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Dabigatran etexilate

More information: STITCH, PubChem (stereo-specific compound: 1) and possibly Wikipedia

ATC Code: B01AE07

Side effects

Options: Show MedDRA Preferred Terms

Side effect Data for drug Placebo Labels
1 2 3 4
Urogenital haemorrhage common x x
Bronchospasm uncommon x x x
Dysphagia uncommon x x x
Drug hypersensitivity uncommon x x x x
Rash uncommon x x x x
Haematoma uncommon x x x
Haematuria uncommon x x
Haemoptysis uncommon x x x
Haemorrhage uncommon x x x x
Pruritus uncommon x x x x
Thrombocytopenia uncommon x x x
Urticaria uncommon x x x x
Hepatic function abnormal uncommon x x x
Haemorrhage intracranial uncommon x x x x
Oesophageal ulcer uncommon x x x
Gastrointestinal ulcer uncommon x x x x
Hepatobiliary disease uncommon x x x
Gastrooesophagitis uncommon x x x
Skin haemorrhage uncommon x x x
Angioedema postmarketing, uncommon x x x
Anaphylactic shock postmarketing x x x x
Haemarthrosis rare x x x
Immune system disorder postmarketing x x x
Traumatic haemorrhage rare x x x
Injection site haemorrhage rare x x x
Incision site haemorrhage rare x x x
Catheter site haemorrhage rare x x x
Abdominal pain x x x x
Anaemia x x x
Angina pectoris x
Arthralgia x
Asthenia x
Back pain x
Bone disorder x
Bronchitis x
Chest pain x
Infection x
Compartment syndrome x x x
Connective tissue disorder x x
Constipation x
Contusion x
Cough x
Diarrhoea x x x x
Dizziness x
Dyspepsia x x x x
Dyspnoea x
Ecchymosis x
Epistaxis x x x
Oesophagitis x x
Fatigue x
Flatulence x
Gastritis x x
Gastrooesophageal reflux disease x x x x
Gastrointestinal disorder x x x
Gastrointestinal haemorrhage x x x x
Gout x
Headache x
Cardiac disorder x
Cardiac failure x
Cardiac failure congestive x
Pericardial haemorrhage x x x
Hyperbilirubinaemia x
Hypersensitivity x
Hypertension x
Hypotension x x x
Influenza x
Mediastinal disorder x x x
Musculoskeletal pain x
Myocardial infarction x
Nasopharyngitis x
Nausea x x x x
Nervous system disorder x x x
Osteoarthritis x
Pain in extremity x
Palpitations x
Pneumonia x
Sinusitis x
Subarachnoid haemorrhage x
Syncope x
Thrombosis x
Upper respiratory tract infection x
Urinary tract infection x
Urinary tract disorder x x x
Angiopathy x x x
Hepatitis viral x
Vomiting x x x
Wound x x x
Oedema peripheral x
Retroperitoneal haemorrhage x x x x
Liver function test abnormal x x
Aspartate aminotransferase increased x x
Alanine aminotransferase increased x
Haemoglobin decreased x x
Malnutrition x
Unspecified disorder of skin and subcutaneous tissue x x
Fatal outcomes x x x
Dyspnoea exertional x
Abdominal discomfort x x
Abdominal pain upper x x
Gastric haemorrhage x x
Chest discomfort x
Hepatic enzyme increased x x
Wound haemorrhage x x x
Haemorrhoidal haemorrhage x x
Rectal haemorrhage x x
Blood bilirubin increased x
Bloody discharge x x x
Wound secretion x x x
Transaminases increased x
Surgical intervention x x x
Haemorrhagic stroke x x x
Haematocrit decreased x
Allergic oedema x
Infestation NOS x
Blood and lymphatic system disorders x x x
Hemorrhage symptom x
Occult blood positive x
Anaemia postoperative x x x
Post procedural haemorrhage x x x
Blood urine present x
Post procedural discharge x x x
Thromboembolic stroke x
Epigastric discomfort x x
Post procedural haematoma x x x
Gastritis haemorrhagic x x
Haemorrhagic erosive gastritis x x
Gastritis erosive x
Major bleed x
Intraspinal bleeding x


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

dabigatran etexilate

Side effects:31
Source:FDA Structured Product Label

PRADAXA / Pradaxa, Capsule

Side effects:58

Color scheme:


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