Drug side effects
ramelteon Side Effects
The reactions most often reported to the FDA for ramelteon (also sold as Rozerem), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 7,215
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2005 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 ramelteon come from 7,215 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 7,215 reports to the FDA Adverse Event Reporting System (FAERS) for ramelteon (Rozerem): 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
7,215
Reports Mentioning Death
784
10.9% of reports — not proof the medicine caused the death
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 |
| 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 |
| 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 initial insomnia with 447 submissions, followed by somnolence and middle insomnia.
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 ramelteon's 7,215.
Read our methodology - how this data is sourced, computed, and verified.