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Dabrafenib Side Effects

In Summary

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

For the Consumer

Applies to dabrafenib: oral capsule

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 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
  • increased hunger
  • increased thirst
  • increased urination
  • lump or growth on the skin
  • nausea
  • nosebleed
  • prolonged bleeding from cuts
  • red or dark brown urine
  • red or black, tarry stools
  • redness, swelling, or pain of the skin
  • scaling of the skin on the hands and feet
  • skin blisters
  • skin rash
  • stomach pain
  • 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
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

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
  • Back pain
  • constipation
  • cough
  • difficulty having a bowel movement
  • difficulty with moving
  • fast heartbeat
  • hair loss or thinning of the hair
  • headache
  • indigestion
  • loss of appetite
  • muscle aches
  • muscle pain or stiffness
  • pain in the joints
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • sore throat
  • stuffy or runny nose
  • yellow eyes or skin

For Healthcare Professionals

Applies to dabrafenib: oral capsule

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]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Tafinlar (dabrafenib)." GlaxoSmithKline, Research Triangle Park, NC.

Some side effects of dabrafenib may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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