Erlotinib (Oral Route)

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Side Effects

Along with its needed effects, a medicine 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:

• Burning, tingling, numbness or pain in the hands, arms, feet, or legs
• Cough or hoarseness
• Diarrhea, severe
• Difficult or labored breathing
• Fever or chills
• Lower back or side pain
• Painful or difficult urination
• Rash, severe
• Sensation of pins and needles
• Shortness of breath
• Stabbing chest pain
• Tightness in the chest
• Wheezing

• Bloody or black, tarry stool
• Blurred vision
• Chest pain or discomfort
• Constipation
• Convulsions (seizures)
• Eye irritation or redness
• Inability to speak
• Pain or discomfort in the arms, jaw, back, or neck
• Severe stomach pain
• Slurred speech
• Sudden, severe chest pain
• Sudden, severe headache
• Sudden, severe weakness in the arm or leg on one side of the body
• Sweating
• Vision changes
• Vomiting of blood or material that looks like coffee grounds

• Agitation
• Blistering, peeling, or loosening of the skin
• Bloody nose
• Burning feeling in the chest or stomach
• Burning upper abdominal or stomach pain
• Coma
• Confusion
• Dark-colored urine
• Darkening of the skin
• Decreased urine output
• General feeling of tiredness or weakness
• Headache
• Increased thirst
• Irregular heartbeat
• Lethargy
• Light-colored stools
• Loss of appetite
• Mood changes
• Muscle twitching
• Nausea or vomiting
• Rapid weight gain
• Red skin lesions, often with a purple center
• Sore throat
• Sores, ulcers, or white spots in the mouth or on the lips
• Stomach pain, continuing
• Stupor
• Swelling of the face, ankles, or hands
• Tenderness in the stomach area
• Trouble breathing
• Unusual tiredness or weakness
• Yellow eyes or skin

Some side effects 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:

• Acid or sour stomach
• Belching
• Blemishes on the skin
• Bloated, full feeling
• Bone pain
• Burning, dry, or itching eyes
• Diarrhea, mild
• Difficulty with moving
• Dizziness
• Dry eyes
• Dry skin
• Excess air or gas in the stomach or intestines
• Excessive tearing
• Fear
• Feeling sad or empty
• Feeling unusually cold
• Hair loss
• Headache
• Heartburn
• Indigestion
• Irritability
• Itching skin
• Joint pain
• Loss of interest or pleasure
• Muscle aching or cramping
• Muscle pains or stiffness
• Nervousness
• Passing gas
• Pimples
• Rash, mild
• Redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• Shivering
• Sleeplessness
• Stomach discomfort, upset, or pain
• Swelling
• Swelling or inflammation of the mouth
• Swollen joints
• Thinning of the hair
• Tiredness
• Trouble with concentrating
• Trouble or inability to sleep
• Weight loss

• Loosening of the fingernails
• Redness or soreness around the fingernails

• Brittle and loose nails
• Discharge, excessive tearing
• Increased hair growth, especially on the face

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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