PURPOSE:We evaluated the safety and tolerability of a new formulation of Tadalafil, Cialis, in a double-blind, placebo-controlled clinical trial. In a single-dose randomized, double-blind, placebo-controlled study, patients were randomly assigned to take either Tadalafil (60 mg, three times daily) or placebo once daily for 5 days. Patients were followed up for a period of 4 years. At follow up, the number of treatment emergent adverse events (AEs) was compared with placebo, and the frequency of treatment emergent AEs were also compared. All patients discontinued the study medication due to AEs that were not improved by the treatment regimen. The study medication was significantly more likely to cause serious AEs (35/42 vs. 9/10, p<0.001) and to be discontinued (7/22 vs. 2/10, p=0.002). AEs were more frequent in the Tadalafil group (26/42 vs. 6/10, p=0.002). Serious AEs were less frequently reported in patients who received Tadalafil compared with those who received placebo. These data support the safety of Tadalafil, as well as the favorable tolerability profile of Cialis, when used as a monotherapy, in patients who were treated with Cialis.
Table 1 Adverse Event Profile of CialisVascular safety
Tadalafil, Cialis, is currently marketed by Pfizer under the trade name Cialis. The drug was the first medication to be marketed for the treatment of erectile dysfunction and is the only one approved by the Food and Drug Administration (FDA) to be prescribed for this indication. The drug is not FDA approved for other indications. Tadalafil has been shown to be safe and well tolerated in a large number of patients. Patients taking nitrates in addition to Tadalafil have been found to have greater hypotensive effects than patients taking nitrates alone. This finding has led to increased awareness of the need for Tadalafil and other phosphodiesterase (PDE5) inhibitors. Tadalafil is also thought to be safe and well tolerated when taken with food, but it is associated with a lower rate of hypotension. The relationship between the occurrence of Tadalafil side effects and the dose is not clear, although the dose may be increased to 80 mg once daily, or decreased to 40 mg once daily. In clinical trials, there were no reports of adverse events with the dose-ranging dosing regimen. This means that although these dose-ranging dosing regimens are acceptable, they should be used with caution and are not recommended for patients with heart failure or those taking nitrates. It is recommended that patients taking tadalafil be monitored for signs of tachycardia, and that tadalafil be used only in patients with heart failure or heart valve problems.
Safety and tolerability
Cialis (Tadalafil) is approved by the FDA for the treatment of erectile dysfunction. In a small number of patients, it has been reported to be safe and well tolerated. The most common side effects reported with tadalafil include headache, flushing, nasal congestion, and indigestion. The most commonly reported adverse events were dizziness, headache, dysuria, and diarrhea. In most patients, the most common dose-ranging events occurred within the first 5 days of treatment. In most patients, the incidence of any adverse events was not greater than the incidence in the placebo group. Cialis is generally well tolerated in all patients, but in the elderly, there was an increased incidence of side effects in patients treated with tadalafil.
Tolerability and safety
In a large, open-label study, 36 patients were treated with Cialis (60 mg once daily) for 36 weeks. The most common adverse events reported were headache, flushing, nasal congestion, dysuria, and diarrhea. There was no significant difference in the incidence of any adverse event between the groups. In the tadalafil group, there were more serious and potentially fatal side effects reported in patients taking tadalafil compared with those taking placebo (33.3% vs. 10.9%, p=0.002). Serious adverse events were less frequently reported in patients treated with Cialis.
The most common adverse effects reported in patients treated with Cialis (30.5%) were headache (10.6%), nasal congestion (5.3%), dizziness (5.1%), and dysuria (5.0%). The most commonly reported side effects of tadalafil were headache (26.
As with any drug product, there may be side effects. Generally, patients who experience side effects usually get them within 12 to 24 hours after taking Tadalafil. Side effects usually resolve on their own within 48 hours.
Most common Tadalafil side effects
Some more serious side effects have been reported. While rare, it is important to stop taking Tadalafil and contact a doctor right away if any of the following occur:
For a complete list of possible side effects,.
Possible drug interactions
Some drugs/medications may interact with Tadalafil. You should not take Tadalafil if you are taking nitrates (such as nitroglycerin tablets or patches) because the combination of these with Tadalafil could significantly lower blood pressure and lead to fainting or even death. Additionally, do not take Tadalafil if you are taking Cisapride, other ED medications (e.g. Viagra), Adcirca, or Riociguat.
On your intake form, please be sure to provide AgelessRx with all medications, herbs, non-prescription drugs, or dietary supplements you use. Also be sure to report if you smoke, drink alcohol, or use illegal drugs, as some may interact with your medication.
For a complete list of possible drug interactions,.
Other important safety information
Patients who have a condition called “left ventricular outlet obstruction” from valvular problems or heart muscle enlargement may get side effects such as fainting or light-headedness. Because patients with recent heart attacks or stroke, heart pains (angina), heart failure, uncontrolled blood pressure or uncontrolled irregular heart beats, severe liver disease, and retinal eye problems have not been studied, Tadalafil (Cialis) is not recommended for these patients. There may be rare occurrences of priapism or painful, prolonged erections. This is a serious condition that requires immediate medical attention. Patients should seek prompt medical attention if their erection lasts longer than four hours.
After taking a single tablet, Tadalafil can remain in the body for up to two days. It can remain longer if patients have problems with their kidneys or liver, or they are taking certain other medications.
Note:All information included on this page is a summary. It may not cover all possible information. If you have questions about this medication, talk to a doctor, pharmacist, or health care provider.
Note: The above statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
Cialis has been shown to cause some mild side effects. Talk to your health care provider if these do not go away within a few days. If you begin to experience more serious reactions, seek medical attention immediately.
Common side effects reported from Cialis use include:
More severe side effects include:
If you experience any of these side effects, seek medical attention immediately. These are symptoms of a severe adverse reaction to this medication that require immediate treatment.
As with all prescription medications, inform your doctor of any medical conditions you currently manage. Tell them about any and all medications, prescription drugs, and supplements you are taking before starting treatment with Cialis. Cialis can interact with bodily substances, causing potentially serious adverse reactions.
Specifically, you should inform your health care provider of any alpha-blocker, antifungal, HIV protease inhibitor, or high blood pressure medication you are taking. Remember to mention any herbal products you use, especially St. John’s wort.
In addition, let your doctor know if you have recently had heart surgery or experience chest pain during sex. If you experience any changes in your heartbeat or chest pain during sex, contact your health care provider immediately.
OpenCialis UsageDo not take Cialis if you:
Hydrate your change in weight on an as-needed basis, if you take Cialis. Do not drive or operate machinery until you know how you should react. Cialis can cause you to consume alcohol while taking this medication, increasing the risk of side effects.
If you experience any serious side effects, such as chest pain, seek medical attention immediately. These conditions are rare, but call your doctor for medical advice.
If you experience any side effects that are not listed, contact your doctor. This includes any changes in mood, thoughts, or behavior.
In the US -
P. O. Box 7615 - In named high-dose oral contraceptives, Inc., 2025arium; Cialis, brand name; capsule, 1 mg/mL; orodispersible tablets, 0.75 mg, 4 mg, 8 mg, 16 mg, 32 mg, 64 mg, 88 mg, 112 mg
Do not drive or operate machinery until you know how you should.
If you experience side effects that are not listed, contact your doctor.
Box 7615 - In named high-dose oral contraceptives, Inc., 2025arium; Cialis, brand name; capsule, 1 mg/mL; orodispersible tablets, 0.
Cialis has been shown to cause some mild side effects. Talk to your health care provider if these do not go away within a few days. If you begin to experience more serious reactions, seek medical attention immediately.
Common side effects reported from Cialis use include:
More severe side effects include:
If you experience any of these side effects, seek medical attention immediately. These are symptoms of a severe adverse reaction to this medication that require immediate treatment.
As with all prescription medications, inform your doctor of any medical conditions you currently manage. Tell them about any and all medications, prescription drugs, and supplements you are taking before starting treatment with Cialis. Cialis can interact with bodily substances, causing potentially serious adverse reactions.
Specifically, you should inform your health care provider of any alpha-blocker, antifungal, HIV protease inhibitor, or high blood pressure medication you are taking. Remember to mention any herbal products you use, especially St. John’s wort.
In addition, let your doctor know if you have recently had heart surgery or experience chest pain during sex. If you experience any changes in your heartbeat or chest pain during sex, contact your health care provider immediately.
azole_medicine_prescriptionAs with most medications, this side effect may occur. If you experience any changes in your condition, seek medical attention immediately.
As with all prescription medications, this side effect may occur.
Zanaflex Roacciawel StanozololIf you experience changes in your condition, seek medical attention immediately.
Cialis
Stade de France Pharmacy