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Tafinlar Side Effects

Generic name: dabrafenib

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

Note: This document provides detailed information about Tafinlar.

Applies to dabrafenib: oral capsule, oral tablet for suspension Side Effects associated with dabrafenib. Some dosage forms listed on this page may not apply specifically to the brand name Tafinlar.

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 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 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 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 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

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

Gastrointestinal

Genitourinary

Hematologic

Hepatic

Hypersensitivity

Immunologic

Metabolic

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

Nervous system

Ocular

Oncologic

Other

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

Renal

Respiratory

See also:

References

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

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

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

Further information

Tafinlar 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.