Soliris Side Effects

Generic Name: eculizumab

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

Soliris

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 Soliris:

Back pain; cough; mild headache; nausea; nose, throat, or sinus irritation; tiredness; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf or leg pain or tenderness; chest pain; confusion; coughing up blood; eyes sensitive to light; fever, chills, or persistent sore throat; mental changes; moderate to severe headache along with nausea, vomiting, fever, stiff neck, or stiff back; mouth sores or fever blisters; severe muscle aches with flu-like symptoms; shortness of breath.

Side Effects by Body System

Immunologic

Immunologic side effects have included meningococcal infections, herpes simplex infections (7%), and influenza-like illness (5%).

Other

Other side effects have included headache (44%), fatigue (12%), pain in extremity (7%), and fever (2%).

Respiratory

Respiratory side effects have included nasopharyngitis (23%), cough (12%), respiratory tract infections (7% to 14%), sinusitis (7%) and low titers of antibodies to eculizumab (2%).

Musculoskeletal

Musculoskeletal side effects have included back pain (19%), arthralgia (7%), and myalgia (7%).

Gastrointestinal

Gastrointestinal side effects have included nausea (16%), diarrhea (9%), constipation (7%), abdominal pain (5%), and vomiting (5%).

Hematologic

Hematologic side effects have included anemia (2%).

Nervous system

Nervous system side effects have included dizziness (5%).

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