RAMELTEON

N/A

Manufactured by Takeda Pharmaceuticals America, Inc.

11,977 FDA adverse event reports analyzed

Last updated: 2026-04-15

About RAMELTEON

RAMELTEON is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Takeda Pharmaceuticals America, Inc.. The most commonly reported adverse reactions for RAMELTEON include DRUG INEFFECTIVE, INITIAL INSOMNIA, SOMNOLENCE, MIDDLE INSOMNIA, INSOMNIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RAMELTEON.

Top Adverse Reactions

DRUG INEFFECTIVE909 reports
INITIAL INSOMNIA447 reports
SOMNOLENCE411 reports
MIDDLE INSOMNIA390 reports
INSOMNIA388 reports
NAUSEA327 reports
FATIGUE283 reports
DIZZINESS268 reports
HEADACHE254 reports
OFF LABEL USE234 reports
POOR QUALITY SLEEP218 reports
DIARRHOEA212 reports
FEELING ABNORMAL208 reports
FALL203 reports
ANXIETY189 reports
PNEUMONIA182 reports
PYREXIA182 reports
VOMITING179 reports
ANAEMIA150 reports
DECREASED APPETITE149 reports
DYSPNOEA148 reports
PAIN147 reports
NIGHTMARE145 reports
MALAISE143 reports
DEPRESSION141 reports
ABNORMAL DREAMS132 reports
ASTHENIA124 reports
RASH120 reports
OVERDOSE119 reports
CONDITION AGGRAVATED117 reports
DEATH115 reports
ACUTE KIDNEY INJURY103 reports
CONSTIPATION103 reports
HALLUCINATION100 reports
RENAL IMPAIRMENT99 reports
DELIRIUM96 reports
DRUG INTERACTION95 reports
HEPATIC FUNCTION ABNORMAL95 reports
PNEUMONIA ASPIRATION94 reports
INTERSTITIAL LUNG DISEASE93 reports
CHRONIC KIDNEY DISEASE92 reports
TREMOR92 reports
PRURITUS91 reports
WEIGHT DECREASED89 reports
URINARY TRACT INFECTION87 reports
PLATELET COUNT DECREASED84 reports
RENAL FAILURE82 reports
HYPERTENSION81 reports
ALTERED STATE OF CONSCIOUSNESS80 reports
RESTLESSNESS80 reports
WEIGHT INCREASED80 reports
RESPIRATORY FAILURE77 reports
HYPOTENSION75 reports
INCORRECT DOSE ADMINISTERED75 reports
CARDIAC FAILURE73 reports
PAIN IN EXTREMITY73 reports
AGITATION71 reports
OEDEMA PERIPHERAL71 reports
HANGOVER70 reports
LOSS OF CONSCIOUSNESS70 reports
BACK PAIN69 reports
ARTHRALGIA67 reports
DEHYDRATION67 reports
GAIT DISTURBANCE67 reports
PALPITATIONS67 reports
ABDOMINAL PAIN66 reports
BLOOD PRESSURE DECREASED66 reports
INTENTIONAL OVERDOSE66 reports
SEPSIS65 reports
MEMORY IMPAIRMENT64 reports
COUGH63 reports
BLOOD PRESSURE INCREASED62 reports
DIABETES MELLITUS62 reports
SUICIDAL IDEATION61 reports
TOXICITY TO VARIOUS AGENTS60 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS60 reports
FEBRILE NEUTROPENIA58 reports
HYPERHIDROSIS58 reports
DYSPHAGIA57 reports
HYPERSOMNIA56 reports
CHEST PAIN54 reports
DEPRESSED LEVEL OF CONSCIOUSNESS54 reports
NO ADVERSE EVENT54 reports
SEIZURE54 reports
MIGRAINE53 reports
DRUG ERUPTION52 reports
WHITE BLOOD CELL COUNT DECREASED52 reports
ABDOMINAL PAIN UPPER51 reports
ALANINE AMINOTRANSFERASE INCREASED51 reports
HEART RATE INCREASED51 reports
NERVOUSNESS51 reports
CONFUSIONAL STATE50 reports
MUSCLE SPASMS50 reports
HAEMOGLOBIN DECREASED49 reports
SUICIDE ATTEMPT49 reports
HYPERSENSITIVITY48 reports
FEELING JITTERY47 reports
HOSPITALISATION47 reports
IRRITABILITY47 reports
SLEEP DISORDER47 reports

Report Outcomes

Out of 7,214 classified reports for RAMELTEON:

Serious 54.8%Non-Serious 45.2%

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

Female3,869 (57.8%)
Male2,736 (40.9%)
Unknown88 (1.3%)

Reports by Age

Age 66106 reports
Age 73105 reports
Age 75103 reports
Age 57100 reports
Age 5498 reports
Age 7098 reports
Age 7796 reports
Age 7996 reports
Age 6592 reports
Age 8591 reports
Age 5290 reports
Age 6489 reports
Age 5188 reports
Age 6983 reports
Age 8283 reports
Age 5582 reports
Age 6281 reports
Age 8081 reports
Age 7280 reports
Age 7680 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 RAMELTEON?

This profile reflects 11,977 FDA FAERS reports that mention RAMELTEON. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for RAMELTEON?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, INITIAL INSOMNIA, SOMNOLENCE, MIDDLE INSOMNIA, INSOMNIA, NAUSEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures RAMELTEON?

Labeling and FAERS entries often list Takeda Pharmaceuticals America, Inc. in connection with RAMELTEON. 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.