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Cialis

Last reviewed on RxList: 5/22/2017
Cialis Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 05/23/2017

Cialis (tadalafil) is a phosphodiesterase inhibitor used for treating impotence (erectile dysfunction, or ED). Common side effects of Cialis include:

  • flushing (redness or warmth of the face, neck, or chest),
  • headaches,
  • stomach upset,
  • diarrhea,
  • flu-like symptoms (such as stuffy nose, sneezing, or sore throat),
  • memory problems,
  • muscle or back pain,
  • nausea,
  • low blood pressure,
  • dizziness,
  • blurred vision and changes in color vision,
  • abnormal ejaculation, and
  • prolonged erections (priapism).

Tell your doctor if you have rare but serious side effects of Cialis including:

  • a painful or prolonged erection lasting 4 or more hours;
  • sudden decreased vision (including permanent blindness, in one or both eyes);
  • a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness.

The recommended dose of Cialis is 5-20 mg per day taken before sexual activity. Cialis may interact with rifamycins, antibiotics, antifungals, antidepressants, barbiturates, drugs to treat high blood pressure or a prostate disorder, heart or blood pressure medications, HIV or AIDS medications or seizure medications. Tell your doctor all medications and supplements you use. Cialis is not approved for use in women and has not been evaluated in women who are breastfeeding.

Our Cialis Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Cialis Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

If you become dizzy or nauseated during sexual activity, or if you have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of tadalafil.

Stop using tadalafil and call your doctor at once if you have any of these serious side effects:

  • changes in vision or sudden vision loss;
  • ringing in your ears, or sudden hearing loss;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • irregular heartbeat;
  • shortness of breath, swelling in your hands or feet;
  • seizure (convulsions);
  • feeling light-headed, fainting; or
  • penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

  • redness or warmth in your face, neck, or chest;
  • cold symptoms such as stuffy nose, sneezing, or sore throat;
  • headache;
  • memory problems;
  • diarrhea, upset stomach; or
  • muscle pain, back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cialis (Tadalafil)

Cialis Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Tadalafil was administered to over 9000 men during clinical trials worldwide. In trials of CIALIS for once daily use, a total of 1434, 905, 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 For Use As Needed For ED

In eight primary placebo-controlled clinical studies of 12 weeks duration, mean age was 59 years (range 22 to 88) and the discontinuation rate due to adverse events in patients treated with tadalafil 10 or 20 mg was 3.1%, compared to 1.4% in placebo treated patients.

When taken as recommended in the placebo-controlled clinical trials, the following adverse reactions were reported (see Table 1) for CIALIS for use as needed:

Table 1: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with CIALIS (10 or 20 mg) and More Frequent on Drug than Placebo in the Eight Primary Placebo-Controlled Clinical Studies (Including a Study in Patients with Diabetes) for CIALIS for Use as Needed for ED

Adverse Reaction Placebo
(N=476)
Tadalafil 5 mg
(N=151)
Tadalafil 10 mg
(N=394)
Tadalafil 20 mg
(N=635)
Headache 5% 11% 11% 15%
Dyspepsia 1% 4% 8% 10%
Back pain 3% 3% 5% 6%
Myalgia 1% 1% 4% 3%
Nasal congestion 1% 2% 3% 3%
Flushinga 1% 2% 3% 3%
Pain in limb 1% 1% 3% 3%
a The term flushing includes: facial flushing and flushing

CIALIS For Once Daily Use For ED

In three placebo-controlled clinical trials of 12 or 24 weeks duration, mean age was 58 years (range 21 to 82) and the discontinuation rate due to adverse events in patients treated with tadalafil was 4.1%, compared to 2.8% in placebotreated patients.

The following adverse reactions were reported (see Table 2) in clinical trials of 12 weeks duration:

Table 2: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with CIALIS for Once Daily Use (2.5 or 5 mg) and More Frequent on Drug than Placebo in the Three Primary Placebo-Controlled Phase 3 Studies of 12 weeks Treatment Duration (Including a Study in Patients with Diabetes) for CIALIS for Once Daily Use for ED

Adverse Reaction Placebo
(N=248)
Tadalafil 2.5 mg
(N=196)
Tadalafil 5 mg
(N=304)
Headache 5% 3% 6%
Dyspepsia 2% 4% 5%
Nasopharyngitis 4% 4% 3%
Back pain 1% 3% 3%
Upper respiratory tract infection 1% 3% 3%
Flushing 1% 1% 3%
Myalgia 1% 2% 2%
Cough 0% 4% 2%
Diarrhea 0% 1% 2%
Nasal congestion 0% 2% 2%
Pain in extremity 0% 1% 2%
Urinary tract infection 0% 2% 0%
Gastroesophageal reflux disease 0% 2% 1%
Abdominal pain 0% 2% 1%

The following adverse reactions were reported (see Table 3) over 24 weeks treatment duration in one placebocontrolled clinical study:

Table 3: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with CIALIS for Once Daily Use (2.5 or 5 mg) and More Frequent on Drug than Placebo in One Placebo-Controlled Clinical Study of 24 Weeks Treatment Duration for CIALIS for Once Daily Use for ED

Adverse Reaction Placebo
(N=94)
Tadalafil 2.5 mg
(N=96)
Tadalafil 5 mg
(N=97)
Nasopharyngitis 5% 6% 6%
Gastroenteritis 2% 3% 5%
Back pain 3% 5% 2%
Upper respiratory tract infection 0% 3% 4%
Dyspepsia 1% 4% 1%
Gastroesophageal reflux disease 0% 3% 2%
Myalgia 2% 4% 1%
Hypertension 0% 1% 3%
Nasal congestion 0% 0% 4%

CIALIS For Once Daily Use For BPH And For ED And BPH

In three placebo-controlled clinical trials of 12 weeks duration, two in patients with BPH and one in patients with ED and BPH, the mean age was 63 years (range 44 to 93) and the discontinuation rate due to adverse events in patients treated with tadalafil was 3.6% compared to 1.6% in placebo-treated patients. Adverse reactions leading to discontinuation reported by at least 2 patients treated with tadalafil included headache, upper abdominal pain, and myalgia. The following adverse reactions were reported (see Table 4).

Table 4: Treatment-Emergent Adverse Reactions Reported by ≥1% of Patients Treated with CIALIS for Once Daily Use (5 mg) and More Frequent on Drug than Placebo in Three Placebo-Controlled Clinical Studies of 12 Weeks Treatment Duration, including Two Studies for CIALIS for Once Daily Use for BPH and One Study for ED and BPH

Adverse Reaction Placebo
(N=576)
Tadalafil 5 mg
(N=581)
Headache 2.3% 4.1%
Dyspepsia 0.2% 2.4%
Back pain 1.4% 2.4%
Nasopharyngitis 1.6% 2.1%
Diarrhea 1.0% 1.4%
Pain in extremity 0.0% 1.4%
Myalgia 0.3% 1.2%
Dizziness 0.5% 1.0%

Additional, less frequent adverse reactions (<1%) reported in the controlled clinical trials of CIALIS for BPH or ED and BPH included: gastroesophageal reflux disease, upper abdominal pain, nausea, vomiting, arthralgia, and muscle spasm.

Back pain or myalgia was reported at incidence rates described in Tables 1 through 4. In tadalafil clinical pharmacology trials, back pain or myalgia generally occurred 12 to 24 hours after dosing and typically resolved within 48 hours. The back pain/myalgia associated with tadalafil treatment was characterized by diffuse bilateral lower lumbar, gluteal, thigh, or thoracolumbar muscular discomfort and was exacerbated by recumbency. In general, pain was reported as mild or moderate in severity and resolved without medical treatment, but severe back pain was reported with a low frequency (<5% of all reports). When medical treatment was necessary, acetaminophen or non-steroidal anti-inflammatory drugs were generally effective; however, in a small percentage of subjects who required treatment, a mild narcotic (e.g., codeine) was used. Overall, approximately 0.5% of all subjects treated with CIALIS for on demand use discontinued treatment as a consequence of back pain/myalgia. In the 1-year open label extension study, back pain and myalgia were reported in 5.5% and 1.3% of patients, respectively. Diagnostic testing, including measures for inflammation, muscle injury, or renal damage revealed no evidence of medically significant underlying pathology. Incidence rates for CIALIS for once daily use for ED, BPH and BPH/ED are described in Tables 2, 3 and 4. In studies of CIALIS for once daily use, adverse reactions of back pain and myalgia were generally mild or moderate with a discontinuation rate of <1% across all indications.

Across placebo-controlled studies with CIALIS for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with CIALIS (2.5% of patients) [see Use In Specific Populations].

Across all studies with any CIALIS dose, reports of changes in color vision were rare (<0.1% of patients). The following section identifies additional, less frequent events (<2%) reported in controlled clinical trials of CIALIS for once daily use or use as needed. A causal relationship of these events to CIALIS is uncertain. Excluded from this list are those events that were minor, those with no plausible relation to drug use, and reports too imprecise to be meaningful:

Body as a Wholeasthenia, face edema, fatigue, pain, peripheral edema

Cardiovascularangina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardia

Digestive – abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting, gastroesophageal reflux disease, hemorrhoidal hemorrhage, rectal hemorrhage

Musculoskeletal – arthralgia, neck pain

Nervous – dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo

Renal and Urinary – renal impairment

Respiratorydyspnea, epistaxis, pharyngitis

Skin and Appendagespruritus, rash, sweating

Ophthalmologic – blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increase, swelling of eyelids

Otologic – sudden decrease or loss of hearing, tinnitus

Urogenital – erection increased, spontaneous penile erection

Postmarketing Experience

The following adverse reactions have been identified during post approval use of CIALIS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors.

Cardiovascular and Cerebrovascular – Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported postmarketing in temporal association with the use of tadalafil. Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of CIALIS without sexual activity. Others were reported to have occurred hours to days after the use of CIALIS and sexual activity. It is not possible to determine whether these events are related directly to CIALIS, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors [see WARNINGS AND PRECAUTIONS].

Body as a Whole – hypersensitivity reactions including urticaria, Stevens-Johnson syndrome, and exfoliative dermatitis

Nervousmigraine, seizure and seizure recurrence, transient global amnesia

Ophthalmologicvisual field defect, retinal vein occlusion, retinal artery occlusion

Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of PDE5 inhibitors, including CIALIS. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking [see WARNINGS AND PRECAUTIONS].

Otologic – Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including CIALIS. 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. It is not possible to determine whether these reported events are related directly to the use of CIALIS, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see WARNINGS AND PRECAUTIONS].

Urogenitalpriapism [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Cialis (Tadalafil)

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© Cialis Patient Information is supplied by Cerner Multum, Inc. and Cialis Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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