Opicapone: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: March 13, 2026🚩 Report this page

Opicapone

Other Dopaminergic Agents

Sold as Ontilyv · Ongentys

GB MHRAEU EMA

Drug class: Other Dopaminergic Agents
Availability: See label
Markets covered: 2
Products on record: 15

Overview

Opicapone is an active pharmaceutical ingredient in the Other Dopaminergic Agents group (N04BX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	14	March 13, 2026
EU European Union	EMA	1	May 7, 2025

GBUnited Kingdom· MHRA

14 products

Uses

GBOfficial regulatory label· revised January 16, 2026[1]

Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end- of-dose motor fluctuations who cannot be stabilised on those combinations.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised May 7, 2025[2]

Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.
3

How to take

Drug interactions

Known interactions involving Opicapone. Select one for details. This list is informational and not a complete interaction checker.

Isocarboxazid Linezolid Methylene Blue Phenelzine Procarbazine Propoxyphene Tranylcypromine Alfentanil Alprazolam Amisulpride Amitriptyline Amobarbital Amoxapine Apomorphine Apraclonidine Aripiprazole Asenapine Azatadine Azelastine Baclofen Benzhydrocodone Biperiden Brexanolone Brexpiprazole Brimonidine Brivaracetam Bromocriptine Brompheniramine Buprenorphine Buspirone Butabarbital Butalbital Butorphanol Cannabidiol Carbamazepine Carbinoxamine Cariprazine Carisoprodol Cenobamate Cetirizine Chlorcyclizine Chlordiazepoxide Chlormezanone Chlorphenesin Chlorpheniramine Chlorpromazine Chlorzoxazone Citalopram Clemastine Clobazam Clomipramine Clonazepam Clonidine Clorazepate Clozapine Codeine Cyclizine Cyclobenzaprine Cyproheptadine Dantrolene Desipramine Desvenlafaxine Deutetrabenazine Dexbrompheniramine Dexmedetomidine Dextromethorphan Dezocine Diazepam Dichloralphenazone Difenoxin Dihydrocodeine Dimenhydrinate Diphenhydramine Diphenoxylate Dobutamine Dopamine Doxepin Doxylamine Dronabinol Droperidol Duloxetine Entacapone Epinephrine Escitalopram Esketamine Eslicarbazepine Estazolam Eszopiclone Ethanol Ethchlorvynol Ethosuximide Ethotoin Ezogabine Felbamate Fentanyl Flavoxate Flibanserin Fluoxetine Fluphenazine Flurazepam Fluvoxamine Fosphenytoin Gabapentin Guanfacine Halazepam Haloperidol Hydrocodone Hydromorphone Hydroxyzine Iloperidone Imipramine Isoetharine Isoproterenol Ketamine Lamotrigine Lasmiditan Lemborexant Levetiracetam Levocetirizine Levodopa Levorphanol Lithium Carbonate Lofexidine Lorazepam Loxapine Lumateperone Lurasidone Maprotiline Meclizine Meperidine Mephenytoin Mephobarbital Meprobamate Mesoridazine Metaxalone Methadone Methdilazine Methocarbamol Methotrimeprazine Methsuximide Methyldopa Metoclopramide Metyrosine Midazolam Mirtazapine Molindone Morphine Nabilone Nalbuphine Nefazodone Norepinephrine Nortriptyline Olanzapine Oliceridine Olopatadine Opium Orphenadrine Oxazepam Oxcarbazepine Oxycodone Oxymorphone Paliperidone Paraldehyde Paramethadione Paroxetine Pentazocine Pentobarbital Perampanel Pergolide Perphenazine Phenacemide Phenindamine Phenobarbital Phensuximide Phenyltoloxamine Phenytoin Pimozide Pramipexole Pregabalin Primidone Prochlorperazine Procyclidine Promazine Promethazine Propiomazine Protriptyline Pyrilamine Quazepam Quetiapine Ramelteon Rasagiline Remifentanil Remimazolam Risperidone Ropinirole Rotigotine Rufinamide Secobarbital Sertraline Sibutramine Solriamfetol Stiripentol Sufentanil Suvorexant Tapentadol Tasimelteon Temazepam Tetrabenazine Thalidomide Thiethylperazine Thiopental Thioridazine Thiothixene Tiagabine Tizanidine Tolcapone Topiramate Tramadol Trazodone Triazolam Trifluoperazine Triflupromazine Trihexyphenidyl Trimeprazine Trimethadione Trimethobenzamide Trimipramine Tripelennamine Triprolidine Tucatinib Valbenazine Valproate Venlafaxine Vigabatrin Zaleplon Ziconotide Ziprasidone Zolpidem Zonisamide Memantine

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PLGB215660004 · revised January 16, 2026
[2]European Medicines Agency · EMEA/H/C/002790 · revised May 7, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised January 16, 2026[1]

Summary of the safety profile The most common adverse reactions reported were nervous system disorders. 7%). Tabulated list of adverse reactions In the table below (Table 1) all adverse reactions are presented by System Organ Class and frequency.
Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
, Nervous system disorders Dyskinesia Dizziness, Headache, Somnolence Dysgeusia, Hyperkinesia, Syncope Eye disorders Dry eye Ear and labyrinth disorders Ear congestion Cardiac disorders Palpitations Vascular disorders Orthostatic Hypotension Hypertension, Hypotension Respiratory, thoracic and mediastinal disorders Dyspnoea Gastrointestinal disorders Constipation, Dry mouth, Nausea, Vomiting Abdominal distention, Abdominal pain, Abdominal pain upper, Dyspepsia Musculoskeletal and connective tissue disorders Muscle spasms Muscle twitching, Musculoskeletal stiffness, Myalgia, Pain in extremity Renal and urinary disorders Chromaturia, Nocturia Investigations Blood creatine phosphokinase increased Weight decreased Injury, poisoning and procedural complications Fall General disorders and administration site conditions Fatigue Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised January 16, 2026[1]

Dose adjustments of antiparkinsonian therapy Ongentys is to be administered as an adjunct to levodopa treatment. Hence, the precautions valid for levodopa treatment should also be taken into account for Ongentys. Opicapone enhances the effects of levodopa.
g. 2). If Ongentys is discontinued it is necessary to adjust the dosing of the other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the symptoms. Psychiatric disorders Patients and care-givers should be made aware that impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments.
Patients should be monitored regularly for the development of impulse control disorders and review of treatment is recommended if such symptoms develop. Others Increases in liver enzymes were reported in studies with nitrocatechol inhibitors of catechol- Omethyltransferase (COMT).
For patients who experience progressive anorexia, asthenia and weight decrease within a relatively short period of time, a general medical evaluation including liver function should be considered. Excipients Ongentys contains lactose.
Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Ongentys contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

This is not medical advice. Consult a qualified healthcare professional.