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Bosentan

More information: STITCH, PubChem and possibly Wikipedia

ATC Code: C02KX01

Side effects

Options: Show MedDRA Preferred Terms

Side effect Data for drug Placebo Labels
1 2 3 4 5
Infection 33% x x x
Oedema 28% 16% x x x x x
Headache 11.5% - 39% 20% - 25% x x x x x
Discomfort 19% x x
Fluid retention 13.2% x x x x
Chest pain 13% 8% x x
Upper respiratory tract infection 12% 11% x
Dizziness 11% 16% x
Nasopharyngitis 11% 8% x x
Vertigo 11% 16% x
Liver function test abnormal 10.9% x x
Flushing 7% - 21% 2% - 5% x x x x x
Palpitations 9% 3% x x x x x
Arthralgia 7% - 9% 3% - 6% x x
Bronchitis 7% 9% x
Hypotension 6% - 10% 3% - 8% x x x x x
Sinusitis 7% - 9% 4% - 5% x x
Pulmonary hypertension 6% 20% x x x
Syncope 6% - 12% 7% - 9% x x x x
Anaemia postmarketing — 8% x x x x x
Cough 5% 10% x
Nausea common x
Back pain 4% 5% x
Dyspnoea 4% 10% x
Cramp muscle 4% 4% x
Respiratory tract infection 4% - 56% 5% - 30% x x
Rectal haemorrhage 4% x
Epistaxis 2% - 5% 2% - 6% x
Contusion 3% 1% x
Urinary tract infection 3% 4% - 5% x
Vision blurred 3% 3% x
Cystitis 2% 1% x
Haemoptysis 2% 3% x
Orthostatic hypotension 2% 5% x
Nasal congestion 2% 3% x
Pain in extremity 2% 8% x
Pneumonia 2% 1% x
Pruritus uncommon, 2% - 4% x x x x
Skin ulcer 2% x
Wheezing 2% x
Acute bronchitis 2% 1% x
Lower respiratory tract infection 2% 3% x
Abdominal pain uncommon x x x
Dermatitis uncommon x x x
Diarrhoea uncommon x x x
Rash postmarketing, uncommon x x x x
Hepatitis uncommon x x x
Hypersensitivity postmarketing, uncommon x x x x
Jaundice postmarketing, uncommon x x x x
Thrombocytopenia postmarketing, uncommon x x x
Vomiting uncommon x
Anaphylactic shock rare x x x
Angioedema postmarketing, rare x x x x x
Leukopenia postmarketing x x x
Hepatic cirrhosis postmarketing, rare x x x x
Neutropenia postmarketing x x x
Hepatic failure postmarketing, rare x x x x
Abdominal distension x
Angina pectoris x
Anorexia x
Anxiety x
Ascites x
Asthenia x
Asthma x
Atrial fibrillation x
Mental disorder x
Bone disorder x
Bronchospasm x
Conjunctivitis x
Constipation x
Dehydration x
Duodenal ulcer x
Dyspepsia x x
Dysuria x
Ecchymosis x
Eczema x
Endophthalmitis x
Eosinophilia x
Erythema multiforme x
Eye disorder x
Fatigue x x
Body temperature increased x
Flatulence x
Gastroenteritis x
Gastrooesophageal reflux disease x x
Gastrointestinal disorder x x x
Gout x
Cardiac arrest x
Cardiac disorder x x x
Cardiac failure x
Haematuria x
Hemiparesis x
Haemorrhage x x
Hydrocephalus x
Hyperglycaemia x
Hypoaesthesia x
Hypoglycaemia x
Hypokalaemia x
Hyponatraemia x
Immune system disorder x x x
Libido increased x
Influenza x
Intestinal obstruction x
Irritability x
Nephropathy x
Lethargy x
Mediastinal disorder x
Musculoskeletal disorder x
Musculoskeletal pain x
Myocardial infarction x
Nervous system disorder x x x
Nightmare x
Oligospermia x
Pain x
Paraesthesia x
Pulmonary oedema x
Renal failure x
Restless legs syndrome x
Shivering x
Stevens-Johnson syndrome x
Cerebrovascular accident x
Subarachnoid haemorrhage x
Tachycardia x
Thirst x
Tinnitus x
Toothache x
Tremor x
Erythema x x x
Pollakiuria x
Urinary tract disorder x
Urticaria x
Angiopathy x x x
Syncope vasovagal x
Ventricular tachycardia x
Weight increased x
Weight decreased x
Xerophthalmia x
Dry mouth x
Ventricular arrhythmia x
Mood swings x
Photophobia x
Oedema peripheral x
Hepatic function abnormal x x x
Panic attack x
Mouth ulceration x
Atrioventricular block complete x
Skin discolouration x
Dry skin x
Liver injury x
Haemoglobin decreased x x x
Malnutrition x
Unspecified disorder of skin and subcutaneous tissue x
Muscle twitching x
Abdominal pain upper x
Disturbance in attention x
Respiratory depression x
Eye irritation x
Peripheral ischaemia x
Leg edema x x
Pain in jaw x
Edema of lower extremities x
Hepatobiliary disease x x x
Glucose tolerance impaired x
Blood pressure systolic decreased x
Blood bilirubin increased x x
Bradycardia x
Influenza like illness x
Urine color abnormal x
Sensation of heaviness x
Sweating increased x
Haematocrit decreased x
Infestation NOS x
Blood and lymphatic system disorders x x x
Blood alkaline phosphatase increased x
Blood lactate dehydrogenase increased x
Electrocardiogram change x
Insomnia x
Bone marrow toxicity x
Venoocclusive disease x
Respiratory failure x
Renal impairment x
Loose stools x
Eosinophil count increased x
Somnolence x
Feeling hot x

Indications

Information about indications was extracted from the indications and usage sections of the labels.

BOSENTAN / TRACLEER

Side effects:16
Source:FDA

bosentan anhydrous

Side effects:26
Source:FDA Structured Product Label

bosentan / bosentan monohydrate

Side effects:35
Source:EMA

BOSENTAN (BOSENTAN MONOHYDRATE) / TRACLEER

Side effects:177
Source:Health Canada

Color scheme:

standard – alternative

    100%
    75%
    50%
    10%
    frequent (1% to 100%)
    infrequent (0.1% to 1%)
    rare (<0.1%)
    postmarketing
    0%
    no frequency information
    not found on label