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Erlotinib Side Effects

In Summary

Commonly reported side effects of erlotinib include: infection, conjunctivitis, diarrhea, dyspnea, keratoconjunctivitis, nausea, pruritus, skin rash, stomatitis, anorexia, and xeroderma. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to erlotinib: oral tablet

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

  • 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

  • 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

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

  • 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

  • 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

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%)

References

1. "Product Information. Tarceva (erlotinib)." Genentech, South San Francisco, CA.

2. Liu V, White DA, Zakowski MF, et al. "Pulmonary toxicity associated with erlotinib." Chest 132 (2007): 1042-4

3. Marquez G, Herrera-Acosta E, Vidal I, Galvany L, Iglesias M, Umbert P "A case of trichomegaly of the eyelashes and facial hypertrichosis induced by erlotinib (Tarceva)." Int J Dermatol 48 (2009): 97-8

4. Cuetara MS, Aguilar A, Martin L, Aspiroz C, Del Palacio A "Erlotinib associated with rosacea-like folliculitis and Malassezia sympodialis." Br J Dermatol 155 (2006): 477-9

5. PharmaLive "Skin rash actually signifies better outcomes for pancreatic and lung cancer patients. Available from: URL: http://pharmalive.com/news/Print.cfm?articleid=456520" ([2007 Jul 3]):

6. Pellegrinotti M, Fimognari FL, Franco A, Repetto L, Pastorelli R "Erlotinib-induced hepatitis complicated by fatal lactic acidosis in an elderly man with lung cancer." Ann Pharmacother 43 (2009): 542-5

7. Lee SM, Buchler T, Joseph T, Lai C "Bilateral eardrum perforation after long-term treatment with erlotinib." J Clin Oncol 26 (2008): 2582-4

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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