Amifostine Side Effects

Brand Names: Ethyol

Please note - some side effects for Amifostine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Amifostine - for the Consumer

Amifostine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amifostine:

Drowsiness; feeling of coldness; flushing/feeling of warmth; hiccups; nausea; sneezing; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; chills or shaking; decreased urination; dizziness; fainting; fast, slow, or irregular heartbeat; fever; muscle twitching/cramping; numbness of an arm or leg; red, swollen, blistered, or peeling skin; seizures; severe or persistent nausea or vomiting; severe stomach pain; shortness of breath; sores on the lips, mouth, or tongue; sudden, severe headache; unusual fatigue or tiredness; vision changes.

Side Effects by Body System

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 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.

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