Cetuximab Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 15, 2023.

Applies to cetuximab: intravenous solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (solution)

Serious and potentially fatal infusion reactions may occur and require immediate interruption of the cetuximab infusion and permanent discontinuation.

Cardiopulmonary arrest and/or sudden death have been reported in patients with squamous cell carcinoma of the head and neck treated with radiation therapy and cetuximab or platinum-based therapy with 5-fluorouracil and cetuximab.

Monitoring of serum electrolytes during and after cetuximab therapy is recommended.

Serious side effects of cetuximab

Along with its needed effects, cetuximab 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 or nurse immediately if any of the following side effects occur while taking cetuximab:

More common

• blemishes on the skin or pimples
• bloating or swelling of the face, arms, hands, lower legs, or feet
• body aches or pain
• chills
• congestion
• cough
• deep cracks, grooves, or lines in the skin
• difficult or labored breathing
• dizziness
• fever
• headache
• hoarseness
• lower back or side pain
• nausea
• painful or difficult urination
• pale skin
• rapid weight gain
• runny nose
• severe dry skin
• skin rash
• tender, swollen glands in the neck
• tightness in the chest
• tingling of the hands or feet
• trouble with breathing on exertion
• trouble with swallowing
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• voice changes
• vomiting

Less common

• anxiety
• black, tarry stools
• chest pain
• confusion
• decreased urination
• dry mouth
• fainting
• fast heartbeat
• increase in heart rate
• lightheadedness
• rapid, shallow breathing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sunken eyes
• thirst
• wrinkled skin

Incidence not known

• blistering, peeling, or loosening of the skin
• cracked lips
• diarrhea
• difficulty in swallowing
• itching
• joint or muscle pain
• red, irritated eyes
• red skin lesions, often with a purple center
• stiff neck or back

Other side effects of cetuximab

Some side effects of cetuximab 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

• belching
• burning, dry, or itching eyes
• difficulty having a bowel movement
• discharge from the eye
• discoloration of the fingernails or toenails
• discouragement
• excessive tearing
• feeling sad or empty
• hair loss or thinning of the hair
• heartburn
• indigestion
• irritability
• lack or loss of appetite
• lack or loss of strength
• loss of interest or pleasure
• pain
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• sleeplessness
• stomach discomfort, upset, or pain
• swelling or inflammation of the mouth
• trouble concentrating
• trouble sleeping

For healthcare professionals

Applies to cetuximab: intravenous solution.

Dermatologic

• Very common (10% or more): Acneiform rash (90%), alopecia (21%), skin fissures (19%), nail disorder (16%), skin disorder (15%), acne (14%)
• Common (1% to 10%): Pruritus
• Very rare (less than 0.01%): Stevens-Johnson syndrome/toxic necrolysis
• Frequency not reported: Superinfection of skin lesions
• Postmarketing reports: Life-threatening/fatal bullous mucocutaneous disease^[Ref]

Cardiovascular

• Common (1% to 10%): Cardiopulmonary arrest and/or sudden death
• Uncommon (0.1% to 1%): Deep vein thrombosis^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (66%), nausea (55%), vomiting (41%), anorexia (36%), constipation (30%), stomatitis (26%), dyspepsia (14%), mucositis, dry mouth (12%)
• Postmarketing reports: Mucosal inflammation^[Ref]

Hematologic

• Very common (10% or more): Leukopenia (25%), anemia (16%)^[Ref]

Respiratory

• Very common (10% or more): Dyspnea (49%), cough (30%)
• Uncommon (0.1% to 1%): Pulmonary embolism, interstitial lung disease^[Ref]

Metabolic

• Very common (10% or more): Hypomagnesemia (55%), sensory neuropathy (45%), weight loss (21%), peripheral edema (16%), dehydration (15%), severe hypomagnesemia (15%)
• Common (1% to 10%): Hypocalcemia, anorexia^[Ref]

Other

• Very common (10% or more): Asthenia (56%), fever (29%), chills (16%), taste disturbance (10%)
• Common (1% to 10%): Fatigue
• Frequency not reported: Late radiation toxicity^[Ref]

Ocular

• Very common (10% or more): Conjunctivitis (14%)
• Uncommon (0.1% to 1%): Blepharitis, keratitis^[Ref]

Nervous system

• Very common (10% or more): Headache (19%)
• Frequency not reported: Aseptic meningitis^[Ref]

Renal

• Common (1% to 10%): Kidney failure^[Ref]

Hypersensitivity

• Very common (10% or more): Mild or moderate infusion related reactions
• Common (1% to 10%): Severe infusion related reactions (in some cases fatal)^[Ref]

Immunologic

• Very common (10% or more): Infection (13%)
• Frequency not reported: Immunogenicity^[Ref]

Musculoskeletal

• Very common (10% or more): Arthralgia (14%), back pain (16%)^[Ref]

Hepatic

• Very common (10% or more): High alanine transaminase (43%), high aspartate transaminase (38%), high alkaline phosphatase (33%)^[Ref]

Psychiatric

• Very common (10% or more): Insomnia (27%), confusion (18%), anxiety (14%), depression (14%)^[Ref]

Local

• Very common (10% or more): Infusion reaction (e.g., chills, rigors, dyspnea, tachycardia, bronchospasm, chest tightness, swelling, urticaria, hypotension, flushing, rash, hypertension, nausea, angioedema, pain, sweating, tremors, shaking, drug fever, or other hypersensitivity reaction) (15%)^[Ref]

Further information

Cetuximab 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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer