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ATC Code: C03XA01

Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2
Thirst Thirst very common, 15.7% 5% x x
Nausea Nausea very common x x
Polyuria Polyuria common, 11.2% 3.18% x x
Urine output increased Polyuria common, 11.2% 3.18% x x
Pollakiuria Pollakiuria common, 11.2% 3.18% x x
Asthenia Asthenia common, 8.52% 4.09% x x
Constipation Constipation common, 7.17% 1.82% x x
Hyperglycaemia Hyperglycaemia common, 6.28% 0.909% x x
Dehydration Dehydration common x
Diarrhoea Diarrhoea common x
Dizziness Dizziness common x
Syncope common x
Ecchymosis Ecchymosis common x
Headache Headache common x
Hyperkalaemia Hyperkalaemia common x
Hypoglycaemia Hypoglycaemia common x
Orthostatic hypotension Orthostatic hypotension common x
Pruritus Pruritus common x
Shock Syncope common x
Syncope Syncope common x
Loss of consciousness Syncope common x
Dry mouth Dry mouth common x x
Polydipsia Polydipsia common x
Aspartate aminotransferase increased Aspartate aminotransferase increased common x
Alanine aminotransferase increased Alanine aminotransferase increased common x
Malaise Malaise common x
Discomfort Malaise common x
Feeling abnormal Malaise common x
Ill-defined disorder Malaise common x
Decreased appetite Decreased appetite common x
Anorexia 3.59% 0.909% x
Neurological symptom Neurological symptom common x
Blood creatinine increased Blood creatinine increased common x
Blood uric acid increased Hyperuricaemia common x
Hyperuricaemia Hyperuricaemia common x
Blood urine present Blood urine present common x
Body temperature increased Body temperature increased common, 4.04% 0.909% x x
Dysgeusia Dysgeusia uncommon x
Prurigo Prurigo uncommon x
Blood bilirubin increased Blood bilirubin increased uncommon x
Renal failure Renal impairment uncommon x
Renal impairment Renal impairment uncommon x
Anaphylactic shock Anaphylactic shock postmarketing x
Hypernatraemia Hypernatraemia postmarketing, common x x
Hypersensitivity Hypersensitivity postmarketing x
Immune system disorder Immune system disorder postmarketing x
Rash generalised Rash generalised postmarketing x
Hyponatraemia Hyponatraemic postmarketing x
Osmotic demyelination syndrome Osmotic demyelination syndrome postmarketing x
Breast disorder Breast disorder x
Connective tissue disorder Connective tissue disorder x
Diabetic ketoacidosis Diabetic ketoacidosis x
Disseminated intravascular coagulation Disseminated intravascular coagulation x
Gastrointestinal disorder Gastrointestinal disorder x x
Gastrointestinal haemorrhage Gastrointestinal haemorrhage x
Cardiac disorder Cardiac disorder x
Mediastinal disorder Mediastinal disorder x
Nervous system disorder Nervous system disorder x
Pulmonary embolism Pulmonary embolism x
Rhabdomyolysis Rhabdomyolysis x
Cerebrovascular accident Cerebrovascular accident x
Urethral disorder Urinary tract disorder x x
Urinary tract disorder Urinary tract disorder x x
Angiopathy Angiopathy x x
Ventricular fibrillation Ventricular fibrillation x
Deep vein thrombosis Deep vein thrombosis x
Prothrombin level increased Prothrombin level increased x
Malnutrition Malnutrition x x
Colitis ischaemic Colitis ischaemic x
Skin disorder Unspecified disorder of skin and subcutaneous tissue x
Urethral haemorrhage Urethral haemorrhage x
Intracardiac thrombus Intracardiac thrombus x
Respiratory failure Respiratory failure x
Vaginal haemorrhage Vaginal haemorrhage x


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

tolvaptan / tolvaptan

Side effects:39


Side effects:40
Source:FDA Structured Product Label

Color scheme:


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