Erlotinib Side Effects

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

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
  • sleeplessness
  • 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

Respiratory side effects have included reports of serious interstitial lung disease, including fatalities in the treatment of non-small cell lung cancer or other advanced solid tumors. Dyspnea (41%) and cough (33%) have also been reported.

Dermatologic

Dermatologic side effects including rash (75%), pruritus (13%), dry skin (12%), alopecia, hirsutism, eyelash/eyebrow changes, paronychia, and brittle and loose nails have been reported. Bullous, blistering and exfoliative skin conditions have been reported including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, which in some cases were fatal. Cases of rosacea-like folliculitis and Malassezia sympodialis have also been reported.

Treatment should be interrupted or discontinued if the patient develops severe bullous, blistering, or exfoliating conditions.

The appearance of a rash in cancer patients treated with erlotinib is strongly associated with longer survival, according to researchers from the drug's developer, OSI Pharmaceuticals, Inc.

Rash resulted in study discontinuation in 1.2% patients. Dose reduction or interruption for rash was needed in 5.1% of patients. In erlotinib-treated patients who developed rash, the onset was within two weeks in 66% and within one month in 81%.

Gastrointestinal

The median time to onset of diarrhea was 12 days. Diarrhea resulted in study discontinuation in 0.5% of patients. Dose reduction or interruption for diarrhea was needed in 2.8% of patients.

Patients receiving concomitant antiangiogenic agents, corticosteroids, NSAIDs, and/or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease are at an increased risk for gastrointestinal perforation. Erlotinib should be permanently discontinued in patients who develop gastrointestinal perforation.

Gastrointestinal side effects including diarrhea (54%), nausea (33%), vomiting (23%), stomatitis (17%), and abdominal pain (11%) have been reported. Gastrointestinal perforation has been reported in patients receiving erlotinib, including fatalities. Gastrointestinal bleeding has been reported infrequently.

Hepatic

Hepatic side effects including hepatic failure, hepatorenal syndrome, and liver function test abnormalities such as elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin have been reported. A case of hepatitis has also been reported.

These elevations were mostly transient or associated with liver metastases.

A pharmacokinetic study in patients with advanced solid tumors and moderate hepatic impairment according to the Child-Pugh criteria has been reported. In this study, 10 of the 15 patients died on treatment or within 30 days of the last erlotinib dose. Eight of these patients died from progressive disease, one patient died from hepatorenal syndrome, and one patient died from rapidly progressing liver failure. Six out of the 10 patients who died had baseline total bilirubin greater than 3 times the upper limit of normal suggesting severe, rather than moderate, hepatic impairment. All patients had hepatic impairment due to advanced cancer with liver involvement such as hepatocellular carcinoma, cholangiocarcinoma, or liver metastases.

Patients with hepatic impairment should be monitored closely during therapy with erlotinib, and dosing should be interrupted or discontinued if changes in liver function are severe.

Liver function test abnormalities (including elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) were observed in patients receiving single-agent erlotinib 150 mg in the Maintenance study. Grade 2 (>2.5 - 5 x ULN) ALT elevations occurred in 2% and 1%, and Grade 3 (>5 - 20 x ULN) ALT elevations were observed in 1% and 0% of erlotinib and placebo treated patients, respectively. The erlotinib treatment group had Grade 2 (>1.5-3 x ULN) bilirubin elevations in 4% and Grade 3 (>3-10 x ULN) in <1% compared with <1% for both Grades 2 and 3 in the placebo group.

General

General side effects including anorexia (52%) and fatigue (52%) have been reported.

Immunologic

Immunologic side effects including infection (24%) have been reported.

Ocular

Ocular disorders including abnormal eyelash growth, keratoconjunctivitis sicca, or keratitis are known risk factors for corneal ulceration/perforation.

Erlotinib therapy should be interrupted or discontinued if patients present with acute/worsening ocular disorders such as eye pain.

Ocular side effects including conjunctivitis (12%), keratoconjunctivitis sicca (12%), corneal perforation and ulceration, abnormal eyelash growth, and keratitis have been reported.

Renal

Renal side effects including cases of hepatorenal syndrome, acute renal failure or renal insufficiency (some with fatalities) have been reported.

Other

Other side effects including a case of bilateral eardrum perforation have been reported.

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