Cialis 20 mg Adverse Reactions

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 Tadalafil (Cialis) for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively.
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 5) for Tadalafil (Cialis) for use as needed: (see Table 5).

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Across placebo-controlled studies with Tadalafil (Cialis) for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with Tadalafil (Cialis) (2.5% of patients) (see Use in Specific Populations under Dosage & Administration).
Across all studies with any Tadalafil (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 Tadalafil (Cialis) for once daily use or use as needed. A causal relationship of these events to Tadalafil (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 Whole: asthenia, face edema, fatigue, pain, peripheral edema.
Cardiovascular: angina 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.
Respiratory: dyspnea, epistaxis, pharyngitis.
Skin and Appendages: pruritus, 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 Tadalafil (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 post marketing in temporal association with the use of tadalafil. Most, but not all, of these patients had pre-existing 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 Tadalafil (Cialis) without sexual activity. Others were reported to have occurred hours to days after the use of Tadalafil (Cialis) and sexual activity. It is not possible to determine whether these events are related directly to Tadalafil (Cialis), to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors, or to other factors (see Precautions).
Body as a Whole: hypersensitivity reactions including rash, urticaria, Stevens-Johnson syndrome, and exfoliative dermatitis.
Nervous System: migraine, seizure and seizure recurrence, transient global amnesia.
Ophthalmologic: visual 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 Tadalafil (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 Precautions).
Otologic: Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including Tadalafil (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 Tadalafil (Cialis), to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors (see Precautions).
Urogenital: priapism (see Precautions).