Applies to idarucizumab: intravenous solution.
Serious side effects of Idarucizumab
Along with its needed effects, idarucizumab 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 idarucizumab:
Incidence not known
- Anxiety
- blurred vision
- bone pain
- chills
- cold sweats
- coma
- confusion
- convulsions
- cool, pale skin
- cough
- dark-colored urine
- deep or fast breathing with dizziness
- depression
- difficulty with breathing
- difficulty with swallowing
- dizziness
- drowsiness
- fast heartbeat
- fever
- general feeling of tiredness or weakness
- headache
- hives, itching, or skin rash
- increased hunger
- light-colored stools
- loss of appetite
- muscle tremors
- nausea
- nervousness
- nightmares
- numbness of the feet, hands, and around the mouth
- pain in the chest, groin, or legs, especially the calves
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid, deep breathing
- restlessness
- seizures
- severe, sudden headache
- shakiness
- slurred speech
- stomach cramps
- stomach pain, continuing
- sudden loss of coordination
- sudden, severe weakness or numbness in the arm or leg
- sudden, unexplained shortness of breath
- tightness in the chest
- unusual tiredness or weakness
- vision changes
- vomiting
- yellow eyes or skin
For Healthcare Professionals
Applies to idarucizumab: intravenous solution.
General
The most common adverse reactions were hypokalemia, delirium, constipation, pyrexia, pneumonia, and headache.[Ref]
Cardiovascular
Common (1% to 10%): Thrombotic events[Ref]
Metabolic
Common (1% to 10%): Hypokalemia[Ref]
Psychiatric
Common (1% to 10%): Delirium[Ref]
Gastrointestinal
Common (1% to 10%): Constipation, nausea[Ref]
Other
Common (1% to 10%): Pyrexia[Ref]
Respiratory
Common (1% to 10%): Pneumonia
Frequency not reported: Bronchospasm, hyperventilation[Ref]
Nervous system
Common (1% to 10%): Headache[Ref]
Dermatologic
Frequency not reported: Rash, pruritus[Ref]
Immunologic
Frequency not reported: Hypersensitivity reactions[Ref]
