Note: This document contains side effect information about ravulizumab. Some dosage forms listed on this page may not apply to the brand name Ultomiris.
Applies to ravulizumab: solution.
Serious side effects of Ultomiris
Along with its needed effects, ravulizumab (the active ingredient contained in Ultomiris) 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 ravulizumab:
More common
- Bladder pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- blurred vision
- body aches or pain
- chills
- confusion
- cough
- decreased urine
- difficult, burning, or painful urination
- difficulty with breathing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- ear congestion
- extremely high fever or body temperature
- fast, shallow breathing
- fast, weak heartbeat
- fever
- frequent urge to urinate
- headache
- increased thirst
- irregular heartbeat
- loss of appetite
- loss of voice
- lower back or side pain
- mood changes
- muscle pain or cramps
- nausea or vomiting
- nervousness
- numbness or tingling in hands, feet, or lips
- pale, clammy skin
- pounding in the ears
- rapid weight gain
- runny or stuffy nose
- sneezing
- slow or fast heartbeat
- sore throat
- sweating
- swollen glands
- thirst
- tingling of the hands or feet
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
Incidence not known
- Chest tightness
- difficulty swallowing
- hives, itching, or skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
Other side effects of Ultomiris
Some side effects of ravulizumab 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
- Back pain
- bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- diarrhea
- difficulty having a bowel movement (stool)
- difficulty with moving
- fear
- hair loss or thinning of the hair
- joint pain
- muscle pain, stiffness ,or spasms
- nausea or vomiting
- pain in the arms or legs
- stomach pain
For Healthcare Professionals
Applies to ravulizumab: intravenous solution.
Immunologic
Frequency not reported: Immunogenicity, increased susceptibility to encapsulated bacterial infections (especially infections caused by Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae), life-threatening meningococcal infections (e.g., septicemia and/or meningitis)[Ref]
Local
Rare (0.01% to 0.1%): Infusion reactions (e.g., lower back pain, drop in blood pressure, infusion-related pain)[Ref]
Musculoskeletal
Common (1% to 10%): Pain in extremity, arthralgia[Ref]
Respiratory
Very common (10% or more): Upper respiratory tract infection (e.g., nasopharyngitis, upper respiratory tract infection, oropharyngeal pain, viral
upper respiratory tract infection, rhinitis, respiratory tract infection, rhinorrhea, pharyngitis, upper respiratory tract inflammation) (39%)[Ref]
Other
Common (1% to 10%): Hyperthermia, pyrexia[Ref]
General
The most frequent adverse drug reactions (greater than 10%) with are upper respiratory tract infection and headache.[Ref]
Nervous system
Very common (10% or more): Headache (32%)
Common (1% to 10%): Dizziness[Ref]
Gastrointestinal
Common (1% to 10%): Diarrhea, nausea, abdominal pain[Ref]
