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In many cases, medical follow-up information was limited. 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 recumbancy. reported for Cialis for use as needed: Table 1: Treatment-Emergent Adverse Events 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 Phase 3 Studies (Including a Study in Patients with Diabetes) for Cialis for Use as Needed a The term flushing includes: facial flushing and flushing Adverse Event 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% Cialis for Once Daily Use In three placebo-controlled Phase 3 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 events were reported in clinical trials of 12 weeks duration: Table 2: Treatment-Emergent Adverse Events Reported by ≥2% of Patients Treated with Cialis for Once Daily viagra sildenafil cialis tadalafil dosage use (2.5 or 5 mg) and More Frequent on Drug than Placebo in the Three Primary Placebo-Controlled Phase 3 Studies at 12 weeks (Including a Study in Patients with Diabetes) for Cialis for Once Daily Use Adverse Event Placebo (N=248) Tadalafil 2.5 mg (N=196) Tadalafil 5 mg (N=304) Headache 5% 3% 6% Dyspepsia 2% 3% 5% Nasopharyngitis 4% 4% 3% Back pain 1% 3% 3% Upper respiratory tract infection 1% 3% 3% Flushing 1% 1% 3% Influenza 2% 3% 2% Myalgia 1% 2% 2% Cough 0% 4% 2% Diarrhea 0% 1% 2% Nasal congestion 0% 2% 2% Pain in extremity 0% 1% 2% Bronchitis 1% 2% 0% Urinary tract infection 0% 2% 0% Gastroesophageal reflux 0% 2% 1% Abdominal pain 0% 2% 1% The following adverse events were reported over 24 weeks treatment duration in one placebo-controlled Phase 3 clinical study: Table 3: Treatment-Emergent Adverse Events Reported by ≥2% viagra sildenafil cialis tadalafil dosage use Patients Treated with Cialis for Once Daily Use (2.5 or viagra sildenafil cialis tadalafil dosage use and More Frequent on Drug than Placebo in One Placebo-Controlled Phase 3 Study of 24 Weeks Treatment Duration for Cialis for Once Daily Use Adverse Event Placebo (N=94) Tadalafil 2.5 mg (N=96) Tadalafil 5 mg (N=97) Nasopharyngitis 5% 6% 6% Gastroenteritis viral 2% 3% 5% Influenza 3% 5% 3% 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% Back pain or myalgia was reported at incidence rates described in Tables 1 and 2. Overall, approximately 0.5% of all subjects treated with viagra sildenafil cialis tadalafil dosage use for on demand use discontinued treatment viagra sildenafil cialis tadalafil dosage use a consequence of back pain/myalgia. In many cases, medical follow-up information was limited. In many cases, medical follow-up information was limited. Diagnostic testing, including measures for inflammation, muscle injury, or renal damage revealed no evidence of medically significant underlying pathology. 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 . 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, viagra sildenafil cialis tadalafil dosage use been reported rarely postmarketing viagra sildenafil cialis tadalafil dosage use temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including Cialis. In tadalafil clinical pharmacology trials, back pain or myalgia generally occurred 12 to 24 hours after dosing and typically resolved within 48 hours. 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). 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 . Urogenital — priapism . Top Side Effects by Body System Cardiovascular Cardiovascular side effects have included angina pectoris, chest pain, hypotension, hypertension, myocardial infarction, postural hypotension, palpitations, syncope, and tachycardia. Dermatologic Dermatologic side effects viagra sildenafil cialis tadalafil dosage use included pruritus, rash, and sweating. Gastrointestinal Gastrointestinal side effects have included dyspepsia, diarrhea, dry mouth, dysphagia, esophagitis, gastroesophageal reflux, gastritis, loose stools, nausea, upper abdominal pain, and vomiting. General General side effects have included asthenia, face edema, facial flushing, fatigue, and pain in a limb. Genitourinary Genitourinary side effects have included increased erection and spontaneous penile erection. Hepatic Hepatic side effects have included abnormal liver function tests such as an increased GGTP. Musculoskeletal Musculoskeletal side effects have included back pain or myalgia, arthralgia, and neck pain. Respiratory Respiratory side effects have included nasal congestion, dyspnea, epistaxis, pharyngitis, nasopharyngitis, upper respiratory tract infection, and bronchitis. Nervous system Nervous system side effects have included headache, dizziness, hypesthesia, insomnia, paresthesia, somnolence, migraine and vertigo. In many cases, medical follow-up information was limited. Most, but not all, of these patients had preexisting cardiovascular risk factors. 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. In tadalafil clinical pharmacology trials, back pain or myalgia generally occurred 12 to 24 hours after dosing and typically resolved within 48 hours. Excluded from this viagra sildenafil cialis tadalafil dosage use 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 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 Musculoskeletal — arthralgia, neck pain Nervous — dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo 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 viagra sildenafil cialis tadalafil dosage use identified during post approval use of Cialis. In many cases, medical follow-up information was limited.

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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. 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 viagra sildenafil cialis tadalafil dosage use whole — viagra sildenafil cialis tadalafil dosage use face edema, fatigue, pain Cardiovascular — angina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension, palpitations, syncope, viagra sildenafil cialis tadalafil dosage use — abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting Musculoskeletal — arthralgia, neck pain Nervous — dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo Respiratory — dyspnea, epistaxis, pharyngitis Skin and Appendages viagra sildenafil cialis tadalafil dosage use 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 Cialis. Most, but not all, of these patients had preexisting cardiovascular risk factors.