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ATC Code: C02KX01

Side effects

Options: Hide MedDRA Preferred Terms

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


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


Side effects:16

bosentan anhydrous

Side effects:26
Source:FDA Structured Product Label

bosentan / bosentan monohydrate

Side effects:35


Side effects:177
Source:Health Canada

Color scheme:


    frequent (1% to 100%)
    infrequent (0.1% to 1%)
    rare (<0.1%)
    no frequency information
    not found on label