ENTACAPONE

N/A

Manufactured by Ajanta Pharma USA Inc.

11,238 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ENTACAPONE

ENTACAPONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Ajanta Pharma USA Inc.. The most commonly reported adverse reactions for ENTACAPONE include DYSKINESIA, HALLUCINATION, FALL, DRUG INEFFECTIVE, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ENTACAPONE.

Top Adverse Reactions

DYSKINESIA461 reports
HALLUCINATION459 reports
FALL443 reports
DRUG INEFFECTIVE332 reports
DEATH318 reports
PARKINSON^S DISEASE274 reports
CONFUSIONAL STATE255 reports
GAIT DISTURBANCE253 reports
TREMOR251 reports
ON AND OFF PHENOMENON225 reports
SOMNOLENCE190 reports
CONSTIPATION188 reports
FATIGUE184 reports
NAUSEA184 reports
HALLUCINATION, VISUAL181 reports
DIZZINESS180 reports
ASTHENIA161 reports
INSOMNIA154 reports
CONDITION AGGRAVATED151 reports
ANXIETY148 reports
BALANCE DISORDER148 reports
MUSCLE RIGIDITY148 reports
FREEZING PHENOMENON133 reports
COUGH131 reports
DEVICE ISSUE131 reports
URINARY TRACT INFECTION131 reports
AGITATION130 reports
MEMORY IMPAIRMENT122 reports
DYSTONIA121 reports
WEIGHT DECREASED120 reports
MOBILITY DECREASED118 reports
THERAPEUTIC RESPONSE SHORTENED115 reports
MALAISE114 reports
MUSCULOSKELETAL STIFFNESS113 reports
PRODUCT DOSE OMISSION ISSUE110 reports
DELUSION108 reports
FEELING ABNORMAL106 reports
PAIN104 reports
COGNITIVE DISORDER101 reports
PNEUMONIA98 reports
PSYCHOTIC DISORDER97 reports
OFF LABEL USE96 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE94 reports
AGGRESSION93 reports
DEPRESSION92 reports
DECREASED APPETITE90 reports
DRUG INTERACTION90 reports
DYSPNOEA89 reports
DYSPHAGIA88 reports
DIARRHOEA86 reports
ORTHOSTATIC HYPOTENSION85 reports
VOMITING85 reports
BRADYKINESIA83 reports
GENERAL PHYSICAL HEALTH DETERIORATION83 reports
SPEECH DISORDER80 reports
DEVICE DISLOCATION77 reports
UNEVALUABLE EVENT77 reports
SLEEP DISORDER74 reports
MUSCLE SPASMS71 reports
HEADACHE70 reports
ABNORMAL BEHAVIOUR68 reports
HYPOTENSION68 reports
STOMA SITE DISCHARGE68 reports
ABNORMAL DREAMS67 reports
DELIRIUM67 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES67 reports
DEMENTIA66 reports
RESTLESSNESS66 reports
HYPERHIDROSIS65 reports
MUSCULAR WEAKNESS63 reports
DEPRESSED MOOD59 reports
LOSS OF CONSCIOUSNESS59 reports
THERAPEUTIC PRODUCT EFFECT VARIABLE57 reports
DEVICE OCCLUSION56 reports
NOCTURIA56 reports
INCORRECT DOSE ADMINISTERED55 reports
DEHYDRATION54 reports
GAIT INABILITY54 reports
DEVICE DIFFICULT TO USE53 reports
PAIN IN EXTREMITY52 reports
PERIPHERAL SWELLING52 reports
IRRITABILITY51 reports
PARANOIA51 reports
DISTURBANCE IN ATTENTION50 reports
ABDOMINAL PAIN49 reports
NEUROLEPTIC MALIGNANT SYNDROME49 reports
URINARY RETENTION49 reports
HYPERSEXUALITY48 reports
ADVERSE DRUG REACTION47 reports
NIGHTMARE47 reports
STRESS45 reports
HIP FRACTURE44 reports
POOR QUALITY SLEEP44 reports
STOMA SITE ERYTHEMA44 reports
HOSPITALISATION43 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION43 reports
DEPRESSED LEVEL OF CONSCIOUSNESS42 reports
DRY MOUTH42 reports
HYPERKINESIA42 reports
STOMA SITE PAIN42 reports

Report Outcomes

Out of 3,955 classified reports for ENTACAPONE:

Serious 70.3%Non-Serious 29.7%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male2,374 (65.6%)
Female1,241 (34.3%)
Unknown2 (0.1%)

Reports by Age

Age 70139 reports
Age 69130 reports
Age 75127 reports
Age 73116 reports
Age 77115 reports
Age 71113 reports
Age 68100 reports
Age 7298 reports
Age 7893 reports
Age 7692 reports
Age 7992 reports
Age 7490 reports
Age 6685 reports
Age 8079 reports
Age 6575 reports
Age 6271 reports
Age 6370 reports
Age 6469 reports
Age 6765 reports
Age 8165 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ENTACAPONE?

This profile reflects 11,238 FDA FAERS reports that mention ENTACAPONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ENTACAPONE?

Frequently reported terms in FAERS include DYSKINESIA, HALLUCINATION, FALL, DRUG INEFFECTIVE, DEATH, PARKINSON^S DISEASE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ENTACAPONE?

Labeling and FAERS entries often list Ajanta Pharma USA Inc. in connection with ENTACAPONE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.