Summary

Commonly reported side effects of dabrafenib include: squamous cell carcinoma, fever, and hyperglycemia. Other side effects include: keratoacanthoma. Continue reading for a comprehensive list of adverse effects.

Applies to dabrafenib: oral capsule, oral tablet for suspension.

Serious side effects of Dabrafenib

Along with its needed effects, dabrafenib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dabrafenib:

More common

• Bleeding gums
• bloody, black, or tarry stools
• bloody or cloudy urine
• blurred vision
• coughing up blood
• difficulty in breathing or swallowing
• dizziness
• dry mouth
• fever
• flushed, dry skin
• fruit-like breath odor
• greatly decreased frequency of urination or amount of urine
• headache
• heartburn
• increased hunger
• increased thirst
• increased urination
• indigestion
• lump or growth on the skin
• nausea
• nosebleed
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• redness, swelling, or pain of the skin
• scaling of the skin on the hands and feet
• skin blisters
• skin rash
• stomach pain or cramps
• sweating
• swelling of the feet or lower legs
• tingling of the hands and feet
• ulceration of the skin
• unable to move
• unexplained weight loss
• unusual tiredness or weakness
• vomiting
• vomiting of material that looks like coffee grounds, severe and continuing

Less common

• Blurred vision or other change in vision
• change in color vision
• difficulty seeing at night
• eye pain
• increased sensitivity of the eyes to sunlight
• redness of the eye
• tearing

Incidence not known

• Blistering, peeling, loosening of the skin
• chills
• cough
• diarrhea
• itching
• joint or muscle pain
• red skin lesions, often with a purple center
• sore throat
• sores, ulcers, or white spots in the mouth or on lips
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• yellow eyes or skin

Other side effects of Dabrafenib

Some side effects of dabrafenib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acne, pimples
• back pain
• bloating
• difficulty having a bowel movement
• fast heartbeat
• hair loss or thinning of the hair
• loosening of the fingernails
• loss of appetite
• muscle ache or stiffness
• pains in the stomach, side, or abdomen, possibly radiating to the back
• redness or soreness around the fingernails
• stuffy or runny nose

For Healthcare Professionals

Applies to dabrafenib: oral capsule, oral tablet soluble.

Metabolic

Very common (10% or more): Hyperglycemia (71%), hypophosphatemia (38%), decreased appetite (29%), hyponatremia (57%)

Common (1% to 10%): Dehydration^[Ref]

Hepatic

Very common (10% or more): Increased alkaline phosphatase (64%), increased AST (61%), increased ALT (38%)

Common (1% to 10%): Increased gamma-glutamyltransferase, hyperbilirubinemia^[Ref]

Other

Very common (10% or more): Pyrexia (55%), fatigue/asthenia/malaise (51%), chills (31%), edema (28%)

Common (1% to 10%): Influenza-like illness, mucosal inflammation^[Ref]

Hematologic

Very common (10% or more): Leukopenia (48%), anemia (46%), neutropenia (44%), lymphopenia (42%)

Common (1% to 10%): Thrombocytopenia^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (45%), vomiting (33%), diarrhea (32%), constipation (13%), abdominal pain (11%)

Common (1% to 10%): Dry mouth, stomatitis

Uncommon (0.1% to 1%): Pancreatitis, gastrointestinal perforation, colitis^[Ref]

Dermatologic

Very common (10% or more): Hyperkeratosis (37%), rash (32%), dry skin (31%), alopecia (22%), palmar-plantar erythrodysesthesia syndrome (20%), pruritus, erythema

Common (1% to 10%): Actinic keratosis, skin lesion, photosensitivity reaction, cellulitis, folliculitis, paronychia, pustular rash, dermatitis acneiform, night sweats, hyperhidrosis, panniculitis, skin fissures

Uncommon (0.1% to 1%): Serious skin toxicity

Frequency not reported: Bullous rash^[Ref]

Nervous system

Very common (10% or more): Headache (32%), dizziness (11%)^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (27%), myalgia (15%), pain in extremity (14%), back pain (12%), muscle spasms

Common (1% to 10%): Increased creatine phosphokinase

Uncommon (0.1% to 1%): Rhabdomyolysis^[Ref]

Oncologic

Very common (10% or more): Papilloma (27%)

Common (1% to 10%): Cutaneous squamous cell carcinoma/keratoacanthoma/Bowen's disease, basal cell carcinoma, seborrheic keratosis, acrochordon

Uncommon (0.1% to 1%): New primary melanoma^[Ref]

Cardiovascular

Very common (10% or more): Hemorrhage (23%), hypertension (22%)

Common (1% to 10%): Cardiomyopathy/decreased left ventricular ejection fraction, hypotension, lymphedema, bradycardia

Uncommon (0.1% to 1%): QT prolongation, cardiac failure

Frequency not reported: Myocarditis^[Ref]

Respiratory

Very common (10% or more): Cough (22%), dyspnea (20%), nasopharyngitis (12%)

Common (1% to 10%): Interstitial lung disease/pneumonitis

Frequency not reported: Respiratory distress^[Ref]

Renal

Very common (10% or more): Increased creatinine (21%)

Common (1% to 10%): Renal failure

Uncommon (0.1% to 1%): Acute renal failure, nephritis

Frequency not reported: Interstitial nephritis^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection^[Ref]

Ocular

Common (1% to 10%): Uveitis, blurred vision, vision impairment

Uncommon (0.1% to 1%): Chorioretinopathy, retinal detachment, periorbital edema^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity^[Ref]