Cialis Side Effects

Generic name: tadalafil

Note: This page contains information about the side effects of tadalafil. Some of the dosage forms included on this document may not apply to the brand name Cialis.

In Summary

Common side effects of Cialis include: dyspepsia and headache. Other side effects include: upper respiratory tract infection, back pain, myalgia, cough, and nasal congestion. See below for a comprehensive list of adverse effects.

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For the Consumer

Applies to tadalafil: oral tablet

In addition to its needed effects, some unwanted effects may be caused by tadalafil (the active ingredient contained in Cialis). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking tadalafil:

Less common: Rare Incidence not known:
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Minor Side Effects

Some of the side effects that can occur with tadalafil may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common: Less common: Rare

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For Healthcare Professionals

Applies to tadalafil: oral tablet

General

The most commonly reported adverse reactions were headache, nausea, dyspepsia, back pain, myalgia, flushing, nasopharyngitis, and pain in the extremity. These adverse reactions were dose dependent, transient, and generally mild or moderate.[Ref]

Cardiovascular

Most patients that experienced side effects such as myocardial infarction, sudden cardiac death, stroke, palpitations, and tachycardia had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity.[Ref]

Very common (10% or more): Flushing (up to 14%)
Common (1% to 10%): Hypertension, hot flush
Uncommon (0.1% to 1%): Hypotension
Frequency not reported: Unstable angina pectoris, postural hypotension, ventricular arrhythmia
Postmarketing reports: Myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported in temporal association with the use of this drug.[Ref]

Gastrointestinal

Very common (10% or more): Dyspepsia (up to 13%), nausea (up to 11%)
Common (1% to 10%): Diarrhea, gastroesophageal reflux disease, abdominal pain, gastroenteritis, constipation
Uncommon (0.1% to 1%): Vomiting
Frequency not reported: Dry mouth, dysphagia, esophagitis, gastritis, loose stools, nausea, upper abdominal pain, hemorrhoidal hemorrhage, rectal hemorrhage[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (up to 14%), back pain (up to 12%), pain in extremity (up to 11%)
Common (1% to 10%): Pain in limb, musculoskeletal stiffness
Uncommon (0.1% to 1%): Arthralgia, muscle spasm
Frequency not reported: Neck pain[Ref]

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Nervous system

Very common (10% or more): Headache (up to 42%)
Common (1% to 10%): Dizziness (1%)
Rare (less than 0.1%): Transient global amnesia, transient ischemic attacks
Frequency not reported: Hypesthesia, somnolence, syncope, paraesthesia
Postmarketing reports: Migraine, seizure and seizure recurrence[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (up to 13%), upper and lower respiratory tract infection (up to 13%)
Common (1% to 10%): Nasal congestion (including sinus congestion), cough, influenza, pulmonary hypertension, rhinitis
Uncommon (0.1% to 1%): Dyspnea, epistaxis
Frequency not reported: Pharyngitis[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, menorrhagia (including uterine bleeding)
Uncommon (0.1% to 1%): Penile hemorrhage, hematospermia
Rare (less than 0.1%): Prolonged erections
Frequency not reported: Erection increased, spontaneous penile erection
Postmarketing reports: Priapism[Ref]

Other

In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited.[Ref]

Common (1% to 10%): Peripheral edema, fatigue, edema
Uncommon (0.1% to 1%): Tinnitus
Rare (less than 0.1%): Facial edema
Frequency not reported: Vertigo, asthenia, pain
Postmarketing reports: Cases of sudden decrease or loss of hearing have been reported in temporal association with the use of this drug.[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, urticaria, hyperhidrosis (sweating)
Rare (less than 0.1%): Angioedema
Frequency not reported: Pruritus
Postmarketing reports: Stevens-Johnson syndrome, exfoliative dermatitis[Ref]

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Ocular

Most of the patients with NAION, but not all, had underlying anatomic or vascular risk factors, including but not necessarily limited to: Low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking.[Ref]

Uncommon (0.1% to 1%): Ocular hyperemia, eye pain, eyelid edema
Rare (less than 0.1%): Changes in color vision
Frequency not reported: Blurred vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increased
Postmarketing reports: Visual field defect, retinal vein occlusion, and retinal artery occlusion. Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported in temporal association with the use of this drug.[Ref]

Renal

Uncommon (0.1% to 1%): Hematuria
Frequency not reported: Renal impairment[Ref]

Hepatic

Frequency not reported: Abnormal liver function tests, GGTP increased[Ref]

References

1. "Product Information. Cialis (tadalafil)." Lilly, Eli and Company, Indianapolis, IN.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. "Product Information. Adcirca (tadalafil)." United Therapeutics Corporation, Silver Spring, MD.

5. Kloner RA, Mitchell M, Emmick JT "Cardiovascular effects of tadalafil." Am J Cardiol 92(9 Suppl) (2003): 37-46

6. Kloner RA, Mitchell M, Emmick JT "Cardiovascular effects of tadalafil in patients on common antihypertensive therapies." Am J Cardiol 92(9A) (2003): 47M-57M

Not all side effects for Cialis may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.