The Food and Drug Administration (FDA) is warning patients to avoid Cialis when taking the medication, a study presented on Wednesday in The New England Journal of Medicine suggests.
The warning is based on two separate studies that looked at how well patients tolerate Cialis in different doses.
The FDA also asked patients to report any side effects, including headache, back pain, muscle pain, flushing, upset stomach, nasal congestion and dizziness, the study found.
The agency also warned patients to avoid taking Cialis if they are taking any of the drugs in question, which the study suggests could affect how they feel.
Cialis, also known as tadalafil, is an FDA-approved drug used to treat erectile dysfunction and is also used in combination with other medications like sildenafil, tadalafil and vardenafil.
Tadalafil works by increasing blood flow to the penis, which can help men regain their erections. Cialis is only approved for use in men 18 and older, but it can still be prescribed for patients with certain medical conditions, such as cardiovascular disease or diabetes.
In a separate study, the FDA and the European Medicines Agency issued warnings about the drug’s potential for causing serious side effects, including sexual dysfunction.
The study’s authors wrote that their findings are supported by clinical studies that showed the drug can cause sexual dysfunction in patients taking nitrates. Other studies have found that sexual dysfunction caused by tadalafil may also occur if the medication is taken in combination with alpha blockers, such as those prescribed for high blood pressure or angina.
The FDA issued the following warning in March about the risk of Cialis use in patients taking nitrates because the drug can interact with alpha blockers, which are prescribed for the treatment of erectile dysfunction.
The FDA also advised patients to report any side effects they experience to their health care professional, including headaches, muscle pain, back pain and flushing.
A recent study of more than 2,000 men with erectile dysfunction found that most men experienced side effects from taking tadalafil. However, the researchers did not find any of the side effects in men taking nitrates or other medications for erectile dysfunction.
“This is a significant safety concern for patients and their physicians,” said Dr. Steven Nissen, a urologist at New York’s Lenox Hill Hospital.
“In conclusion, it is important to use Cialis as directed by a healthcare professional and to avoid taking any nitrates or other medications that could be causing severe side effects.”
Cialis, also known as tadalafil, is used to treat erectile dysfunction and is also prescribed to patients with diabetes and high blood pressure. It works by increasing blood flow to the penis, which can help men regain their erections.
A study published in the Journal of Sexual Medicine in April found that patients who took tadalafil for several months experienced a significant decrease in their erectile function.
The study, which was conducted by the Urologic Association of New York City, showed that patients who took tadalafil had an average improvement in their ability to get and maintain an erection for about four to six hours after taking the drug.
The drug may interact with other drugs, including those prescribed for the treatment of high blood pressure, high cholesterol and certain types of blood cancers, according to the drug’s maker, Novartis AG.
The FDA also issued a warning about tadalafil’s possible interaction with other drugs used to treat erectile dysfunction, including antidepressants, antipsychotics and painkillers, which the company did not disclose.
The FDA also warned patients that the drug could cause a sudden drop in blood pressure, which could be dangerous if left untreated. The FDA also advised patients to seek medical attention if they have vision problems or an erection that lasts more than four hours.
“In most cases, this is not a side effect,” said Dr. Elizabeth Arbab, director of the Urology Department at New York’s Lenox Hill Hospital. “In fact, the most common side effects of Cialis are headache, flushing, back pain, nasal congestion and dizziness.”
The FDA also cautioned patients about the risk of having side effects from taking the drug, which may be serious. Some patients may also experience chest pain, nasal congestion and dizziness when taking the drug.
1.Nitrates (e.g., nitroglycerin, isosorbide dinitrate): Cialis and nitrates both lower blood pressure. Taking them together can cause a significant and potentially life-threatening drop in blood pressure (hypotension), leading to dizziness, fainting, or even heart attack or stroke. It is contraindicated to use Cialis with nitrates or recreational "poppers" (amyl nitrites).
2.Alpha-blockers (e.g., prazosin, terazosin, tamsulosin): Both Cialis and alpha-blockers relax blood vessels, which can lead to excessive blood pressure reduction when used together. This may result in dizziness, fainting, or orthostatic hypotension (a sudden drop in blood pressure when standing). If needed, your doctor may adjust the dosage or recommend spacing the medications.
3.Other antihypertensive drugs (e.g., atenolol, propranolol, enalapril, lisinopril): Cialis can enhance the blood-pressure-lowering effects of these medications. While this interaction is usually less severe than with nitrates or alpha-blockers, it can still cause dizziness or fainting in sensitive individuals. Close monitoring of blood pressure is recommended.
Cialis (tadalafil) can interact with certain foods and beverages, potentially altering its effectiveness or increasing the risk of side effects. Here are the key drug-food interactions to be aware of:
If you take Cialis with medications like alpha-blockers or other drugs that may interact with it, it is important to inform your doctor of your other drug interactions. This includes allergies can create serious side effects, such as heart attack or stroke, which may require spacing the medications.
Here are the key drug-food Interactions to be aware of:
2023-08-18
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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.
Read More This Side effect is also reported in a small number of people who take Cialis. You should not use Cialis if you are pregnant, planning to become pregnant, or are breastfeeding.Possible Side Effects (3 reports of side effects, 1%)........................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................
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