Cialis 5 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 once daily use, a total of 1434, 905, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively.
Tadalafil (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 placebo-treated patients.
The following adverse reactions were reported (see Table 7) in clinical trials of 12 weeks duration: See Table 7.

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The following adverse reactions were reported (see Table 8) over 24 weeks treatment duration in one placebo-controlled clinical study: See Table 8.

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Tadalafil (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 9).

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Additional, less frequent adverse reactions (<1%) reported in the controlled clinical trials of Tadalafil (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 7 through 9. 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. 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 Tadalafil (Cialis) for once daily use for ED, BPH and BPH/ED are described in Table 7-9. In studies of Tadalafil (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 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. 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.
Post-marketing 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 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 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 urticaria, Stevens-Johnson syndrome, and exfoliative dermatitis.
Nervous: 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 post-marketing 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 post-marketing 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).