Drug side effects
entacapone Side Effects
The reactions most often reported to the FDA for entacapone (also sold as Comtan), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 3,955
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2003 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of entacapone come from 3,955 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 3,955 reports to the FDA Adverse Event Reporting System (FAERS) for entacapone (Comtan): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
3,955
Reports Mentioning Death
603
15.2% of reports — not proof the medicine caused the death
Hospitalizations
1,340
33.9% of reports
Top Indication
Parkinson^S Disease
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 603 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 318 |
| PARKINSON^S DISEASE | 88 |
| HALLUCINATION | 74 |
| FALL | 71 |
| PNEUMONIA | 45 |
| DYSKINESIA | 44 |
| CONFUSIONAL STATE | 42 |
| AGITATION | 35 |
| DEMENTIA | 25 |
| HYPONATRAEMIA | 25 |
| CARDIAC ARREST | 24 |
| ASTHENIA | 23 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 23 |
| ORTHOSTATIC HYPOTENSION | 22 |
| URINARY RETENTION | 21 |
| DYSPHAGIA | 20 |
| MYOCARDIAL INFARCTION | 20 |
| CONSTIPATION | 19 |
Reactions in Hospitalization Reports
Top reactions in 1,340 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| FALL | 238 |
| DYSKINESIA | 195 |
| HALLUCINATION | 159 |
| CONFUSIONAL STATE | 120 |
| ON AND OFF PHENOMENON | 105 |
| PARKINSON^S DISEASE | 102 |
| GAIT DISTURBANCE | 97 |
| URINARY TRACT INFECTION | 88 |
| MUSCLE RIGIDITY | 87 |
| TREMOR | 84 |
| ASTHENIA | 83 |
| PSYCHOTIC DISORDER | 74 |
| PNEUMONIA | 73 |
| AGITATION | 68 |
| HALLUCINATION, VISUAL | 67 |
| FATIGUE | 65 |
| THERAPEUTIC PRODUCT EFFECT INCOMPLETE | 64 |
| DYSTONIA | 63 |
| MOBILITY DECREASED | 63 |
Nearby, Related Medications
What the FAERS Data Reveals About entacapone Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 3,955 voluntary reports linked to entacapone and its brand equivalents (Comtan), spanning 2003 through 2025. Of those, 603 (15.2%) listed death as an outcome and 1,340 (33.9%) involved hospitalization. The most common indication reported alongside adverse events was Parkinson^S Disease.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 34% were female and 66% male; age distribution skews toward 65-74, with 1,011 reports in that bracket. The single most reported reaction is dyskinesia with 461 submissions, followed by hallucination and fall.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to entacapone's 3,955.
Read our methodology - how this data is sourced, computed, and verified.