Dabrafenib Side Effects

Medically reviewed by Drugs.com. Last updated on May 13, 2024.

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 side effects

• 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 side effects

• 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 side effects

• 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.

General adverse events

The most common adverse reactions for this drug as a single agent were hyperkeratosis, headache, pyrexia, arthralgia, asthenia, fatigue, nausea, papilloma, alopecia, rash, vomiting, cough, dry skin, dyspnea, and palmar-plantar erythrodysesthesia syndrome.

The most common adverse reactions for this drug in combination with trametinib in adult patients were pyrexia, fatigue, nausea, chills, headache, diarrhea, vomiting, arthralgia, myalgia, rash, hypertension, peripheral edema, edema, decreased appetite, asthenia, dry skin, hemorrhage, dyspnea, and cough.

The most common adverse reactions for this drug in combination with trametinib in pediatric patients were pyrexia, rash, vomiting, musculoskeletal pain, fatigue, dry skin, cough, diarrhea, acneiform dermatitis, headache, abdominal pain, nausea, hemorrhage, constipation, and paronychia.

The manufacturer product information for trametinib should be consulted as appropriate.^[Ref]

Cardiovascular

• Very common (10% or more): Hemorrhage (includes hemoptysis, hematoma, epistaxis, purpura, hematuria, subarachnoid hemorrhage, gastric hemorrhage, urinary bladder hemorrhage, contusion, hematochezia, injection site hemorrhage, pulmonary hemorrhage, retroperitoneal hemorrhage, conjunctival hemorrhage, rectal hemorrhage, hemorrhoidal hemorrhage, melena, eye contusion, eye hemorrhage, gingival bleeding/hemorrhage, hematemesis, intracranial hemorrhage, hemorrhagic stroke, hemothorax, increased tendency to bruise, large intestinal hemorrhage, mouth hemorrhage, petechiae, pharyngeal hemorrhage, prothrombin time prolonged, pulmonary hematoma, retinal hemorrhage, vaginal hemorrhage, vitreous hemorrhage, decreased RBC count, postprocedural hemorrhage, upper gastrointestinal hemorrhage, brainstem hemorrhage, cerebral hemorrhage; up to 29%), hypertension (includes hypertension crisis; up to 22%), hemorrhagic events (up to 17%), hypotension (up to 15%)
• Common (1% to 10%): Cardiomyopathy (defined as a decrease in left ventricular ejection fraction [LVEF] at least 10% from baseline and below the institutional lower limit of normal [LLN]), decreased ejection fraction, decreased LVEF, bradycardia, lymphoedema
• Uncommon (0.1% to 1%): Fatal hemorrhage, QT prolongation, left ventricular dysfunction, cardiac failure
• Frequency not reported: Major hemorrhage (defined as symptomatic bleeding in a critical area or organ), myocarditis
• Postmarketing reports: Venous thromboembolism (includes pulmonary embolism, deep vein thrombosis, embolism, venous thrombosis)

Fatal hemorrhage occurred in 0.5% of patients; the fatal events were cerebral hemorrhage and brainstem hemorrhage.

Decreased LVEF has been reported in 6% (65/1076) of patients in the integrated safety population of this drug in combination with trametinib; most cases were asymptomatic and reversible. Patients with LVEF lower than the institutional LLN were not included in clinical trials with this drug.

Dermatologic

• Very common (10% or more): Rash (includes rash, generalized rash, pruritic rash, erythematous rash, papular rash, vesicular rash, macular rash, maculopapular rash, folliculitis rash, nodular rash, pustular rash, eczema, erythema multiforme, dermatitis, exfoliative dermatitis, skin exfoliation, palmar-plantar erythrodysesthesia syndrome, bullous dermatitis; up to 42%), hyperkeratosis (includes hyperkeratosis, actinic keratosis, seborrheic keratosis, keratosis pilaris; up to 37%), dry skin (includes xerosis, xeroderma; up to 32%), alopecia (up to 26%), palmar-plantar erythrodysesthesia syndrome (up to 20%), pruritus (includes pruritus, generalized pruritus, genital pruritus, eye pruritus; up to 15%), acneiform dermatitis (includes acneiform dermatitis, acne, pustular acne; up to 12%), erythema (includes generalized erythema; up to 12%), palmoplantar keratoderma (up to 11%), night sweats, skin effects (rash, hyperkeratosis)
• Common (1% to 10%): Skin effects (actinic keratosis, skin lesion, erythema, pruritus), photosensitivity reaction, cellulitis, folliculitis, paronychia, pustular rash, actinic keratosis, skin lesion, hyperhidrosis, skin fissures, panniculitis
• Frequency not reported: Other serious skin toxicity, serious adverse events of skin and subcutaneous tissue disorders, generalized exfoliative dermatitis
• Postmarketing reports: Severe cutaneous adverse reactions (including Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms), photosensitivity

Gastrointestinal

• Very common (10% or more): Nausea (up to 46%), vomiting (up to 37%), diarrhea (includes diarrhea, colitis, enterocolitis, enteritis; up to 33%), constipation (up to 27%), abdominal pain (includes abdominal pain, upper abdominal pain, lower abdominal pain; up to 16%), dry mouth (up to 11%)
• Common (1% to 10%): Gastrointestinal hemorrhage, stomatitis (includes stomatitis, cheilitis, mouth ulceration, aphthous ulcer, glossitis), acute pancreatitis
• Uncommon (0.1% to 1%): Pancreatitis, gastrointestinal perforation, colitis

Genitourinary

• Very common (10% or more): Urinary tract infection
• Frequency not reported: Uterine hemorrhage

Hematologic

• Very common (10% or more): Leukopenia (includes leukopenia, decreased WBC count, lymphopenia; up to 48%), neutropenia (includes neutropenia, febrile neutropenia, decreased neutrophil count; up to 47%), anemia (up to 46%), decreased hemoglobin (up to 44%), lymphopenia (up to 42%)
• Common (1% to 10%): Decreased lymphocyte count, thrombocytopenia
• Frequency not reported: Decreased neutrophils, decreased platelets, increased lymphocytes, decreased leukocytes

Hepatic

• Very common (10% or more): Increased AST (includes increased hepatic enzyme, increased liver function test, abnormal liver function test, hypertransaminasemia; up to 61%), increased ALT (includes increased hepatic enzyme, increased liver function test, abnormal liver function test, hypertransaminasemia; up to 48%)
• Common (1% to 10%): Hyperbilirubinemia, increased GGT
• Frequency not reported: Increased total bilirubin

Hypersensitivity

• Common (1% to 10%): Hypersensitivity (includes drug hypersensitivity)
• Frequency not reported: Hypersensitivity manifesting as bullous rash

Immunologic

• Postmarketing reports: Sarcoidosis, hemophagocytic lymphohistiocytosis

Metabolic

• Very common (10% or more): Hyperglycemia (up to 71%), hyponatremia (up to 57%), hypophosphatemia (up to 42%), decreased appetite (up to 29%), hypoalbuminemia (up to 25%), more intensive hypoglycemic therapy required (up to 15%)
• Common (1% to 10%): Dehydration
• Frequency not reported: Hypocalcemia, hypernatremia, hypokalemia, increased serum fasting glucose

In the pooled safety population, 14% of patients with history of diabetes who received this drug as a single agent required more intensive hypoglycemic therapy; grade 3 and 4 hyperglycemia occurred in 3% of patients.

In the pooled safety population, 15% of patients with history of diabetes who received this drug with trametinib required more intensive hypoglycemic therapy; grade 3 and 4 hyperglycemia occurred in 2% of patients.

Musculoskeletal

• Very common (10% or more): Arthralgia (up to 31%), myalgia (includes myalgia, musculoskeletal pain, musculoskeletal chest pain; up to 24%), pain in extremity (up to 16%), back pain (up to 12%), muscle spasms (includes muscle spasms, musculoskeletal stiffness; up to 11%)
• Common (1% to 10%): Increased blood creatine phosphokinase, rhabdomyolysis
• Frequency not reported: Musculoskeletal pain (includes back pain, myalgia, pain in extremity, arthralgia, bone pain, noncardiac chest pain, neck pain, musculoskeletal stiffness), pain in jaw

Nervous system

• Very common (10% or more): Headache (includes headache, tension headache, migraine with aura; up to 39%), dizziness (includes dizziness, vertigo, positional vertigo; up to 14%)
• Uncommon (0.1% to 1%): Intracranial hemorrhage
• Frequency not reported: Cerebral hemorrhage, brainstem hemorrhage, peripheral neuropathy (includes peripheral neuropathy, peripheral motor neuropathy, peripheral sensorimotor neuropathy, paresthesia, neuralgia, hypoesthesia, peripheral sensory neuropathy)

Ocular

• Common (1% to 10%): Uveitis, blurred vision, visual impairment, chorioretinopathy (includes chorioretinal disorder), retinal detachment (includes detachment of macular retinal pigment epithelium, detachment of retinal pigment epithelium), detachment of retinal pigment epithelium
• Uncommon (0.1% to 1%): Periorbital edema

Oncologic

• Very common (10% or more): Papilloma (includes skin papilloma, papilloma; up to 27%), skin papilloma (up to 24%), cutaneous squamous cell carcinoma (includes squamous cell carcinoma of the skin, squamous cell carcinoma in situ [Bowen's disease], keratoacanthoma; up to 11%)
• Common (1% to 10%): Keratoacanthomas, basal cell carcinoma, new primary melanoma (includes malignant melanoma, metastatic malignant melanoma, superficial spreading melanoma stage III), noncutaneous malignancies, acrochordon (skin tags), seborrheic keratosis, squamous cell carcinoma, squamous cell carcinoma of skin

Other

• Very common (10% or more): Increased blood alkaline phosphatase (up to 64%), pyrexia/fever (includes pyrexia, hyperpyrexia, increased body temperature; up to 63%), fatigue (includes fatigue, asthenia, malaise; up to 59%), asthenia (up to 47%), serum phosphate abnormalities (up to 42%), chills (up to 37%), decreased sodium (up to 35%), edema (includes peripheral edema, edema, generalized edema; up to 35%), serum albumin abnormalities (up to 25%), decreased magnesium (up to 24%), peripheral edema (includes peripheral edema, peripheral swelling; up to 22%), influenza-like illness (up to 15%)
• Common (1% to 10%): Serious febrile reactions, fever complicated by hypotension, fever complicated by dehydration, fever complicated by syncope, fever complicated by renal failure, serious noninfectious febrile events, mucosal inflammation, face edema
• Frequency not reported: Postprocedural hemorrhage, fever complicated by severe chills/rigors, increased weight, decreased phosphate, increased magnesium, increased potassium, decreased calcium, decreased potassium

In the pooled safety population for this drug as a single agent, fever (serious and non-serious) occurred in 30% of patients; about 13% of these patients experienced 3 or more discrete episodes. Serious febrile reactions and fever of any severity complicated by hypotension, rigors, or chills occurred in 6% of patients.

In the pooled safety population for this drug in combination with trametinib, fever occurred in 58% of patients. Serious febrile reactions and fever of any severity complicated by hypotension, rigors/chills, dehydration, or renal failure occurred in 5% of patients. Fever was complicated by hypotension in 4%, dehydration in 3%, syncope in 2%, renal failure in 1%, and severe chills/rigors in less than 1% of patients.

In 1% of patients in clinical trials, serious noninfectious febrile events (defined as fever accompanied by severe rigors, dehydration, hypotension, and/or acute renal dysfunction of prerenal origin in patients with normal baseline renal function) were identified. The onset of these events was typically within the first month of therapy. Patients with serious noninfectious febrile events responded well to dose interruption and/or dose reduction and supportive care.

Psychiatric

• Frequency not reported: Anxiety

Renal

• Very common (10% or more): Increased creatinine (up to 21%)
• Common (1% to 10%): Renal failure, tubulointerstitial nephritis
• Uncommon (0.1% to 1%): Acute renal failure, nephritis
• Frequency not reported: Interstitial nephritis

Respiratory

• Very common (10% or more): Cough (includes cough, productive cough; up to 29%), dyspnea (up to 20%), nasopharyngitis (includes pharyngitis; up to 12%)
• Common (1% to 10%): Respiratory distress, pulmonary embolism
• Uncommon (0.1% to 1%): Pneumonitis, interstitial lung disease
• Frequency not reported: Epistaxis, upper respiratory tract infection, oropharyngeal pain

Further information

Dabrafenib side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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