bosentan
Bosentan (Tracleer) improves your ability to exercise and slows worsening of pulmonary arterial hypertension (PAH), but it has several drug interactions and can cause liver damage.
What is Bosentan (Tracleer)?
What is Bosentan (Tracleer) used for?
- Pulmonary arterial hypertension (PAH)
How Bosentan (Tracleer) works
Bosentan (Tracleer) is an endothelin receptor antagonist. It works on proteins in your body that control the blood flow going to your lungs. This medication relaxes the arteries in your lung and allows more blood to flow through. As a result, your heart is able to pump better, your body gets more oxygen, and you should be able to breathe and exercise easier.
Drug facts
Side effects of Bosentan (Tracleer)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Common cold symptoms or lung infection (22%)
- Headache (15%)
- Swelling due to fluid buildup (11%)
- Chest pain (5%)
- Fainting (5%)
Less Common Side Effects
- Warmth and redness in the face, neck, or chest
- Low blood pressure
- Sinus inflammation
- Joint pain
- Changes to liver blood tests
- Feeling like your heart is skipping beats
- Low number of red blood cells (anemia)
Bosentan (Tracleer) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Liver failure
- Heart failure
- Allergic reactions
The following Bosentan (Tracleer) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Blurred vision
confusion
dizziness
dark urine
faintness or lightheadedness when getting up from a lying or sitting position
fever with or without chills
light-colored stools
loss of appetite
stomach pain
sudden sweating
unusual tiredness or weakness
vomiting
yellow eyes or skin
Less common
Swelling
Incidence not known
Black, tarry stools
bleeding gums
blood in the urine or stools
blue lips and fingernails
chills
clay-colored stools
coughing that sometimes produces a pink frothy sputum
coughing up blood
dark urine
decrease in the amount of urine
difficult, fast, or noisy breathing
fainting
fast heartbeat
fatigue on exertion
headache
hoarseness
increased sweating
irritation
joint pain, stiffness, or swelling
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
noisy, rattling breathing
pale skin
pinpoint red spots on the skin
redness of the skin
shortness of breath
swelling of the eyelids, face, lips, hands, fingers, legs, ankles, or feet
tightness in the chest
troubled breathing at rest or exertion
troubled breathing or swallowing
unpleasant breath odor
unusual bleeding or bruising
vomiting of blood
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
Increased heart rate
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Fast, irregular, pounding, or racing heartbeat or pulse
feeling of warmth
muscle aches
redness of the face, neck, arms, and occasionally upper chest
stuffy or runny nose
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Bosentan (Tracleer)
Pros
- Helps slow down the worsening of PAH, so you are able to live longer with the condition
- Can make it easier to breathe, exercise, and walk longer distances
- Can be used in children as young as 3 years old
- Also available as a dissolvable tablet
- Safe to use if you have kidney problems
Cons
- If you are female, you will need to use birth control and take pregnancy tests every month.
- Not all pharmacies can fill bosentan (Tracleer) prescriptions.
- Can affect male sperm count and ability to have children
- Can cause serious liver damage
- Cannot be taken with cyclosporine A or glyburide
Pharmacist tips for Bosentan (Tracleer)
- Take bosentan (Tracleer) with or without food twice a day (in the morning and evening).
- Don't stop taking bosentan (Tracleer) unless your provider tells you to, even if you start feel better. Stopping bosentan (Tracleer) can cause your symptoms to come back and can worsen your PAH.
- The 32 mg tablet can be broken in half but not into quarter pieces. If you are saving half of a tablet for a future dose, put it back in the opened package, and make sure to use it within 7 days.
- Bosentan (Tracleer) interacts with quite a few medications. Some of these interactions can be serious or life-threatening. Make sure your provider and pharmacist are aware of all the medications that you are currently taking, including over-the-counter products, vitamins, and herbal supplements.
- If you are a female, you'll need to be on an approved form of birth control and provide a negative pregnancy test each month before getting refills of bosentan (Tracleer). Depending on which primary birth control method you choose, you might need to use two forms of birth control.
- Do not try to get pregnant while taking bosentan (Tracleer) and for at least 1 month after stopping it. Do not take bosentan (Tracleer) if you are breastfeeding.
- Bosentan (Tracleer) lowers the number of sperm males make. This can affect your ability to have children. Be sure to let your provider know if there's a possibility you might want children in the future. This might not be the best option for you.
Common questions about Bosentan (Tracleer)
The 62.5 mg and 125 mg tablets have a film coating on them. Crushing these tablets is not usually recommended. The 32 mg dissolvable tablet is specially designed to easily and safely dissolve in water. They can also be split in half if needed. If you have trouble swallowing tablets, ask your provider if the 32 mg tablet could work for you.
Most people will start to notice better exercise ability after taking bosentan (Tracleer) for one month. It can take up to two months to notice the full effect of this medication.
Alcohol is not known to interact directly with bosentan (Tracleer). But, drinking too much alcohol can cause liver problems and increase your chance of liver damage from bosentan (Tracleer). It's best to ask your provider how much alcohol you can safely drink while on this medication.
Bosentan (Tracleer) is not known to hurt the kidneys. Providers are usually more worried about its effects on the liver. Your dose does not need to be adjusted if you have kidney problems.
Sildenafil and tadalafil work differently from bosentan (Tracleer). Like bosentan (Tracleer), they also help relax the blood vessels in the lungs so that blood flows through better, improving your ability to breathe and exercise. Depending on how severe your PAH is, your provider may prescribe one of those medications along with bosentan (Tracleer).
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Risks and warnings for Bosentan (Tracleer)
Bosentan (Tracleer) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Liver damage
- Risk factors: Current liver problems | People taking high doses of bosentan (Tracleer)
Rarely, bosentan (Tracleer) can cause severe liver damage, including liver failure. This is one of reasons why you, your provider, and your pharmacy are required to sign up with the Risk Evaluation and Mitigation Strategies (REMS) program for this medication. You'll need to get liver blood tests every month, since it is usually hard to tell if there is damage early on. Liver damage is more likely to happen if you already have liver problems or are taking more than 125 mg of bosentan (Tracleer) twice a day. Do not take more medication than what your provider prescribed for you. Never take extra or double up in order to make up for a missed dose. If you notice severe nausea, vomiting, right-sided stomach pain, fatigue, low or no appetite, or yellowing of the skin or eyes, seek medical help right away.
Birth defects
Bosentan (Tracleer) can cause serious birth defects, which is why all female patients, their provider, and their pharmacy are required to sign up with the Risk Evaluation and Mitigation Strategies (REMS) program for this medication. If you're a female and haven't gone through menopause yet, you will be required to use 2 types of approved birth control while taking bosentan (Tracleer) and for one month after stopping the medication. You will need to provide a negative pregnancy test every month before you can get a medication refill. Tell your provider right away if you think you're pregnant or if you are unable to use your prescribed birth control.
Fluid build-up
- Risk factors: Heart failure
Bosentan (Tracleer) can cause fluid build-up, especially if you have a history of heart failure. If you have any heart problems, let your provider know before starting bosentan (Tracleer). Contact your provider immediately if you notice unusual swelling in your arms or legs, rapid weight gain (more than 3 pounds in a day or 5 pounds in a week), or trouble breathing.
Serious lung disease
Although rare, bosentan (Tracleer) can cause a serious type of lung condition called pulmonary veno-occlusive disease, which can cause fluid build-up in the lungs. If your PAH symptoms get worse, breathing becomes difficult when you lie down, or if you develop a cough that doesn't go away, seek medical help right away.
Low sperm count
Bosentan (Tracleer) can cause problems with sperm production. This can affect your ability to have children. If you are a male and would like to have children in the future, let your provider know before starting bosentan (Tracleer).
Red blood cell effects
- Risk factors: Low hemoglobin (anemia)
Bosentan (Tracleer) might cause your hemoglobin levels to go down. Hemoglobin is the protein on your red blood cells that carries oxygen. You will need regular blood tests while taking this medication to make sure your hemoglobin stays at a healthy level. If you experience difficulty breathing, lightheadedness, or more fatigue, let your provider know.
Bosentan (Tracleer) dosage
Typical dosage for Bosentan (Tracleer)
- Adults and children over 12 years old: Start with 62.5 mg by mouth twice daily. After 4 weeks, if you weigh over 40 kg (88 pounds), your provider might increase your dose to 125 mg by mouth twice daily.
- Children ages 3 to 12 years old: Depending on your child's weight, they can take between 16 mg and 64 mg by mouth twice daily.
Interactions between Bosentan (Tracleer) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Alfentanil
- Atazanavir
- Avapritinib
- Axitinib
- Benzhydrocodone
- Brigatinib
- Buprenorphine
- Capmatinib
- Cobicistat
- Cobimetinib
- Codeine
- Daclatasvir
- Darolutamide
- Darunavir
- Deflazacort
- Desogestrel
- Dienogest
- Dihydrocodeine
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Dronedarone
- Drospirenone
- Elbasvir
- Elvitegravir
- Enasidenib
- Encorafenib
- Entrectinib
- Enzalutamide
- Erdafitinib
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Etonogestrel
- Fedratinib
- Fentanyl
- Fosamprenavir
- Gestodene
- Glasdegib
- Grazoprevir
- Hemin
- Hydrocodone
- Lefamulin
- Leflunomide
- Lemborexant
- Levonorgestrel
- Lopinavir
- Lorlatinib
- Lumateperone
- Lurbinectedin
- Medroxyprogesterone
- Meperidine
- Mestranol
- Methadone
- Neratinib
- Nifedipine
- Nomegestrol
- Norelgestromin
- Norethindrone
- Norgestimate
- Norgestrel
- Olaparib
- Oxycodone
- Pemigatinib
- Pentazocine
- Perampanel
- Pexidartinib
- Piperaquine
- Pretomanid
- Rimegepant
- Ritonavir
- Saquinavir
- Segesterone
- Selpercatinib
- Selumetinib
- Simeprevir
- Sufentanil
- Tacrolimus
- Tazemetostat
- Teriflunomide
- Tipranavir
- Tramadol
- Ubrogepant
- Velpatasvir
- Venetoclax
- Voclosporin
- Voxelotor
- Voxilaprevir
- Zanubrutinib
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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