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Tafinlar Side Effects

Generic name: dabrafenib

Medically reviewed by Drugs.com. Last updated on May 17, 2023.

Note: This document contains side effect information about dabrafenib. Some dosage forms listed on this page may not apply to the brand name Tafinlar.

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

Serious side effects of Tafinlar

Along with its needed effects, dabrafenib (the active ingredient contained in Tafinlar) 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

Less common

Incidence not known

Other side effects of Tafinlar

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

For Healthcare Professionals

Applies to dabrafenib: oral capsule, oral tablet soluble.

General

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

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.

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)

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

References

1. Product Information. Tafinlar (dabrafenib). Novartis Pharmaceuticals. 2023;SUPPL-27.

2. Product Information. Tafinlar (daBRAFEnib). Novartis Pharmaceuticals Pty Ltd. 2023.

3. Product Information. Tafinlar (dabrafenib). Novartis Pharmaceuticals UK Ltd. 2023.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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