Eculizumab Side Effects

Brand Names: Soliris

Please note - some side effects for Eculizumab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Eculizumab - for the Consumer

Eculizumab

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 Eculizumab:

Back pain; diarrhea; mild cough; mild headache; nausea; nose, throat, or sinus irritation; stomach pain; stuffy nose; tiredness; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling mouth, face, lips, or tongue); difficult or painful urination; fast heartbeat; fever or chills; light-headedness; persistent cough or sore throat; severe or persistent headache or dizziness; swelling of the hands, ankles, or feet; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Immunologic

Immunologic side effects have included herpes simplex infections (up to 7%) and influenza-like illness (up to 5%). Postmarketing cases of serious or fatal meningococcal infections have also been reported.

Respiratory

Respiratory side effects have included upper respiratory tract infection (up to 35%), nasopharyngitis (up to 23%), cough ( up to 14%), pharyngolaryngeal pain (up to 14%), sinusitis (up to 7%), and low titers of antibodies to eculizumab (up to 3%).

Musculoskeletal

Musculoskeletal side effects have included back pain (up to 19%), pain in extremity (up to 11%), arthralgia (up to 7%), and myalgia (up to 7%).

Gastrointestinal

Gastrointestinal side effects have included diarrhea (up to 32%), vomiting (up to 22%), nausea (up to 19%), abdominal pain (up to 11%), and constipation (up to 7%).

Hematologic

Hematologic side effects have included anemia (up to 24%), and leukopenia (up to 16%).

Cardiovascular

Cardiovascular side effects have included hypertension (up to 35%).

Nervous system

Nervous system side effects have included headache (up to 44%), vertigo (up to 11%), and dizziness (up to 5%).

General

General side effects have included fatigue (up to 12%), peripheral edema (up to 11%), and pyrexia (up to 11%).

Psychiatric

Psychiatric side effects have included insomnia (up to 14%).

Genitourinary

Genitourinary side effects have included urinary tract infection (up to 16%).

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