Brand — one of two labels for one molecule
Cialis
One tablet approved for erectile dysfunction, for an enlarged prostate and for both at once — taken either occasionally at up to 20 mg or every day at 2.5 to 5 mg. The same molecule is sold as Adcirca at 40 mg daily, and each label says not to take the other.
- Molecule
- tadalafil
- Manufacturer
- Eli Lilly and Company
- Products under this name
- 1
- Last reviewed
Why a tadalafil dose needs a regimen and a brand attached to it
Cialis is one tablet with three approved uses and two incompatible ways of taking it. Section 1 lists erectile dysfunction, the signs and symptoms of benign prostatic hyperplasia, and the two together. Section 2 then splits into an as-needed regimen — 10 mg before anticipated sexual activity, adjustable to 20 mg or 5 mg, at most once a day — and a once-daily regimen taken at the same time every day without regard to sexual activity, starting at 2.5 mg and rising to 5 mg. The same 5 mg tablet is a reduced occasional dose under one regimen and a standing daily dose under the other.
Then there is the second brand. Tadalafil is also sold as ADCIRCA (NDA022332) for pulmonary arterial hypertension, at 40 mg once daily — two unscored 20 mg tablets taken together, with the label adding that "Dividing the dose (40 mg) over the course of the day is not recommended." Forty milligrams a day is twice the largest amount any Cialis prescription permits in a day, and it is taken every day rather than before an occasion. Each label contraindicates a serious hypersensitivity to the other and tells the patient not to take both.
So "tadalafil 5 mg" and "tadalafil 40 mg" are not two points on one scale. They are different regimens under different applications for different diseases, and the only figure that transfers between them is the molecule’s 17.5-hour half-life, which is why the nitrate interval is 48 hours on both. The table below separates what belongs to Cialis from what belongs to tadalafil.
What is true of Cialis and not of tadalafil
Each row is something a reader would reasonably assume belongs to the molecule, and does not. These are the facts that change when the brand name on the carton changes, while the drug inside it does not.
| Attribute | Cialis | Elsewhere, same molecule |
|---|---|---|
| What it is approved to treatA tadalafil prescription can be a treatment for an erection problem, for urinary symptoms, for both, or for a lung disease. The tablet does not distinguish them; only the label the prescription was written against does. | Three indications on one tablet: erectile dysfunction, the signs and symptoms of benign prostatic hyperplasia, and the two together — the only PDE5 inhibitor in the United States with a second, non-sexual indication on the same product. | Adcirca, the same molecule, is approved only for pulmonary arterial hypertension (WHO Group 1) to improve exercise ability, and carries no sexual or urological indication at all. |
| How much may be taken in a dayForty milligrams of tadalafil a day is a labelled dose of one brand and twice the single-day ceiling of the other, taken every day rather than occasionally. The number 20 mg is simultaneously the Cialis maximum and half of one Adcirca dose. | 20 mg, and only once: the label pairs "The dose may be increased to 20 mg" with "The maximum recommended dosing frequency is once per day in most patients". On the once-daily regimen the standing dose is 5 mg. | Adcirca is 40 mg once daily — two 20 mg tablets taken together — with the added instruction that "Dividing the dose (40 mg) over the course of the day is not recommended." |
| How many regimens the label describesThe same milligram figure means different things in the two Cialis regimens: 5 mg is a reduced occasional dose under one and a standing daily dose under the other. Asking "what dose of Cialis am I on" without naming the regimen does not identify a treatment. | Two, and they are alternatives rather than steps. As needed before anticipated sexual activity at 10 mg, adjustable to 20 mg or 5 mg; or once daily at the same time each day, starting at 2.5 mg and increasable to 5 mg, without regard to the timing of sexual activity. | Adcirca has one regimen with no alternatives and no as-needed option: 40 mg once daily, taken with or without food, and explicitly not divided across the day. |
| Whether the label supplies the tablet its own instruction requiresThree sentences of one label cannot all be satisfied by a CIALIS tablet. The 2.5 mg dose is supplied as generic tadalafil; this page states the conflict rather than resolving it, because resolving it would mean inventing an instruction the label does not give. | It does not. Section 2 opens "Do not split CIALIS tablets; entire dose should be taken." Section 2.2 names 2.5 mg as the once-daily starting dose for ED. Section 3 lists three strengths — 5 / 10 / 20 mg — and no 2.5 mg tablet. | Adcirca has the mirror-image arrangement and no conflict: one strength, a 20 mg tablet described in section 3 as "not scored", and a dose of two of them taken at once. |
| What to do about an alpha-blockerThe same combination is permitted with a dose caveat, not recommended at all, and undiscussed, depending on which of two labels and which of two indications applies. A blanket "tadalafil and alpha-blockers" rule does not exist. | It depends on the indication, and the two answers are opposite. For ED: be stable on the alpha-blocker first and initiate CIALIS at the lowest recommended dose. For BPH: "CIALIS is not recommended for use in combination with alpha-blockers for the treatment of BPH." | The Adcirca label carries no dose instruction and no recommendation against. Its alpha-blocker section describes the additive blood-pressure effect and names the drugs studied, and stops there. |
| What happens in severe renal impairmentBelow a clearance of 30, one tadalafil brand becomes a 5 mg dose every three days and the other becomes a drug to avoid. Which instruction applies is decided by the indication on the prescription, not by the kidneys. | The as-needed regimen survives at a reduced frequency — "Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours" — while for once daily use at the same clearance the label says CIALIS for once daily use is not recommended. | Adcirca allows no reduced regimen: "Severe (creatinine clearance <30 mL/min and on hemodialysis): Avoid use of ADCIRCA because of increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis." |
| How long the effect is documented to lastThe best-known fact about this molecule — the 36 hours — is an efficacy window from one regimen of one brand, not a property of tadalafil and not a description of an erection. The measurement that does belong to the molecule is the 17.5-hour half-life, which is why both labels treat nitrates as a 48-hour problem. | up to 36 hours, and only for the as-needed ED regimen: "CIALIS for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing." (section 2.1 CIALIS for Use as Needed for Erectile Dysfunction). improved erectile function vs placebo, not a 36 hr erection. | Adcirca states no duration of effect. Its endpoint is 6-minute walk distance measured over weeks, so there is no comparable figure and nothing to read across. |
| What the label says about finasterideA labelled stop date is unusual and easy to miss. The combination is endorsed for initiating BPH treatment and then explicitly runs out of evidence at 26 weeks, which is a fact about this brand and this indication only. | A Limitation of Use unique to this product: "If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of CIALIS decreases from 4 weeks until 26 weeks, and the incremental benefit of CIALIS beyond 26 weeks is unknown." | Adcirca says nothing about finasteride, because it has no prostate indication for finasteride to be combined with. |
Cialis tablets
- Dosage form
- Tablet, film coated
- Route
- Oral — either as needed before sexual activity, or once daily at the same time each day
- Marketing category
- NDA — NDA021368
- Label read
- SPL version 52, effective June 3, 2026
What this product is approved to treat
- —CIALIS is indicated for the treatment of erectile dysfunction (ED).
- —CIALIS is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
- —CIALIS is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).
- —Limitation of Use: If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of CIALIS decreases from 4 weeks until 26 weeks, and the incremental benefit of CIALIS beyond 26 weeks is unknown.
The labelled ladder
| When | Dose | What the label attaches to this step |
|---|---|---|
| As needed, ED — start | 10 mg before activity | The recommended starting dose of CIALIS for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity. Section 2.1 CIALIS for Use as Needed for Erectile Dysfunction. The label names no number of minutes — unlike sildenafil and vardenafil, it says only "prior to anticipated sexual activity". |
| As needed, ED — up | 20 mg before activity | The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients. |
| As needed, ED — down | 5 mg before activity | The same sentence permits the reduction. Note that 5 mg appears three times on this label with three different meanings — a reduced as-needed dose, a once-daily ED maintenance dose, and the BPH dose. |
| Once daily, ED — start | 2.5 mg every day | The recommended starting dose of CIALIS for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. Section 2.2 CIALIS for Once Daily Use for Erectile Dysfunction. Section 3 of this label lists no 2.5 mg CIALIS tablet, and section 2 opens with "Do not split CIALIS tablets; entire dose should be taken" — the page states both and does not reconcile them. |
| Once daily, ED — up | 5 mg every day | The CIALIS dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability. |
| Once daily, BPH | 5 mg every day | The recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day. The same dose covers the combined ED/BPH indication: "The recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity." |
| As needed, CrCl 30–50 | 5 mg start, 10 mg ceiling | The label states: "Creatinine clearance 30 to 50 mL/min: A starting dose of 5 mg not more than once per day is recommended, and the maximum dose is 10 mg not more than once in every 48 hours." The once-a-day ceiling becomes a once-in-48-hours one. |
| As needed, CrCl under 30 | 5 mg per 72 hours | The label states: "Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours." For once-daily use at this clearance the label instead says CIALIS for once daily use is not recommended. |
| As needed, Child Pugh A or B | 10 mg ceiling | The label states: "Mild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day." For severe hepatic impairment (Child Pugh Class C) the use of CIALIS is not recommended. |
Ceiling. 20 mg as needed, no more than once in a day: "The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability." and "The maximum recommended dosing frequency is once per day in most patients." On the once-daily regimen the ceiling is lower still, 5 mg. Neither figure is a tadalafil maximum — ADCIRCA is 40 mg once daily, every day.
How it is supplied
| Presentation | Total strength | Concentration | Delivers |
|---|---|---|---|
| Almond-shaped tablet, film coated | 5 mg | Not applicable — a solid oral dose form has no concentration | One tablet, debossed "C 5" |
| Almond-shaped tablet, film coated | 10 mg | Not applicable — a solid oral dose form has no concentration | One tablet, debossed "C 10" |
| Almond-shaped tablet, film coated | 20 mg | Not applicable — a solid oral dose form has no concentration | One tablet, debossed "C 20" |
Administration, as the label words it
- —Do not split CIALIS tablets; entire dose should be taken.
- —CIALIS may be taken without regard to food. The label states that the rate and extent of absorption of tadalafil are not influenced by food, the only one of the four oral PDE5 inhibitors with no food effect at all.
- —Concomitant use of nitrates in any form is contraindicated. In a patient who has taken CIALIS, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse after the last dose of CIALIS before nitrate administration is considered.
- —Do not use CIALIS in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including CIALIS, may potentiate the hypotensive effects of GC stimulators.
- —For ED with an alpha-blocker: patients should be stable on alpha-blocker therapy prior to initiating treatment, and CIALIS should be initiated at the lowest recommended dose. For BPH: CIALIS is not recommended for use in combination with alpha-blockers for the treatment of BPH.
- —Inform patients not to take CIALIS with other PDE5 inhibitors, including ADCIRCA.
Storage
- Tablets
- Store at 25 °C (77 °F); excursions permitted to 15–30 °C (59–86 °F). Keep out of reach of children.
- Until the expiration date on the bottle
Children and adolescents
CIALIS is not indicated for use in pediatric patients. Safety and efficacy in patients below the age of 18 years have not been established. A randomized, double-blind, placebo-controlled trial in pediatric patients aged 7 to 14 with Duchenne muscular dystrophy failed to demonstrate any benefit on muscle strength and performance.
This statement belongs to Cialis tablets. It is not a statement about tadalafil, and another brand of the same molecule may say the opposite.
The same molecule under other brand names
Everything below is tadalafil. None of it is Cialis, and a dose from one column carried into another is not a smaller or larger version of the same instruction — it is a different product’s schedule.
| Brand | Form | Approved for | Ladder | Maximum |
|---|---|---|---|---|
| Adcirca | Oral tablet, 20 mg, once daily — two tablets taken together | Pulmonary arterial hypertension (WHO Group 1) in adults, to improve exercise ability | 40 mg once daily; 20 mg once daily in mild or moderate renal or hepatic impairment, or on ritonavir | 40 mg once daily, not divided across the day; avoid entirely below CrCl 30 mL/min |
Switching between products
The two tadalafil brands are not alternatives, and must not be combined
The safety and efficacy of combinations of CIALIS and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied. Inform patients not to take CIALIS with other PDE5 inhibitors, including ADCIRCA.
Cialis and Adcirca
Whole tablets only
Do not split CIALIS tablets; entire dose should be taken.
Cialis
Nitrates are contraindicated, and this is the only PDE5 label that names a number in hours
In a patient who has taken CIALIS, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse after the last dose of CIALIS before nitrate administration is considered.
Cialis
What this page does not tell you
- Price — list, cash or copay
- No price appears anywhere on this page, and no price is emitted in its structured data. Tadalafil is sold as a brand and as many generics, at both an as-needed and a daily regimen whose monthly tablet counts differ by an order of magnitude, at rates that vary by pharmacy and discount card. We could not find a source for a current US figure we could cite and re-verify the way every other number here is cited, so the field is absent rather than estimated.
- How many minutes before sex to take it
- The Cialis label does not say. Its as-needed instruction is "taken prior to anticipated sexual activity" with no number attached — unlike sildenafil ("approximately 1 hour before") and avanafil ("as early as approximately 15 minutes"). The widely repeated "tadalafil works in 30 minutes" appears on this label in no form at all. What the label does give is a time to peak concentration between 30 minutes and 6 hours, median 2 hours, which is a measurement rather than an instruction.
- Which regimen is better
- The label describes two regimens for erectile dysfunction and does not compare them. It gives no head-to-head result, no criterion for choosing and no statement that one is preferred, and the choice turns on how often a man expects to need the drug, how he tolerates it and what his kidney function is. Any ranking printed here would be our opinion wearing a label’s clothes.
- Where the 2.5 mg once-daily tablet comes from
- Section 2.2 recommends 2.5 mg as the once-daily starting dose for erectile dysfunction, section 3 of this label lists only 5, 10 and 20 mg CIALIS tablets, and section 2 forbids splitting. Those three statements cannot all be satisfied by a CIALIS tablet. The 2.5 mg strength is supplied as generic tadalafil; this page says so and stops, because reconciling the sections would mean writing an instruction the label does not contain.
Frequently asked questions
- What is the maximum dose of Cialis?
- 20 mg, and not more than once a day: "The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability" and "The maximum recommended dosing frequency is once per day in most patients." On the once-daily regimen the ceiling is 5 mg. Neither figure is a tadalafil maximum — Adcirca, the same molecule, is 40 mg once daily, every day, for pulmonary arterial hypertension.
- Is Adcirca the same as Cialis?
- Same molecule, different products. Adcirca (NDA022332) is tadalafil for pulmonary arterial hypertension at 40 mg once daily, supplied as an unscored 20 mg orange almond-shaped tablet taken two at a time. Cialis (NDA021368) is tadalafil for erectile dysfunction, benign prostatic hyperplasia, or both, at 2.5 to 20 mg. Each label contraindicates a serious hypersensitivity to the other and tells the patient not to take both.
- Is Cialis taken daily or only before sex?
- Either — the label describes both and treats them as alternatives, not as steps. As needed: 10 mg before anticipated sexual activity, adjustable to 20 mg or 5 mg, at most once a day. Once daily: 2.5 mg at approximately the same time every day, increasable to 5 mg, "without regard to timing of sexual activity". For benign prostatic hyperplasia only the once-daily regimen exists, at 5 mg.
- Does Cialis really last 36 hours?
- The label says something narrower: "CIALIS for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing." That is an efficacy window from one regimen, not a 36-hour erection and not a statement that the drug is at full strength throughout. The mean terminal half-life is 17.5 hours, which is also why both tadalafil labels treat a nitrate as a 48-hour problem.
- Can Cialis tablets be split?
- No. Section 2 of the label opens with the instruction: "Do not split CIALIS tablets; entire dose should be taken." That creates a real puzzle, because section 2.2 recommends 2.5 mg as the once-daily starting dose for erectile dysfunction and section 3 lists only 5, 10 and 20 mg CIALIS tablets. The 2.5 mg strength is supplied as generic tadalafil rather than as Cialis.
- Is Cialis approved for an enlarged prostate?
- Yes — "CIALIS is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)", at 5 mg once daily, and there is a third indication covering ED and BPH together at the same dose. It is the only PDE5 inhibitor in the United States with a urological indication on the same product. The label also caps the finasteride combination: recommended for up to 26 weeks when used to initiate BPH treatment.
- Does food affect Cialis?
- No, and it is the only one of the four oral PDE5 inhibitors of which that is true. The label states: "The rate and extent of absorption of tadalafil are not influenced by food; thus CIALIS may be taken with or without food." For comparison, a high-fat meal delays sildenafil’s peak by a full hour and cuts it by 29%, and reduces vardenafil’s peak by 18% to 50%.
- What dose applies with poor kidney function?
- For the as-needed regimen, creatinine clearance 30 to 50 mL/min gets a 5 mg starting dose with a 10 mg maximum no more than once every 48 hours; below 30 mL/min or on haemodialysis the maximum is 5 mg no more than once every 72 hours. For once-daily use below 30 mL/min the label says CIALIS for once daily use is not recommended. Adcirca, at the same clearance, says to avoid the drug altogether.
Sources
- [1]FDA label — CIALIS (tadalafil) tablets, film coated, for oral use, Eli Lilly and Company. DailyMed SPL version 52, effective 2026-06-03, marketing category NDA, application NDA021368
- [2]FDA label — ADCIRCA (tadalafil) tablet, United Therapeutics Corporation. DailyMed SPL version 34, effective 2025-12-15, marketing category NDA, application NDA022332 — cited for the sibling dosing, the renal instruction and the absence of an alpha-blocker rule
Next steps
- Viagra — the other PDE5 brand with a pulmonary twin
- Tadalafil daily vs on-demand
- ED medication comparison chart — all four PDE5 inhibitors
- Tadalafil: the compound reference
- Propecia — the finasteride the BPH limitation of use refers to
Other brands
- ViagraSildenafil for erectile dysfunction: 25, 50 or 100 mg, once a day at most, and no relation to the sildenafil sold for lung disease.
- OzempicA weekly injection capped at 2 mg and a daily tablet capped at 9 mg, sold under the same brand name and described in two different labels.
- WegovyA once-weekly injection and a once-daily 25 mg tablet sharing one label, one boxed warning and almost nothing else.
- MounjaroTirzepatide for type 2 diabetes and cardiovascular risk, with a conditional ladder, two maximum doses and no named maintenance dose.
- ZepboundTirzepatide for weight reduction and obstructive sleep apnoea, with named maintenance dosages and a 2.5 mg step the label excludes from them.
- PropeciaFinasteride 1 mg once daily for male pattern hair loss, with handling rules that turn entirely on whether the tablet is intact.
Educational reference, not medical advice. Tadalafil is a prescription-only medicine and its use with nitrates in any form is an absolute contraindication. This page reports what two FDA labels state; it does not recommend a dose or a regimen.