Pegvisomant Side Effects

Brand Names: Somavert

Please note - some side effects for Pegvisomant 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 Pegvisomant - for the Consumer

Pegvisomant

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 Pegvisomant:

Diarrhea; dizziness; nausea; pain; pain, redness, or itching at the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; flu-like symptoms (eg, chills, fever, muscle aches, weakness); severe stomach pain; swelling of the legs and feet; thickening of the skin or lumps at the injection site; unusual weight gain; yellowing of the skin or eyes.

Side Effects by Body System

Hepatic

During premarketing clinical studies two patients (0.8%) had elevations of serum concentrations of alanine aminotransferase and aspartate aminotransferase greater than 10 times the upper limit of normal. In both patients, the transaminase elevations normalized after discontinuation of the drug. In other studies, up to 12% of patients experienced abnormal liver function tests.

Hepatic side effects have included abnormal liver function tests (elevations of serum concentrations of alanine aminotransferase and aspartate aminotransferase) in up to 12% of patients treated.

Immunologic

Immunologic side effects have included the development of low titer non-neutralizing antigrowth hormone antibodies.

General

General side effects have included infection (23 to 33%), pain (8 to 23%), flu syndrome (12 to 21%), and accidental injury (8 to 18%).

Musculoskeletal

Musculoskeletal side effects have included back pain (8%) and chest pain (4%).

Respiratory

Respiratory side effects have included sinusitis (8%).

Gastrointestinal

Gastrointestinal side effects have included diarrhea (4%) and nausea (8%).

Nervous system

Nervous system side effects have included headache (26%), dizziness (8%) and paresthesias (7%).

Cardiovascular

Cardiovascular side effects have included hypertension (8%) and peripheral edema (8%).

Local

Local side effects have included injection site reactions (11%).

Metabolic

Metabolic side effects have included hypercholesterolemia (14%). Lipohypertrophy has been reported in lass than 5% of patients following pegvisomant administration.

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