Erlotinib Side Effects

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

Applies to erlotinib: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should continue to use birth control during treatment and for 1 month after your last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

It is important that you talk to your doctor right away if you have severe or continuing diarrhea, nausea, loss of appetite, or vomiting.

Call your doctor right away if you have unexplained shortness of breath, cough, and fever that comes on suddenly. These could be symptoms of a serious lung condition.

Check with your doctor right away if you have bloody or black, tarry stools, severe stomach pain, or vomiting of blood or material that looks like coffee grounds. These could be symptoms of a serious stomach or bowel problem.

Tell your doctor right away if you have dark urine or pale stools, yellow skin or eyes, nausea or vomiting, or upper stomach pain. These could be symptoms of a liver problem.

Kidney problems may occur while you are using this medicine. Tell your doctor right away if you have decreased urine output, dizziness, headache, irritability, rapid weight gain, seizures, swelling of the face, ankles, or hands, or unusual tiredness or weakness.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

You may use alcohol-free emollient creams, sunscreen, or sun blocking lotions to prevent dry skin and other serious skin reactions.

Check with your doctor right away if blurred vision or any vision change, eye pain, or eye irritation occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

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:

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:

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%)

See also:

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