Others were reported to have occurred hours to days after the use of tadalafil tablets and sexual activity.

Tadalafil 5mg is primarily used to treat erectile dysfunction.
It works by relaxing blood vessels in the penis.
Typically taken once daily for ongoing management.

It is not possible to determine whether these events are related directly to tadalafil tablets, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors [see Warnings and Precautions (5.1)].Body as a Whole — hypersensitivity reactions including urticaria, Stevens-Johnson syndrome, and exfoliative dermatitisNervous — migraine, seizure and seizure recurrence, transient global amnesiaOphthalmologic — visual field defect, retinal vein occlusion, retinal artery occlusionNon-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 tablets. 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 tadalafil tablets. 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.

Aspect	Details
Recommended Dose	5 mg once daily
Timing of Dose	With or without food, same time daily
Missed Dose	Take as soon as remembered, do not double dose
Duration of Use	As prescribed, typically long-term
Overdose	Seek medical attention; symptoms may include headache, dizziness

Property	Description	Value/Notes
Active Ingredient	Tadalafil	5 mg
Drug Class	Phosphodiesterase type 5 inhibitor	-
Half-life	17.5 hours	Approximate
Bioavailability	~80%	Oral administration
Absorption Time	2 hours	Peak plasma concentration
Metabolism	Liver (via CYP3A4 enzyme)	-
Excretion	Feces (~61%), Urine (~36%)	-

Tadalafil was administered to over 9000 men during clinical trials worldwide.

In rare cases, tadalafil can cause vision changes.
Allergic reactions may include rash, swelling, or difficulty breathing.
Seek medical advice if side effects are severe or persistent.

For tadalafil tablets for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively. Tadalafil Tablets 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.

What can cause erectile dysfunction?

In studies of tadalafil tablets 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 tadalafil tablets for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with tadalafil tablets (2.5% of patients) [see Use in Specific Populations ()]. Across all studies with any tadalafil tablets 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 tablets for once daily use or use as needed. 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 tadalafil tablets.

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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 tadalafil weekend pill temporal association with the use of tadalafil. It is not possible to determine whether these events are related directly to tadalafil tablets, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors [see Warnings and Precautions (5.1)]. 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 tadalafil tablets. 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 ()].

Sample size

Otologic — Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including tadalafil tablets. It is not possible to determine whether these reported events are related directly to the use of tadalafil tablets, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Warnings and Precautions ()]. 7 DRUG INTERACTIONS 7.1 Potential for Pharmacodynamic Interactions with Tadalafil TabletsNitrates — Administration of tadalafil tablets to patients who are using any form of organic nitrate, is contraindicated. In clinical pharmacology studies, tadalafil tablets were shown to potentiate the hypotensive effect of nitrates. In a patient who has taken tadalafil tablets, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse after the last dose of tadalafil tablets before nitrate administration is considered. When taken as recommended in the placebo-controlled clinical trials, the following adverse reactions were reported (see Table 1) for tadalafil tablets for use as needed: Table 1: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with Tadalafil Tablets (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 Tadalafil Tablets for Use as Needed for ED Tadalafil Tablets 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.

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Cialis Generic	2.5mg	180 + 10 Pills	154.86€ 147.49€
Cialis Generic	5mg	180 + 10 Pills	159.65€ 152.05€
Tadalista Super Active	20mg	120 + 16 Pills	382.15€ 363.95€
Cialis Generic	40mg	10 Pills	37.79€ 35.99€
Tadalista Super Active	20mg	270 + 30 Pills	661.49€ 629.99€
Cialis Generic	20mg	270 + 10 Pills	335.21€ 319.25€
Tadalista Super Active	20mg	30 + 6 Pills	128.09€ 121.99€
Cialis Generic	2.5mg	20 Pills	40.73€ 38.79€
Cialis Generic	2.5mg	30 + 4 Pills	51.95€ 49.48€

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 Tadalafil Tablets 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 Tadalafil Tablets for Once Daily Use for ED The following adverse reactions were reported (see Table 3) over 24 weeks treatment duration in one placebo-controlled clinical study: Table 3: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with Tadalafil Tablets 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 Tadalafil Tablets for Once Daily Use for ED Tadalafil Tablets 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. The tadalafil in women following adverse reactions were reported (see Table 4). Table 4: Treatment-Emergent Adverse Reactions Reported by ≥1% of Patients Treated with Tadalafil Tablets 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 Tadalafil Tablets for Once Daily Use for BPH and One Study for ED and BPH Additional, less frequent adverse reactions (<1%) reported in the controlled clinical trials of tadalafil tablets for BPH or ED and BPH included: gastroesophageal reflux disease, upper abdominal pain, nausea, vomiting, arthralgia, and muscle spasm.

5.12 Effects on Bleeding

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 ()].Alpha-Blockers — Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers.

Patient characteristics

Does tadalafil interact with foods or drinks?

Back pain or myalgia was reported at incidence rates described in Tables 1 through 4.

Scientific Strategy

Others were reported to have occurred hours to days after the use of tadalafil tablets and sexual activity. It is not possible to determine whether these events are related directly to tadalafil tablets, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors [see Warnings and Precautions (5.1)].Body as a Whole — hypersensitivity reactions including urticaria, Stevens-Johnson syndrome, and exfoliative dermatitisNervous — migraine, seizure and seizure recurrence, transient global amnesiaOphthalmologic — visual field defect, retinal vein occlusion, retinal artery occlusionNon-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 tablets. 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 tadalafil tablets. 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.

Missed Dose

It is not possible to determine whether these reported events are related directly to the use of tadalafil tablets, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Warnings and Precautions ()].Urogenital — priapism [see Warnings and Precautions ()]. 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. For tadalafil tablets for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively. Tadalafil Tablets 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.

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When taken as recommended in the placebo-controlled clinical trials, the following adverse reactions were reported (see Table 1) for tadalafil tablets for use as needed: Table 1: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with Tadalafil Tablets (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 Tadalafil Tablets for Use as Needed for ED Tadalafil Tablets 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 2) in clinical trials of 12 weeks duration: Table 2: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with Tadalafil Tablets 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 Tadalafil Tablets for Once Daily Use for ED The following adverse reactions were reported (see Table 3) over 24 weeks treatment duration in one placebo-controlled clinical study: Table 3: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with Tadalafil Tablets 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 Tadalafil Tablets for Once Daily Use for ED Tadalafil Tablets 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. The tadalafil in women following adverse reactions were reported (see Table 4). Table 4: Treatment-Emergent Adverse Reactions Reported by ≥1% of Patients Treated with Tadalafil Tablets 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 Tadalafil Tablets for Once Daily Use for BPH and One Study for ED and BPH Additional, less frequent adverse reactions (<1%) reported in the controlled clinical trials of tadalafil tablets 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 studies of tadalafil tablets 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 tadalafil tablets for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with tadalafil tablets (2.5% of patients) [see Use in Specific Populations ()]. Across all studies with any tadalafil tablets dose, reports of changes in color vision were rare (<0.1% of patients).

Mechanism of action

The following section identifies additional, less frequent events (<2%) reported in controlled clinical trials of tadalafil tablets for once daily use or use as needed. 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 tadalafil tablets. 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.

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Competing interests

Trial Registration

Cardiovascular and Cerebrovascular — Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported postmarketing in tadalafil weekend pill temporal association with the use of tadalafil. It is not possible to determine whether these events are related directly to tadalafil tablets, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors [see Warnings and Precautions (5.1)].

6.2 Postmarketing Experience

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 tadalafil tablets.

Additional files

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 tadalafil tablets. It is not possible to determine whether these reported events are related directly to the use of tadalafil tablets, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Warnings and Precautions ()]. 7 DRUG INTERACTIONS 7.1 Potential for Pharmacodynamic Interactions with Tadalafil TabletsNitrates — Administration of tadalafil tablets to patients who are using any form of organic nitrate, is contraindicated. In clinical pharmacology studies, tadalafil tablets were shown to potentiate the hypotensive effect of nitrates.

Tadalafil 5mg can be part of a comprehensive ED treatment plan.
Lifestyle changes like exercise and quitting smoking may enhance results.
Regular medical check-ups are recommended during use.

In a patient who has taken tadalafil tablets, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse after the last dose of tadalafil tablets 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 ()].Alpha-Blockers — Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers.