Tadalafil is a phosphodiesterase 5 inhibitor indicated for the treatment of erectile dysfunction (ED) the signs and symptoms of benign prostatic hyperplasia (BPH), among other approved uses. It is available as tablets and oral suspension. MedsAcross supplies Tadalafil for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
CIALIS ® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) the signs and symptoms of benign prostatic hyperplasia (BPH). ED and the signs and symptoms of BPH (ED/BPH). If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks.
Source: US FDA prescribing information
Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum. The inhibition of phosphodiesterase type 5 (PDE5) enhances erectile function by increasing the amount of cGMP. Tadalafil inhibits PDE5. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 by tadalafil has no effect in the absence of sexual stimulation.
Source: US FDA prescribing information
Do not split CIALIS tablets, entire dose should be taken. CIALIS for use as needed: ED: Starting dose: 10 mg as needed prior to sexual activity. Increase to 20 mg or decrease to 5 mg based upon efficacy/tolerability. Improves erectile function compared to placebo up to 36 hours post dose. Not to be taken more than once per day. CIALIS for once daily use: ED: 2.5 mg taken once daily, without regard to timing of sexual activity. May increase to 5 mg based upon efficacy and tolerability. BPH: 5 mg, taken at approximately the same time every day. ED and BPH: 5 mg, taken at approximately the same time every day. CIALIS may be taken without regard to food.
Source: US FDA prescribing information
Administration of CIALIS to patients using any form of organic nitrate is contraindicated. CIALIS was shown to potentiate the hypotensive effect of nitrates. History of known serious hypersensitivity reaction to CIALIS or ADCIRCA ®. Administration with guanylate cyclase (GC) stimulators, such as riociguat.
Source: US FDA prescribing information
Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. Before prescribing CIALIS, it is important to note the following: Patients should not use CIALIS if sex is inadvisable due to cardiovascular status. Use of CIALIS with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension. CIALIS is not recommended in combination with alpha-blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering. Caution is advised when CIALIS is used as a treatment for ED in men taking alpha-blockers. Patients should seek emergency treatment if an erection lasts >4 hours. Use CIALIS with caution in patients predisposed to priapism.
Source: US FDA prescribing information
Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb.
Source: US FDA prescribing information
CIALIS can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol. CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) increase CIALIS exposure requiring dose adjustment: 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.
Source: US FDA prescribing information
Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
10 presentations of Tadalafil, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Tadalafil 20 mg tabletOralGeneric name | — | US FDA | Available on request |
| Tadalafil 5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Tadalafil 10 mg tabletOralGeneric name | — | US FDA | Available on request |
| Tadalafil 2.5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Adcirca 20 mg tabletOral | United Therapeutics | US FDA | Available on request |
| Alyq 20 mg tabletOral | Teva Pharmaceuticals | US FDA | Available on request |
| Cialis 10 mg tabletOral | Eli Lilly | US FDA | Available on request |
| Cialis 20 mg tabletOral | Eli Lilly | US FDA | Available on request |
| Cialis 5 mg tabletOral | Eli Lilly | US FDA | Available on request |
| Tadliq 20 mg/5 mL oral suspensionOral | CMP Pharma | US FDA | Available on request |
4 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Tadalafil in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 10 presentations of Tadalafil and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 4 brand names for Tadalafil, including Adcirca, Alyq, Cialis, Tadliq.
Yes. The US FDA first approved Tadalafil on 21 November 2003, according to Drugs@FDA.
Yes. Tadalafil has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Tadalafil is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tadalafil is classified under ATC code G04BE08 (Tadalafil).
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