Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Erbitux (Cetuximab). If you are concerned about side effects, discuss the risks and benefits of Erbitux (Cetuximab) with your doctor.

The following side effects have been reported by at least 1% of people taking Erbitux (Cetuximab). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• acne-like rash
• Constipation
• Diarrhea
• Dry Mouth
• dry skin
• fatigue
• general feeling of being unwell
• headache
• heartburn
• increased skin sensitivity to sunlight
• loss of appetite
• muscle aches
• nausea
• swelling at the base of finger and toenails
• vomiting
• weakness
• weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• hand-foot syndrome (e.g., redness, swelling and pain on the palms of hands/soles of feet)
• mouth sores
• shortness of breath
• signs of Anemia (low red blood cells; e.g., dizziness,  pale skin, unusual tiredness or weakness, shortness of breath)
• signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
• signs of electrolyte imbalance (e.g., muscle pain or cramps, weakness, irregular heartbeat, lack of coordination, thirst, confusion)
• signs of fluid build-up around the lungs (e.g., chest pain, cough, hiccups, rapid breathing)
• signs of heart problems (e.g., fast, irregular heartbeat or pulse, chest pain, difficulty breathing)
• signs of infection (symptoms may include Fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine)
• symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)
• vision problems (e.g., redness, blurred vision, eye pain, severe dry eye)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• infusion-related reactions (e.g., fever, chills, rigors, difficulty breathing, itching, severe dizziness)
• signs of Heart Attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of tightness or pressure of the chest; nausea; vomiting; sweating; anxiety)
• signs of Meningitis not caused by infection (e.g., headache [severe], throbbing, or with stiff neck or back)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of a severe skin reaction (e.g., blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Erbitux (Cetuximab).

Each mL of sterile, clear, colourless liquid for intravenous administration contains 2 mg of Erbitux (Cetuximab). Nonmedicinal ingredients: sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sodium chloride, sodium hydroxide (NF as 10 M Solution For pH adjustment), hydrochloric acid (NF as 6 M Solution For pH adjustment), water for injection.

Do not use Erbitux (Cetuximab) if you are allergic to Erbitux (Cetuximab) or any ingredients of the medication.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Erbitux (Cetuximab).

Contact Lenses: Erbitux (Cetuximab) can cause severe eye irritation. Wearing contact lenses makes this irritation more likely to occur. It is recommended that you wear glasses while you are receiving treatment with Erbitux (Cetuximab), to reduce the risk of permanently damaging your vision.

Fluid and electrolyte balance: Erbitux (Cetuximab) may cause the levels of electrolytes such as potassium, sodium, magnesium, chloride, and calcium in the blood to change while taking Erbitux (Cetuximab). If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible. Your doctor will do blood tests regularly to monitor the levels of these electrolytes in your blood while you are taking Erbitux (Cetuximab).

Heart problems: Serious and potentially life-threatening heart problems such as heart attack and sudden death have occurred rarely in people who were using Erbitux (Cetuximab). If you have a heart problem (e.g., arrhythmia, Angina, heart failure), you will be monitored closely by your doctor during the infusion and immediately after the infusion is finished.

Kidney function: Erbitux (Cetuximab) may cause decreased kidney function and rarely, kidney failure. If you have reduced kidney function or Kidney Disease, discuss with your doctor how Erbitux (Cetuximab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erbitux (Cetuximab), and whether any special monitoring is needed.

If you experience a decrease in urine produced or the number of times you need to urinate daily, let your doctors know as soon as possible.

Infection: As well as killing cancer cells, Erbitux (Cetuximab) can reduce the number of cells that fight infection in the body (white blood cells). This increases the risk of developing an infection or reactivating an inactive infection (e.g., herpes, Shingles). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of white blood cells in your blood.

Infusion-related reactions: There have been reports of severe infusion-related reactions, sometimes resulting in death, in people with who were given Erbitux (Cetuximab). Your health care provider will closely monitor you during and after the infusion. These reactions usually occur within 30 minutes to 2 hours of starting the infusion. Your doctor will probably want you to stay at the clinic for at least one hour after the infusion is finished, to watch for signs of an infusion reaction.

If you experience symptoms of an infusion reaction, such as fever, chills, difficulty breathing, tightness of chest or throat, stomach upset, and rash, tell your health care provider immediately.

It is important to take the medication(s) recommended by your doctor before your infusion of Erbitux (Cetuximab). If you experience a severe infusion reaction, your doctor will give you additional medications to treat the reaction. Ask your doctor for more information.

Lung inflammation: Lung inflammation (interstitial lung disease), causing difficulty breathing has occurred rarely in some people taking Erbitux (Cetuximab). This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking Erbitux (Cetuximab) contact your doctor immediately.

Skin problems: Erbitux (Cetuximab) can cause skin disorders, such as an acne-like rash, dry and cracked skin and inflammation. These may lead to infection of the skin. If you notice cuts or sores that become inflamed and do not heal, or wounds that develop discharge, let your doctor know immediately.

Erbitux (Cetuximab) can also cause the skin to be more sensitive to sunlight resulting in Sunburn, skin blisters, skin rash, redness, itching, or discolouration. If you experience any of these skin reactions, contact your doctor. Try to limit the length of time you are out in the sunlight or using tanning beds while you are receiving Erbitux (Cetuximab) treatment and for 2 months after your last dose of Erbitux (Cetuximab).

Pregnancy: It is not known if Erbitux (Cetuximab) causes harm to the developing baby if it is used by the mother during pregnancy. Erbitux (Cetuximab) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Erbitux (Cetuximab), contact your doctor immediately. A reliable form of birth control should be used by both males and females during and for 6 months after the last dose of Erbitux (Cetuximab).

Breast-feeding: It is not known if Erbitux (Cetuximab) passes into breast milk. If you are a breast-feeding mother and are taking Erbitux (Cetuximab), it may affect your baby. Breast-feeding should be stopped while you are being treated with Erbitux (Cetuximab) and should not be re-started until at least 60 days after the last dose of medication.

Children: The safety and effectiveness of using Erbitux (Cetuximab) have not been established for children.