Note: This document contains side effect information about opicapone. Some dosage forms listed on this page may not apply to the brand name Ongentys.

Applies to opicapone: oral capsule.

Serious side effects of Ongentys

Along with its needed effects, opicapone (the active ingredient contained in Ongentys) 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 immediately if any of the following side effects occur while taking opicapone:

More common

• Twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

Less common

• Blurred vision
• confusion
• dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
• headache
• nervousness
• pounding in the ears
• seeing, hearing, or feeling things that are not there
• slow or fast heartbeat
• sweating
• unusual tiredness or weakness

Other side effects of Ongentys

Some side effects of opicapone 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

• Constipation

Less common

• Dry mouth
• trouble sleeping
• weight loss

For Healthcare Professionals

Applies to opicapone: oral capsule.

General

The most commonly reported adverse reaction was dyskinesia.^[Ref]

Nervous system

Very common (10% or more): Dyskinesia (17.7%)

Common (1% to 10%): Dizziness, headache, somnolence

Uncommon (0.1% to 1%): Dysgeusia, hyperkinesia, syncope

Postmarketing reports: Balance disorder, hyperkinesia tremor^[Ref]

Psychiatric

Common (1% to 10%): Abnormal dreams, hallucination, visual hallucination, insomnia

Uncommon (0.1% to 1%): Anxiety, depression, auditory hallucination, nightmares, sleep disorder

Postmarketing reports: Agitation, psychotic disorder, confusional state^[Ref]

Cardiovascular

Common (1% to 10%): Orthostatic hypotension

Uncommon (0.1% to 1%): Palpitations, hypertension, hypotension^[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, dry mouth, vomiting

Uncommon (0.1% to 1%): Abdominal distention, abdominal pain, upper abdominal pain, dyspepsia

Postmarketing reports: Diarrhea, nausea^[Ref]

Metabolic

Uncommon (0.1% to 1%): Decreased appetite, hypertriglyceridemia, decreased weight^[Ref]

Respiratory

Uncommon (0.1% to 1%): Dyspnea^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Chromaturia, nocturia^[Ref]

Musculoskeletal

Common (1% to 10%): Muscle spasms

Uncommon (0.1% to 1%): Muscle twitching, musculoskeletal stiffness, myalgia, extremity pain^[Ref]

Ocular

Uncommon (0.1% to 1%): Dry eye

Other

Common (1% to 10%): Blood creatine phosphokinase increased

Uncommon (0.1% to 1%): Ear congestion

Postmarketing reports: Fatigue, malaise^[Ref]