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Because of insufficient information in patients with severe hepatic impairment, use of tadalafil in this group is not recommended [see Use in Specific Populations (8.6)].

What is Tadalafil (Cialis)?

Because of insufficient information in patients with severe hepatic impairment, use of tadalafil in this group is not recommended [see Use in Specific Populations (8.6)]. Patients should be made aware that both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators. Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache [see Clinical Pharmacology (12.2)]. Tadalafil is metabolized predominantly by CYP3A4 in the liver. In patients taking potent inhibitors of CYP3A4 and tadalafil for once daily use, the maximum recommended dose is 2.5 mg [see Dosage and Administration (2.7)].

Viagra 25mg Tablet

The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied. Inform patients not to take tadalafil with other PDE5 inhibitors, including ADCIRCA. Although tadalafil has not been shown to increase bleeding times in healthy subjects, use in patients with bleeding disorders or significant active peptic ulceration should be based upon a careful risk-benefit assessment and caution. The use of tadalafil offers no protection against sexually transmitted diseases. 6 ADVERSE REACTIONS 6.1 Clinical Trials ExperienceBecause 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 9,000 men during clinical trials worldwide.

Priapism warning

In trials of tadalafil for once daily use, a total of 1434, 905, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively. For tadalafil for use as needed, over 1,300 and 1,000 subjects were treated for at least 6 months and 1 year, respectively.Tadalafil for Use as Needed for EDIn 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 mg 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 1) for tadalafil for use as needed:Table 1: Treatment-Emergent Adverse Reactions Reported by ≥ 2% of Patients Treated with Tadalafil (10 mg 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 for Use as Needed for EDTadalafil for Once Daily Use for EDIn 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 (seeTable 2) in clinical trials of 12 weeks duration:Table 2: Treatment-Emergent Adverse Reactions Reported by ≥ 2% of Patients Treated with Tadalafil for Once Daily Use (2.5 mg 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 for Once Daily Use for EDThe 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 for Once Daily Use (2.5 mg or 5 mg) and More Frequent on Drug than Placebo in One Placebo-Controlled Clinical Study of 24 Weeks Treatment Duration for Tadalafil for Once Daily Use for EDTadalafil for Once Daily Use for BPH and for ED and BPHIn 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 following adverse reactions were reported (see Table 4).Table 4: Treatment-Emergent Adverse Reactions Reported by ≥ 1% of Patients Treated with Tadalafil for Once Daily Use (5 mg) and viagra super More Frequent on Drug than Placebo in Three Placebo-Controlled Clinical Studies of 12 Weeks Treatment Duration, including Two Studies for Tadalafil for Once Daily Use for BPH and One Study for ED and BPHAdditional, less frequent adverse reactions (< 1%) reported in the controlled clinical trials of tadalafil 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 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). Patients should be made aware that both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators. Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache [see Clinical Pharmacology (12.2)].

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Tadalafil is metabolized predominantly by CYP3A4 in the liver. In patients taking potent inhibitors of CYP3A4 and tadalafil for once daily use, the maximum recommended dose is 2.5 mg [see Dosage and Administration (2.7)].

Mechanism of action

Related treatment guides

What should I do if I accidentally use too much tadalafil?

The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied. Inform patients not to take tadalafil with other PDE5 inhibitors, including ADCIRCA. Although tadalafil has not been shown to increase bleeding times in healthy subjects, use in patients with bleeding disorders or significant active peptic ulceration should be based upon a careful risk-benefit assessment and caution.

What is Sildenafil (Viagra)?

The use of tadalafil offers no protection against sexually transmitted diseases.

  • Some yellow Viagra pills are designed for specific markets or regions.
  • The pill's shape, imprint, and color help verify authenticity.
  • Overuse or misuse can lead to serious health consequences including heart issues.
  • Viagra does not protect against sexually transmitted diseases.
  • The yellow Viagra pill has contributed to many people's improved sexual health.
  • Always follow medical advice and instructions when taking Viagra or its variants.

6 ADVERSE REACTIONS 6.1 Clinical Trials ExperienceBecause 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 9,000 men during clinical trials worldwide.

  • The impact of the yellow Viagra pill can vary based on physical health and age.
  • Its use is not recommended for individuals taking certain antifungals or antibiotics.
  • The pill is effective only if the underlying cause of ED is suitable for sildenafil.
  • Discreet packaging is common for online purchases of yellow Viagra pills.
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In trials of tadalafil for once daily use, a total of 1434, 905, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively. For tadalafil for use as needed, over 1,300 and 1,000 subjects were treated for at least 6 months and 1 year, respectively.Tadalafil for Use as Needed for EDIn 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 mg 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 1) for tadalafil for use as needed:Table 1: Treatment-Emergent Adverse Reactions Reported by ≥ 2% of Patients Treated with Tadalafil (10 mg 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 for Use as Needed for EDTadalafil for Once Daily Use for EDIn 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 (seeTable 2) in clinical trials of 12 weeks duration:Table 2: Treatment-Emergent Adverse Reactions Reported by ≥ 2% of Patients Treated with Tadalafil for Once Daily Use (2.5 mg 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 for Once Daily Use for EDThe 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 for Once Daily Use (2.5 mg or 5 mg) and More Frequent on Drug than Placebo in One Placebo-Controlled Clinical Study of 24 Weeks Treatment Duration for Tadalafil for Once Daily Use for EDTadalafil for Once Daily Use for BPH and for ED and BPHIn 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.

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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 Tadalafil for Once Daily Use (5 mg) and viagra super More Frequent on Drug than Placebo in Three Placebo-Controlled Clinical Studies of 12 Weeks Treatment Duration, including Two Studies for Tadalafil for Once Daily Use for BPH and One Study for ED and BPHAdditional, less frequent adverse reactions (< 1%) reported in the controlled clinical trials of tadalafil 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 tadalafil clinical pharmacology trials, back pain or myalgia generally occurred 12 to 24 hours after dosing and typically resolved within 48 hours.

2.4 Dosage Adjustments Due to Drug Interactions

Overall, approximately 0.5% of all subjects treated with tadalafil for on demand use discontinued treatment as a consequence of back pain/myalgia. Incidence rates for tadalafil for once daily use for ED, BPH and BPH/ED are described in Tables 2, 3 and 4. In studies of tadalafil 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 for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with tadalafil (2.5% of patients) [see Use in Specific Populations (8.5)].Across all studies with any tadalafil 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 for once daily use or use as needed. A causal relationship of these events to tadalafil 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 edemaCardiovascular — angina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardiaDigestive — abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting, gastroesophageal reflux disease, hemorrhoidal hemorrhage, rectal hemorrhageMusculoskeletal — arthralgia, neck painNervous — dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigoRenal and Urinary — renal impairmentRespiratory — dyspnea, epistaxis, pharyngitisSkin and Appendages — pruritus, rash, sweatingOphthalmologic — blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increase, swelling of eyelidsOtologic — sudden decrease or loss of hearing, tinnitusUrogenital — erection increased, spontaneous penile erection6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of tadalafil.

Erectile dysfunction

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 temporal association with the use of tadalafil. 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 without sexual activity. Others were reported to have occurred hours to days after the use of tadalafil and sexual activity. It is not possible to determine whether these events are related directly to tadalafil, 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. 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 (5.4)].Otologic — Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including tadalafil.

What should I know about tadalafil before using it?

It is not possible to determine whether these reported events are related directly to the use of tadalafil, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Warnings and Precautions (5.5)].Urogenital — priapism [see Warnings and Precautions (5.3)]. Tadalafil was administered to over 9,000 men during clinical trials worldwide. For tadalafil for use as needed, over 1,300 and 1,000 subjects were treated for at least 6 months and 1 year, respectively. 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).

  • Yellow Viagra should be stored out of reach of children and pets.
  • It is not suitable for use in individuals with severe hypotension or stroke history.
  • The medication can cause priapism, a prolonged erection that requires medical attention.
  • Do not take yellow Viagra if you are allergic to sildenafil or other ingredients.
  • The pill's nutritional compatibility is generally unaffected by diet unless high-fat.
  • Discontinue use and seek medical help if adverse reactions occur.

Overall, approximately 0.5% of all subjects treated with tadalafil for on demand use discontinued treatment as a consequence of back pain/myalgia.

Brand Name Dosage (mg) Appearance Active Ingredient
Viagra Yellow 50 Oval, yellow Sildenafil Citrate
SuperYellow 100 Round, bright yellow Sildenafil Citrate
YellowMax 25 Triangular, pale yellow Sildenafil Citrate
GoldYellow 50 Oval, shiny yellow Sildenafil Citrate

Incidence rates for tadalafil for once daily use for ED, BPH and BPH/ED are described in Tables 2, 3 and 4. In studies of tadalafil 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 for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with tadalafil (2.5% of patients) [see Use in Specific Populations (8.5)].Across all studies with any tadalafil 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 for once daily use or use as needed.

2.5 Dosage Adjustments in Special Populations

A causal relationship of these events to tadalafil is uncertain.

  • The yellow Viagra pill is a version of sildenafil used to treat erectile dysfunction.
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  • Consult a healthcare provider before using any form of Viagra or similar pills.

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 edemaCardiovascular — angina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardiaDigestive — abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting, gastroesophageal reflux disease, hemorrhoidal hemorrhage, rectal hemorrhageMusculoskeletal — arthralgia, neck painNervous — dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigoRenal and Urinary — renal impairmentRespiratory — dyspnea, epistaxis, pharyngitisSkin and Appendages — pruritus, rash, sweatingOphthalmologic — blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increase, swelling of eyelidsOtologic — sudden decrease or loss of hearing, tinnitusUrogenital — erection increased, spontaneous penile erection6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of tadalafil. 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 temporal association with the use of tadalafil. 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 without sexual activity. Others were reported to have occurred hours to days after the use of tadalafil and sexual activity. It is not possible to determine whether these events are related directly to tadalafil, 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.

Precaution Explanation Risk if Ignored
Do not mix with nitrates Can cause severe hypotension Heart issues, fainting
Avoid heavy meals before intake Delays absorption Reduced effectiveness
Consult doctor if on other medications Potential interactions Adverse reactions
Do not exceed recommended dose Overdose risk Severe side effects

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 (5.4)].Otologic — Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including tadalafil. It is not possible to determine whether these reported events are related directly to the use of tadalafil, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Warnings and Precautions (5.5)].Urogenital — priapism [see Warnings and Precautions (5.3)]. Tadalafil was administered to over 9,000 men during clinical trials worldwide. For tadalafil for use as needed, over 1,300 and 1,000 subjects were treated for at least 6 months and 1 year, respectively.

8.4 Pediatric Use

What should I tell my healthcare provider before using tadalafil?

What does TADALAFIL (Generic for ADCIRCA) look like?