Side effects, cost, operation, alternatives, etc.

Tavalisse can cause mild or severe side effects. The following lists contain some of the main side effects that can occur when taking Tavalisse. These lists do not include all possible side effects.

For more information about the possible side effects of Tavalisse, talk to your doctor or pharmacist. They can give you advice on managing side effects that might worry or bother you.

To note: The Food and Drug Administration (FDA) tracks the side effects of drugs it has approved. If you would like to notify the FDA about a side effect you have had with Tavalisse, you can do so via MedWatch.

Mild side effects

Mild side effects* of Tavalisse may include:

Most of these side effects may disappear within a few days to a few weeks. If they get worse or don’t go away, talk to your doctor or pharmacist.

*This is a partial list of mild Tavalisse side effects. To learn about other mild side effects, talk to your doctor or pharmacist, or check out Tavalisse prescribing information.
† For more information on this side effect, see “Details of side effects” below.

Serious side effects

Serious side effects from Tavalisse are not common, but they can occur. Call your doctor right away if you experience any serious side effects. Call 911 or your local emergency number if your symptoms are life-threatening or you think you have a medical emergency.

Serious side effects and their symptoms may include:

* For more information on this side effect, see ‘Details of side effects’ below.

Details of side effects

Here are some details about some side effects that this drug can cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Tavalise.

High blood pressure

People who have taken Tavalisse in clinical tests commonly reported high blood pressure. It was usually mild, but some people had severe high blood pressure.

what you can do

Your doctor will probably ask you to monitor your blood pressure at home while you are taking Tavalisse. In most cases, they will want to check your blood pressure in their office every 2 weeks until you are on a stable dose. * Your doctor will then usually monitor your blood pressure once a month to see if it is still at a safe level. .

If your blood pressure is rising, your doctor may prescribe medication to lower it. After you start taking the medicine for high blood pressure, your blood pressure may remain high. In this situation, your doctor may lower your dose of Tavalisse. If you have very high blood pressure which may become dangerous, your doctor may interrupt or stop treatment with Tavalisse.

* Your doctor may need to adjust your dose of Tavalisse to find the dose that is right for you.

Diarrhea

Diarrhea may occur with Tavalisse. It was one of the most common side effects in people who took Tavalisse in clinical tests. Most cases of diarrhea in the trials were mild. However, a few severe cases of diarrhea have been reported.

what you can do

If you have diarrhea during your treatment with Tavalisse, talk to your doctor. They may recommend drinking more water and changing your diet. The goal is to relieve diarrhea and help prevent dehydration. Additionally, your doctor may recommend medication for diarrhea.

If you have severe diarrhoea, your doctor may lower your dose of Tavalisse. Or they could interrupt or stop your treatment with the medicine.

Low levels of certain white blood cells

It is possible to develop low levels of certain white blood cells with Tavalisse. Although this is not a common side effect in people who have taken the drug in clinical testsit can still happen.

Tavalisse can lower the level of neutrophils in your body. These are white blood cells that help your immune system fight infections. With low neutrophils, your immune system may weaken. This can increase your risk of infection. A low neutrophil count (called neutropenia) usually does not cause symptoms. However, an infection due to neutropenia can cause symptoms such as fever, sore throat, or cough.

what you can do

If you develop symptoms of infection while taking Tavalisse, tell your doctor. An infection can mean that your neutrophil count is low. Your doctor will monitor your neutrophil count throughout your treatment.

If you develop low white blood cell count with Tavalisse, your doctor may stop your treatment. In some cases, they may lower your dose. If your level is very low, your doctor may recommend a medicine other than Tavalisse.

Allergic reaction

As with most medicines, some people may have an allergic reaction after taking Tavalisse.

Symptoms of a mild allergic reaction may include:

A more serious allergic reaction is rare but possible. Symptoms of a severe allergic reaction may include:

  • swelling under the skin, usually in the eyelids, lips, hands, or feet
  • swelling of the tongue, mouth or throat
  • difficulty breathing

Call your doctor right away if you have an allergic reaction to Tavalisse, as the reaction could become serious. Call 911 or your local emergency number if your symptoms are life-threatening or you think you have a medical emergency.

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