Drugs › Catechol-O-Methyltransferase inhibitor
Brand name · Opicapone
Ongentys: adverse event reports filed with FDA
1,056 reports list it as a suspect or interacting product, 2017–2026. Class: Catechol-O-Methyltransferase inhibitor.
- 1,056
- reports as suspect product
- 0% of all reports · about 114 a year
- 133
- reports, 12 months to June 2026
- 103 in the 12 months before
- 64.6%
- marked serious by the reporter
- 75.3% across the class
- 7.5%
- record death among outcomes, as reported
- 79 reports · not verified by FDA
1,056 adverse event reports received by FDA list the brand name Ongentys (opicapone) as a suspect or interacting product, from April 2017 to June 2026. A further 679 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 133 reports listed it, up 29% from 103 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 114 reports a year and 0% of the 20,646,523 reports in the database, and 52.3% of the reports for the catechol-O-Methyltransferase inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are dyskinesia (14.7%), hallucination (13.4%) and fall (7.3%). A report can list several reactions, so shares add to more than 100%; 260 different terms appear across these reports. Dyskinesia is recorded in 14.7% of these reports, about the same share as in the median catechol-O-Methyltransferase inhibitor drug (17.7%).
64.6% of the reports are marked serious by the reporter (75.3% across the class); 7.5% record death among the outcomes and 27% record hospitalisation, as reported. 35.9% of the reports came from consumers, and the largest patient age group is 65 to 74 (10.6%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Ongentys reports recording the termmedian drug in catechol-o-methyltransferase inhibitor
- Dyskinesiainvoluntary movements14.7%155
- Hallucinationseeing or hearing things that are not there13.4%141
- Falla fall7.3%77
- Tremorshaking7.2%76
- Constipationconstipation6.3%66
- Confusional stateconfusion5.6%59
- Dizzinesslight-headedness or unsteadiness5.6%59
- Dysphagiadifficulty swallowing5.5%58
- Gait disturbancedifficulty walking5.4%57
- Anxietyanxiety5.3%56
- Drug ineffectivethe medicine did not work as expected5%53
- Dystoniainvoluntary muscle contractions4.9%52
- Deaththe patient died; cause not stated by this term4.6%49
- Fatiguetiredness4.5%48
- Insomniadifficulty sleeping4.5%48
- Bradykinesia4.5%47
- Muscle rigidity4.4%46
- Off label useused for a purpose or in a way not on the label4.2%44
- Delusiona fixed false belief4%42
- Somnolencedrowsiness4%42
- Malaisegeneral feeling of being unwell3.8%40
- Freezing phenomenon3.7%39
- Parkinson's disease3.7%39
- Deliriumsudden confusion3.6%38
- Hallucination, visual3.6%38
- Nauseafeeling sick3.6%38
- Balance disorderproblems with balance3.3%35
- Reduced facial expression3.3%35
- Sleep disordera sleep problem3.2%34
Top 30 of 260 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the catechol-o-methyltransferase inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 2,018 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 49.2% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Parkinson's disease | 756 | 71.6% |
| On and off phenomenon | 39 | 3.7% |
| Parkinsonism | 11 | 1% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,056 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Ongentys reports |
|---|---|---|
| Carbidopa levodopa | 163 | 15.4% |
| Sinemet | 118 | 11.2% |
| Carbidopa and levodopa | 79 | 7.5% |
| Levodopa | 76 | 7.2% |
| Rytary | 53 | 5% |
| Neupro | 49 | 4.6% |
| Azilect | 40 | 3.8% |
| Pramipexole | 39 | 3.7% |
| Gabapentin | 34 | 3.2% |
| Rotigotine | 34 | 3.2% |
Other products listed in reports where Ongentys is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Ongentys | Catechol-O-Methyltransferase inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 1,056 | 2,018 | 20,646,523 |
| Share of that pool | — | 52.3% | 0% |
| Reports, latest 12 months | 133 | — | 1,332,454 |
| Marked serious | 64.6% | 75.3% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 75 | 79 | 91 |
| Hospitalisation recorded, per 1,000 reports | 270 | 330 | 213 |
| Consumer-filed share | 35.9% | 30.6% | 45.8% |
| Top term, share of reports | Dyskinesia 14.7% | median 17.7% | 0.2% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the catechol-o-methyltransferase inhibitor class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Entacapone | generic | 962 | 40 | 87% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Ongentys reports
How many adverse event reports has FDA received for Ongentys?
1,056 reports list Ongentys as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 133 of them arrived in the latest 12 months. Another 679 list it only as a concomitant medication.
What reactions are recorded in Ongentys reports?
dyskinesia (14.7%), hallucination (13.4%), fall (7.3%), tremor (7.2%) and constipation (6.3%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Ongentys was responsible.
How serious are the reports?
64.6% are marked serious by the reporter. Among the outcomes recorded, 7.5% of reports include death and 27% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (35.9%), physician (22.8%) and other health professional (21.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Ongentys rising?
133 reports in the 12 months to June 2026, up 29% from 103 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Ongentys was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Ongentys?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Ongentys as a suspect or interacting product; reports listing it only as a concomitant medication (679) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.