A causal relationship of these events to CIALIS is uncertain.
Drug Label Information
Phi Lambda Sigma Outstanding Achievement Award
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 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 postmarketing in temporal association with the use of tadalafil.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Generic | 10mg | 60 + 6 Pills | 105.81€ 100.77€ | |
| Cialis Generic | 5mg | 60 + 4 Pills | 86.02€ 81.92€ | |
| Cialis Professional | 20mg | 180 + 4 Pills | 423.11€ 402.96€ | |
| Cialis Generic | 60mg | 10 Pills | 41.22€ 39.26€ | |
| Cialis Generic | 40mg | 90 + 6 Pills | 171.35€ 163.19€ | |
| Cialis Generic | 20mg | 90 + 6 Pills | 154.71€ 147.34€ | |
| Cialis Soft Tabs | 20mg | 30 + 4 Pills | 87.43€ 83.27€ | |
| Cialis Original | 20mg | 76 + 4 Pills | 319.19€ 303.99€ | |
| Cialis Professional | 40mg | 60 + 2 Pills | 262.32€ 249.83€ | |
| Cialis Generic | 10mg | 10 Pills | 31.41€ 29.91€ | |
| Cialis Professional | 20mg | 20 Pills | 78.33€ 74.60€ | |
| Cialis Super Active | 20mg | 120 + 16 Pills | 382.15€ 363.95€ | |
| Cialis Generic | 40mg | 360 + 10 Pills | 477.87€ 455.11€ | |
| Cialis Professional | 20mg | 120 + 4 Pills | 291.68€ 277.79€ |
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.
5.5 Sudden Hearing Loss
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 CIALIS. 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 (5.5)]. Urogenital — priapism [see Warnings and Precautions (5.3)]. 7 DRUG INTERACTIONS 7.1 Potential for Pharmacodynamic Interactions with CIALISNitrates — Administration of CIALIS to patients who are using any form of organic nitrate, is contraindicated.
Tadalafil and insulin sensitivity: why it matters for muscle gain
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 (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 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 (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 CIALIS.
5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)
Dosage forms
In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events.
| Benefit | Description | Relevant Ingredients |
|---|---|---|
| Enhanced Erectile Function | Increases blood flow for stronger erections | Tadalafil, Ginseng |
| Increased Libido | Boosts sexual desire naturally | Maca root, Zinc |
| Improved Circulatory Health | Supports vascular health for better circulation | L-arginine, Rhodiola |
| Reduced Anxiety During Sex | Helps reduce performance anxiety | Ginseng, Rhodiola |
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 (5.5)].Urogenital — priapism [see Warnings and Precautions (5.3)]. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly cialis professional order 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 CIALIS for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively.
17.11 Recommended Administration
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 (5.5)].Urogenital — priapism [see Warnings and Precautions (5.3)]. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly cialis professional order 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 CIALIS for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively.
Phi Lambda Sigma
CIALIS 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. When taken as recommended in the placebo-controlled clinical trials, the following adverse reactions were reported (see Table 1) for CIALIS for use as needed: CIALIS for Once Daily Use for ED In three placebo-controlled clinical original cialis 20mg 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: The following adverse reactions were reported (see Table 3) over 24 weeks treatment duration in one placebo-controlled clinical study: 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. The following adverse reactions were reported (see Table 4). Additional, less frequent adverse reactions (<1%) reported in the controlled clinical trials of CIALIS for BPH or ED and BPH included: gastroesophageal reflux disease, upper abdominal pain, nausea, vomiting, arthralgia, and muscle spasm. CIALIS 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. When taken as recommended in the placebo-controlled clinical trials, the following adverse reactions were reported (see Table 1) for CIALIS for use as needed: CIALIS for Once Daily Use for ED In three placebo-controlled clinical original cialis 20mg 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: The following adverse reactions were reported (see Table 3) over 24 weeks treatment duration in one placebo-controlled clinical study: 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.
Other similar profiles
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 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 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 postmarketing in temporal association with the use of tadalafil. Most, but not all, of these patients had preexisting cardiovascular risk factors.
What happens to muscle gains after stopping 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 CIALIS without sexual activity. 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 (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 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 (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 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. The following adverse reactions were reported (see Table 4).
Society and culture
Back pain or myalgia was reported at incidence rates described in Tables 1 through 4. In studies of 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 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 (8.5)]. 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 of CIALIS for once daily use or use as needed.
Why Should I Pay More For the Same Results?
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. 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 generic cialis softtabs infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported postmarketing in temporal association with the use of tadalafil. 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 (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 CIALIS. Additional, less frequent adverse reactions (<1%) reported in the controlled clinical trials of 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 1 through 4. In studies of 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.
| Variant Name | Active Ingredient | Potency | Available Forms | Price Range (USD) |
|---|---|---|---|---|
| Cialis Lily Classic | Tadalafil 10 mg | Moderate | Tablet | 15-30 |
| Cialis Lily Forte | Tadalafil 20 mg | High | Capsule | 25-45 |
| Cialis Lily Mini | Tadalafil 5 mg | Low | Chewable Tablet | 10-20 |
| Cialis Lily Ultra | Vardenafil 10 mg | Moderate | Tablet | 20-40 |
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 (8.5)]. Across all studies with any CIALIS dose, reports of changes in color vision were rare (<0.1% of patients).
- Cialis is a brand-name prescription medication for erectile dysfunction.
- Its active ingredient is tadalafil, a PDE5 inhibitor.
- A common dosage is 5 mg daily for both ED and BPH.
- The medication works by increasing blood flow to the penis.
- Effects can last up to 36 hours, earning the nickname "weekend pill."
- Common side effects include headache, indigestion, and back pain.
- It requires a prescription and is not safe with nitrates.
The following section identifies additional, less frequent events (<2%) reported in controlled clinical trials of CIALIS 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 CIALIS. 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.
- Follow-up with a doctor is important after starting Cialis.
- Report any persistent or severe side effects immediately.
- Efficacy should be assessed; the dose may need adjustment.
- Underlying causes of ED or BPH should continue to be investigated.
- Regular check-ups are needed to monitor cardiovascular health.
- Discuss if the treatment still meets your needs and expectations.
- Do not stop or change your dose without consulting your doctor.
Cardiovascular and Cerebrovascular — Serious cardiovascular events, including myocardial generic cialis softtabs infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported postmarketing in temporal association with the use of tadalafil. 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 (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 CIALIS.
17.1 Nitrates
International Society for Pharmaceutical Engineering (ISPE)
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 CIALIS. 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 (5.5)].
| Step | Description | Notes |
|---|---|---|
| Take dose as directed | 1 tablet per day or as prescribed | Follow medical advice |
| Time to effect | 30-60 minutes after ingestion | Varies individually |
| Duration of effect | Up to 36 hours | Longer-lasting than some alternatives |
| Avoid alcohol | Alcohol can decrease effectiveness and increase side effects | Limit intake during use |
Urogenital — priapism [see Warnings and Precautions (5.3)]. 7 DRUG INTERACTIONS 7.1 Potential for Pharmacodynamic Interactions with CIALISNitrates — Administration of CIALIS to patients who are using any form of organic nitrate, is contraindicated.