Opicapone
Pronunciation: pronunciation varies by local usage.
- Generic name
- opicapone
- Brand names
- Ongentys (United States)
- Drug class
- Catechol-O-methyltransferase (COMT) inhibitor
- Form
- Capsule
- Route
- Oral
- Legal status
- Not established from the sources reviewed: specific legal/prescription status beyond FDA approval was not established in the sources reviewed for this page.
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What opicapone is and how it works
Opicapone is a peripheral, selective, reversible catechol-O-methyltransferase (COMT) inhibitor. It is used as an adjunct to levodopa/carbidopa in patients with Parkinson's disease who have motor fluctuations ('off' episodes). (1)
Opicapone is added to existing levodopa therapy to reduce 'off' time. It does not replace levodopa. Dosing and monitoring require a prescriber's guidance.
Mechanism of action: how opicapone works
Opicapone is a peripheral, selective, reversible COMT inhibitor that increases and extends the dopaminergic effect of levodopa by reducing its metabolism. (1)
What opicapone is used for
Parkinson's disease
Opicapone is indicated as adjunctive therapy to levodopa/carbidopa in patients with Parkinson's disease experiencing motor fluctuations ('off' episodes). (1)
Before taking opicapone
Do not take / not appropriate for
- Concurrent use of monoamine oxidase (MAO) inhibitors (other than those used for Parkinson's disease) is a contraindication for opicapone because of the risk of hypertensive crisis. Tell your prescriber or pharmacist about all MAO inhibitors you take for an urgent medication review. (all uses) (1)
- A history of neuroleptic malignant syndrome and/or nontraumatic rhabdomyolysis is a contraindication for opicapone. Tell your prescriber about this history for an urgent medication review. (all uses) (1)
- Pheochromocytoma, paraganglioma, or other catecholamine-secreting neoplasms are a contraindication for opicapone. Tell your prescriber about this history for an urgent medication review. (all uses) (1)
- A prior hypersensitivity reaction to opicapone or any ingredient in Ongentys capsules is a contraindication. Tell your prescriber about any prior reaction for an urgent medication review. (all uses) (1)
Tell your clinician about
- If you have a history of dyskinesia, as opicapone may worsen it.
- If you experience hallucinations or impulsive behaviors (e.g., gambling, sexual urges, spending).
- If you feel dizzy or faint upon standing (orthostatic hypotension).
- If you are pregnant, planning pregnancy, or breastfeeding.
- If you are taking any other medicines, especially MAO inhibitors, sympathomimetics, or other Parkinson's medications.
- If you have a history of neuroleptic malignant syndrome or rhabdomyolysis.
- If you have blood pressure issues or symptoms of orthostatic hypotension.
How to take opicapone
- Opicapone is taken as a 50 mg capsule once daily, in the evening, at least one hour after the last levodopa/carbidopa dose of the day.
- Contact your doctor before making any change to the dose or treatment plan; the treating clinician determines any change, including whether tapering is needed.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
Do not take an extra dose to make up for a missed one; ask the prescribing clinician or pharmacist for guidance.
Overdose
If an overdose is suspected, seek medical attention. (1)
Side effects
The most common side effects of opicapone are dyskinesia, constipation, increased blood creatine kinase, hypotension/syncope, weight decrease, diarrhea, dry mouth, and dizziness.
Dyskinesia
What to notice: Uncontrolled, involuntary movements; may be new or worsening.
What to do: Report to your doctor; the treating clinician determines whether a levodopa dose adjustment is needed. (1)
Constipation
What to notice: Difficulty passing stools, less frequent bowel movements.
What to do: Contact your doctor if severe. (1)
Increased blood creatine kinase
What to notice: Often asymptomatic; may be detected on blood tests.
What to do: Your doctor monitors blood levels as appropriate. (1)
Hypotension/syncope
What to notice: Feeling dizzy or faint, especially when standing up. Fainting may occur.
What to do: Inform your doctor. (1)
Weight decrease
What to notice: Unexplained loss of body weight.
What to do: Report to your doctor if significant. (1)
Diarrhea
What to notice: Loose, watery stools.
What to do: Contact your doctor if persistent. (1)
Dry mouth
What to notice: A feeling of dryness in the mouth.
What to do: Consult your doctor if troublesome. (1)
Dizziness
What to notice: Feeling lightheaded or unsteady.
What to do: Report to your doctor. (1)
Hallucinations / psychotic behavior
What to notice: Signs of hallucinations or psychotic behavior.
What to do: Contact your doctor promptly. (1)
Impulse control disorders
What to notice: Uncontrollable urges to gamble, spend money, binge eat, or have increased sexual desires.
What to do: Report immediately to your doctor; these behaviors can be harmful. (1)
Hyperpyrexia and confusion on withdrawal
What to notice: Abrupt discontinuation poses a serious risk.
What to do: Seek immediate medical attention. The label supports gradual tapering rather than abrupt discontinuation; the treating clinician manages any dose change. (1)
Serious warnings
Hallucinations/psychosis — urgent
Symptoms: Signs of hallucinations or psychotic behavior.
Action: Contact your doctor promptly. (1)
Impulse control disorders — urgent
Symptoms: Uncontrollable urges to gamble, spend money, binge eat, or have increased sexual desires.
Action: Report immediately to your doctor; these behaviors can be harmful. (1)
Hyperpyrexia and confusion on withdrawal — emergency
Symptoms: Abrupt discontinuation poses a serious risk.
Action: Seek emergency medical attention. The label supports gradual tapering rather than abrupt discontinuation; the treating clinician manages any dose change. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Levodopa/carbidopa | Opicapone increases levodopa plasma levels, which may worsen dyskinesia or cause other dopaminergic side effects. | Your doctor may adjust your levodopa dose after starting opicapone. Do not adjust levodopa yourself. (1) |
| Monoamine oxidase (MAO) inhibitors | Concomitant use is contraindicated, except for MAO inhibitors specifically used for Parkinson's disease, due to risk of hypertensive crisis. | Inform the prescriber or pharmacist urgently for a medication review; the clinician determines whether opicapone may be used. (1) |
| Sympathomimetics and other catecholamine-metabolized drugs | Risk of hypertensive crisis when combined with sympathomimetic agents and certain other catecholamine-metabolized drugs. | Tell your doctor about all medications you take. (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Limited human data are available. Use only if the potential benefit justifies the potential risk to the fetus. Discuss with your doctor. (1)
Lactation/breastfeeding
It is unknown whether opicapone passes into human breast milk. Consult your doctor before breastfeeding. (1)
Monitoring
Before starting
- Assess contraindications: MAO inhibitor use, history of neuroleptic malignant syndrome/rhabdomyolysis, catecholamine-secreting tumors, or hypersensitivity.
During treatment
- Monitor for worsening dyskinesia; a levodopa dose adjustment may be needed.
- Observe for hallucinations, psychotic symptoms, and impulse control disorders.
- Monitor blood pressure, given the risk of orthostatic hypotension.
- Any decision to stop opicapone is managed by the treating clinician; the label supports gradual tapering rather than abrupt discontinuation.
Storage
Follow the exact product label and keep medicines away from children.
Study the drug class: Antiparkinsonian agents
Professional information
Clinician-facing summary based on US FDA label. Refer to the full prescribing information for detailed dosing and monitoring.
United States
Indication: Parkinson's disease motor fluctuations
Dose summary: 50 mg oral capsule once daily in the evening, taken at least one hour after the last levodopa/carbidopa dose of the day. A levodopa dose adjustment is typically needed after starting opicapone.
Renal context: No dose adjustment is needed for mild, moderate or severe renal impairment, though monitoring is recommended in severe impairment. Avoid use in end-stage renal disease (creatinine clearance below 15 mL/min). (1)
Hepatic guidance
No adjustment is required in mild hepatic impairment. In moderate hepatic impairment the recommended dose is 25 mg orally once daily at bedtime. Avoid use in severe (Child-Pugh C) hepatic impairment.
Frequently asked questions
What is opicapone used for?
Opicapone is used together with levodopa/carbidopa to treat motor fluctuations ('off' episodes) in people with Parkinson's disease. (1)
When should I take opicapone?
Take one 50 mg capsule once daily in the evening, at least one hour after the last levodopa/carbidopa dose of the day. (1)
Can I stop taking opicapone on my own?
Contact your doctor before making any change. The label supports gradual tapering rather than abrupt discontinuation; the treating clinician manages any dose change. (1)
Does opicapone replace my levodopa?
Opicapone is adjunctive to levodopa/carbidopa, meaning it is used together with it rather than in place of it. The treating clinician directs any change to either medicine. (1)
What is the mechanism of action of opicapone?
Opicapone is a peripheral, selective, reversible COMT inhibitor that increases and extends the dopaminergic effect of levodopa by reducing its metabolism. (1)
What is the generic name of Opicapone?
The generic name is opicapone. It is sold under brand names including Ongentys (United States). (1)
What class of drug is opicapone?
Opicapone is classed as: Catechol-O-methyltransferase (COMT) inhibitor. (1)
References
- ONGENTYS (opicapone) — prescribing informationU.S. Food and Drug Administration · United States · dated 2025 · accessed 2026-08-05 · source 1
- ONGENTYS (OPICAPONE) CAPSULE [AMNEAL PHARMACEUTICALS LLC] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 2
- Opicapone — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 3
- ONGENTYS — FDA approval record (Drugs@FDA NDA212489)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- opicapone — RxNorm normalized drug concept (RXCUI 2362167)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient opicapone names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- ONGENTYS25 mg, 50 mg · amneal pharmaceuticals llc