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Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2 3
Lymphopenia Lymphopenia 6% - 59% x
Gamma-glutamyltransferase increased Gamma-glutamyltransferase increased 2% - 56% x
Decreased appetite Decreased appetite very common, 0% - 30% x x x
Hypophosphataemia Hypophosphataemia common, 0% - 47% x x x
Hypoalbuminaemia Hypoalbuminaemia 0% - 53% x
Hypokalaemia Hypokalaemia 2% - 29% x
Blood alkaline phosphatase increased Phosphatase alkaline increased 0% - 67% x x
Aspartate aminotransferase increased Aspartate aminotransferase increased 0% - 60% x
Hyperkalaemia Hyperkalaemia 0% - 22% x
Chills Chills very common, 0% - 58% x x x
Rigors x
Body temperature increased Body temperature increased very common, 0% - 71% x x x
Reaction febrile x
Oedema peripheral Oedema peripheral 0% - 31% x
Alanine aminotransferase increased Alanine aminotransferase increased 0% - 42% x
Blood creatinine increased Creatinine increased 0% - 24% x
Neutropenia Neutropenia 0% - 55% x x
Hyperglycaemia Hyperglycaemia common, 0% - 67% x x x
Nausea Nausea very common, 0% - 50.8% x x x
Thrombocytopenia Thrombocytopenia 0% - 31% x
Hyponatraemia Hyponatraemia 0% - 55% x x
Pruritus Pruritus 0% - 13% x x
Bowen's disease Bowen's disease common x
Basal cell carcinoma Basal cell carcinoma common x x
Asthenia Fatigue very common, 0% - 57% x x x
Asthenia very common, 0% - 17.6% x x x
Fatigue Fatigue very common, 0% - 57% x x x
Keratoacanthoma Keratoacanthoma common x x x
Actinic keratosis Actinic keratosis common, 0% - 15% x x x
Seborrhoeic keratosis Actinic keratosis common, 0% - 15% x x x
Seborrhoeic keratosis common x x
Skin lesion Skin lesion common x x
Acrochordon Acrochordon common x x
Dry skin Dry skin common, 0% - 18% x x x
Influenza like illness Influenza like illness common x x
Squamous cell carcinoma of skin Squamous cell carcinoma of skin common x x x
Insomnia Insomnia 0% - 18% x
Dizziness Dizziness 0% - 16% x
Hypocalcaemia Hypocalcaemia 0% - 20% x
Back pain Back pain 0% - 18% x x
Urinary tract infection Urinary tract infection 0% - 13% x
Vomiting Vomiting very common, 0% - 43% x x x
Anaemia Anaemia 0% - 55% x x
Leukopenia Leukopenia 0% - 62% x x
Haemorrhage Haemorrhage 0% - 16% x
Haemoglobin Haemorrhage 0% - 16% x
Hypercalcaemia Hypercalcaemia 0% - 19% x
Night sweats Night sweats 0% - 24% x
Dry mouth Dry mouth 0% - 11% x
Abdominal pain Abdominal pain 0% - 33% x x x
Gastrointestinal pain Abdominal pain 0% - 33% x x x
Constipation Constipation common, 0% - 22% x x x
Dehydration Dehydration 0% - 11% x x
Diarrhoea Diarrhoea very common, 0% - 36% x x x
Headache Headache very common, 0% - 37% x x x
Hyperbilirubinaemia Hyperbilirubinaemia 0% - 15% x
Pain in extremity Pain in extremity very common, 0% - 19% x x x
Erythema Erythema common, 0% - 15% x x x
Hypomagnesaemia Hypomagnesaemia 0% - 18% x
Dermatitis acneiform Dermatitis acneiform 0% - 16% x
Alopecia Alopecia very common, 0% - 22% x x x
Arthralgia Arthralgia very common, 0% - 44% x x x
Musculoskeletal discomfort Arthralgia very common, 0% - 44% x x x
Myalgia very common, 0% - 24% x x x
Papilloma Papilloma 0% - 27% x x x
Muscle spasms Muscle spasms 0% - 16% x
Hypersensitivity Hypersensitivity uncommon x x x
Renal failure acute Renal failure acute uncommon x x x
Acute renal insufficiency x
Malignant melanoma Malignant melanoma uncommon x
Nephritis Nephritis uncommon x x
Pancreatitis Pancreatitis uncommon x x x
Panniculitis Panniculitis uncommon x x
Renal failure Renal failure uncommon, 0% - 7% x x x
Uveitis Uveitis uncommon x x
Hyperkeratosis Hyperkeratosis very common, 0% - 37% x x x
Arrhythmia Arrhythmia x
Mental disorder Mental disorder x
Bone disorder Bone disorder x
Neoplasm malignant Neoplasm malignant x x
Squamous cell carcinoma Squamous cell carcinoma x x
Cellulitis Cellulitis x
Infection Infection x
Connective tissue disorder Connective tissue disorder x x x
Cough Cough very common, 0% - 29% x x x
Cyst Cyst x x x
Oedema Oedema x
Epistaxis Epistaxis x
Dermatitis Rash very common, 0% - 53% x x x
Rash Rash very common, 0% - 53% x x x
Eye disorder Eye disorder x x x
Eye haemorrhage Eye haemorrhage x
Folliculitis Folliculitis x
Gastrointestinal disorder Gastrointestinal disorder x x x
Gingival bleeding Gingival bleeding x
Cardiac failure congestive Cardiac failure congestive x
Haematuria Haematuria x
Hyperhidrosis Hyperhidrosis x
Hypertension Hypertension x
Refractory hypertension x
Hypotension Hypotension x
Immune system disorder Immune system disorder x x x
Nephropathy Nephropathy x
Lymphoedema Lymphoedema x
Mediastinal disorder Mediastinal disorder x x x
Nasopharyngitis Nasopharyngitis 0% - 10.2% x x
Neoplasm Neoplasm x x x
Tubulointerstitial nephritis Nephritis interstitial x
Nervous system disorder Nervous system disorder x x x
Paronychia Paronychia x
Polyp Polyp x x x
Prurigo Prurigo x
Stomatitis Stomatitis x
Urethral disorder Urinary tract disorder x x
Urinary tract disorder Urinary tract disorder x x
Angiopathy Angiopathy x
Vitreous haemorrhage Vitreous haemorrhage x
Rash pustular Rash pustular x
Haemorrhage intracranial Haemorrhage intracranial x
Blindness transient Blindness transient x
Malnutrition Malnutrition x x x
Skin disorder Unspecified disorder of skin and subcutaneous tissue x x x
Rash macular Rash macular x
Rash vesicular Rash vesicular x
Myalgia Myalgia very common, 0% - 24% x x x
Abdominal discomfort Abdominal discomfort x
Abdominal pain upper Abdominal pain upper x
Abdominal pain lower Abdominal pain lower x
Rash erythematous Rash erythematous x
Gastric haemorrhage Gastric haemorrhage x
Dermatitis bullous Rash bullous x
Azotaemia Azotaemia x
Disease progression Disease progression x
Vision blurred Vision blurred x
Skin papilloma Skin papilloma 0% - 24.1% x x
Rash maculo-papular Rash maculo-papular x
Rash generalised Rash generalised x
Brain stem haemorrhage Brain stem haemorrhage x
Ejection fraction decreased Ejection fraction decreased x
Infestation Infestation NOS x
Electrocardiogram QT prolonged Electrocardiogram QT corrected interval prolonged x
Cardiomyopathy Cardiomyopathy x
Skin toxicity Skin toxicity x
Ocular toxicity Ocular toxicity x
Rash papular Rash papular x
Embolism venous Venous thromboembolism x
Oropharyngeal pain Oropharyngeal pain 0% - 13% x
Cerebral haemorrhage Cerebral haemorrhage x
Vaginal haemorrhage Vaginal haemorrhage x


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

dabrafenib / dabrafenib

Side effects:59

Dabrafenib mesilate / TAFINLAR CAPSULES

Side effects:60


Side effects:125
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