Soliris Side Effects

Generic name: eculizumab

Medically reviewed by Drugs.com. Last updated on Jul 15, 2024.

Note: This document provides detailed information about Soliris Side Effects associated with eculizumab. Some dosage forms listed on this page may not apply specifically to the brand name Soliris.

Applies to eculizumab: intravenous solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (solution)

Meningococcal infections, which may rapidly become life-threatening or fatal if not recognized and treated early, have been reported in patients treated with eculizumab.

Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.

Immunize patients with a meningococcal vaccine at least 2 weeks prior to administering the first dose of eculizumab, unless the risks of delaying eculizumab therapy outweigh the risk of developing a meningococcal infection.

Vaccination reduces, but does not eliminate, the risk of meningococcal infections.

Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.

Eculizumab is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).

Under the eculizumab REMS prescribers must enroll in the program.

Enrollment in the eculizumab REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at solirisrems.com.

Serious side effects of Soliris

Along with its needed effects, eculizumab (the active ingredient contained in Soliris) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking eculizumab:

More common

• back pain
• black, tarry stools
• bladder pain
• blindness
• bloody or cloudy urine
• blurred vision
• body aches or pain
• burning or stinging of the skin
• burning, dry, or itching eyes
• chest pain or tightness
• chills
• cough
• cough producing mucus
• diarrhea
• difficult, burning, or painful urination
• difficulty breathing or swallowing
• difficulty with moving
• dizziness
• ear congestion
• fast heartbeat
• fever
• frequent urge to urinate
• general feeling of discomfort or illness
• headache
• hives, itching, skin rash
• joint pain or swelling
• loss of appetite
• loss of voice
• lower back or side pain
• muscle ache, cramp, pain, or stiffness
• nausea
• nervousness
• pain or tenderness around the eyes and cheekbones
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• pale skin
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• shivering
• slow or fast heartbeat
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stuffy or runny nose
• sweating
• swollen glands
• trouble breathing
• trouble sleeping
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Less common

• general feeling of discomfort or illness
• hoarseness
• itching, pain, redness, swelling, tenderness, or warmth on the skin

Other side effects of Soliris

Some side effects of eculizumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• bone pain
• constipation
• difficulty having a bowel movement
• difficulty in moving
• mouth or throat pain
• pain in the arms or legs
• bruise
• hair loss or thinning of hair
• lack or loss of strength

For healthcare professionals

Applies to eculizumab: intravenous solution.

General

The most common adverse reaction was headache (occurred mostly in the initial phase) and the most serious adverse reaction was meningococcal sepsis.^[Ref]

Respiratory

• Common (1% to 10%): Upper respiratory tract infection, nasopharyngitis, bronchitis, dyspnea, cough, nasal congestion, pharyngolaryngeal pain, rhinorrhea, pneumonia
• Uncommon (0.1% to 1%): Lower respiratory tract infection, sinusitis, epistaxis, throat irritation^[Ref]

Musculoskeletal

• Very common (10% or more): Back pain (15%), arthralgia (17%)
• Common (1% to 10%): Myalgia, muscle spasms, bone pain, neck pain, pain in extremity
• Uncommon (0.1% to 1%): Trismus, joint swelling^[Ref]

Gastrointestinal

• Common (1% to 10%): Diarrhea, vomiting, nausea, abdominal pain, constipation, dyspepsia
• Uncommon (0.1% to 1%): Gastrointestinal infection, peritonitis, gastroesophageal reflux disease, abdominal distension, gingival pain
• Rare (0.01% to 0.1%): Gingivitis^[Ref]

Hematologic

• Common (1% to 10%): Thrombocytopenia, leukopenia, anemia, hemolysis
• Uncommon (0.1% to 1%): Coagulopathy, red blood cell agglutination, abnormal clotting factor, anemia, lymphopenia, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, hematocrit decreased, hemoglobin decreased, thrombocytopenia, lymphopenia
• Rare (0.01% to 0.1%): Hemolysis, abnormal clotting factor, red blood cell agglutination, coagulopathy^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (33%), hypotension (17%)
• Uncommon (0.1% to 1%): Palpitation, accelerated hypertension, hematoma, hot flush, vein disorder^[Ref]

Nervous system

• Very common (10% or more): Headache (41%)
• Common (1% to 10%): Dizziness, dysgeusia
• Uncommon (0.1% to 1%): Syncope, tremor, paresthesia^[Ref]

Immunologic

• Common (1% to 10%): Meningococcal sepsis, aspergillus infection, arthritis bacterial, oral herpes, viral infection
• Uncommon (0.1% to 1%): Meningococcal meningitis, Neisseria infection, sepsis, septic shock, fungal infection, Haemophilus influenza infection, abscess, cellulitis, influenza, cystitis, gingival infection, impetigo, tooth infection
• Rare (0.01% to 0.1%): Aspergillus infection, bacterial arthritis, impetigo^[Ref]

Psychiatric

• Uncommon (0.1% to 1%): Depression, anxiety, insomnia, sleep disorder, abnormal dreams, mood swings^[Ref]

Genitourinary

• Common (1% to 10%): Proteinuria, urinary tract infection
• Uncommon (0.1% to 1%): Hematuria, dysuria, spontaneous penile erection, menstrual disorder
• Rare (0.01% to 0.1%): Genitourinary tract gonococcal infection^[Ref]

Dermatologic

• Very common (10% or more): Rash (15%), pruritus (10%)
• Common (1% to 10%): Alopecia
• Uncommon (0.1% to 1%): Urticaria, dermatitis, erythema, petechiae, skin depigmentation, hyperhidrosis, dry skin^[Ref]

Endocrine

• Uncommon (0.1% to 1%): Grave's disease^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Jaundice^[Ref]

Hypersensitivity

• Common (1% to 10%): Anaphylactic reaction
• Uncommon (0.1% to 1%): Hypersensitivity^[Ref]

Local

• Uncommon (0.1% to 1%): Infusion site paresthesia, infusion site pain, extravasation^[Ref]

Metabolic

• Very common (10% or more): Hypokalemia (18%)
• Common (1% to 10%): Decreased appetite
• Uncommon (0.1% to 1%): Anorexia^[Ref]

Ocular

• Uncommon (0.1% to 1%): Vision blurred, conjunctival irritation^[Ref]

Oncologic

• Uncommon (0.1% to 1%): Malignant melanoma, myelodysplastic syndrome^[Ref]

Other

• Common (1% to 10%): Edema, chest discomfort, pyrexia, chills, fatigue, asthenia, influenza like illness
• Uncommon (0.1% to 1%): Tinnitus, vertigo, feeling hot^[Ref]

Renal

• Uncommon (0.1% to 1%): Renal impairment^[Ref]

Frequently asked questions

• How does Ultomiris compare to Soliris for PNH?
• How does Soliris work for PNH?
• How does Empaveli compare to Soliris?
• How many biosimilars have been approved in the United States?

Further information

Soliris side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer