6 ADVERSE REACTIONS

8.3 Nursing Mothers
Avoiding Interactions
1.1 Erectile Dysfunction
What About Other ED Medications?
17.1 Nitrates
5.3 Prolonged Erection

In trials of CIALIS for once daily use, a total of 716, 389, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively. For CIALIS for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively.CIALIS for Use as NeededIn 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:CIALIS for Once Daily UseIn 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 tadalafil clinical pharmacology trials, back pain or myalgia generally occurred 12 to 24 hours after dosing and typically resolved within 48 hours. The back pain/myalgia associated with tadalafil treatment was characterized by diffuse bilateral lower lumbar, gluteal, thigh, or thoracolumbar muscular discomfort and was exacerbated by recumbancy.

Cialis 20mg requires a doctor's prescription in most regions.
Some men prefer Cialis over other ED treatments due to longer effects.
The medication can sometimes cause back pain or muscle aches.
Cialis has been widely studied in clinical trials.
In some cases, Cialis may be less effective with certain health conditions.
The medication may influence blood pressure levels.
Cialis 20mg should not be used in combination with riociguat.
Men should avoid excessive alcohol consumption with Cialis.
Regular assessment by a healthcare provider ensures safe use.
Cialis’s long duration makes it suitable for spontaneous activity.
Generic tadalafil provides a cost-effective alternative.
Proper storage extends the medication's efficacy.

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). When medical treatment was necessary, acetaminophen or non-steroidal anti-inflammatory drugs were generally effective; however, in a small percentage of subjects who required treatment, a mild narcotic (e.g., codeine) was used. Overall, approximately 0.5% of all subjects treated with CIALIS for on demand use discontinued treatment as a consequence of back pain/myalgia. In the 1-year open label extension study, back pain and myalgia were reported in 5.5% and 1.3% of patients, respectively.

8.3 Nursing Mothers

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.

Product	Dosage	Quantity + Bonus	Price
Cialis Original	20mg	64 + 4 Pills	274.18€ 261.12€
Cialis Professional	40mg	60 + 2 Pills	262.32€ 249.83€
Cialis Super Active	20mg	10 Pills	55.64€ 52.99€
Cialis Professional	20mg	270 + 6 Pills	623.07€ 593.40€
Cialis Soft Tabs	20mg	180 + 8 Pills	353.17€ 336.35€
Cialis Professional	20mg	30 Pills	104.57€ 99.59€
Cialis Soft Tabs	20mg	90 + 6 Pills	216.71€ 206.39€
Cialis Original	20mg	92 + 4 Pills	377.99€ 359.99€
Cialis Generic	10mg	360 + 10 Pills	388.49€ 369.99€
Cialis Generic	60mg	20 Pills	65.61€ 62.49€
Cialis Original	20mg	4 Pills	41.99€ 39.99€
Cialis Generic	10mg	180 + 8 Pills	236.88€ 225.60€
Cialis Generic	2.5mg	90 + 6 Pills	112.43€ 107.08€
Cialis Generic	2.5mg	20 Pills	40.73€ 38.79€
Cialis Original	20mg	34 + 2 Pills	183.99€ 175.23€

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.

Avoiding Interactions

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 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)].

Daily Dosage

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 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.

Clinical trials demonstrated the efficacy and safety of tadalafil for ED.
In studies, 20mg on-demand improved erectile function in ~80% of men.
Placebo response rates were typically around 30-35%.
The International Index of Erectile Function (IIEF) is a common assessment tool.
For BPH, tadalafil 5mg daily significantly improved IPSS (symptom score) vs. placebo.
Long-term studies support the safety of daily use for up to 4 years.
Cardiovascular safety profile was established in large, controlled trials.
Studies excluded men with unstable cardiovascular disease or recent cardiac events.
No causal link to melanoma was found in large epidemiological studies.
Post-marketing surveillance continues to monitor long-term safety.
Efficacy is maintained in men with diabetes and after prostate surgery.

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 order cialis super force of CIALIS and sexual activity.

1.1 Erectile Dysfunction

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.

What Are the Side Effects of Cialis and Tadalafil?

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. Others were reported to have occurred hours to days after the use order cialis super force 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. 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.

Cialis 20mg is effective for many men but not all.
Tadalafil was initially used for treating angina before ED.
Cialis is also marketed for daily low-dose use.
Always follow the prescribing guidelines for safety.
Use Cialis only under medical supervision if other health issues exist.
Cialis 20mg interacts with some antihypertensive medications.
The medication helps with both erectile and urinary symptoms.
Be aware of potential side effects like dizziness and vision changes.
Cialis has a rapid onset, usually within 30 minutes.
The drug is approved by various health authorities worldwide.
Combined use with certain recreational drugs is dangerous.
Regular use can build confidence in managing ED.

What About Other ED Medications?

Sexual Stimulation Triggers Nitric Oxide

When medical treatment was necessary, acetaminophen or non-steroidal anti-inflammatory drugs were generally effective; however, in a small percentage of subjects who required treatment, a mild narcotic (e.g., codeine) was used. Overall, approximately 0.5% of all subjects treated with CIALIS for on demand use discontinued treatment as a consequence of back pain/myalgia. In the 1-year open label extension study, back pain and myalgia were reported in 5.5% and 1.3% of patients, respectively. 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 some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events.

17.1 Nitrates

In many cases, medical follow-up information was limited.

Patient Group	Recommended Dosage	Timing	Comments
Erectile Dysfunction Patients	20 mg as needed	30 minutes before activity	Do not exceed once per day
Men on other medications	Consult doctor	Varies	Watch for drug interactions
Elderly Men	20 mg or lower	As directed	Adjust based on tolerability
Patients with liver issues	Lower dose advisable	Consult physician	Risk of accumulation

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)].

Cialis 20mg is sometimes used off-label for other medical conditions.
The medication is designed to improve quality of life for men with ED.
Tadalafil acts by increasing blood flow during sexual arousal.
Cialis can be used with certain lifestyle adjustments for better results.
Patients should monitor their response and side effects.
Cialis 20mg might interact with certain antifungal medications.
It is sometimes prescribed alongside other ED treatment options.
The safety profile of Cialis is well established.
Cialis 20mg helps improve confidence in intimate moments.
The medication should not be shared with others.
It is crucial to follow the prescribed dosage.
Always report any adverse effects to your healthcare provider.

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: 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%.

Country	Average Price	Price Range	Purchase Options
USA	$30	$25 - $40	Pharmacy, Online pharmacies
UK	£25	£20 - £30	Local pharmacy, Online stores
Canada	CAD 40	CAD 35 - CAD 50	Prescription or online sources
Australia	AUD 45	AUD 40 - AUD 55	Pharmacies, online telemedicine

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.

Brand Name	Manufacturer	Price (per 20mg tablet)	Certification	Notes
Cialis	Lilly	$30	FDA, EMA	Original branded drug
Tadalafil Generic	Multiple	$8 - $15	ISO-certified	Cheaper alternative
Adcirca	Lilly	Prescription only	FDA	For pulmonary hypertension
Tadylof	Local pharma	$10 - $12	Local cert	Generic version

5.3 Prolonged Erection

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%. 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.

Ernst-Reuter-Schule