This site is intended for U.S. residents.

Safety Information

ERBITUX® (cetuximab) may cause side effects. Some can be serious. Be sure to work closely with your doctor and nurse throughout your treatment so you know what to expect. Tell them about any side effects that you experience. They can tell you what can be done if you have certain side effects. Being prepared and having a plan can make a difference.

Click on each side effect to learn more.

To report an adverse event, call 1-888-ERBITUX (372-4889) or contact the FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.

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Allergic Reaction
  • Severe allergic reactions due to ERBITUX therapy have occurred in 42 of 1373 patients (3%) receiving ERBITUX during studies, resulting in death in less than 1 in 1000 patients
    • Symptoms can include trouble with breathing (including tightening of the airways, wheezing, or hoarseness), low blood pressure, shock, loss of consciousness, and/or heart attack
    • Approximately (90%) of the severe allergic reactions occurred with the first dose of ERBITUX, although some patients experienced their first severe allergic reaction during a subsequent dose of ERBITUX
    • Your doctor or nurse should watch you closely for these symptoms during treatment and may need to stop therapy in the event of an allergic reaction
    • Severe allergic reactions require that treatment with ERBITUX be stopped immediately and not started again
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Lung Disease
  • Lung disease, which resulted in 1 death, occurred in 4 of 1570 patients (<0.5%) receiving ERBITUX in several clinical trials in colorectal cancer and head and neck cancer
    • Notify your doctor if you develop shortness of breath while receiving ERBITUX
    • ERBITUX treatment should be stopped if symptoms worsen or lung disease is confirmed
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Skin Problems
  • In several clinical trials in colorectal cancer and head and neck cancer with ERBITUX, skin problems including an acne-like rash, skin drying and cracking, infections (including infections of the blood, skin, eyes, and lips), and abnormal hair growth were seen
    • Sun exposure may worsen these effects
    • Patients taking ERBITUX should wear sunscreen and hats to limit sun exposure
    • A related nail disorder that causes painful swelling of the skin around the nails—most often of the large toes and thumbs—also was reported
    • Notify your doctor if you develop any of these symptoms while receiving ERBITUX

Below are pictures of the types of skin changes you may notice.

Skin rash, called papulopustular reaction

Severe rash on the face
Severe rash on the face.

What may happen

A skin rash is the most common side effect that patients notice.

This rash may:

  • Look like acne, but it is not
  • Be red, swollen, crusty, and very dry
  • Feel itchy, tender, painful, or warm or burning (like a sunburn)
  • Happen on the scalp, face, chest, or upper back
  • Start and may be the worst during the first few weeks of ERBITUX treatment
  • Get better or stay the same during treatment
  • Go away after ERBITUX treatment is stopped
  • Cause the skin to look pink after the rash has gone away; scarring is not likely

Dry skin

Dry skin on the neck.
Dry skin on the neck.

What may happen

People taking ERBITUX may have dry skin.

Dry skin may:

  • Look flaky or scaly
  • Feel itchy or tender
  • Appear on the scalp, face, chest, or upper back, or where a rash is seen
  • Be more likely to occur if you ever have had eczema or have had skin problems related to EGFR treatment
  • Happen with a rash
  • Cause the skin to look pink after the rash has gone away; scarring is not likely

What can be done

Below are tips your doctor may recommend to help you care for your skin. Please talk to your doctor.

  • Keep skin moist; use a thick, alcohol-free lotion or cream at least 2 times a day, including right after bathing
  • Wear a hat and use sunscreen with at least a 30 SPF when in the sun; limit time in the sun
  • Bathe in cool or lukewarm water; pat yourself dry
  • Use soaps, body washes, lotions, and laundry detergents WITHOUT alcohol, perfumes, or dyes
  • Ask your doctor or nurse for directions on shaving
  • Drink plenty of water
  • Wear gloves to wash dishes or do chores
  • Don’t use acne treatments; your rash may look like acne, but it is not
  • Do not scratch, rub, or scrub your skin
  • Ask your doctor about a cream, a gel, or a medicine you take by mouth to treat these changes

Tell your doctor or nurse about any changes you experience.

Nail changes

Below are pictures of 2 types of nail changes you may notice.

Skin cuts or cracks, called fissures

Small cuts on the skin of thumbs.
Small cuts on the skin of thumbs.

What may happen

Some people will notice changes to the skin on their fingers or toes, such as small cuts or cracks on the skin around their nails. These cuts or cracks may:

  • Look like small paper cuts
  • Appear on the knuckles or the skin around the fingers and toes
  • Appear 2 to 4 months after starting treatment and last for many months after treatment

Swollen or discolored nails, called paronychial inflammation

Discolored, swollen fingernail.
Discolored, swollen nails.

What may happen

Some people may notice changes to their fingernails or toenails. These changes may last for many months after treatment. Nail changes during ERBITUX treatment may:

  • Look like pus-filled blisters or swollen, red skin around the fingernails or toenails
  • Cause ingrown nails or infection
  • Cause nails to form ridges or fall off
  • Be swollen and painful
  • Appear 2 to 4 months after starting treatment

What can be done

Below are tips your doctor may recommend to help you care for your nails. Please talk to your doctor.

  • Don’t bite your nails or the skin around your nails
  • Wear gloves to wash dishes or do chores
  • Keep skin moist; use a thick alcohol-free lotion or cream at least 2 times a day, including right after bathing
  • Drink plenty of water
  • Ask your doctor if you need medicine to help deal with your symptoms

Hair changes

What may happen

Hair changes can happen with ERBITUX treatment. These hair changes may:

  • Make the eyelashes grow very fast and become very long and bother your eyes
  • Cause the fast growth of eyebrows
  • Cause hair on the scalp to become curly, fine, or brittle
  • Start a few weeks to months after starting ERBITUX treatment and go away after treatment is stopped
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Electrolyte Depletion
  • Low levels of magnesium and accompanying low calcium and potassium levels have been reported with ERBITUX® (cetuximab) when given by itself and in combination with other cancer drugs
    • Your doctor or nurse should periodically monitor your blood electrolyte levels and administer intravenous replacement as needed
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Pregnancy and Nursing
  • Notify your doctor if you are pregnant or if you become pregnant while receiving ERBITUX. Contraception must be used, in both males and females, during ERBITUX therapy and for six months following the last dose of ERBITUX. ERBITUX may be passed from the mother to the developing fetus, and may cause harm to the fetus. ERBITUX should only be used during pregnancy if the potential benefit is greater than the potential risk to the fetus
  • ERBITUX may be passed through human breast milk. Because of the potential for serious side effects in nursing infants from ERBITUX, nursing is not recommended during ERBITUX therapy and for two months following the last dose of ERBITUX
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Additional Side Effects

In studies of ERBITUX:

  • The most serious side effects associated with ERBITUX are: allergic reactions, heart attack, skin problems, skin irritation in the radiation area, infection, kidney failure, lung disease, and blood clots in the lung
  • The most frequent side effects associated with ERBITUX (reported in at least 25% of patients) are skin problems (including rash, itching, and nail changes), headache, diarrhea, and infection

In a study of European cetuximab in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) given to 317 patients versus FOLFIRI alone given to 350 patients with colorectal cancer that had spread to other parts of the body whose tumors had a (KRAS) status known as “wild-type,” as well as a protein called Epidermal Growth Factor Receptor (EGFR):

  • The most frequent side effects were: acne-like rash (86% versus 13%) and diarrhea (66% versus 60%)
  • Serious side effects reported by at least 10% of patients in either arm were: abnormal decrease in white blood cell count (31% versus 24%), acne-like rash (18% versus <1%), and diarrhea (16% versus 10%)
  • ERBITUX yields approximately 22% higher blood levels of cetuximab relative to European cetuximab. In this study, the side effects and severity of adverse reactions seen with European cetuximab were consistent with other studies of U.S. patients receiving ERBITUX for metastatic colorectal cancer

In a study where ERBITUX and supportive care were given to 118 patients versus supportive care which was given to 124 patients with colorectal cancer that had spread to other parts of the body whose tumors had a (KRAS) status known as “wild-type,” as well as a protein called Epidermal Growth Factor Receptor (EGFR):

  • The most frequent side effects reported were: rash or shedding of the outer layer of the skin (95% versus 21%), feeling tired (91% versus 79%),
    nausea (64% versus 50%), dry skin (57% versus 15%),
    other pain (59% versus 37%), and constipation (53% versus 38%)
  • Serious side effects reported by at least 10% of patients included:
    fatigue (31% versus 29%), other pain (18% versus 10%), rash or shedding of the
    outer layer of the skin (16% versus 1%), shortness of breath (16% versus 13%), other intestinal problems (12% versus 5%) and infection without abnormal decrease in
    white blood cell count (11% versus 5%)

In studies where ERBITUX and irinotecan were given to 354 patients with colorectal cancer that had spread to other parts of the body whose tumors had a protein called Epidermal Growth Factor Receptor (EGFR):

  • The most frequent side effects reported were: acne-like rash (88%),
    feeling weakness or discomfort (73%), diarrhea (72%), and nausea (55%)
  • Serious side effects reported by at least 10% of patients included:
    diarrhea (22%),decrease in white blood cell count (17%), feeling
    weakness or discomfort (16%), and acne-like rash (14%)

Fatigue

During treatment with ERBITUX, you may feel very tired. This is called fatigue. Many patients will experience fatigue during therapy.

What can be done

If you have fatigue, talk with your doctor. He or she may suggest that you:

  • Develop a realistic daily schedule, including rest and structured work times. One way to help you with this is to keep a fatigue journal of your progress, noting when fatigue occurs, lifts, or lingers
  • Conserve energy—for instance, get dressed while sitting on a chair or toilet seat. Lack of exercise or overexertion may also cause fatigue, so speak with your doctor for recommendations
  • If you are having problems sleeping at night, you may also want to avoid long or late afternoon naps in order to optimize your sleep quality
  • For persistent fatigue, consult your doctor

Diarrhea

Diarrhea is a side effect that may occur during ERBITUX treatment. Call your doctor or nurse if you have diarrhea.

What can be done

Your doctor may suggest that you:

  • Eat many small meals, rather than 3 normal-size meals
  • Eat bananas, rice, applesauce, toast, also called the BRAT diet
  • Do not drink milk or eat milk products, such as ice cream
  • Do not eat greasy or spicy foods
  • Avoid whole wheat or whole-grain foods and other foods high in fiber, such as raw vegetables, beans, and nuts
  • Drink plenty of water, clear liquids, or sports drinks
  • Take an antidiarrheal medicine

Nausea

Some people may have an upset stomach during ERBITUX treatment. If you have an upset stomach, call your doctor or nurse.

What can be done

There are ways to help settle your stomach. There are also ways to help prevent or control nausea with medicines. Your doctor may suggest that you:

  • Eat smaller meals more often during the day
  • Eat foods that are light or bland (have a mild flavor), such as chicken noodle soup or scrambled eggs
  • Eat dry foods, such as crackers, bread, or dry cereal, when you first wake up or if your stomach is empty
  • Sip clear liquids, such as water or a sports drink, or suck on ice chips or ice pops
  • Rest a bit after eating, but avoid lying down flat for at least 2 hours after a meal
  • Rinse your mouth before and after you eat a meal

If your stomach is still upset, your doctor may prescribe medicine to help settle your stomach.

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Get more information about ERBITUX

Indications and Important Safety Information including Boxed WARNINGS

Indications

Head & Neck Cancer:

ERBITUX® (cetuximab), in combination with radiation therapy, is indicated for the initial treatment of a certain type of locally or regionally advanced head and neck cancer.

ERBITUX, in combination with platinum-based chemotherapy with 5-fluorouracil, is indicated for the initial treatment of patients with a certain type of head and neck cancer whose tumor has returned in the same location or spread to other parts of the body.

ERBITUX is also indicated for use alone to treat patients with a certain type of head and neck cancer whose tumor has returned in the same location or spread to other parts of the body and whose disease has progressed following platinum-based chemotherapy.

Colorectal Cancer:

ERBITUX® (cetuximab) is approved for the treatment of certain patients who have colorectal cancer that has spread to other parts of the body. Only patients whose tumors have a KRAS mutation-negative gene, commonly known as “wild-type,” and whose tumors have a protein called Epidermal Growth Factor Receptor (EGFR), should receive ERBITUX. FDA-approved tests are used to determine if tumors have these particular traits. Treatment with ERBITUX is given in the following three ways:

  • In combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for patients who are being treated for this type of cancer for the first time
  • In combination with another chemotherapy drug, irinotecan, for patients whose disease has progressed after receiving chemotherapy with irinotecan
  • As a single agent:
    • for patients whose disease has progressed after receiving both irinotecan and oxaliplatin
    • for patients who are unable to tolerate chemotherapy with irinotecan

ERBITUX is not approved for the treatment of patients whose colorectal cancer tumors are KRAS mutation-positive, or “mutant.”

ERBITUX is available by prescription only.

Important Safety Information including Boxed WARNINGS

Allergic Reaction

  • Severe allergic reactions due to ERBITUX® (cetuximab) therapy have occurred in 42 of 1373 patients (3%) receiving ERBITUX during clinical studies, resulting in death in less than 1 in 1000 patients
    • Symptoms can include trouble with breathing (including tightening of the airways, wheezing, or hoarseness), low blood pressure, shock, loss of consciousness, and/or heart attack
    • Approximately 90% of the severe allergic reactions occurred with the first dose of ERBITUX, although some patients experienced their first severe allergic reaction during a subsequent dose of ERBITUX
    • Your doctor or nurse should watch you closely for these symptoms during treatment and may need to stop therapy in the event of an allergic reaction
    • Severe allergic reactions require that treatment with ERBITUX be stopped immediately and not started again

Heart Attack

  • Heart attack and/or sudden death occurred in 4 of 208 patients (2%) with head and neck cancer treated with radiation therapy and ERBITUX (cetuximab) as compared to none of 212 patients treated with radiation therapy alone
  • Heart problems resulting in death and/or sudden death occurred in 7 of 219 patients (3%) with head and neck cancer treated with platinum-based chemotherapy with 5-fluorouracil and cetuximab compared to 4 of 215 patients (2%) treated with chemotherapy alone, based on a study conducted in Europe using European cetuximab
  • Notify your doctor if you have a history of any heart disease

Lung Disease

  • Lung disease, which resulted in one death, occurred in 4 of 1570 patients (<0.5%) receiving ERBITUX in several clinical trials in colorectal cancer and head and neck cancer
    • Notify your doctor if you develop shortness of breath while receiving ERBITUX
    • ERBITUX treatment should be stopped if symptoms worsen or lung disease is confirmed

Skin Problems

  • In several clinical trials in colorectal cancer and head and neck cancer with ERBITUX, skin problems including an acne-like rash, skin drying and cracking, infections (including infections of the blood, skin, eyes, and lips), and abnormal hair growth were seen
    • Sun exposure may worsen these effects
    • Patients taking ERBITUX should wear sunscreen and hats to limit sun exposure
    • A related nail disorder that causes painful swelling of the skin around the nails—most often of the large toes and thumbs—also was reported
    • Notify your doctor if you develop any of these symptoms while receiving ERBITUX

ERBITUX Plus Chemotherapy and Radiation

  • In a controlled study, 940 patients with head and neck cancer received either ERBITUX with radiation therapy and cisplatin (a cancer drug) or radiation therapy and cisplatin alone. Adding ERBITUX resulted in an increase in occurrence of severe or life-threatening redness and sores of the lining of the mouth, lips or throat and other digestive organs; skin reactions caused by certain cancer drugs given after radiation; acne-like rash; heart problems and blood electrolyte disturbances compared to radiation and cisplatin alone
  • Side effects resulting in death occurred in 20 patients (4.4%) in the ERBITUX treatment arm, and 14 patients (3.0%) in the radiation therapy and cisplatin alone treatment arm
  • Nine patients in the ERBITUX treatment arm (2.0%) experienced decreased blood flow to the heart compared to 4 patients (0.9%) in the radiation therapy and cisplatin alone treatment arm
  • The main point of the study was to measure how long patients survived before their cancer got worse. Adding ERBITUX to radiation and cisplatin did not improve this measure

Electrolyte Depletion

  • Low levels of magnesium and accompanying low calcium and potassium levels have been reported with ERBITUX when given by itself and in combination with other cancer drugs
    • Your doctor or nurse should periodically monitor your blood electrolyte levels and administer intravenous replacement as needed

Late Radiation Side Effects

  • The percentage of late radiation side effects was higher in patients given ERBITUX with radiation therapy compared with patients given radiation therapy alone
    • The following sites were affected: organs that produce saliva (65% versus 56%), voice box (52% versus 36%), tissue below the skin (49% versus 45%), lining of the mouth and some organs (48% versus 39%), food pipe (44% versus 35%), and skin (42% versus 33%) in the patients given ERBITUX and radiation versus patients given radiation alone, respectively
  • The percentage of severe late radiation side effects was similar among patients given radiation therapy alone and patients given ERBITUX plus radiation therapy

Pregnancy and Nursing

  • Notify your doctor if you are pregnant or if you become pregnant while receiving ERBITUX. Contraception must be used, in both males and females, during ERBITUX therapy and for 6 months following the last dose of ERBITUX. ERBITUX may be passed from the mother to the developing fetus, and may cause harm to the fetus. ERBITUX should only be used during pregnancy if the potential benefit is greater than the potential risk to the fetus
  • ERBITUX may be passed through human breast milk. Because of the potential for serious side effects in nursing infants from ERBITUX, nursing is not recommended during ERBITUX therapy and for 2 months following the last dose of ERBITUX

Additional Side Effects

In studies of ERBITUX:

  • The most serious side effects associated with ERBITUX are: allergic reactions, heart attack, skin problems, skin irritation in the radiation area, infection, kidney failure, lung disease, and blood clots in the lung
  • The most frequent side effects associated with ERBITUX (reported in at least 25% of patients) are skin problems (including rash, itching, and nail changes), headache, diarrhea, and infection

In a study of ERBITUX and radiation therapy given to 208 patients versus radiation therapy alone given to 212 patients with head and neck cancer:

  • The most frequent side effects were: acne-like rash (87% versus 10%), skin irritation in the radiation area (86% versus 90%), weight loss (84% versus 72%), and feeling weak (56% versus 49%)
  • Serious side effects reported by at least 10% of patients that received ERBITUX in combination with radiation therapy versus radiation therapy alone included: skin irritation in the radiation area (23% versus 18%), acne-like rash (17% versus 1%), and weight loss (11% versus 7%)

In a study of European cetuximab in combination with platinum-based chemotherapy with 5-fluorouracil given to 219 patients versus chemotherapy alone given to 215 patients with head and neck cancer:

  • The most frequent side effects were: acne-like rash (70% versus 2%), nausea (54% versus 47%), and infection (44% versus 27%)
  • Serious side effects reported by at least 10% of patients in either arm were: infection (11% versus 8%)
  • ERBITUX yields approximately 22% higher blood levels of cetuximab relative to European cetuximab. It is possible that U.S. patients receiving ERBITUX may experience more frequent or severe side effects than patients in the study conducted in Europe

In a study of European cetuximab in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) given to 317 patients versus FOLFIRI alone given to 350 patients with colorectal cancer that had spread to other parts of the body whose tumors had a (KRAS) status known as “wild-type,” as well as a protein called Epidermal Growth Factor Receptor (EGFR):

  • The most frequent side effects were: acne-like rash (86% versus 13%) and diarrhea (66% versus 60%)
  • Serious side effects reported by at least 10% of patients in either arm were: abnormal decrease in white blood cell count (31% versus 24%), acne-like rash (18% versus <1%), and diarrhea (16% versus 10%)
  • ERBITUX yields approximately 22% higher blood levels of cetuximab relative to European cetuximab. In this study, the side effects and severity of adverse reactions seen with European cetuximab were consistent with other studies of U.S. patients receiving ERBITUX for metastatic colorectal cancer

In a study where ERBITUX and supportive care were given to 118 patients versus supportive care which was given to 124 patients with colorectal cancer that had spread to other parts of the body whose tumors had a (KRAS) status known as “wild-type,” as well as a protein called Epidermal Growth Factor Receptor (EGFR):

  • The most frequent side effects reported were: rash or shedding of the outer layer of the skin (95% versus 21%), feeling tired (91% versus 79%), nausea (64% versus 50%), dry skin (57% versus 15%), other pain (59% versus 37%), and constipation (53% versus 38%)
  • Serious side effects reported by at least 10% of patients included: fatigue (31% versus 29%), other pain (18% versus 10%), rash or shedding of the outer layer of the skin (16% versus 1%), shortness of breath (16% versus 13%), other intestinal problems (12% versus 5%) and infection without abnormal decrease in white blood cell count (11% versus 5%)

In studies where ERBITUX and irinotecan were given to 354 patients with colorectal cancer that had spread to other parts of the body whose tumors had a protein called Epidermal Growth Factor Receptor (EGFR):

  • The most frequent side effects reported were: acne-like rash (88%), feeling weakness or discomfort (73%), diarrhea (72%), and nausea (55%)
  • Serious side effects reported by at least 10% of patients included: diarrhea (22%), decrease in white blood cell count (17%), feeling weakness or discomfort (16%), and acne-like rash (14%)
Please see Important Safety Information and U.S. Complete Product Information including Boxed WARNINGS.