Dabrafenib
Side effects
Options:
Show MedDRA Preferred Terms
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
Lymphopenia
|
6% - 59%
|
|
|
|
x
|
Gamma-glutamyltransferase increased
|
2% - 56%
|
|
|
|
x
|
Decreased appetite
|
very common, 0% - 30%
|
|
x
|
x
|
x
|
Hypophosphataemia
|
common, 0% - 47%
|
|
x
|
x
|
x
|
Hypoalbuminaemia
|
0% - 53%
|
|
|
|
x
|
Hypokalaemia
|
2% - 29%
|
|
|
|
x
|
Phosphatase alkaline increased
|
0% - 67%
|
|
|
x
|
x
|
Aspartate aminotransferase increased
|
0% - 60%
|
|
|
|
x
|
Hyperkalaemia
|
0% - 22%
|
|
|
|
x
|
Chills
|
very common, 0% - 58%
|
|
x
|
x
|
x
|
Body temperature increased
|
very common, 0% - 71%
|
|
x
|
x
|
x
|
Oedema peripheral
|
0% - 31%
|
|
|
|
x
|
Alanine aminotransferase increased
|
0% - 42%
|
|
|
|
x
|
Creatinine increased
|
0% - 24%
|
|
|
|
x
|
Neutropenia
|
0% - 55%
|
|
|
x
|
x
|
Hyperglycaemia
|
common, 0% - 67%
|
|
x
|
x
|
x
|
Nausea
|
very common, 0% - 50.8%
|
|
x
|
x
|
x
|
Thrombocytopenia
|
0% - 31%
|
|
|
|
x
|
Hyponatraemia
|
0% - 55%
|
|
|
x
|
x
|
Pruritus
|
0% - 13%
|
|
x
|
|
x
|
Bowen's disease
|
common
|
|
|
x
|
|
Basal cell carcinoma
|
common
|
|
x
|
x
|
|
Fatigue
|
very common, 0% - 57%
|
|
x
|
x
|
x
|
Keratoacanthoma
|
common
|
|
x
|
x
|
x
|
Actinic keratosis
|
common, 0% - 15%
|
|
x
|
x
|
x
|
Seborrhoeic keratosis
|
common
|
|
x
|
x
|
|
Skin lesion
|
common
|
|
x
|
x
|
|
Acrochordon
|
common
|
|
x
|
x
|
|
Dry skin
|
common, 0% - 18%
|
|
x
|
x
|
x
|
Influenza like illness
|
common
|
|
x
|
x
|
|
Squamous cell carcinoma of skin
|
common
|
|
x
|
x
|
x
|
Insomnia
|
0% - 18%
|
|
|
|
x
|
Dizziness
|
0% - 16%
|
|
|
|
x
|
Hypocalcaemia
|
0% - 20%
|
|
|
|
x
|
Back pain
|
0% - 18%
|
|
|
x
|
x
|
Urinary tract infection
|
0% - 13%
|
|
|
|
x
|
Vomiting
|
very common, 0% - 43%
|
|
x
|
x
|
x
|
Anaemia
|
0% - 55%
|
|
|
x
|
x
|
Leukopenia
|
0% - 62%
|
|
|
x
|
x
|
Haemorrhage
|
0% - 16%
|
|
|
|
x
|
Hypercalcaemia
|
0% - 19%
|
|
|
|
x
|
Night sweats
|
0% - 24%
|
|
|
|
x
|
Dry mouth
|
0% - 11%
|
|
|
|
x
|
Abdominal pain
|
0% - 33%
|
|
x
|
x
|
x
|
Constipation
|
common, 0% - 22%
|
|
x
|
x
|
x
|
Dehydration
|
0% - 11%
|
|
x
|
|
x
|
Diarrhoea
|
very common, 0% - 36%
|
|
x
|
x
|
x
|
Headache
|
very common, 0% - 37%
|
|
x
|
x
|
x
|
Hyperbilirubinaemia
|
0% - 15%
|
|
|
|
x
|
Pain in extremity
|
very common, 0% - 19%
|
|
x
|
x
|
x
|
Erythema
|
common, 0% - 15%
|
|
x
|
x
|
x
|
Hypomagnesaemia
|
0% - 18%
|
|
|
|
x
|
Dermatitis acneiform
|
0% - 16%
|
|
|
|
x
|
Alopecia
|
very common, 0% - 22%
|
|
x
|
x
|
x
|
Asthenia
|
very common, 0% - 17.6%
|
|
x
|
x
|
x
|
Arthralgia
|
very common, 0% - 44%
|
|
x
|
x
|
x
|
Papilloma
|
0% - 27%
|
|
x
|
x
|
x
|
Muscle spasms
|
0% - 16%
|
|
|
|
x
|
Hypersensitivity
|
uncommon
|
|
x
|
x
|
x
|
Renal failure acute
|
uncommon
|
|
x
|
x
|
x
|
Malignant melanoma
|
uncommon
|
|
|
x
|
|
Nephritis
|
uncommon
|
|
x
|
x
|
|
Pancreatitis
|
uncommon
|
|
x
|
x
|
x
|
Panniculitis
|
uncommon
|
|
x
|
x
|
|
Renal failure
|
uncommon, 0% - 7%
|
|
x
|
x
|
x
|
Uveitis
|
uncommon
|
|
x
|
x
|
|
Hyperkeratosis
|
very common, 0% - 37%
|
|
x
|
x
|
x
|
Arrhythmia
|
|
|
|
|
x
|
Mental disorder
|
|
|
|
|
x
|
Bone disorder
|
|
|
|
|
x
|
Neoplasm malignant
|
|
|
x
|
|
x
|
Squamous cell carcinoma
|
|
|
x
|
|
x
|
Cellulitis
|
|
|
|
|
x
|
Infection
|
|
|
|
|
x
|
Connective tissue disorder
|
|
|
x
|
x
|
x
|
Cough
|
very common, 0% - 29%
|
|
x
|
x
|
x
|
Cyst
|
|
|
x
|
x
|
x
|
Oedema
|
|
|
|
|
x
|
Epistaxis
|
|
|
|
|
x
|
Rash
|
very common, 0% - 53%
|
|
x
|
x
|
x
|
Eye disorder
|
|
|
x
|
x
|
x
|
Eye haemorrhage
|
|
|
|
|
x
|
Folliculitis
|
|
|
|
|
x
|
Gastrointestinal disorder
|
|
|
x
|
x
|
x
|
Gingival bleeding
|
|
|
|
|
x
|
Cardiac failure congestive
|
|
|
|
|
x
|
Haematuria
|
|
|
|
|
x
|
Hyperhidrosis
|
|
|
|
|
x
|
Hypertension
|
|
|
|
|
x
|
Hypotension
|
|
|
x
|
|
|
Immune system disorder
|
|
|
x
|
x
|
x
|
Nephropathy
|
|
|
|
x
|
|
Lymphoedema
|
|
|
|
|
x
|
Mediastinal disorder
|
|
|
x
|
x
|
x
|
Nasopharyngitis
|
0% - 10.2%
|
|
|
x
|
x
|
Neoplasm
|
|
|
x
|
x
|
x
|
Nephritis interstitial
|
|
|
|
|
x
|
Nervous system disorder
|
|
|
x
|
x
|
x
|
Paronychia
|
|
|
|
|
x
|
Polyp
|
|
|
x
|
x
|
x
|
Prurigo
|
|
|
|
|
x
|
Stomatitis
|
|
|
|
|
x
|
Urinary tract disorder
|
|
|
x
|
|
x
|
Angiopathy
|
|
|
|
|
x
|
Vitreous haemorrhage
|
|
|
|
|
x
|
Rash pustular
|
|
|
|
|
x
|
Haemorrhage intracranial
|
|
|
|
|
x
|
Blindness transient
|
|
|
|
|
x
|
Malnutrition
|
|
|
x
|
x
|
x
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
x
|
x
|
x
|
Rash macular
|
|
|
|
|
x
|
Rash vesicular
|
|
|
|
|
x
|
Myalgia
|
very common, 0% - 24%
|
|
x
|
x
|
x
|
Abdominal discomfort
|
|
|
|
|
x
|
Abdominal pain upper
|
|
|
|
|
x
|
Abdominal pain lower
|
|
|
|
|
x
|
Rash erythematous
|
|
|
|
|
x
|
Gastric haemorrhage
|
|
|
|
|
x
|
Reaction febrile
|
|
|
|
|
x
|
Rash bullous
|
|
|
|
|
x
|
Azotaemia
|
|
|
x
|
|
|
Disease progression
|
|
|
|
|
x
|
Vision blurred
|
|
|
|
|
x
|
Skin papilloma
|
0% - 24.1%
|
|
|
x
|
x
|
Rash maculo-papular
|
|
|
|
|
x
|
Rigors
|
|
|
x
|
|
|
Rash generalised
|
|
|
|
|
x
|
Brain stem haemorrhage
|
|
|
|
|
x
|
Ejection fraction decreased
|
|
|
|
|
x
|
Infestation NOS
|
|
|
|
|
x
|
Electrocardiogram QT corrected interval prolonged
|
|
|
x
|
|
|
Refractory hypertension
|
|
|
|
|
x
|
Cardiomyopathy
|
|
|
|
|
x
|
Skin toxicity
|
|
|
|
|
x
|
Ocular toxicity
|
|
|
|
|
x
|
Rash papular
|
|
|
|
|
x
|
Acute renal insufficiency
|
|
|
x
|
|
|
Venous thromboembolism
|
|
|
|
|
x
|
Oropharyngeal pain
|
0% - 13%
|
|
|
|
x
|
Cerebral haemorrhage
|
|
|
|
|
x
|
Vaginal haemorrhage
|
|
|
|
|
x
|
Indications
Information about indications was extracted from the indications and usage sections of the labels.
Side effects: | 59 |
Source: | EMA |
---|
Side effects: | 60 |
Source: | medicines.org.au |
---|
Side effects: | 125 |
Source: | FDA Structured Product Label |
---|
Color scheme:
standard – alternative
|
|
100%
|
|
|
75%
|
|
|
50%
|
|
|
10%
|
|
|
frequent (1% to 100%)
|
|
|
infrequent (0.1% to 1%)
|
|
|
rare (<0.1%)
|
|
|
postmarketing
|
|
|
0%
|
|
|
no frequency information
|
|
|
not found on label
|