07/30/2024 | Press release | Distributed by Public on 07/30/2024 15:39
Key takeaways:
Adempas (riociguat) is a prescription medication for adults with pulmonary arterial hypertension (PAH). It's also used to treat chronic thromboembolic pulmonary hypertension.
Common Adempas side effects include headache, upset stomach, and dizziness. Diarrhea, low blood pressure, and anemia are also possible.
While rare, Adempas may also cause serious bleeding problems and harm a growing fetus. To manage this risk, you'll be enrolled in a mandatory safety program if you're able to get pregnant.
Adempas (riociguat) is an oral medication used to manage pulmonary arterial hypertension (PAH) in adults. It's also approved to treat chronic thromboembolic pulmonary hypertension (CTEPH). Adempas can help improve your ability to exercise and perform daily activities. And if you have PAH, it can slow your condition from getting worse.
As a soluble guanylate cyclase (sGC) stimulator, Adempas works on the same pathway in the body as medications such as sildenafil (Revatio) and tadalafil (Adcirca), which are also used for PAH. Because of this, it shares several common side effects with these medications - from headaches to low blood pressure. But what other Adempas side effects can you expect?
Adempas side effects are often mild and can be managed at home. Others are less common and may require assistance from your healthcare team. Below are side effects that were reported during initial clinical trials.
How they compare: Many medications help manage pulmonary arterial hypertension (PAH). Learn about the different types of PAH medications and how they stack up against each other.
Guide to pulmonary arterial hypertension: Experts break down the different symptoms, causes, and treatments of PAH.
Portable oxygen therapy: Oxygen therapy can help with PAH symptoms such as shortness of breath. Learn more about portable oxygen options that allow you to use oxygen outside the home.
Common Adempas side effects (reported by at least 3% of people) include:
Headache
Upset stomach or indigestion
Nausea or vomiting
Acid reflux
Dizziness
Diarrhea
Low blood pressure
Anemia (low red blood cell count)
Constipation
Common cold
Swelling in the extremities
While less common, bleeding is a potential Adempas side effect that can be serious. Adempas can also cause harm to a growing fetus if taken during pregnancy.
Below, we review eight Adempas side effects and risks, as well as what you can do to manage them.
Headaches are the most commonly reported Adempas side effect. In fact, over 25% of people taking the medication in clinical trials reported headaches. As mentioned above, Adempas works on the same pathway as medications such as sildenafil, which are commonly known to cause headaches.
If your headaches are persistent or bothersome to you, talk to your prescriber. They may try lowering your Adempas dose to see if that helps. Or, they may recommend the occasional use of an over-the-counter (OTC) pain reliever, such as acetaminophen (Tylenol). Check with them first before taking one. Home remedies may also help.
Stomach-related side effects are also common with Adempas. Upset stomach, nausea, and acid reflux are a few examples.
Side effects such as nausea often go away without any treatment. But if you've been taking Adempas on an empty stomach, try taking it with a small snack to see if that makes a difference. It may also help to avoid foods that can worsen your symptoms, such as acidic, fatty, or spicy foods. Try eating smaller, more frequent meals rather than larger meals.
If these changes aren't helping, your prescriber can provide other tips for relief. This may include taking an OTC antacid 2 hours before or 1 hour after your Adempas dose.
If your nausea continues or you startvomiting, talk to your healthcare team. They can help you determine the cause and what you should do to resolve it.
Diarrhea is another common Adempas side effect. Constipation is also possible, but diarrhea seems to be reported more frequently.
Diarrhea is usually mild and goes away without any kind of treatment. It can be helpful todrink plenty of fluids to prevent dehydration, especially if your diarrhea continues. You can also try limiting or avoiding foods that canworsen diarrhea, such dairy products and fatty foods.
Diarrhea can be a side effect ofother medications and can be related to certain health conditions. If your diarrhea continues, gets worse, or seems severe,talk to your healthcare team. If appropriate for you, they may suggest trying an OTCantidiarrheal medication.
Adempas may leave you feelingdizzy, especially when you start taking it and after dose increases. This is because it causes your blood vessels to widen, which can cause your blood pressure to drop. Avoid driving or performing other tasks where dizziness can be dangerous until you know how Adempas affects you.
If you start feeling dizzy, sit or lie down until you're feeling more stable. Change positions slowly (such as going from sitting to standing) to avoid falling down. Dehydration can worsen dizziness, so be sure to drink enough fluids throughout the day to stay hydrated.
Tell your prescriber if you're feeling dizzy after starting Adempas. It's possible that your blood pressure is dropping too low, which we'll cover next. In this case, your dose may need to be lowered.
As mentioned above, Adempas can lower your blood pressure. To manage this side effect, your prescriber will typically have you start with a low dose that's increased over time. They'll monitor your blood pressure every few weeks to ensure that it's not getting too low. This helps them find the right dose that's safe and effective for you.
When your blood pressure gets too low (hypotension), you can feel dizzy, lightheaded, or weak. If you experience these symptoms, contact your prescriber right away. But if you feel like you're going to pass out, have someone take you to the nearest ER.
Low blood pressure from Adempas may be more likely if you take it with other medications that have a similar effect. For this reason, you shouldn't take Adempas with nitrates, phosphodiesterase 5 (PDE 5) inhibitors, or another sGC stimulator. These medications can cause dangerously low blood pressure with Adempas.
Anemia (low red blood cell count) has also been reported with Adempas. Your healthcare team may run blood tests before and during Adempas treatment to monitor for this side effect. Tell them if you notice symptoms such as pale skin, unusual tiredness, or cold hands and feet.
Bleeding is a rare but potentially serious Adempas side effect. Serious bleeding was reported in a little over 2% of people taking Adempas during clinical trials. This included coughing or vomiting up blood, vaginal bleeding, and other serious bleeding events.
While taking Adempas, watch for signs of bleeding and get immediate medical attention if they occur. Examples of these include:
Vomiting or coughing up blood
Vomit that looks like coffee grounds
Unusual bleeding from the vagina
Black or bloody stools
If taken during pregnancy, Adempas can harm a growing fetus. Because of this, you'll be enrolled in a mandatory safety program called a Risk Evaluation and Mitigation Strategy (REMS) to help manage this issue if you're able to get pregnant. If you are, you need a negative pregnancy test before starting Adempas, a monthly negative test during treatment, and a negative test one month after stopping the medication.
As part of the program, you'll also need to use effective forms of birth control while you take Adempas and for one month after stopping it.
Common Adempas (riociguat) side effects include headache, upset stomach, and dizziness. Diarrhea, low blood pressure, and anemia are also possible. Your prescriber will regularly monitor your blood pressure to ensure that it isn't getting too low. This helps them find a dose that's safe and effective for you.
While rare, serious bleeding has been linked to Adempas. Get immediate medical attention if you notice signs of bleeding, such as vomiting or coughing up blood.
Talk to your prescriber or pharmacist if you have any questions about Adempas side effects or for more tips on how to manage them.
American Lung Association. (n.d.). Chronic thromboembolic pulmonary hypertension (CTEPH).
Bayer HealthCare Pharmaceuticals Inc. (2023). Adempas [package insert].
Halank, M., et al. (2019). Practical management of riociguat in patients with pulmonary arterial hypertension. Therapeutic Advances in Respiratory Disease.
National Heart, Lung, and Blood Institute. (2022). What is anemia?
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