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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

In addition to its needed effects, some unwanted effects may be caused by dabrafenib. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking dabrafenib:

More common:
  • Abdominal or stomach pain
  • bloody or cloudy urine
  • blurred vision
  • dry mouth
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • greatly decreased frequency of urination or amount of urine
  • increased hunger
  • increased thirst
  • increased urination
  • lump or growth on the skin
  • nausea
  • redness, swelling, or pain of the skin
  • scaling of the skin on the hands and feet
  • skin blisters
  • skin rash
  • sweating
  • swelling of the feet or lower legs
  • tingling of the hands and feet
  • troubled breathing
  • ulceration of the skin
  • 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

Minor Side Effects

Some of the side effects that can occur with dabrafenib may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Back pain
  • constipation
  • cough
  • darkened urine
  • difficulty having a bowel movement (stool)
  • 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

General

The most frequently reported side effects included hyperkeratosis, headache, pyrexia, arthralgia, papilloma, alopecia, and palmar-plantar erythrodysesthesia syndrome (PPES).

The most common side effect resulting in dose reduction were pyrexia (9%), PPES (3%), chills (3%), fatigue (2%), and headache (2%).[Ref]

Oncologic

Very common (10% or more): Papilloma (27%)
Common (1% to 10%): Cutaneous squamous cell carcinoma (7%)[Ref]

Dermatologic

Very common (10% or more): Hyperkeratosis (37%), alopecia (22%), palmar-plantar erythrodysesthesia syndrome (20%), rash (17%)[Ref]

Gastrointestinal

Very common (10% or more): Constipation (12%)
Frequency not reported: Pancreatitis[Ref]

Other

Very common (10% or more): Pyrexia (28%)
Common (1% to 10%): Serious febrile drug reactions (3.7%)[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity manifesting as bullous rash[Ref]

Metabolic

Very common (10% or more): Hyperglycemia (50%), hypophosphatemia (37%), increased alkaline phosphatase (19%)
Common (1% to 10%): Hyponatremia (8%)[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (27%), back pain (12%), myalgia (11%)[Ref]

Nervous system

Very common (10% or more): Headache (32%)[Ref]

Ocular

Common (1% to 10%): Uveitis (1%)[Ref]

Renal

Frequency not reported: Interstitial nephritis[Ref]

Respiratory

Very common (10% or more): Cough (12%), nasopharyngitis (10%)[Ref]

References

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

Not all side effects for dabrafenib may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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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