Fintepla (fenfluramine) is a brand-name oral solution prescribed for certain seizures due to Lennox-Gastaut syndrome or Dravet syndrome in adults and some children. Fintepla can cause side effects, such as sleepiness, decreased appetite, or vomiting.

Fintepla has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section below.

Fintepla can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Fintepla in clinical trials:

  • sleepiness
  • diarrhea
  • vomiting
  • decreased appetite, which may cause reduced body weight*
  • fatigue

* For more information about this side effect, see “Side effect specifics” below.

Mild side effects can occur with Fintepla use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Fintepla’s prescribing information.

Mild side effects that people taking Fintepla to treat Lennox-Gastaut syndrome have reported include:

  • diarrhea
  • vomiting
  • sleepiness
  • decreased appetite, which may lead to reduced body weight*

Mild side effects that people taking Fintepla to treat Dravet’s syndrome have reported include:

  • sleepiness or decreased energy
  • respiratory infections
  • fever
  • drooling
  • difficulty with walking or balancing
  • falling
  • weakness
  • diarrhea or vomiting
  • decreased appetite, which may lead to decreased body weight*
  • constipation

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Fintepla and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.

Fintepla may cause serious side effects. However, serious side effects from this drug were not common. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Fintepla’s prescribing information.

If you develop serious side effects while taking Fintepla, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects and their symptoms that people have reported include:

* For more information about this side effect, see “Side effect specifics” below.

ALLERGIC REACTION

For some people, Fintepla oral solution can cause an allergic reaction.

But it’s unclear whether this side effect occurred in studies of Fintepla oral solution.

In general, symptoms of allergic reaction can be mild or serious. You can learn more about possible symptoms in this article.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Fintepla oral solution, your doctor may recommend taking a different medication instead.

Fintepla may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

How do the side effects of Fintepla compare with those of Epidiolex (cannabidiol)?

Fintepla and Epidiolex (cannabidiol) are medications that can help manage seizures in people with Lennox-Gastaut syndrome and Dravet syndrome. Epidiolex is approved for seizures in people with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex.

These medications have some side effects that are the same and others that are different. Both medications can cause sleepiness, decreased energy, suicidal thoughts or behaviors, and decreased appetite. However, Fintepla can cause high blood pressure, valvular heart disease, or PAH to occur. Additionally, Epidiolex can cause increased liver function blood tests, which may indicate liver problems.

Before you start treatment for your seizures, your doctor will discuss the risks and benefits of both treatment options with you, including the side effects of the medications. They may also discuss other factors, such as the price of Fintepla or Epidiolex, the available forms of each drug, and the dosing.

If you have questions or concerns about which drug is right for you, talk with your doctor or pharmacist.

Is there a risk of misuse or dependence with Fintepla?

No, Fintepla is not a drug that can cause misuse or dependence. Misuse of a medication is when you take a drug in a way that’s different than how it was prescribed. Being dependent on a drug is when you need to take it to function. If you suddenly stop taking a medication that you’re dependent on, it can lead to withdrawal symptoms.

If you are stopping treatment with Fintepla, your doctor may recommend slowly decreasing your dose of medication. This is not because the drug causes dependence or withdrawal symptoms. But if you suddenly stop taking Fintepla, you may be at an increased risk of seizures occurring, which can be serious.

If you have questions or concerns about taking Fintepla, talk to your doctor or pharmacist.

Learn more about some of the side effects that Fintepla may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Fintepla.

Valvular heart disease and pulmonary arterial hypertension

It’s possible to experience problems with the valves of your heart (valvular heart disease) or high blood pressure in your lungs (PAH) from taking Fintepla. In fact, the drug has a boxed warning for these side effects. A boxed warning is the most serious warning that the FDA recommends. The purpose of a boxed warning is to alert patients and prescribers about the risks of taking a medication.

It’s important to note that valvular heart disease and PAH are not common side effects of this medication. In fact, in studies, no one taking Fintepla developed these side effects. But, because of how the drug works, it is possible to develop these two conditions. So, your doctor will monitor your heart throughout your treatment on this medication.

What you can do

Before you start taking Fintepla, your doctor will do a heart test called an echocardiogram. This will check your heart and the pressure in the arteries of your lungs before you start treatment. You’ll have an echocardiogram once every 6 months during your treatment to monitor for valvular heart disease or PAH. In addition, you’ll need to complete another echocardiogram 3 to 6 months after stopping treatment with Fintepla to monitor your heart and lung health.

It’s important to watch for symptoms of heart or lung problems throughout your treatment with Fintepla. Symptoms to look for include:

  • fatigue
  • dizziness or fainting
  • swollen ankles or feet
  • shortness of breath
  • chest pain
  • heart palpitations or an irregular pulse
  • blue lips or skin

If you notice any of these side effects, be sure to call your doctor right away. They may recommend that you visit their office or go to the hospital to check for valvular heart disease or pulmonary arterial hypertension.

Due to the risks of valvular heart disease or PAH occurring, the FDA approved Fintepla through a REMS (Risk Evaluation and Mitigation Strategy) program. You, your doctor, and your pharmacy will need to enroll in the Fintepla REMS program to be sure that you are aware of the risks of the medication and that you are being monitored. If you have questions about the risks of valvular heart disease or PAH occurring, talk to your doctor or pharmacist. You can also visit the Fintepla REMS webpage or call 1-877-964-3649.

Decreased appetite or weight

It’s possible for Fintepla to cause decreased appetite, which may lead to weight loss. In fact, decreased appetite and weight loss were common side effects that people taking this medication in studies reported. Sometimes, appetite or weight loss can be serious. Decreased appetite or weight loss can occur regardless of whether you are taking the drug to treat Dravet syndrome or Lennox-Gastaut syndrome.

What you can do

Throughout Fintepla treatment, a doctor will monitor your or your child’s weight. Because decreased appetite and weight loss are common side effects, a doctor will. monitor your body weight throughout treatment. If you do experience weight loss from Fintepla, your doctor or child’s doctor may recommend decreasing the dose. Sometimes, they may even recommend you stop treatment with Fintepla and try a different medication.

Below is important information you should consider before taking Fintepla.

Fintepla has a boxed warning for the risk of valvular heart disease and PAH. A boxed warning is the most serious warning from the FDA. For details, see the “Side effect specifics” section above.

Other precautions

Before taking Fintepla, discuss your health history with your doctor. Fintepla may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

  • heart problems
  • weight loss
  • mood problems, depression, or suicidal thoughts or behaviors
  • kidney problems
  • liver problems
  • previous allergic reaction to this or a similar drug
  • pregnancy
  • breastfeeding
  • alcohol consumption

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.