Ethyol Side Effects

Generic name: amifostine

Note: This document contains side effect information about amifostine. Some of the dosage forms listed on this page may not apply to the brand name Ethyol.

Some side effects of Ethyol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to amifostine: intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking amifostine (the active ingredient contained in Ethyol) hives, itching; chest tightness, difficult breathing; fever or chills; swelling of your face, lips, tongue, or throat.

Some of the side effects of amifostine may occur up to several weeks after you receive this medication.

Tell your caregiver right away if you have a serious side effect such as:

• feeling like you might pass out;

• chest pain, fast or slow heart rate;

• weak or shallow breathing;

• seizure (convulsions);

• urinating less than usual or not at all;

• severe skin rash on your stomach, back, or trunk;

• redness, rash, or blisters on the palms of your hands or the soles of your feet; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of amifostine may include:

• nausea, vomiting;

• dizziness, drowsiness;

• flushing (warmth, redness, or tingly feeling);

• cold feeling;

• hiccups;

• sneezing; or

• mild fever, general ill feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to amifostine: intravenous powder for injection

Cardiovascular

Cardiovascular side effects include a transient reduction in blood pressure in 62% of patients. Arrhythmias such as atrial fibrillation/flutter and supraventricular tachycardia have been reported. (These have sometimes been associated with hypotension or allergic reactions.) Transient hypertension and exacerbations of preexisting hypertension, and short term, reversible loss of consciousness have been reported rarely.

The mean time of onset until reduction in blood pressure was 14 minutes into the 15 minute amifostine infusion. The mean duration was six minutes. Blood pressure generally returned to normal within five to fifteen minutes.

In order to avoid hypotension, amifostine has sometimes been administered by the subcutaneous route.

Gastrointestinal

Gastrointestinal side effects frequently include nausea and/or vomiting which may be severe.

Other

These effects have not generally precluded the completion of therapy.

Other side effects include flushing/feeling of warmth, fever, malaise, chills/feeling of coldness, dizziness, somnolence, hiccups, syncope, and sneezing.

Hypersensitivity

In case of an acute allergic reaction, amifostine (the active ingredient contained in Ethyol) should be immediately and permanently discontinued. Epinephrine and other measures should be available for the treatment of serious allergic events such as anaphylaxis.

Hypersensitivity side effects have included hypotension, fever, chills/rigors, dyspnea, skin rashes, and urticaria. Anaphylactoid reactions including hypoxia, laryngeal edema, and chest tightness have also been reported. Anaphylactoid reactions associated with cardiac arrest have been reported rarely. A case of Stevens-Johnson syndrome has also been reported.

Dermatologic

Cutaneous eruptions have been commonly reported during clinical trials and were generally not serious.

Dermatologic side effects include skin rashes, pruritus, urticaria, erythema multiforme, and rarely Stevens-Johnson Syndrome or toxic epidermal necrolysis.

Nervous system

Nervous system side effects rarely include seizures.

Musculoskeletal

Musculoskeletal side effects including a case of amifostine-induced back pain have been reported.

Metabolic

Metabolic side effects including hypocalcemia (up to 1%) have been reported.

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