LOW-VOLUME · HOSP-MID
ramelteon Side Effects
ramelteon (also sold as Rozerem) is a LOW-VOLUME FAERS extract #358 of 524 by FAERS report count. Still opens on HOSP-MID: 28.3% mention hospitalization (2,039 reports).
Data updated 2026-05-15
- 7,215
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
ramelteon: 28.3% mention hospitalization (2,039 reports). Death stamp DEATH-HEAVY; volume band LOW-VOLUME #358 of 524 by FAERS report count.
Thinner FAERS extract for ramelteon (Rozerem) (7,215 reports #358 of 524 by FAERS report count). 28.3% mention hospitalization (2,039 reports). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2005–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
INITIAL INSOMNIA leads 447 of 7,215 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (1,498 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (784 reports, 10.9%). Top co-reported reactions in that subset - voluntary, not causal.
| 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
Hospitalization mid-share (2,039, 28.3%). Co-reported reactions:
| 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 |
How to read ramelteon FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-MID)
FAERS holds 7,215 voluntary reports linked to ramelteon (Rozerem), 2005-2025. Death is listed on 784 (10.9%). Hospitalization appears on 2,039 (28.3%). Top co-reported indication: Insomnia.
Sparse extract - named reactions and SEX-BALANCED skew still differ by drug; not a complete safety profile.
Read with ramelteon
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 7,235 FAERS cases (Δ 20 heavier vs ramelteon); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 7,188 FAERS cases (Δ 27 lighter vs ramelteon); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 7,180 FAERS cases (Δ 35 lighter vs ramelteon); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 7,348 FAERS cases (Δ 133 heavier vs ramelteon); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 51.2 pp vs ramelteon's DEATH-HEAVY): CASELOAD · HOSP-MID.
ramelteon stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.