalafil did not potentiate the increase in bleeding time caused by aspirin. |
| Carbamazepine | drug interactions | Although specific interactions have not been studied, other CYP3A4 inducers, such as carbamazepine, phenytoin, and phenobarbital, would likely decrease tadalafil exposure. |
| Digoxin | drug interactions | P-glycoprotein (e.g. Digoxin) – Coadministration of tadalafil (40 mg once per day) for 10 days did not have a significant effect on the steady-state pharmacokinetics of digoxin (0.25 mg/day) in healthy subjects. |
| Doxazosin | drug interactions | Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin, tamsulosin or alfuzosin. [see Dosage and Administration ( 2.7 ), Warnings and Precautions ( 5.6 ), and Clinical Pharmacology ( 12.2 )]. |
| Enalapril | drug interactions | 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, bendrofluazide, enalapril, and metoprolol). |
| Erythromycin | drug interactions | Although specific interactions have not been studied, other CYP3A4 inhibitors, such as erythromycin, itraconazole, and grapefruit juice, would likely increase tadalafil exposure. |
| Itraconazole | drug interactions | Although specific interactions have not been studied, other CYP3A4 inhibitors, such as erythromycin, itraconazole, and grapefruit juice, would likely increase tadalafil exposure. |
| Ketoconazole | drug interactions | CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) increase CIALIS exposure ( 2.7 , 5.10 , 7.2 ) requiring dose adjustment: |
| Lovastatin | drug interactions | CYP3A4 (e.g. Midazolam or Lovastatin) – Tadalafil had no significant effect on exposure (AUC) to midazolam or lovastatin. |
| Magnesium hydroxide | drug interactions | Antacids – Simultaneous administration of an antacid (magnesium hydroxide/aluminum hydroxide) and tadalafil reduced the apparent rate of absorption of tadalafil without altering exposure (AUC) to tadalafil. |
| Metoprolol | drug interactions | 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, bendrofluazide, enalapril, and metoprolol). |
| Midazolam | drug interactions | CYP3A4 (e.g. Midazolam or Lovastatin) – Tadalafil had no significant effect on exposure (AUC) to midazolam or lovastatin. |
Every other medicine the tadalafil label names
| Medicine named | Section | What the label says |
|---|---|---|
| Nitric oxide | contraindications | This potentiation is thought to result from the combined effects of nitrates and ADCIRCA on the nitric oxide/cGMP pathway [see Clinical Pharmacology ( 12.2 )]. |
| Nitroglycerin | warnings and precautions | Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of CIALIS. |
| Nizatidine | drug interactions | H 2 Antagonists (e.g. Nizatidine) – An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics. |
| Phenobarbital | drug interactions | Although specific interactions have not been studied, other CYP3A4 inducers, such as carbamazepine, phenytoin, and phenobarbital, would likely decrease tadalafil exposure. |
| Phenytoin | drug interactions | Although specific interactions have not been studied, other CYP3A4 inducers, such as carbamazepine, phenytoin, and phenobarbital, would likely decrease tadalafil exposure. |
| Rifampin | drug interactions | CIALIS for use as needed: no more than 10 mg every 72 hours CIALIS for once daily use: dose not to exceed 2.5 mg CYP3A4 inducers (e.g. rifampin) decrease CIALIS exposure ( 7.2 ). |
| Riociguat | contraindications | Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3 ). |
| Ritonavir | drug interactions | CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) increase CIALIS exposure ( 2.7 , 5.10 , 7.2 ) requiring dose adjustment: |
| Tamsulosin | drug interactions | Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin, tamsulosin or alfuzosin. … |
| Theophylline | drug interactions | CYP1A2 (e.g. Theophylline) – Tadalafil had no significant effect on the pharmacokinetics of theophylline. |
| Warfarin | drug interactions | CYP2C9 (e.g. Warfarin) – Tadalafil had no significant effect on exposure (AUC) to S-warfarin or R-warfarin, nor did tadalafil affect changes in prothrombin time induced by warfarin. |
Other labels that name tadalafil
Source: FDA drug label (Cialis), Eli Lilly and Company, effective June 3, 2026 (SPL set bcd8f8ab-81a2-4891-83db-24a0b0e25895), via openFDA; the full label on DailyMed
What do FAERS reports show for tadalafil?
The FDA Adverse Event Reporting System holds 99,551 reports that list tadalafil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11,120 are coded as a death and 37,358 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tadalafil?
3 other medicines are given the same way (oral) and in the same FDA class as tadalafil or labeled mainly for the same use (erectile dysfunction), the same class first. Erectile dysfunction lists all 5 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Sildenafil | Pulmonary arterial hypertension, Erectile dysfunction | 59 labelers | $0.132 per tablet 100 mg tablet | No current entry |
| Vardenafil | Erectile dysfunction | 11 labelers | $2.79 per tablet 20 mg tablet | No current entry |
| Avanafil | Erectile dysfunction | 1 labeler | $50.00 per tablet 200 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does tadalafil compare with medicines for the same use?
6 side-by-side pages set tadalafil beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to tadalafil
- 3 medicines for the same use
- Other PDE5 inhibitors
- the pharmacologic class, with prices and generics
- Tadalafil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other