Ongentys Side Effects

Generic name: opicapone

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jul 5, 2024.

Note: This document provides detailed information about Ongentys.

Applies to opicapone: oral capsule Side Effects associated with opicapone. Some dosage forms listed on this page may not apply specifically to the brand name Ongentys.

Applies to opicapone: oral capsule.

Precautions

It is very important that your doctor check you closely to make sure that this medicine is working properly. Blood and urine tests are needed to check for unwanted effects.

Do not use this medicine together with non-selective MAO inhibitors [eg, isocarboxazid (Marplan®), phenelzine (Nardil®), tranylcypromine (Parnate®)]. Using these medicines together may increase your risk for more serious side effects.

This medicine may cause dizziness, fainting, or fast, slow, or irregular heartbeat, especially when used together with dobutamine, dopamine, epinephrine, isoproterenol, or norepinephrine. Talk to your doctor if you have any concerns.

This medicine may make you drowsy and less alert than you are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause uncontrolled sudden movements (dyskinesia) or make such movements you already have worse or more frequent. Tell your doctor if this happens.

If you develop any unusual or strange thoughts and behavior while using this medicine, be sure to discuss it with your doctor. Other changes might be confusion, delusion (believing things that are not real), hallucinations (seeing or hearing things that are not there), getting paranoid, suicidal thoughts, and unusual excitement, nervousness, or irritability.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having problems with gambling or an increased interest in sex while using this medicine.

Do not stop using this medicine or change your dose without first checking with your doctor. Stopping this medicine suddenly may cause fever, confusion, or severe muscle stiffness.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with opicapone (the active ingredient contained in Ongentys) may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Ongentys

Along with its needed effects, opicapone 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:

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:

For healthcare professionals

Applies to opicapone: oral capsule.

General adverse events

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]

See also:

Frequently asked questions

• When is the best time to take Ongentys?
• How long does it take for Ongentys to work?
• Is Ongentys better than Comtan?

Further information

Ongentys 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