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Cetuximab Side Effects

Not all side effects for cetuximab 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 cetuximab: intravenous solution

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

If any of the following side effects occur while taking cetuximab, check with your doctor or nurse immediately:

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 or hoarseness
  • deep cracks, grooves, or lines in the skin
  • difficult or labored breathing
  • dizziness
  • facial swelling
  • fever
  • headache
  • lower back or side pain
  • nausea
  • painful or difficult urination
  • pale skin
  • rapid weight gain
  • runny nose
  • severe dry skin
  • shortness of breath
  • 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
  • weakness
  • wheezing
Less common or rare
  • 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
  • swollen glands
  • thirst
  • wrinkled skin

Some of the side effects that can occur with cetuximab 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
  • burning, dry, or itching eyes
  • diarrhea
  • difficulty having a bowel movement (stool)
  • 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
  • itching skin
  • 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
  • unable to sleep

For Healthcare Professionals

Applies to cetuximab: intravenous solution

Dermatologic

Very common (10% or more): Acneiform rash (90% in patients on this drug alone, alopecia (21% in patients on this drug with irinotecan), nail disorder (16% in patients on this drug alone), skin disorder (15% in patients on this drug with irinotecan)
Common (1% to 10%): Pruritus
Very rare (less than 0.01%): Stevens-Johnson syndrome/toxic necrolysis
Frequency not reported: Superinfection of skin lesions[Ref]

Cardiovascular

Common (1% to 10%): Cardiopulmonary arrest and/or sudden death have been reported in 2% of patients with squamous cell carcinoma of the head and neck treated with radiation therapy and this drug as compared to none of the patients treated with radiation therapy alone
Uncommon (0.1% to 1%): Deep vein thrombosis[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (72%), nausea (55%), vomiting (41%), anorexia (36%), constipation (30%), stomatitis (26%), dyspepsia (14%), mucositis, in some cases severe (mucositis may lead to epistaxis), abdominal pain (45% in patients receiving this drug with irinotecan)[Ref]

Hematologic

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

Respiratory

Very common (10% or more): Dyspnea (23%) and increased cough (20%) have been reported in patients receiving this drug with irinotecan
Uncommon (0.1% to 1%): Pulmonary embolism, interstitial lung disease[Ref]

Metabolic

Very common (10% or more): Hypomagnesemia (up to 55%), high alanine transaminase (43% in patients receiving this drug with radiation), high aspartate transaminase (38% in patients receiving this drug with radiation), and high alkaline phosphatase (33% in patients receiving this drug with radiation), weight loss (21% in patients receiving this drug with irinotecan), peripheral edema (16% in patients receiving this drug with irinotecan), dehydration (15% in patients receiving this drug with irinotecan) and severe hypomagnesemia (10% to 15% in patients receiving this drug with irinotecan)
Common (1% to 10%): Dehydration, hypocalcemia, anorexia[Ref]

Other

Very common (10% or more): Asthenia/malaise (73% in patients receiving cetuximab with irinotecan), pain (23% in patients receiving this drug with irinotecan)
Common (1% to 10%): Fatigue
Frequency not reported: Late radiation toxicities (higher with this drug in combination with radiation therapy compared with radiation therapy alone)[Ref]

Ocular

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

Nervous system

Very common (10% or more): Headache (25% in patients receiving this drug as monotherapy)
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 (16% in patients receiving this drug with irinotecan)[Ref]

Musculoskeletal

Very common (10% or more): Back pain (16% in patients receiving this drug with irinotecan)[Ref]

Hepatic

Very common (10% or more): Increase in liver enzyme levels (ASAT, ALAT, AP)[Ref]

Psychiatric

Very common (10% or more): Insomnia (12%), depression (10%)[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Erbitux (cetuximab)." Bristol-Myers Squibb, Princeton, NJ.

4. Schrag D, Chung KY, Flombaum C, Saltz L "Cetuximab therapy and symptomatic hypomagnesemia." J Natl Cancer Inst 97 (2005): 1221-4

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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