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Safety Profile

CIALIS has been administered to over 6550 men in worldwide clinical trials. In trials of CIALIS for once daily use, a total of 716, 389, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively. For CIALIS for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively.


CIALIS was generally well tolerated in clinical trials*

Most common adverse events
  • Discontinuation rate due to adverse events for patients taking CIALIS as needed was 3.1%1
  • Discontinuation rate due to adverse events for patients taking CIALIS once daily was 4.1%1

Not studied in head-to-head trials.

Cardiovascular safety
Pooled results from 36 controlled and open-label clinical trials are presented in the table below. Doses of CIALIS ranged from 2 mg to 50 mg, with most patients receiving 20 mg. Patients were excluded from trials if they had an underlying cardiovascular disorder sufficiently severe or unstable to make sexual intercourse inadvisable.2

Myocardial infarction (MI) rates with CIALIS were comparable to placeboost common adverse events
  • CIALIS taken as needed n=12,978; CIALIS taken once daily n=10772
  • The incidence of serious cardiovascular treatment-emergent adverse events with CIALIS taken once daily was comparable to placebo§2
  • In a clinical trial, there was one reported MI in a patient taking CIALIS 2.5 mg once daily3

Important Safety Information for CIALIS

Indication
CIALIS® (tadalafil) is indicated for the treatment of erectile dysfunction.

Dosage and Administration
  • CIALIS for use as needed. Starting dose: 10 mg up to once daily. 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
  • CIALIS for once daily use. Starting dose: 2.5 mg taken once daily, without regard to timing of sexual activity. May increase to 5 mg based upon efficacy and tolerability
  • Renal Insufficiency:
    • Moderate: For use as needed: Dosage adjustment may be needed. For once daily use: No dose adjustment is needed
    • Severe: For use as needed: Dose should not exceed 5 mg every 72 hours. Once daily use is not recommended
  • Hepatic Impairment:
    • Mild or Moderate: Dosage adjustment may be needed
    • Severe: Use is not recommended
  • Concomitant use of potent inhibitors of CYP3A4 (e.g., ketoconazole, ritonavir, itraconazole): limited to CIALIS 10 mg for use as needed once every 72 hours. Dosing should not exceed 2.5 mg for CIALIS for once daily use
  • When CIALIS is co-administered with an alpha blocker, patients should be stable on alpha-blocker therapy prior to initiating treatment with CIALIS, and CIALIS should be initiated at the lowest recommended dose
Contraindications
  • Administration of CIALIS to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. Use of CIALIS with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, MI, or stroke
Warnings and Precautions
  • Since there is a degree of cardiac risk associated with sexual activity, treatments for erectile dysfunction, including CIALIS, should not be used if sexual activity is inadvisable
  • Patients with left ventricular outflow obstruction (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors
  • CIALIS was not studied and is not recommended in patients who have recently suffered a heart attack (within 90 days) or stroke (within 6 months), or patients with uncontrolled hypertension, hypotension, uncontrolled arrhythmias, heart failure (NYHA ≥Class 2 in last 6 months), unstable angina or angina occurring during sexual activity, severe liver impairment, or hereditary degenerative retinal disorders including retinitis pigmentosa
  • PDE5 inhibitors, including CIALIS, are mild systemic vasodilators. While this effect should not be of consequence in most patients, physicians should consider this potential when prescribing CIALIS
  • CIALIS for once daily use provides continuous plasma tadalafil levels which should be considered when evaluating the potential for interactions with medications (e.g., nitrates, alpha-blockers, anti-hypertensives and potent inhibitors of CYP3A4) and with substantial consumption of alcohol
  • There have been rare reports of erections lasting more than 4 hours or priapism with this class of compounds. Patients should be advised to seek immediate medical attention should this occur. CIALIS should be used with caution in patients who have conditions that might predispose them to priapism
  • Non-arteritic anterior ischemic optic neuropathy (NAION) has been reported rarely post-marketing in temporal association with the use of PDE5 inhibitors, including CIALIS. Physicians should consider that the risk of NAION may be increased in patients with a history of NAION. Patients should stop use of all PDE5 inhibitors and seek medical attention in the event of a sudden decrease or loss in vision in one or both eyes
  • Sudden decrease or loss of hearing has been reported rarely in temporal association with use of PDE5 inhibitors, including CIALIS. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors. Physicians should advise patients to stop taking PDE5 inhibitors, including CIALIS, and seek prompt medical attention in the event of sudden decrease or loss of hearing
  • Due to potential increased blood-pressure-lowering effects, caution is advised when PDE5 inhibitors, including CIALIS, are co-administered with alpha blockers
  • Alcohol is a mild vasodilator. Substantial consumption of alcohol (5 units or greater) in combination with CIALIS can increase the potential for orthostatic signs and symptoms
Adverse Reactions
  • Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb

For complete safety profile and other important prescribing considerations, see the full Prescribing Information.

  1. *Safety profile demonstrated in more than 5700 subjects in worldwide trials.
  2. †Treatment-emergent adverse events reported by ≥2% of patients treated with CIALIS (20 mg) and more frequent on drug than placebo in 8 primary, placebo-controlled, Phase 3 studies (including a study in patients with diabetes).
  3. ‡Treatment-emergent adverse events reported by ≥2% of patients treated with CIALIS (2.5 and 5 mg) and more frequent on drug than placebo in the primary, placebo-controlled, Phase 3 studies (including a study in patients with diabetes) for CIALIS for once daily use.
  4. §Serious CVTEAEs included MI, cardiovascular death, and cerebrovascular death (no cerebrovascular deaths occurred).
  1. Cialis [package insert]. Indianapolis, Ind: Eli Lilly and Company; February 2008.
  2. Kloner RA, Jackson G, Hutter AM, et al. Cardiovascular safety update of tadalafil: retrospective analysis of data from placebo-controlled and open-label clinical trials of tadalafil with as needed, three times-per-week or once-a-day dosing. Am J Cardiol. 2006;97:1778-1784.
  3. Rajfer J, Aliotta PJ, Steidle CP, et al. Tadalafil dosed once a day in men with erectile dysfunction: a randomized, double-blind, placebo-controlled study in the US. Int J Impot Res. 2007;19:95-103.
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