Erlotinib Side Effects

Brand Names: Tarceva

Please note - some side effects for Erlotinib may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Erlotinib - for the Consumer

Erlotinib

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Erlotinib:

Bone pain; constipation; diarrhea; dry skin; fatigue; hair loss; loss of appetite; mild stomach pain; mouth sores or ulcers; nausea; vomiting; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; chest, jaw, or left arm pain; confusion; cough; dark urine; decreased urine; excessive hair growth; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; nosebleed; numbness of arm or leg; one-sided weakness; pale stools; red, swollen, blistered, or peeling skin; severe eye dryness, irritation, pain, redness, or discharge; severe or persistent diarrhea, nausea, loss of appetite, stomach pain, or vomiting; severe rash accompanied by fever, blistering, mouth sores, swelling, muscle or joint aches, or discomfort; shortness of breath; slurred speech; sudden, severe headache; swelling of the hands, legs, or feet; unusual bruising or bleeding; unusual tiredness or weakness; vision problems or decrease in vision; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

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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