Once daily use is not recommended.See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 3/2026 CIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 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). CIALIS for use as needed: ED: Starting dose: 10 mg as needed prior to sexual activity.

8.1 Pregnancy

2 DOSAGE AND ADMINISTRATION Do not split CIALIS tablets; entire dose should be taken.2.1 CIALIS for Use as Needed for Erectile DysfunctionThe recommended starting dose of CIALIS for use as needed in most patients is 10 mg, taken prior to anticipated sexual 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.CIALIS for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of CIALIS, this should be taken into consideration.2.2 CIALIS for Once Daily Use for Erectile DysfunctionThe 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.The CIALIS dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.2.3 CIALIS for Once Daily Use for Benign Prostatic HyperplasiaThe recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day.When therapy for BPH is initiated with CIALIS and finasteride, the recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks.2.4 CIALIS for Once Daily Use for Erectile Dysfunction and Benign Prostatic HyperplasiaThe 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.2.6 Use in Specific PopulationsRenal ImpairmentCIALIS for Use as NeededCreatinine 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.Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)].CIALIS for Once Daily UseBenign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic HyperplasiaCreatinine clearance 30 to 50 mL/min: A starting dose of 2.5 mg is recommended. An increase to 5 mg may be considered based on individual response.Creatinine clearance less than 30 mL/min or on hemodialysis: CIALIS for once daily use is not recommended [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)].Hepatic ImpairmentCIALIS for Use as NeededMild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day. The use of CIALIS once per day has not been extensively evaluated in patients with hepatic impairment and therefore, caution is advised.Severe (Child Pugh Class C): The use of CIALIS is not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)].CIALIS for Once Daily UseMild or moderate (Child Pugh Class A or B): CIALIS for once daily use has not been extensively evaluated in patients with hepatic impairment.

Related treatment guides

Not to be taken more than once per day (2.1). ED: Starting dose: 10 mg as needed prior to sexual activity. CIALIS may be taken without regard to food (2.5). Administration of CIALIS to patients using any form of organic nitrate is contraindicated.

• For BPH, Cialis 5 mg daily improves urinary flow rate.
• Reduces frequency and urgency of urination.
• Also decreases nocturia (waking up to urinate at night).
• Clinical efficacy measured by IPSS (International Prostate Symptom Score).
• Improvement typically seen within 1-4 weeks of daily use.
• Long-term safety shown in up to 1-year studies.
• Does not reduce PSA levels; continue prostate cancer screening.
• May be used alone or with other BPH medications.

CIALIS was shown to potentiate the hypotensive effect of nitrates (4.1).

History of known serious hypersensitivity reaction to CIALIS or ADCIRCA® (4.2).

7.1 Potential for Pharmacodynamic Interactions with CIALIS

Once daily use is not recommended.See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 3/2026 CIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 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). CIALIS for use as needed: ED: Starting dose: 10 mg as needed prior to sexual activity. Not to be taken more than once per day (2.1). ED: Starting dose: 10 mg as needed prior to sexual activity. CIALIS may be taken without regard to food (2.5).

Benign prostatic hyperplasia

Administration of CIALIS to patients using any form of organic nitrate is contraindicated. CIALIS was shown to potentiate the hypotensive effect of nitrates (4.1). History of known serious hypersensitivity reaction to CIALIS or ADCIRCA® (4.2). Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3). Patients should not use CIALIS if sex is inadvisable due to cardiovascular status (5.1). Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3). Patients should not use CIALIS if sex is inadvisable due to cardiovascular status (5.1).

8.5 Geriatric Use

Related Products

Use of CIALIS with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension (5.6, 5.9).

• Common side effects include muscle aches and indigestion.
• Cialis 5 mg offers the convenience of a once-daily dose.
• Patients should avoid sudden standing movements due to possible dizziness.
• The medication is not a cure but helps achieve and maintain an erection.

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.

7.3 Potential for CIALIS to Affect Other Drugs

ketoconazole, ritonavir) increase CIALIS exposure (2.7, 5.10, 7.2) requiring dose adjustment: CIALIS for use as needed: no more than 10 mg every 72 hoursCIALIS for once daily use: dose not to exceed 2.5 mg 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 Hepatic Impairment (2.6, 5.8, 8.6): Mild or Moderate: Dosage adjustment may be needed. Renal Impairment (2.6, 5.7, 8.7): Patients with creatinine clearance 30 to 50 mL/min: Dosage adjustment may be needed. Patients with creatinine clearance less than 30 mL/min or on hemodialysis: For use as needed: Dose should not exceed 5 mg every 72 hours. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE1.1 Erectile Dysfunction1.2 Benign Prostatic Hyperplasia1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia1.4 Limitation of Use2 DOSAGE AND ADMINISTRATION2.1 CIALIS for Use as Needed for Erectile Dysfunction2.2 CIALIS for Once Daily Use for Erectile Dysfunction2.3 CIALIS for Once Daily Use for Benign Prostatic Hyperplasia2.4 CIALIS for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia2.5 Use with Food2.6 Use in Specific Populations2.7 Concomitant Medications3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Hypersensitivity Reactions4.3 Concomitant Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Potential for Drug Interactions When Taking CIALIS for Once Daily Use5.3 Prolonged Erection5.4 Effects on the Eye5.5 Sudden Hearing Loss5.6 Alpha-blockers and Antihypertensives5.7 Renal Impairment5.8 Hepatic Impairment5.9 Alcohol5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)5.11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies5.12 Effects on Bleeding5.13 Counseling Patients About Sexually Transmitted Diseases5.14 Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with CIALIS7.2 Potential for Other Drugs to Affect CIALIS7.3 Potential for CIALIS to Affect Other Drugs8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.3 Females and Males of Reproductive Potential8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility13.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES14.1 CIALIS for Use as Needed for ED14.2 CIALIS for Once Daily Use for ED14.3 CIALIS 5 mg for Once Daily Use for Benign Prostatic Hyperplasia (BPH)14.4 CIALIS 5 mg for Once Daily Use for ED and BPH16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage17 PATIENT COUNSELING INFORMATION17.1 Nitrates17.2 Guanylate Cyclase (GC) Stimulators17.3 Cardiovascular Considerations17.4 Concomitant Use with Drugs Which Lower Blood Pressure17.5 Potential for Drug Interactions When Taking CIALIS for Once Daily Use17.6 Priapism17.7 Sudden Loss of Vision17.8 Sudden Hearing Loss17.9 Alcohol17.10 Sexually Transmitted Disease17.11 Recommended Administration*Sections or subsections omitted from the full prescribing information are not listed.

Alternatives for benign prostatic hyperplasia (BPH)

Sections or subsections omitted from the full prescribing information are not listed. 1 INDICATIONS AND USAGE 1.2 Benign Prostatic HyperplasiaCIALIS is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).1.3 Erectile Dysfunction and Benign Prostatic HyperplasiaCIALIS is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).1.4 Limitation of UseIf 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 [see Clinical Studies (14.3)]. 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). 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 [see Clinical Studies (14.3)]. (2.7, 5.6, 7.1, 12.2) Patients should seek emergency treatment if an erection lasts >4 hours. Use CIALIS with caution in patients predisposed to priapism (5.3). Patients should stop CIALIS and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Patients with a "crowded" optic disc may also be at an increased risk of NAION (5.4, 6.2). Patients should stop CIALIS and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.5). Prior to initiating treatment with CIALIS for BPH, consideration should be given to other urological conditions that may cause similar symptoms (5.14).

Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in cialis no perscription limb (6.1).

5.8 Hepatic Impairment

To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or CIALIS can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol (7.1). ketoconazole, ritonavir) increase CIALIS exposure (2.7, 5.10, 7.2) requiring dose adjustment: CIALIS for use as needed: no more than 10 mg every 72 hoursCIALIS for once daily use: dose not to exceed 2.5 mg 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 Hepatic Impairment (2.6, 5.8, 8.6): Mild or Moderate: Dosage adjustment may be needed.

5.2 Potential for Drug Interactions When Taking CIALIS for Once Daily Use

Renal Impairment (2.6, 5.7, 8.7): Patients with creatinine clearance 30 to 50 mL/min: Dosage adjustment may be needed. Patients with creatinine clearance less than 30 mL/min or on hemodialysis: For use as needed: Dose should not exceed 5 mg every 72 hours. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE1.1 Erectile Dysfunction1.2 Benign Prostatic Hyperplasia1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia1.4 Limitation of Use2 DOSAGE AND ADMINISTRATION2.1 CIALIS for Use as Needed for Erectile Dysfunction2.2 CIALIS for Once Daily Use for Erectile Dysfunction2.3 CIALIS for Once Daily Use for Benign Prostatic Hyperplasia2.4 CIALIS for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia2.5 Use with Food2.6 Use in Specific Populations2.7 Concomitant Medications3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Hypersensitivity Reactions4.3 Concomitant Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Potential for Drug Interactions When Taking CIALIS for Once Daily Use5.3 Prolonged Erection5.4 Effects on the Eye5.5 Sudden Hearing Loss5.6 Alpha-blockers and Antihypertensives5.7 Renal Impairment5.8 Hepatic Impairment5.9 Alcohol5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)5.11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies5.12 Effects on Bleeding5.13 Counseling Patients About Sexually Transmitted Diseases5.14 Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with CIALIS7.2 Potential for Other Drugs to Affect CIALIS7.3 Potential for CIALIS to Affect Other Drugs8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.3 Females and Males of Reproductive Potential8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility13.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES14.1 CIALIS for Use as Needed for ED14.2 CIALIS for Once Daily Use for ED14.3 CIALIS 5 mg for Once Daily Use for Benign Prostatic Hyperplasia (BPH)14.4 CIALIS 5 mg for Once Daily Use for ED and BPH16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage17 PATIENT COUNSELING INFORMATION17.1 Nitrates17.2 Guanylate Cyclase (GC) Stimulators17.3 Cardiovascular Considerations17.4 Concomitant Use with Drugs Which Lower Blood Pressure17.5 Potential for Drug Interactions When Taking CIALIS for Once Daily Use17.6 Priapism17.7 Sudden Loss of Vision17.8 Sudden Hearing Loss17.9 Alcohol17.10 Sexually Transmitted Disease17.11 Recommended Administration*Sections or subsections omitted from the full prescribing information are not listed. Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS AND USAGE 1.2 Benign Prostatic HyperplasiaCIALIS is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).1.3 Erectile Dysfunction and Benign Prostatic HyperplasiaCIALIS is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).1.4 Limitation of UseIf 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 [see Clinical Studies (14.3)].

• Cialis 5 mg is designed for once-daily use for ongoing erectile issues.
• It is available in tablet form in pharmacies with a prescription.
• Cialis 5 mg may be covered by some health insurance plans.
• Proper storage of Cialis 5 mg involves keeping it in a cool, dry place.

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). 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 [see Clinical Studies (14.3)]. 2 DOSAGE AND ADMINISTRATION Do not split CIALIS tablets; entire dose should be taken.2.1 CIALIS for Use as Needed for Erectile DysfunctionThe recommended starting dose of CIALIS for use as needed in most patients is 10 mg, taken prior to anticipated sexual 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.CIALIS for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of CIALIS, this should be taken into consideration.2.2 CIALIS for Once Daily Use for Erectile DysfunctionThe 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.The CIALIS dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.2.3 CIALIS for Once Daily Use for Benign Prostatic HyperplasiaThe recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day.When therapy for BPH is initiated with CIALIS and finasteride, the recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks.2.4 CIALIS for Once Daily Use for Erectile Dysfunction and Benign Prostatic HyperplasiaThe 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.2.6 Use in Specific PopulationsRenal ImpairmentCIALIS for Use as NeededCreatinine 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.Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)].CIALIS for Once Daily UseBenign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic HyperplasiaCreatinine clearance 30 to 50 mL/min: A starting dose of 2.5 mg is recommended. An increase to 5 mg may be considered based on individual response.Creatinine clearance less than 30 mL/min or on hemodialysis: CIALIS for once daily use is not recommended [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)].Hepatic ImpairmentCIALIS for Use as NeededMild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day. The use of CIALIS once per day has not been extensively evaluated in patients with hepatic impairment and therefore, caution is advised.Severe (Child Pugh Class C): The use of CIALIS is not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)].CIALIS for Once Daily UseMild or moderate (Child Pugh Class A or B): CIALIS for once daily use has not been extensively evaluated in patients with hepatic impairment.

16.2 Storage

Use of CIALIS with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension (5.6, 5.9). 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. (2.7, 5.6, 7.1, 12.2) Patients should seek emergency treatment if an erection lasts >4 hours. Use CIALIS with caution in patients predisposed to priapism (5.3). Patients should stop CIALIS and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION).

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Patients with a "crowded" optic disc may also be at an increased risk of NAION (5.4, 6.2). Patients should stop CIALIS and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.5). Prior to initiating treatment with CIALIS for BPH, consideration should be given to other urological conditions that may cause similar symptoms (5.14). Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in cialis no perscription limb (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or CIALIS can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol (7.1).