The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Reaction at the infusion or catheter site (62%)
- Infection at the infusion or catheter site (28%)
- Hallucination (12%)
- Uncontrolled movements (11%)
- "On and off" phenomenon (8%)
Less Common Side Effects
- Balance problems
- Constipation
- Swelling in the arms or legs
- Agitation
- Trouble sleeping
- Mood problems (e.g., delusions, paranoia)
- Shortness of breath
Vyalev serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Infection at the infusion site: redness, swelling, pain, fever
- Falling asleep suddenly or feeling very sleepy
- Hallucinations: seeing things that aren't there, hearing sounds that aren't real, feeling unreal sensations
- Abnormal thinking or behavior: confusion; trouble sleeping; paranoia; delusions; aggression; agitation; strong urges to gamble, shop, or eat
- Low vitamin B6: depression, confusion, swollen or sore tongue, cracked corners of your mouth, skin irritation, numbness or tingling in the hands or feet, seizure
- Heart problems: chest pain that spreads to the arm, neck, or jaw; cold sweat; irregular heartbeat; dizziness
- Withdrawal symptoms after stopping or lowering the dose suddenly: very high fevers, sweating, confusion, irregular heartbeat, muscle stiffness, changes in blood pressure
Source: FDA
The following Vyalev side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Falling asleep during daily activities
- Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
- Low vitamin B6 level—swollen or sore tongue, cracks at the corners of the mouth, rash, pain, tingling, or numbness in the hands or feet, irritability, confusion, feelings of depression, unusual weakness or fatigue, seizures
- Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
- New or worsening uncontrolled and repetitive movements of the face, mouth, or upper body
- Painful swelling, warmth, or redness of the skin, blisters or sores at the infusion site
- Skin infection—skin redness, swelling, warmth, or pain at the injection site
- Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
- Urges to engage in impulsive behaviors such as gambling, binge eating, sexual activity, or shopping in ways that are unusual for you
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Constipation
- Irritability
- Swelling of the ankles, hands, or feet
