Erlotinib Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Sep 19, 2024.

Applies to erlotinib: oral tablet.

Serious side effects of erlotinib

Along with its needed effects, erlotinib 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 erlotinib:

More common side effects

• 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
• stabbing chest pain
• tightness in the chest

Rare side effects

• bloody or black, tarry stools
• 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

Incidence not known

• agitation
• blistering, peeling, or loosening of the skin
• bloody nose
• burning feeling in the chest or stomach
• burning upper abdominal or stomach pain
• 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 pain or stiffness
• 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

Other side effects of erlotinib

Some side effects of erlotinib 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

• acid or sour stomach
• belching
• blemishes on the skin
• bloated or 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
• nervousness
• passing gas
• pimples
• rash, mild
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• shivering
• stomach discomfort, upset, or pain
• swelling
• swelling or inflammation of the mouth
• swollen joints
• thinning of the hair
• tiredness
• trouble or inability to sleep
• trouble with concentrating
• weight loss

Less common side effects

• loosening of the fingernails
• redness or soreness around the fingernails

Incidence not known

• brittle and loose nails
• discharge, excessive tearing
• increased hair growth, especially on the face

For healthcare professionals

Applies to erlotinib: oral tablet.

Respiratory adverse events

• Very common (10% or more): Dyspnea (41%), cough (33%)
• Common (1% to 10%): Epistaxis, interstitial lung disease^[Ref]

Dermatologic

• Very common (10% or more): Rash (75%), alopecia (14%), pruritus (13%), dry skin (12%)
• Common (1% to 10%): Acne, dermatitis acneiform, folliculitis, skin fissures, paronychia
• Uncommon (0.1% to 1%): Hyperpigmentation, hirsutism, brittle/loose nails, eyebrow changes
• Rare (less than 0.1%): Palmar plantar erythrodysesthesia syndrome, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (54%), nausea (33%), vomiting (23%), stomatitis (22%), dyspepsia (17%), flatulence (13%), abdominal pain (11%)
• Common (1% to 10%): GI bleeding
• Uncommon (0.1% to 1%): GI perforations^[Ref]

Hepatic

• Common (1% to 10%): Liver function test abnormalities (including elevated ALT, AST, bilirubin)
• Rare (less than 0.1%): Hepatic failure and hepatorenal syndrome (including fatalities)^[Ref]

Immunologic

• Very common (10% or more): Infections (24%)^[Ref]

Ocular

• Very common (10% or more): Keratoconjunctivitis sicca (12%), conjunctivitis (12%)
• Common (1% to 10%): Keratitis
• Uncommon (0.1% to 1%): Eyelash changes
• Rare (less than 0.1%): Corneal ulcerations or perforations
• Postmarketing reports: Uveitis^[Ref]

Renal

• Common (1% to 10%): Renal insufficiency
• Uncommon (0.1% to 1%): Nephritis, proteinuria

Other

• Very common (10% or more): Fatigue (73%), pyrexia (36%)^[Ref]

Cardiovascular

• Common (1% to 10%): Myocardial infarction/ischemia, cerebrovascular accident

Metabolic

• Very common (10% or more): Anorexia (53%), weight decreased (39%)

Musculoskeletal

• Very common (10% or more): Rigors (12%)
• Postmarketing reports: Myopathy, including rhabdomyolysis, in combination with statin therapy

Nervous system

• Very common (10% or more): Headache (15%), neuropathy (13%)

Psychiatric

• Very common (10% or more): Depression (19%)

Frequently asked questions

• How does erlotinib work (mechanism of action)?
• Can Tarceva (erlotinib) cure lung cancer?

Further information

Erlotinib 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.

Medical Disclaimer