7 DRUG INTERACTIONS

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.

Side Effect	Occurrence Percentage	Severity
Headache	15-20%	Mild to moderate
Flushing	10-15%	Mild
Indigestion	10%	Mild
Muscle pain	3-5%	Mild

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.

Warnings & Precautions

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. 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 cardiovascular risk factors.

Less common

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 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. 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 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.

Product	Dosage	Quantity + Bonus	Price
Cialis Generic	5mg	20 Pills	41.99€ 39.99€	Buy
Cialis Generic	60mg	90 + 6 Pills	196.67€ 187.30€	Buy
Cialis Generic	10mg	10 Pills	31.41€ 29.91€	Buy
Cialis Original	20mg	14 + 2 Pills	95.75€ 91.19€	Buy
Cialis Professional	40mg	60 + 2 Pills	262.32€ 249.83€	Buy
Cialis Super Active	20mg	30 + 6 Pills	128.09€ 121.99€	Buy
Cialis Black	80mg	10 Pills	43.27€ 41.21€	Buy
Cialis Black	80mg	30 + 2 Pills	89.11€ 84.87€	Buy
Cialis Soft Tabs	20mg	270 + 10 Pills	471.40€ 448.95€	Buy
Cialis Generic	40mg	180 + 10 Pills	277.29€ 264.09€	Buy
Cialis Original	20mg	22 + 2 Pills	129.20€ 123.05€	Buy
Cialis Black	80mg	120 + 8 Pills	264.77€ 252.16€	Buy

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

16.1 How Supplied

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.

Cialis and herbs and supplements

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 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)]. 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.

5.8 Hepatic Impairment

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. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see Contraindications (4.1), Dosage and Administration (2.4) and Clinical Pharmacology (12.2)].Alpha Blockers — Caution is advised when PDE5 inhibitors are coadministered with alpha blockers. Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin or tamsulosin [see Warnings and Precautions (5.6), Dosage and Administration (2.4) and Clinical Pharmacology (12.2)].Antihypertensives — PDE5 inhibitors, including tadalafil, are mild systemic vasodilators.

80,000 stores

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.

Symptom	Management Approach	When to Seek Help
Headache	Over-the-counter pain relievers	Severe or persistent headache
Muscle pain	Rest, hydrate, consult doctor if severe	Severe muscle cramps
Flushing	Cooling measures, avoid hot drinks	If accompanied by dizziness
Indigestion	Antacids or dietary adjustments	Severe or prolonged indigestion

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.

Region	Average Price per Pack	Prescription Required	Available Over-the-counter
USA	$60 - $80 per pack	Yes	No
UK	£45 - £60 per pack	Yes	No
India	₹1500 - ₹2500 per pack	Yes	No

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, cialis soft gel over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively.

6.1 Clinical Studies Experience

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. 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.

Oral Administration

For CIALIS for use as needed, cialis soft gel 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: 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%. 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: 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%.

• The future of ED treatment may include new formulations or delivery methods.
• Research into gene therapy and stem cells is ongoing but not yet standard.
• For now, oral PDE5 inhibitors like Cialis remain first-line therapy.
• Their safety and efficacy profiles are well-established.
• Patient education is key to safe and effective use of Cialis 20mg.
• Understanding how it works, its limits, and potential risks empowers users.
• This knowledge leads to better adherence and better outcomes.
• Your healthcare provider is your best source for personalized advice.
• Never hesitate to ask questions about your medication and treatment plan.

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.

• The FDA approved Cialis for erectile dysfunction in 2003.
• Approval for daily use and BPH symptoms came later.
• It was one of the first ED drugs to offer a 36-hour window.
• This longer duration was a significant marketing point versus Viagra.
• Patent exclusivity for Cialis in the US expired around 2017-2018.
• This expiration led to the influx of generic tadalafil products.
• The medication is widely studied with a large body of clinical evidence.
• Ongoing post-marketing surveillance monitors for rare adverse events.
• Patients are encouraged to report side effects via the FDA MedWatch program.

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 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)].

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Urogenital — priapism [see Warnings and Precautions (5.3)].

• 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.

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. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see Contraindications (4.1), Dosage and Administration (2.4) and Clinical Pharmacology (12.2)].Alpha Blockers — Caution is advised when PDE5 inhibitors are coadministered with alpha blockers. Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin or tamsulosin [see Warnings and Precautions (5.6), Dosage and Administration (2.4) and Clinical Pharmacology (12.2)].Antihypertensives — PDE5 inhibitors, including tadalafil, are mild systemic vasodilators.