Vyalev Side Effects

Generic name: foscarbidopa / foslevodopa

Medically reviewed by Drugs.com. Last updated on Dec 10, 2024.

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

Applies to foscarbidopa / foslevodopa: subcutaneous solution.

Important warnings This medicine can cause some serious health issues

Do not use this medicine if you have used a MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, aggressive, more active or talkative, or have thoughts about suicide or hurting yourself.

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Call your doctor at once if you have:

• fever, very stiff (rigid) muscles, high fever, sweating, confusion;

• hallucinations (seeing or hearing things that are not real);

• bruising, swelling, warmth, redness, oozing, or bleeding where an injection was given;

• uncontrolled muscle movements, blurred vision, eye pain or redness, seeing halos around lights; or

• high blood pressure, fast or pounding heartbeats, or chest pain.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Your dose may be reduced or permanently discontinued if you have certain side effects.

Common side effects may include:

• infection where an injection was given;

• drowsiness;

• uncontrolled muscle movements; or

• hallucinations.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to foscarbidopa / foslevodopa: subcutaneous solution.

General adverse events

The most frequent adverse reactions occurring in 10% of patients or greater specifically administered this drug included infusion site events, hallucination, fall, anxiety, dyskinesia, depression, and urinary tract infection. Reported adverse events include reactions following exposure to either this drug or a carbidopa/levodopa intestinal gel preparation.

Adverse reactions resulting in discontinuation in 22% of patients were hallucinations, infusion site reactions, and infusion site infections.^[Ref]

Cardiovascular

• Common (1% to 10%): Irregular heart rate, hypertension, hypotension, orthostatic hypotension, peripheral swelling
• Uncommon (0.1% to 1%): Palpitations, phlebitis^[Ref]

Dermatologic

• Common (1% to 10%): Contact dermatitis, hyperhidrosis, pruritus, rash
• Uncommon (0.1% to 1%): Alopecia, erythema, urticaria
• Rare (0.01% to 0.1%): Sweat discoloration^[Ref]

Gastrointestinal

• Common (1% to 10%): Abdominal distension, abdominal pain, constipation, diarrhea, dry mouth, dysgeusia, dyspepsia, dysphagia, flatulence, nausea, vomiting
• Uncommon (0.1% to 1%): Salivary hypersecretion
• Rare (0.01% to 0.1%): Bruxism, saliva discoloration, glossodynia, hiccups^[Ref]

Genitourinary

• Common (1% to 10%): Urinary incontinence, urinary retention
• Uncommon (0.1% to 1%): Chromaturia
• Rare (0.01% to 0.1%): Priapism
• Frequency not reported: Leukocytes in urine, bacteria in urine, blood in urine^[Ref]

Hematologic

• Common (1% to 10%): Anemia
• Uncommon (0.1% to 1%): Leucopenia, thrombocytopenia
• Frequency not reported: Decreased hemoglobin, decreased hematocrit, positive Coomb's test

Hepatic

• Frequency not reported: Elevated AST, elevated ALT, elevated bilirubin^[Ref]

Hypersensitivity

• Postmarketing reports: Anaphylactic reaction^[Ref]

Local

• Very common (10% or more): Infusion site: cellulitis, infection (up to 28%), erythema (46.7%), reaction (up to 62%), nodule (24.5%), edema (17.7%), pain (up to 21.1%)
• Common (1% to 10%): Infusion site: abscess, bruising, exfoliation, extravasation, hematoma, hemorrhage, induration, inflammation, irritation, mass, papule, pruritus, peripheral edema, rash, swelling^[Ref]

Infusion site events, including infusion site reactions (up to 77.6%) and infections (up to 41.4%), were commonly seen with subcutaneous administration in the clinical studies. Most events were mild or moderate in severity. In a few cases, infusion site infections resulted in sepsis requiring hospitalization.^[Ref]

Metabolic

• Common (1% to 10%): Decreased appetite, increased blood homocysteine level, decreased vitamin B6, vitamin B12 deficiency
• Frequency not reported: Elevated blood sugar, elevated uric acid^[Ref]

Musculoskeletal

• Common (1% to 10%): Muscle spasms, neck pain^[Ref]

Nervous system

• Very common (10% or more): Dyskinesia (11%)
• Common (1% to 10%): Balance disorder, cognitive disorder, dizziness, postural dizziness, dystonia, headache, hypoesthesia, on and off phenomenon, paresthesia, polyneuropathy, somnolence, syncope, tremor
• Uncommon (0.1% to 1%): Ataxia, convulsion, gait disturbance
• Frequency not reported: Hypersomnia (Falling Asleep During Activities of Daily Living), Parkinson's disease^[Ref]

Polyneuropathy included peripheral neuropathy, decreased vibratory sense, peripheral sensory neuropathy, sensory disturbance, and sensory loss.^[Ref]

Ocular

• Uncommon (0.1% to 1%): Angle closure glaucoma, blepharospasm, diplopia, optic ischemic neuropathy, blurred vision^[Ref]

Oncologic

• Rare (0.01% to 0.1%): Malignant melanoma^[Ref]

Other

• Very common (10% or more): Fall (up to 20.1%)
• Common (1% to 10%): Malaise, asthenia, fatigue, pain, increased weight, decreased weight, increased amino acid level (increased methylmalonic acid)
• Uncommon (0.1% to 1%): Chest pain
• Frequency not reported: Elevated LDH, elevated alkaline phosphatases, withdrawal-emergent hyperpyrexia^[Ref]

Psychiatric

• Very common (10% or more): Anxiety (reported as 10% or greater), depression (reported as 10% or greater), hallucination (up to 24.5%),
• Common (1% to 10%): Abnormal dreams, agitation, confusional state, delusion, impulse control disorder, insomnia, paranoia, psychotic disorder, sleep attacks, sleep disorder, suicidal ideation
• Uncommon (0.1% to 1%): Completed suicide, dementia, disorientation, dopamine dysregulation syndrome, euphoric mood, fear, increased libido, nightmare, suicide attempt
• Rare (0.01% to 0.1%): Abnormal thinking
• Frequency not reported: Withdrawal emergent confusion^[Ref]

Hallucination included visual, auditory, olfactory, tactile, and mixed hallucinations.^[Ref]

Renal

• Frequency not reported: Elevated creatinine, elevated urea nitrogen^[Ref]

Respiratory

• Common (1% to 10%): Dyspnea, oropharyngeal pain
• Uncommon (0.1% to 1%): Dysphonia
• Rare (0.01% to 0.1%): Abnormal respiration^[Ref]

Further information

Vyalev 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer