Dabrafenib Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 10, 2024.

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

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, diaphragms, contraceptive foams or jellies) along with your pills. Use an effective form of birth control during treatment with this medicine and for at least 2 weeks after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

Some men and women who use this medicine have become infertile (unable to have children). Talk to your doctor before using this medicine if you plan to have children.

This medicine may increase your risk of having cutaneous squamous cell carcinoma (cuSCC) or other skin cancers. Check with your doctor right away if you develop any skin changes, including a new wart, change in size or color of a mole, or a skin sore or reddish bump that does not heal. Your doctor may want your skin be checked for new skin lesions before treatment, during treatment, and for up to 6 months after the last dose.

This medicine may cause hemorrhage (severe bleeding) in the stomach and bowel areas or in the brain. Call your doctor right away if you have any unusual or unexplained bleeding.

Dabrafenib may cause heart problems. Check with your doctor right away if you have chest discomfort or pain, dizziness or faintness, fast, irregular, or pounding heartbeat, swelling of the feet or lower legs, trouble with breathing, or unusual tiredness or weakness.

Check with your doctor right away if eye pain or a change in vision occurs during treatment. This could be a sign of a serious eye problem. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

This medicine may cause fever, including severe fever that sometimes happens with low blood pressure, chills, dehydration, or kidney problems. Check with your doctor right away if you have a fever while using this medicine.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, cough, sore throat, trouble breathing or swallowing, swelling of your hands, face, mouth, or throat, swollen, painful, or tender lymph glands in the neck, armpit, or groin, or yellow skin or eyes while using this medicine.

This medicine may affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.

This medicine may cause a severe inflammatory condition that could be life-threatening, including hemophagocytic lymphohistiocytosis (HLH), which is caused by an overactive immune system. Check with your doctor right away if you have a bruising, fever, skin rash, or swollen glands.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

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

See also:

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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