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Generally well tolerated in clinical studies1

In the pooled analysis of 2 double-blind studies:

  • Discontinuation rates for the double-blind period due to adverse events were 8% for patients taking ONGENTYS® (opicapone) capsules and 6% for patients taking placebo1
  • The most common adverse reaction leading to discontinuation was dyskinesia, reported in 3% of patients taking ONGENTYS and 0.4% of patients taking placebo1
Adverse Reactions Safety Table showing incidence of ≥2% in patients taking ONGENTYS and >placebo in Study 1 and Study 2 Adverse Reactions Safety Table showing incidence of ≥2% in patients taking ONGENTYS and >placebo in Study 1 and Study 2

*Includes hallucinations, hallucinations visual, hallucinations auditory, and hallucinations mixed.1

Includes hypotension, orthostatic hypotension, syncope, and presyncope.1

  • Dyskinesia rates lowered: After the initial 2- to 3-week levodopa/DDCI adjustment period, dyskinesia rates were 8.3% for ONGENTYS and 1.6% for placebo2
  • Baseline dyskinesia: 50.2% of all patients taking ONGENTYS in the studies (N=265) had dyskinesia at baseline2
  • Mild to moderate dyskinesia: Most events of dyskinesia were mild (10.9% for ONGENTYS vs. 3.5% for placebo) or moderate (8.3% for ONGENTYS vs. 1.9% for placebo). The incidence of severe dyskinesia was low and similar across treatment groups (1.1% for ONGENTYS vs. 0.8% for placebo)2

ONGENTYS (N=265); placebo (N=257).2

DDCI=dopa decarboxylase inhibitor.





ONGENTYS® (opicapone) capsules is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing "off" episodes.



ONGENTYS is contraindicated in patients with:

  • Concomitant use of non-selective monoamine oxidase (MAO) inhibitors.
  • Pheochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.


Cardiovascular Effects with Concomitant Use of Drugs Metabolized by Catechol-O-Methyltransferase (COMT)

Possible arrhythmias, increased heart rate, and excessive changes in blood pressure may occur with concomitant use of ONGENTYS and drugs metabolized by COMT, regardless of the route of administration (including inhalation). Monitor patients treated concomitantly with ONGENTYS and drugs metabolized by COMT.

Falling Asleep During Activities of Daily Living and Somnolence

Patients treated with dopaminergic medications and medications that increase levodopa exposure, including ONGENTYS, have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes has resulted in accidents. If a patient develops daytime sleepiness or somnolence, consider discontinuing ONGENTYS or adjusting other dopaminergic or sedating medications and advise patients to avoid driving and other potentially dangerous activities.


Monitor patients for hypotension and advise patients about the risk for syncope. If these adverse reactions occur, consider discontinuing ONGENTYS or adjusting the dosage of other medications that can lower blood pressure.


ONGENTYS potentiates the effects of levodopa which may result in dyskinesia or exacerbate pre-existing dyskinesia. Reducing the patient’s levodopa dosage or the dosage of another dopaminergic drug may reduce dyskinesia that occurs during treatment with ONGENTYS.

Hallucinations and Psychosis

Consider stopping ONGENTYS if hallucinations or psychotic-like behaviors occur. Patients with a major psychotic disorder should ordinarily not be treated with ONGENTYS.

Impulse Control/Compulsive Disorders

Patients may experience intense urges (eg, gambling, sexual, spending money, binge eating) and the inability to control them. It is important for prescribers to specifically ask patients or their caregivers about the development of new or increased urges.

Re-evaluate the patient’s current therapies for Parkinson’s disease and consider stopping ONGENTYS if a patient develops such urges while taking ONGENTYS.

Withdrawal-Emergent Hyperpyrexia and Confusion

A symptom complex resembling neuroleptic malignant syndrome (elevated temperature, muscular rigidity, altered consciousness, and autonomic instability) has been reported in association with rapid dose reduction or withdrawal of drugs that increase central dopaminergic tone. There were no reports of neuroleptic malignant syndrome in ONGENTYS controlled clinical studies. When discontinuing ONGENTYS, monitor patients and consider adjustment of other dopaminergic therapies as needed.


The most common adverse reactions (incidence at least 4% and greater than placebo) were dyskinesia, constipation, blood creatine kinase increased, hypotension/syncope, and weight decreased.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at or call 1-800-FDA-1088.

Please see ONGENTYS full Prescribing Information.


  1. ONGENTYS [package insert]. San Diego, CA: Neurocrine Biosciences, Inc; 2020.
  2. Data on file. Neurocrine Biosciences, Inc.