Search results :

Dabigatran etexilate

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

ATC Code: B01AE07

Side effects

Options: Hide MedDRA Preferred Terms

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