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Lapatinib Side Effects

For the Consumer

Applies to lapatinib: oral tablet

Along with its needed effects, lapatinib 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 lapatinib:

Less common
  • Difficult or labored breathing
  • fainting
  • fast or irregular heartbeat
  • severe diarrhea
  • tightness in the chest
  • unusual tiredness or weakness
Rare
  • Abdominal or stomach pain or tenderness
  • clay colored stools
  • dark urine
  • decreased appetite
  • fever
  • headache
  • itching or skin rash
  • loss of appetite
  • nausea and vomiting
  • swelling of the feet or lower legs
  • yellow eyes or skin
Incidence not known
  • Blistering, peeling, loosening of the skin
  • chest pain
  • chills
  • cough
  • diarrhea
  • difficulty with swallowing
  • dizziness
  • general feeling of discomfort or illness
  • hives
  • joint or muscle pain
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • thickening of bronchial secretions

Some side effects of lapatinib 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
  • Acid or sour stomach
  • back pain
  • belching
  • cracked lips
  • diarrhea (mild)
  • dry skin
  • heartburn
  • indigestion
  • pain in the arms or legs
  • redness, swelling, or painful skin
  • scaling of the skin on the hands and feet
  • sores, ulcers, or white spots on the lips, tongue, or the inside of the mouth
  • stomach discomfort, upset, or pain
  • swelling or inflammation of the mouth
  • tingling of the hands and feet
  • trouble sleeping
Incidence not known
  • Loosening of the fingernails
  • redness or soreness around the fingernails

For Healthcare Professionals

Applies to lapatinib: oral tablet

Gastrointestinal

Very common (10% or more): Diarrhea (77%), nausea (44%), vomiting (26%), stomatitis (14%), dyspepsia (11%), constipation, abdominal pain[Ref]

Hematologic

Very common (10% or more): Neutropenia (77%), hemoglobin lab abnormality (56%), leukopenia (53%), anemia (23%), neutrophils lab abnormality (22%), platelets lab abnormality (18%), decreased hemoglobin (10%)[Ref]

Dermatologic

Very common (10% or more): Rash (including dermatitis acneiform, 59%), Palmar-plantar erythrodysesthesia (53%), alopecia (13%), dry skin (13%), pruritus (12%), nail disorders (including paronychia, 11%)
Frequency not reported: Serious cutaneous reactions[Ref]

Hepatic

Very common (10% or more): AST lab abnormality (53%), ALT lab abnormality (46%), total bilirubin lab abnormality (45%), increased ALT (11%), hyperbilirubinemia
Common (1% to 10%): Hepatotoxicity[Ref]

Metabolic

Very common (10% or more): Decreased appetite (32%), anorexia (11%)[Ref]

Other

Very common (10% or more): Fatigue (22%), mucosal inflammation (15%), asthenia[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (14%), pain in extremity (12%), back pain (11%), arthralgia[Ref]

Respiratory

Very common (10% or more): Dyspnea (12%), cough (10%), epistaxis
Uncommon (0.1% to 1%): Interstitial lung disease/pneumonitis[Ref]

Psychiatric

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

Cardiovascular

Very common (10% or more): Hot flush
Common (1% to 10%): Decreased left ventricular ejection fraction[Ref]

Nervous system

Very common (10% or more): Peripheral neuropathy
Common (1% to 10%): Headache[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity reactions (including anaphylaxis)[Ref]

References

1. "Product Information. Tykerb (lapatinib)." Novartis Pharmaceuticals, East Hanover, NJ.

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

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

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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