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 are described in Table 2.
Pregnancy & Lactation
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 are described in Table 2. In studies of CIALIS for once daily use, events of back pain and myalgia were generally mild or moderate with a discontinuation rate of 0.3%.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. 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, painCardiovascular — 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, vomitingMusculoskeletal — arthralgia, neck painNervous — dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigoRespiratory — 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.
Dosage for erectile dysfunction (ED)
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. 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. The list does not include adverse events that are reported from clinical trials and that are listed elsewhere in this section.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 cialis 20 mg 30 pills 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.
Patient resources
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 phosphodiesterase type 5 (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. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient's underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors [see Warnings and Precautions (5.4) and Patient Counseling Information (17.6)].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. In studies of CIALIS for once daily use, events of back pain and myalgia were generally mild or moderate with a discontinuation rate of 0.3%.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. 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, painCardiovascular — 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, vomitingMusculoskeletal — arthralgia, neck painNervous — dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigoRespiratory — 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. 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. 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.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Original | 20mg | 8 Pills | 61.70€ 58.76€ | |
| Cialis Generic | 2.5mg | 360 + 10 Pills | 260.03€ 247.65€ | |
| Cialis Original | 20mg | 4 Pills | 41.99€ 39.99€ | |
| Cialis Super Active | 20mg | 30 + 6 Pills | 128.09€ 121.99€ | |
| Cialis Generic | 2.5mg | 180 + 10 Pills | 154.86€ 147.49€ | |
| Cialis Generic | 20mg | 180 + 10 Pills | 254.09€ 241.99€ | |
| Cialis Generic | 20mg | 270 + 10 Pills | 335.21€ 319.25€ | |
| Cialis Generic | 5mg | 10 Pills | 29.39€ 27.99€ | |
| Cialis Generic | 10mg | 60 + 6 Pills | 105.81€ 100.77€ | |
| Cialis Generic | 10mg | 90 + 6 Pills | 146.17€ 139.21€ | |
| Cialis Professional | 20mg | 120 + 4 Pills | 291.68€ 277.79€ |
The list does not include adverse events that are reported from clinical trials and that are listed elsewhere in this section.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.
- Some men may experience flushing (redness of face and neck).
- Nasal congestion or a runny nose is a possible side effect.
- These side effects are usually mild and diminish over time.
- Back pain and muscle aches are more common with higher doses like 20mg.
- These pains typically occur 12-24 hours after taking the pill.
- They usually resolve within 48 hours and respond to over-the-counter pain relievers.
- Staying hydrated may help reduce the incidence of muscle-related side effects.
- If side effects are severe or persistent, contact your healthcare provider.
- Do not stop taking other prescribed medications without consulting your doctor.
Most, but not all, of these patients had preexisting cialis 20 mg 30 pills cardiovascular risk factors.
- Men with cardiovascular disease require careful evaluation before use.
- Sexual activity poses a cardiac risk for men with heart conditions.
- Your doctor may recommend a cardiac stress test before prescribing.
- Do not use if you have had a recent heart attack, stroke, or arrhythmia.
- It can cause a mild, temporary decrease in blood pressure.
- Combining it with other blood pressure-lowering drugs may amplify this effect.
- Report chest pain, dizziness, or nausea during sexual activity to your doctor.
- Nitrates are absolutely contraindicated due to risk of severe hypotension.
- This includes recreational amyl nitrite or nitrite "poppers."
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.
17.4 Potential for Drug Interactions When Taking CIALIS for Once Daily Use
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 phosphodiesterase type 5 (PDE5) inhibitors, including CIALIS. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient's underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors [see Warnings daily cialis cost and Precautions (5.4) and Patient Counseling Information (17.6)]. 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) and Patient Counseling Information (17.7)]. Urogenital — priapism [see Warnings and Precautions (5.3)].
How is tadalafil supplied (dosage forms)?
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. 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.
More common
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 phosphodiesterase type 5 (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.
- The global market for ED drugs is substantial, with Cialis being a major product.
- Marketing and direct-to-consumer advertising have increased awareness.
- Stigma around ED has decreased, leading more men to seek treatment.
- Cialis 20mg is sometimes used off-label for other conditions.
- Off-label use should only be undertaken under direct medical supervision.
- Research continues on new applications for PDE5 inhibitors.
- Adherence to prescribed dosing is crucial for safety and effectiveness.
- Keep all medications out of reach of children and pets.
- Dispose of unused or expired medication through a take-back program.
It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient's underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors [see Warnings and Precautions (5.4) and Patient Counseling Information (17.6)].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. In many cases, medical follow-up information was limited.
17.5 Priapism
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) and Patient Counseling Information (17.7)].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 compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Tadalafil was administered to over 6550 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. In eight primary placebo-controlled Phase 3 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 events were reported (see Table 1) for CIALIS for use as needed: 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 (see Table 2) in clinical trials of 12 weeks duration: tadalafil cialis daily The following adverse events were reported (see Table 3) over 24 weeks treatment duration in one placebo-controlled Phase 3 clinical study: Back pain or myalgia was reported at incidence rates described in Tables 1 and 2.
2.4 Concomitant Medications
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) and Patient Counseling Information (17.7)].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 compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Tadalafil was administered to over 6550 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.
Muscular Dystrophy (Orphan)
In eight primary placebo-controlled Phase 3 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 events were reported (see Table 1) for CIALIS for use as needed: 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 (see Table 2) in clinical trials of 12 weeks duration: tadalafil cialis daily The following adverse events were reported (see Table 3) over 24 weeks treatment duration in one placebo-controlled Phase 3 clinical study: Back pain or myalgia was reported at incidence rates described in Tables 1 and 2. In studies of CIALIS for once daily use, events of back pain and myalgia were generally mild or moderate with a discontinuation rate of 0.3%. Across all studies with any CIALIS dose, reports of changes in color vision were rare (<0.1% of patients).
Drug details
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 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 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. The list does not include adverse events that are reported from clinical trials and that are listed elsewhere in this section. 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. 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)]. In studies of CIALIS for once daily use, events of back pain and myalgia were generally mild or moderate with a discontinuation rate of 0.3%.
| Parameter | Value | Description |
|---|---|---|
| Absorption Rate | Peak plasma levels in 2 hours | Fast absorption |
| Bioavailability | ~36% | Percentage of dose reaching circulation |
| Half-life | 17.5 hours | Duration of action |
| Elimination | Mainly via feces | Metabolism primarily by CYP3A4 |
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. 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 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 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. The list does not include adverse events that are reported from clinical trials and that are listed elsewhere in this section. 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. 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 phosphodiesterase type 5 (PDE5) inhibitors, including CIALIS. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient's underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors [see Warnings daily cialis cost and Precautions (5.4) and Patient Counseling Information (17.6)]. 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) and Patient Counseling Information (17.7)]. 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. 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.