Opicapone side effects: what 2,261 FDA adverse event reports show

Opicapone · Ongentys · 130 reaction terms · 4,290 drug–reaction co-reports · data 2026-09-14

Drug class

Catechol-O-Methyltransferase Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Ongentys

openFDA label

Who reports

2,261 reports · 75% serious · 235 with death outcome · 39% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes. ONGENTYS is a catechol-O-methyltransferase (COMT) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes. ( 1 )

FDA label, Indications and Usage

What it is

ONGENTYS contains opicapone, a peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 5Labeled (related wording) 3Reporting / coding artifact 5Not in label — unassessed 27

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 90 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Dyskinesia (involuntary movements)	306	70.5 63.5–78.3ROR 81.4 · χ² 20,775 / p <1e-300	69.7 EB05 63.4 · IC025 +5.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 54.5	no trial data cached
Muscle rigidity	78	60.9 48.9–75.8ROR 63.1 · χ² 4,510 / p <1e-300	59.7 EB05 49.4 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 50.7	no trial data cached
Hypokinesia	79	50.7 40.8–63.0ROR 52.5 · χ² 3,780 / p <1e-300	49.8 EB05 41.3 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 47.6	no trial data cached
Hallucination, visual	95	42.2 34.6–51.4ROR 44.0 · χ² 3,764 / p <1e-300	41.7 EB05 35.1 · IC025 +4.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 34.7	no trial data cached
Dystonia	85	40.7 33.0–50.1ROR 42.2 · χ² 3,238 / p <1e-300	40.2 EB05 33.5 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 34.2	no trial data cached
Delusion	67	40.3 31.8–51.0ROR 41.5 · χ² 2,519 / p <1e-300	39.7 EB05 32.3 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 35.9	no trial data cached
Hallucination (hallucinations)	314	39.0 35.2–43.2ROR 45.1 · χ² 11,583 / p <1e-300	38.8 EB05 35.3 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 34.3	no trial data cached
Orthostatic hypotension (dizziness on standing)	44	23.4 17.5–31.4ROR 23.9 · χ² 921 / p 1e-202	23.2 EB05 18.0 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 19.0 · ♀ 15% (drug 39%)	no trial data cached
Therapeutic response shortened	74	21.6 17.3–27.0ROR 22.3 · χ² 1,433 / p <1e-300	21.5 EB05 17.7 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 46.5	no trial data cached
Joint dislocation	22	19.4 12.8–29.4ROR 19.6 · χ² 365 / p 9e-82	19.0 EB05 13.1 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 16.7	no trial data cached
Infusion site pain	26	18.9 12.9–27.7ROR 19.1 · χ² 423 / p 3e-94	18.6 EB05 13.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=25	no trial data cached
Delirium	64	17.2 13.5–21.9ROR 17.7 · χ² 960 / p 5e-211	17.1 EB05 13.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 13.2	no trial data cached
Device occlusion	25	16.7 11.3–24.7ROR 16.9 · χ² 353 / p 5e-79	16.3 EB05 11.4 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious n=20 · 92% consumer	no trial data cached
Anosmia (loss of smell)	25	16.0 10.8–23.7ROR 16.2 · χ² 337 / p 2e-75	15.6 EB05 10.9 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=24	no trial data cached
Psychotic disorder	49	15.4 11.7–20.3ROR 15.7 · χ² 646 / p 1e-142	15.2 EB05 11.9 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.5	no trial data cached
Dementia	44	14.7 10.9–19.7ROR 14.9 · χ² 547 / p 3e-121	14.5 EB05 11.1 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.8	no trial data cached
Movement disorder	47	13.5 10.2–18.0ROR 13.8 · χ² 533 / p 3e-118	13.3 EB05 10.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 10.7	no trial data cached
Pneumonia aspiration	33	12.3 8.8–17.3ROR 12.5 · χ² 331 / p 3e-74	11.8 EB05 8.6 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.4	no trial data cached
Hallucination, auditory	21	12.3 8.0–18.8ROR 12.4 · χ² 206 / p 6e-47	11.4 EB05 7.5 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.8	no trial data cached
Mobility decreased	93	12.1 9.9–14.7ROR 12.5 · χ² 934 / p 2e-205	11.9 EB05 10.0 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.7	no trial data cached
Upper limb fracture	25	11.6 7.9–17.1ROR 11.7 · χ² 232 / p 1e-52	10.9 EB05 7.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 10.1 · ♀ 14% (drug 39%) · 76% consumer	no trial data cached
Motor dysfunction	12	11.0 6.3–19.4ROR 11.1 · χ² 99 / p 1e-23	9.3 EB05 5.1 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.6	no trial data cached
Paranoia	20	10.7 6.9–16.6ROR 10.8 · χ² 167 / p 2e-38	9.7 EB05 6.3 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.7	no trial data cached
Gait inability	35	9.8 7.1–13.6ROR 10.0 · χ² 268 / p 1e-60	9.2 EB05 6.8 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 8.0 · 80% consumer	no trial data cached
Aggression	51	9.4 7.2–12.4ROR 9.6 · χ² 377 / p 3e-84	9.0 EB05 7.0 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.0	no trial data cached
Speech disorder	52	9.2 7.0–12.1ROR 9.4 · χ² 373 / p 2e-83	8.8 EB05 6.9 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Initial insomnia	10	9.1 4.9–16.9ROR 9.1 · χ² 64 / p 6e-16	7.1 EB05 3.9 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Urinary retention	32	8.9 6.3–12.6ROR 9.0 · χ² 217 / p 2e-49	8.3 EB05 6.0 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.7 · ♀ 8% (drug 39%)	no trial data cached
Drug effect less than expected	13	8.6 5.0–14.7ROR 8.6 · χ² 79 / p 3e-19	7.0 EB05 4.2 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious n=10	no trial data cached
Mania	15	8.5 5.1–14.0ROR 8.5 · χ² 92 / p 6e-22	7.1 EB05 4.4 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.9	no trial data cached
Dysphagia (difficulty swallowing)	86	8.4 6.9–10.4ROR 8.7 · χ² 558 / p 1e-123	8.2 EB05 6.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Dysarthria (slurred speech)	34	8.4 6.0–11.7ROR 8.5 · χ² 214 / p 9e-49	7.8 EB05 5.7 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 6.9	no trial data cached
Poor quality sleep	19	8.2 5.3–12.9ROR 8.3 · χ² 114 / p 7e-27	7.2 EB05 4.7 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 9.8	no trial data cached
Balance disorder	76	8.1 6.5–10.2ROR 8.4 · χ² 471 / p 1e-104	7.9 EB05 6.5 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Restlessness	32	8.1 5.7–11.4ROR 8.2 · χ² 192 / p 5e-44	7.5 EB05 5.5 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.5	no trial data cached
Hypophagia	22	8.0 5.3–12.2ROR 8.1 · χ² 129 / p 4e-30	7.1 EB05 4.9 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.1	no trial data cached
Tremor (shaking)	143	8.0 6.8–9.4ROR 8.5 · χ² 873 / p 4e-192	7.8 EB05 6.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached
Cognitive disorder	40	8.0 5.9–10.9ROR 8.1 · χ² 238 / p 7e-54	7.5 EB05 5.7 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.3 · ♀ 14% (drug 39%)	no trial data cached
Disorientation	33	7.7 5.5–10.8ROR 7.8 · χ² 186 / p 1e-42	7.1 EB05 5.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.6	no trial data cached
Device dislocation	35	7.5 5.4–10.4ROR 7.6 · χ² 190 / p 1e-43	6.9 EB05 5.2 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 7.1	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hallucination (hallucinations)	314	39.0 35.2–43.2ROR 45.1 · χ² 11,583 / p <1e-300	38.8 EB05 35.3 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 34.3	no trial data cached
Dyskinesia (involuntary movements)	306	70.5 63.5–78.3ROR 81.4 · χ² 20,775 / p <1e-300	69.7 EB05 63.4 · IC025 +5.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 54.5	no trial data cached
Fall	258	7.2 6.4–8.1ROR 8.0 · χ² 1,393 / p <1e-300	7.1 EB05 6.4 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.0	no trial data cached
Tremor (shaking)	143	8.0 6.8–9.4ROR 8.5 · χ² 873 / p 4e-192	7.8 EB05 6.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached
Gait disturbance	131	6.3 5.4–7.5ROR 6.7 · χ² 588 / p 3e-130	6.2 EB05 5.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 6.2	no trial data cached
Confusional state (confusion)	120	6.9 5.8–8.2ROR 7.2 · χ² 601 / p 5e-133	6.7 EB05 5.8 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.9	no trial data cached
Hallucination, visual	95	42.2 34.6–51.4ROR 44.0 · χ² 3,764 / p <1e-300	41.7 EB05 35.1 · IC025 +4.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 34.7	no trial data cached
Somnolence (drowsiness)	94	4.3 3.6–5.3ROR 4.5 · χ² 240 / p 2e-54	4.3 EB05 3.6 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.0	no trial data cached
Mobility decreased	93	12.1 9.9–14.7ROR 12.5 · χ² 934 / p 2e-205	11.9 EB05 10.0 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.7	no trial data cached
Dysphagia (difficulty swallowing)	86	8.4 6.9–10.4ROR 8.7 · χ² 558 / p 1e-123	8.2 EB05 6.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Dystonia	85	40.7 33.0–50.1ROR 42.2 · χ² 3,238 / p <1e-300	40.2 EB05 33.5 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 34.2	no trial data cached
Hypokinesia	79	50.7 40.8–63.0ROR 52.5 · χ² 3,780 / p <1e-300	49.8 EB05 41.3 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 47.6	no trial data cached
Muscle rigidity	78	60.9 48.9–75.8ROR 63.1 · χ² 4,510 / p <1e-300	59.7 EB05 49.4 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 50.7	no trial data cached
Balance disorder	76	8.1 6.5–10.2ROR 8.4 · χ² 471 / p 1e-104	7.9 EB05 6.5 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Therapeutic response shortened	74	21.6 17.3–27.0ROR 22.3 · χ² 1,433 / p <1e-300	21.5 EB05 17.7 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 46.5	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Muscle rigidity — n=78, PRR 60.9
Hypokinesia — n=79, PRR 50.7
Dystonia — n=85, PRR 40.7
Joint dislocation — n=22, PRR 19.4
Infusion site pain — n=26, PRR 18.9
Delirium — n=64, PRR 17.2
Anosmia — n=25, PRR 16.0
Dementia — n=44, PRR 14.7
Movement disorder — n=47, PRR 13.5
Pneumonia aspiration — n=33, PRR 12.3

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Opicapone?

In FDA FAERS, the most frequently co-reported reaction terms for Opicapone are hallucination, dyskinesia, fall, tremor, gait disturbance, confusional state. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Opicapone have an FDA boxed warning?

No. The FDA label retrieved for Opicapone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Opicapone causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID a511a531-112e-43f8-a43f-5334b0efe979, effective 20251015; matched on openfda.generic_name.exact:"OPICAPONE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 130 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.