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

In addition to its needed effects, some unwanted effects may be caused by erlotinib. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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 of the side effects that can occur with erlotinib may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

Very common (10% or more): Dyspnea (41%), cough (Up to 33%)
Common (1% to 10%): Epistaxis, interstitial lung disease

Dermatologic

Very common (10% or more): Rash (69 to 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, toxic epidermal necrolysis

Gastrointestinal

Very common (10% or more): Diarrhea (48 to 54%), nausea (33%), vomiting (23%), stomatitis (17 to 22%), dyspepsia (17%), flatulence (13%), abdominal pain (11%)
Common (1% to 10%): Gastrointestinal bleeding
Uncommon (0.1% to 1%): Gastrointestinal perforations

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)

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 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.

General

The most common side effects included rash, diarrhea, anorexia, dyspnea, cough, fatigue, nausea, and vomiting.

Immunologic

Very common (10% or more): Infection (24 to 31%)

Ocular

Very common (10% or more): Conjunctivitis (12%), keratoconjunctivitis sicca (12%)
Common (1% to 10%): Keratitis
Uncommon (0.1% to 1%): Eyelash changes
Rare (less than 0.1%): Corneal ulcerations or perforations
Post-marketing surveillance: Uveitis

Renal

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

Other

Very common (10% or more): Fatigue (Up to 73%), pyrexia (36%)

Cardiovascular

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

Metabolic

Very common (10% or more): Anorexia (52%), weight decreased (39%)

Musculoskeletal

Very common (10% or more): Rigors (12%)
Post-marketing surveillance: 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%)

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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