ramelteon Side Effects
Also known as: Rozerem
Analysis of 7,215 adverse event reports submitted to the FDA from 2005 to 2025.
Total Reports
7,215
Death-Related
784
10.9% of reports
Hospitalizations
2,039
28.3% of reports
Top Indication
Insomnia
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 784 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 115 |
| PNEUMONIA | 69 |
| INTERSTITIAL LUNG DISEASE | 52 |
| RESPIRATORY FAILURE | 49 |
| ANAEMIA | 44 |
| PNEUMONIA ASPIRATION | 41 |
| COMPLETED SUICIDE | 38 |
| PYREXIA | 33 |
| MALIGNANT NEOPLASM PROGRESSION | 32 |
| CARDIAC ARREST | 31 |
| DECREASED APPETITE | 30 |
| OFF LABEL USE | 30 |
| CARDIAC FAILURE | 29 |
| DIARRHOEA | 29 |
| PLATELET COUNT DECREASED | 29 |
| SEPSIS | 29 |
| DISEASE PROGRESSION | 25 |
| DISSEMINATED INTRAVASCULAR COAGULATION | 25 |
| RENAL IMPAIRMENT | 25 |
| HEPATIC FUNCTION ABNORMAL | 24 |
Reactions in Hospitalization Reports
Top reactions in 2,039 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| PNEUMONIA | 134 |
| FALL | 129 |
| PYREXIA | 129 |
| DIARRHOEA | 116 |
| OFF LABEL USE | 104 |
| NAUSEA | 98 |
| DECREASED APPETITE | 95 |
| ANAEMIA | 90 |
| INSOMNIA | 89 |
| VOMITING | 83 |
| DYSPNOEA | 75 |
| PNEUMONIA ASPIRATION | 72 |
| PAIN | 66 |
| SOMNOLENCE | 63 |
| URINARY TRACT INFECTION | 63 |
| INTERSTITIAL LUNG DISEASE | 62 |
| MALAISE | 62 |
| DEPRESSION | 60 |
| FATIGUE | 60 |
| HEADACHE | 60 |
Nearby — Related Medications
What the FAERS Data Reveals About ramelteon Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 7,215 voluntary reports linked to ramelteon and its brand equivalents (Rozerem), spanning 2005 through 2025. Of those, 784 (10.9%) listed death as an outcome and 2,039 (28.3%) involved hospitalization. The most common indication reported alongside adverse events was Insomnia.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 58% were female and 41% male; age distribution skews toward 45-64, with 1,498 reports in that bracket. The single most reported reaction is drug ineffective with 909 submissions, followed by initial insomnia and somnolence.
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.
Read our methodology — how this data is sourced, computed, and verified.