Drug · FAERS side-effect profile with label screen
Ramelteon side effects: what 7,347 FDA adverse event reports show
Drug class
Melatonin Receptor Agonist
FDA label (Established Pharmacologic Class)
Who reports
7,347 reports · 55% serious · 802 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Ramelteon Tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were perfo.
FDA label, Indications and Usage
What it is
Ramelteon is an orally active hypnotic chemically designated as (S-N-[2-(1,6,7,8-tetrahydro -2H-indeno-[5,4-b]furan-8-yl)ethyl] propionamide and containing one chiral center. The compound is p.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 2Labeled (related wording) 1Likely indication confounding 3Reporting / coding artifact 2Not in label — unassessed 32
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 373 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Initial insomnia | 447 | 130.8 119.3–143.5ROR 139.3 · χ² 54,942 / p <1e-300 | 124.4 EB05 115.0 · IC025 +6.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 · 82% consumer | no trial data cached |
| Middle insomnia | 390 | 61.1 55.4–67.4ROR 64.5 · χ² 22,528 / p <1e-300 | 59.7 EB05 54.9 · IC025 +5.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.0 · 80% consumer | no trial data cached |
| Poor quality sleep | 218 | 29.4 25.7–33.5ROR 30.2 · χ² 5,889 / p <1e-300 | 29.0 EB05 25.9 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 · 71% consumer | no trial data cached |
| Abnormal dreams | 133 | 13.7 11.6–16.2ROR 13.9 · χ² 1,549 / p <1e-300 | 13.6 EB05 11.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Nightmare | 145 | 11.9 10.2–14.0ROR 12.2 · χ² 1,440 / p <1e-300 | 11.8 EB05 10.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Pneumonia aspiration | 98 | 11.3 9.2–13.7ROR 11.4 · χ² 904 / p 8e-199 | 11.1 EB05 9.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · ♀ 33% (drug 58%) | no trial data cached |
| Altered state of consciousness | 80 | 10.6 8.5–13.2ROR 10.7 · χ² 686 / p 1e-151 | 10.4 EB05 8.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 | no trial data cached |
| Disseminated intravascular coagulation | 43 | 8.7 6.5–11.7ROR 8.8 · χ² 285 / p 3e-64 | 8.2 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 · ♀ 33% (drug 58%) | no trial data cached |
| Drug eruption | 52 | 8.4 6.4–11.1ROR 8.5 · χ² 333 / p 1e-74 | 8.0 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Delirium | 99 | 8.2 6.7–10.0ROR 8.3 · χ² 617 / p 2e-136 | 8.0 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Hepatic function abnormal | 98 | 7.6 6.2–9.2ROR 7.7 · χ² 551 / p 4e-122 | 7.3 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · 90% clinician | no trial data cached |
| Drug dispensing error | 39 | 7.2 5.3–9.8ROR 7.2 · χ² 202 / p 5e-46 | 6.7 EB05 5.1 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=26 · ♀ 93% (drug 58%) · 100% clinician | no trial data cached |
| Feeling jittery | 47 | 7.0 5.3–9.4ROR 7.1 · χ² 237 / p 8e-54 | 6.6 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 23 | 6.5 4.3–9.7ROR 6.5 · χ² 101 / p 6e-24 | 5.8 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Restlessness | 81 | 6.3 5.1–7.8ROR 6.4 · χ² 357 / p 6e-80 | 6.1 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Ileus | 27 | 6.3 4.3–9.1ROR 6.3 · χ² 114 / p 6e-27 | 5.7 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Somnolence (drowsiness) | 418 | 5.9 5.4–6.5ROR 6.2 · χ² 1,727 / p <1e-300 | 5.9 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Hypersomnia | 57 | 5.7 4.4–7.4ROR 5.7 · χ² 216 / p 4e-49 | 5.4 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Interstitial lung disease | 94 | 5.6 4.5–6.8ROR 5.6 · χ² 347 / p 9e-78 | 5.4 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 92% clinician | no trial data cached |
| Neuroleptic malignant syndrome | 23 | 5.5 3.7–8.3ROR 5.5 · χ² 81 / p 1e-19 | 5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Cerebral infarction | 45 | 5.3 3.9–7.0ROR 5.3 · χ² 151 / p 6e-35 | 5.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · ♀ 30% (drug 58%) · 91% clinician | no trial data cached |
| Prescribed overdose | 35 | 5.2 3.7–7.2ROR 5.2 · χ² 113 / p 9e-27 | 4.8 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Atelectasis | 17 | 5.0 3.1–8.1ROR 5.0 · χ² 51 / p 6e-13 | 4.4 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Parkinsonism | 16 | 4.7 2.9–7.7ROR 4.7 · χ² 43 / p 3e-11 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Restless legs syndrome | 29 | 4.6 3.2–6.5ROR 4.6 · χ² 77 / p 1e-18 | 4.3 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Hallucination, visual | 32 | 4.4 3.1–6.2ROR 4.4 · χ² 79 / p 3e-19 | 4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Iron deficiency anaemia | 14 | 4.4 2.6–7.3ROR 4.4 · χ² 33 / p 5e-9 | 3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Insomnia (trouble sleeping) | 398 | 4.3 3.9–4.7ROR 4.4 · χ² 1,002 / p 3e-220 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.6 | no trial data cached |
| Schizophrenia | 18 | 4.2 2.7–6.7ROR 4.2 · χ² 41 / p 7e-11 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Oesophagitis | 16 | 4.2 2.6–6.8ROR 4.2 · χ² 36 / p 1e-9 | 3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Psychomotor hyperactivity | 24 | 4.1 2.8–6.1ROR 4.1 · χ² 53 / p 1e-13 | 3.8 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Sedation | 37 | 4.1 2.9–5.6ROR 4.1 · χ² 82 / p 6e-20 | 3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Hyperlipidaemia | 17 | 4.1 2.5–6.5ROR 4.1 · χ² 36 / p 1e-9 | 3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Sleep apnoea syndrome | 27 | 4.0 2.8–5.9ROR 4.0 · χ² 59 / p 1e-14 | 3.8 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 | no trial data cached |
| Acute respiratory failure | 27 | 4.0 2.8–5.9ROR 4.0 · χ² 58 / p 1e-14 | 3.8 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Depressed level of consciousness | 55 | 4.0 3.1–5.2ROR 4.0 · χ² 120 / p 3e-28 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Subarachnoid haemorrhage | 14 | 3.9 2.3–6.6ROR 3.9 · χ² 28 / p 8e-8 | 3.5 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Hallucination (hallucinations) | 101 | 3.8 3.2–4.7ROR 3.9 · χ² 211 / p 5e-48 | 3.8 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Hepatic steatosis | 25 | 3.8 2.6–5.7ROR 3.8 · χ² 50 / p 9e-13 | 3.6 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 79% (drug 58%) | no trial data cached |
| Delusion | 20 | 3.7 2.4–5.7ROR 3.7 · χ² 37 / p 8e-10 | 3.4 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 923 | 2.0 1.9–2.1ROR 2.1 · χ² 492 / p 3e-109 | 2.0 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 0.6 · 73% consumer | no trial data cached |
| Initial insomnia | 447 | 130.8 119.3–143.5ROR 139.3 · χ² 54,942 / p <1e-300 | 124.4 EB05 115.0 · IC025 +6.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 · 82% consumer | no trial data cached |
| Somnolence (drowsiness) | 418 | 5.9 5.4–6.5ROR 6.2 · χ² 1,727 / p <1e-300 | 5.9 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Insomnia (trouble sleeping) | 398 | 4.3 3.9–4.7ROR 4.4 · χ² 1,002 / p 3e-220 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.6 | no trial data cached |
| Middle insomnia | 390 | 61.1 55.4–67.4ROR 64.5 · χ² 22,528 / p <1e-300 | 59.7 EB05 54.9 · IC025 +5.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.0 · 80% consumer | no trial data cached |
| Dizziness | 273 | 1.6 1.4–1.8ROR 1.6 · χ² 56 / p 3e-14 | 1.6 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.1 | no trial data cached |
| Poor quality sleep | 218 | 29.4 25.7–33.5ROR 30.2 · χ² 5,889 / p <1e-300 | 29.0 EB05 25.9 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 · 71% consumer | no trial data cached |
| Fall | 207 | 1.8 1.6–2.0ROR 1.8 · χ² 71 / p 2e-17 | 1.8 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Feeling abnormal | 207 | 2.5 2.1–2.8ROR 2.5 · χ² 179 / p 3e-41 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Anxiety | 194 | 1.9 1.7–2.2ROR 2.0 · χ² 89 / p 2e-21 | 1.9 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Decreased appetite (loss of appetite) | 157 | 1.9 1.7–2.3ROR 2.0 · χ² 71 / p 2e-17 | 1.9 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Anaemia (low red blood cells) | 151 | 2.3 1.9–2.6ROR 2.3 · χ² 106 / p 5e-25 | 2.2 EB05 2.0 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Depression | 146 | 1.8 1.6–2.1ROR 1.8 · χ² 54 / p 1e-13 | 1.8 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Nightmare | 145 | 11.9 10.2–14.0ROR 12.2 · χ² 1,440 / p <1e-300 | 11.8 EB05 10.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Abnormal dreams | 133 | 13.7 11.6–16.2ROR 13.9 · χ² 1,549 / p <1e-300 | 13.6 EB05 11.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Abnormal dreams — n=133, PRR 13.7
- Nightmare — n=145, PRR 11.9
- Pneumonia aspiration — n=98, PRR 11.3
- Altered state of consciousness — n=80, PRR 10.6
- Disseminated intravascular coagulation — n=43, PRR 8.7
- Drug eruption — n=52, PRR 8.4
- Delirium — n=99, PRR 8.2
- Hepatic function abnormal — n=98, PRR 7.6
- Feeling jittery — n=47, PRR 7.0
- Inappropriate antidiuretic hormone secretion — n=23, PRR 6.5
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Ramelteon?
In FDA FAERS, the most frequently co-reported reaction terms for Ramelteon are initial insomnia, somnolence, insomnia, middle insomnia, dizziness, fall. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Ramelteon have an FDA boxed warning?
No. The FDA label retrieved for Ramelteon has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ramelteon causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 00f0fbda-eb62-4f79-ae9c-286b31eca733, effective 20260507; matched on
openfda.generic_name.exact:"RAMELTEON") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 413 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.