Many medications can cause side-effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Tracleer (Bosentan). If you are concerned about side effects, discuss the risks and benefits of Tracleer (Bosentan) with your doctor.

The following side effects have been reported by at least 1% of people taking Tracleer (Bosentan). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects

• Diarrhea
• fatigue
• flu-like symptoms (e.g., Fever, cough, sore throat, runny nose, headache)
• flushing
• headache
• heartburn
• inflammation of the throat and nasal passages
• itching
• Low Blood Pressure
• nasal congestion
• nausea
• skin rash
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal pain
• chest pain
• irregular heartbeat
• swelling of the ankles and legs
• swelling in other parts of the body (severe)
• symptoms of Anemia (e.g., fatigue, shortness of breath)
• symptoms of liver problems (e.g., yellowing of the skin or eyes, nausea, vomiting, fever, abdominal pain, or unusual tiredness)
• wheezing

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., swelling of face or throat, Hives, or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Tracleer (Bosentan).

62.5 mg
Each orange-white, round, film-coated tablet, embossed with "62.5" on one side, contains 62.5 mg of Tracleer (Bosentan) monohydrate. Nonmedicinal ingredients: corn starch, glyceryl behenate, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, ethylcellulose, hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, talc, titanium dioxide, and triacetin.

125 mg
Each orange-white, oval, film-coated tablet, embossed with "125" on one side, contains 125 mg of Tracleer (Bosentan) monohydrate. Nonmedicinal ingredients: corn starch, glyceryl behenate, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, ethylcellulose, hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, talc, titanium dioxide, and triacetin.

Do not take Tracleer (Bosentan) if you:

• are allergic to Tracleer (Bosentan) or any ingredients of the medication
• are pregnant, planning to become pregnant, or may become pregnant (unless using adequate contraception)
• are taking a medication called Cyclosporine A
• are taking a medication called Glyburide
• have moderately to severely reduced liver function

There may be an interaction between Tracleer (Bosentan) and any of the following:

• Abiraterone acetate
• alpha-blockers (e.g., Alfuzosin, Doxazosin, Silodosin, Tamsulosin)
• Amiodarone
• anticancer medications (e.g., Cabazitaxel, Docetaxel, Doxorubicin, Etoposide, Ifosfamide, Irinotecan, Vincristine)
• Apremilast
• Aprepitant
• Aripiprazole
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• benzodiazepines (e.g., Chlordiazepoxide, Clonazepam, Diazepam, Lorazepam)
• Bisoprolol
• Buprenorphine
• Buspirone
• Calcitriol
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Carbamazepine
• chloroquine
• Clozapine
• Cobicistat
• Codeine
• conivaptan
• cyclosporine
• Dantrolene
• Dapsone
• Darifenacin
• Dexamethasone
• Digoxin
• Disopyramide
• Dronedarone
• Eltrombopag
• Enzalutamide
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Everolimus
• Fentanyl
• Fesoterodine
• Flibanserin
• Gemfibrozil
• "gliptin" Diabetes medications (e.g., Linagliptin, Saxagliptin, Sitagliptin)
• glyburide
• grapefruit juice
• Guanfacine
• Haloperidol
• Hepatitis C antiviral medications (e.g., daclatasvir, elbasvir, grazoprevir, ledipasvir, sofosbuvir, velpatasvir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hormonal birth control (e.g., tablets, injections, patches, implants)
• Hydrocodone
• Leflunomide
• lidocaine
• Lomitapide
• Losartan
• Lurasidone
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Macitentan
• maraviroc
• Mefloquine
• Meperidine
• Methadone
• mifepristone
• milk thistle
• Mirtazapine
• Modafinil
• Naloxegol
• nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
• Ondansetron
• Oxycodone
• Perampanel
• phosphodiesterase-5 inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil)
• Pimozide
• praziquantel
• Primaquine
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• protein kinase inhibitors (e.g., Axitinib, Bosutinib, imatinib, Nilotinib, Pazopanib)
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
• Quetiapine
• quinidine
• quinine
• Repaglinide
• rifabutin
• rifampin
• rilpivirine
• Riociguat
• Rivaroxaban
• Romidepsin
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Sirolimus
• Solifenacin
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• Tacrolimus
• Tamoxifen
• Teriflunomide
• Tetracycline
• Theophylline
• Ticagrelor
• Ticlopidine
• Tolterodine
• Tolvaptan
• Tramadol
• Trazodone
• Ulipristal
• Venlafaxine
• Warfarin
• Zolpidem
• Zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Tracleer (Bosentan). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medication conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Tracleer (Bosentan).

Anemia: Tracleer (Bosentan) can reduce the number of red blood cells, which carry oxygen throughout your body. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Your doctor will periodically do blood work to monitor your red blood cell levels to ensure that this does not happen.

Heart failure: People with severe chronic heart failure may see a worsening of their condition when they first start Tracleer (Bosentan). This may be due to fluid retention, which is one of the side effects of Tracleer (Bosentan). If you have severe chronic heart failure, discuss with your doctor how Tracleer (Bosentan) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Tracleer (Bosentan), and whether any special monitoring is needed.

Liver problems: Tracleer (Bosentan) can affect your liver. Your doctor will perform regular blood tests to make sure your liver is functioning properly. Tracleer (Bosentan) should not be used by people who have moderately to severely reduced liver function.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Low blood pressure: If you have low blood pressure, discuss with your doctor how Tracleer (Bosentan) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Tracleer (Bosentan), and whether any special monitoring is needed.

Stopping medication: Suddenly stopping Tracleer (Bosentan) may worsen your symptoms. Do not stop taking Tracleer (Bosentan) unless directed by your doctor. If you are stopping treatment, your doctor will monitor you and reduce the dose over a period of time before stopping the medication completely.

Pregnancy: The medication should not be used during pregnancy, as it may cause serious harm to the fetus. Your doctor should perform a pregnancy test before you start Tracleer (Bosentan), and monthly thereafter while you are taking Tracleer (Bosentan). Since Tracleer (Bosentan) decreases the effectiveness of hormonal birth control, you should use more than one form of contraception (e.g., non-hormonal forms such as condoms) while taking Tracleer (Bosentan). If you become pregnant while taking Tracleer (Bosentan), contact your doctor immediately.

Breast-feeding: It is not known if Tracleer (Bosentan) passes into breast milk. If you are a breast-feeding mother and are taking Tracleer (Bosentan), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Tracleer (Bosentan) for children are not well established. Your doctor will determine if the benefits of the medication outweigh the risks for your child.

Seniors: People over 65 years old may be more at risk of side effects from Tracleer (Bosentan) due to age-related decreases in liver function.