ULTOMIRIS ® Safety

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ULTOMIRIS® Safety Profile1

MedDRA System Organ Class

Very common
(≥ 1/10)

Common
(≥ 1/100 to < 1/10)

Uncommon
(≥ 1/1,000 to < 1/100)

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Gastrointestinal disorders

Diarrhoea, Nausea

Vomiting, Abdominal pain, Dyspepsia

General disorders and administration site conditions

Fatigue

Pyrexia, influenza like illness, Asthenia

Chills

Immune system disorders

Hypersensitivity, Anaphylactic reaction*

Infections and infestations

Upper respiratory tract infection, Nasopharyngitis

Meningococcal infection, Gonococcal infection

Injury, poisoning and procedural complications

Infusion-related reaction

Musculoskeletal and connective tissue disorders

Arthralgia, Back pain, Myalgia, Muscle spasms

Nervous system disorders

Headache

Dizziness

Skin and subcutaneous tissue disorders

Urticaria*, Pruritus, Rash

* Estimated from post-marketing experience.

† Meningococcal infection includes preferred terms of meningococcal infection and meningococcal sepsis.

‡ Gonococcal infection includes disseminated gonococcal infection.

ULTOMIRIS® Summary of Product Characteristics, July 2023.