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The following adverse reactions were reported ( see Table 4). Table 4: Treatment-Emergent Adverse Reactions Reported by ≥1% of Patients Treated with CIALIS forOnce Daily Use (5 mg) and More Frequent on Drug than Placebo in Three Placebo-Controlled ClinicalStudies of 12 Weeks Treatment Duration, including Two Studies for CIALIS for Once Daily Use for BPHand One Study for ED and BPH Additional, less frequent adverse reactions (<1%) reported in the controlled clinical trials of CIALIS for BPH orED 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.

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In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and CLINICAL PHARMACOLOGY] . Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. PDE5inhibitors, including CIALIS, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin, tamsulosin or alfuzosin.

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[see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and CLINICAL PHARMACOLOGY] . PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. Small reductions in blood pressure occurred following coadministration of tadalafil with these agents compared with placebo. [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY] . Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators.

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When mild vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased.Substantial consumption of alcohol (e.g., 5 units or greater) in combination with CIALIS can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache. Tadalafil did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations. [See DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS] . An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics. CIALIS is a substrate of and predominantly metabolized by CYP3A4. 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 byrecumbency. 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).

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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 ofCIALIS 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 ofCIALIS 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 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 Nervous - dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo 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 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. 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.

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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 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 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] .

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Otologic - Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with canadian cialis 5mg the use of PDE5 inhibitors, including CIALIS. In some of the cases, medical conditions andother factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited.

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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] . Administration of CIALIS to patients who are using any form of organic nitrate, is contraindicated.In clinical pharmacology studies, CIALIS was shown to potentiate the hypotensive effect of nitrates. In a patient who has taken CIALIS, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse after the last dose of CIALIS before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and CLINICAL PHARMACOLOGY] . Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. PDE5inhibitors, including CIALIS, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin, tamsulosin or alfuzosin. [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and CLINICAL PHARMACOLOGY] . PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. Small reductions in blood pressure occurred following coadministration of tadalafil with these agents compared with placebo. [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY] .

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Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased.Substantial consumption of alcohol (e.g., 5 units or greater) in combination with CIALIS can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache. Tadalafil did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations. [See DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS] .

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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. 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.

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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 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 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 canadian cialis 5mg the use of PDE5 inhibitors, including CIALIS.

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In some of the cases, medical conditions andother 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] . Administration of CIALIS to patients who are using any form of organic nitrate, is contraindicated.In clinical pharmacology studies, CIALIS was shown to potentiate the hypotensive effect of nitrates. In a patient who has taken CIALIS, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse after the last dose of CIALIS before nitrate administration is considered. An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics. CIALIS is a substrate of and predominantly metabolized by CYP3A4. Studies have shown that drugs that inhibit CYP3A4 can increase tadalafil exposure.

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The following adverse reactions were reported ( see Table 4). Table 4: Treatment-Emergent Adverse Reactions Reported by ≥1% of Patients Treated with CIALIS forOnce Daily Use (5 mg) and More Frequent on Drug than Placebo in Three Placebo-Controlled ClinicalStudies of 12 Weeks Treatment Duration, including Two Studies for CIALIS for Once Daily Use for BPHand One Study for ED and BPH Additional, less frequent adverse reactions (<1%) reported in the controlled clinical trials of CIALIS for BPH orED 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 byrecumbency.

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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.

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In studies ofCIALIS 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 ofCIALIS 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 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 Nervous - dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo 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 The following adverse reactions have been identified during post approval use of CIALIS. Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4,increased tadalafil 20 mg single-dose exposure (AUC) by 312% and Cmax by 22%, relative to the values for tadalafil 20 mg alone. Ketoconazole (200 mg daily) increased tadalafil 10-mg single-dose exposure (AUC) by107% and Cmax by 15%, relative to the values for tadalafil 10 mg alone [see DOSAGE AND ADMINISTRATION] . Although specific interactions have not been studied, other CYP3A4 inhibitors, such as erythromycin, itraconazole, and grapefruit juice, would likely increase tadalafil exposure. Ritonavir (500 mg or 600 mg twice daily at steady state), an inhibitor of CYP3A4,CYP2C9, CYP2C19, and CYP2D6, increased tadalafil 20-mg single-dose exposure (AUC) by 32% with a 30%reduction in Cmax , relative to the values for tadalafil 20 mg alone. Ritonavir (200 mg twice daily), increased tadalafil 20-mg single-dose exposure (AUC) by 124% with no change in Cmax , relative to the values for tadalafil 20 mg alone. Although specific interactions have not been studied, other HIV protease inhibitors would likely increase tadalafil exposure [see DOSAGE AND ADMINISTRATION] . Studies have shown that drugs that induce CYP3A4 can decrease tadalafil exposure. Rifampin (600 mg daily), a CYP3A4 inducer, reduced tadalafil 10-mg single-dose exposure (AUC) by 88% and Cmax by 46%, relative to the values for tadalafil 10 mg alone.

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Studies have shown that drugs that inhibit CYP3A4 can increase tadalafil exposure. Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4,increased tadalafil 20 mg single-dose exposure (AUC) by 312% and Cmax by 22%, relative to the values for tadalafil 20 mg alone. Ketoconazole (200 mg daily) increased tadalafil 10-mg single-dose exposure (AUC) by107% and Cmax by 15%, relative to the values for tadalafil 10 mg alone [see DOSAGE AND ADMINISTRATION] . Although specific interactions have not been studied, other CYP3A4 inhibitors, such as erythromycin, itraconazole, and grapefruit juice, would likely increase tadalafil exposure. Ritonavir (500 mg or 600 mg twice daily at steady state), an inhibitor of CYP3A4,CYP2C9, CYP2C19, and CYP2D6, increased tadalafil 20-mg single-dose exposure (AUC) by 32% with a 30%reduction in Cmax , relative to the values for tadalafil 20 mg alone.

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Ritonavir (200 mg twice daily), increased tadalafil 20-mg single-dose exposure (AUC) by 124% with no change in Cmax , relative to the values for tadalafil 20 mg alone. Although specific interactions have not been studied, other HIV protease inhibitors would likely increase tadalafil exposure [see DOSAGE AND ADMINISTRATION] . Studies have shown that drugs that induce CYP3A4 can decrease tadalafil exposure. Rifampin (600 mg daily), a CYP3A4 inducer, reduced tadalafil 10-mg single-dose exposure (AUC) by 88% and Cmax by 46%, relative to the values for tadalafil 10 mg alone.