What the label lists and what reports show
Ramelteon side effects
Ramelteon's FDA label: “Most common adverse reactions (≥3% and more common than with placebo) are: somnolence, dizziness, fatigue, nausea, and exacerbated insomnia.” FAERS holds 7,347 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is initial insomnia (447 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the ramelteon FDA label on DailyMed (effective April 15, 2026, Takeda Pharmaceuticals America, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ROZEREM?Possible serious side effects of ROZEREM include: severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking ROZEREM. getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See " What is the most important information I should know about ROZEREM? ") abnormal thoughts and behavior. Symptoms include worsening of depression, suicidal thoughts or actions, nightmares, and hallucinations. hormone effects. ROZEREM can decrease testosterone levels and increase prolactin levels in the blood. […]
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective April 15, 2026 (SPL set 9de82310-70e8-47b9-b1fc-6c6848b99455), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥3% and more common than with placebo) are: somnolence, dizziness, fatigue, nausea, and exacerbated insomnia.
Table 1. Incidence (% of subjects) of Treatment-Emergent Adverse Events
| MedDRA Preferred Term | Placebo (n=1456) | Ramelteon 8 mg (n=1405) |
|---|---|---|
| Somnolence | 2% | 3% |
| Fatigue | 2% | 3% |
| Dizziness | 3% | 4% |
| Nausea | 2% | 3% |
| Insomnia exacerbated | 2% | 3% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed in greater detail in other sections: Severe anaphylactic and anaphylactoid reactions [see Warnings and Precautions (5.1) ] Abnormal thinking, behavior changes, and complex behaviors [see Warnings and Precautions (5.3) ] CNS effects [see Warnings and Precautions (5.4) ] Most common adverse reactions (≥3% and more common than with placebo) are: somnolence, dizziness, fatigue, nausea, and exacerbated insomnia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Adverse Reactions Resulting in Discontinuation of Treatment The data described in this section reflect exposure to ROZEREM in 5373 subjects, including 722 exposed for six months or longer, and 448 subjects for one year. Six percent of the 5373 individual subjects exposed to ROZEREM in clinical studies discontinued treatment owing to an adverse event, compared with 2% of the 2279 subjects receiving placebo. The most frequent adverse events leading to discontinuation in subjects receiving ROZEREM were somnolence, dizziness, nausea, fatigue, headache, and insomnia; all of which occurred in 1% of the patients or less. …
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective April 15, 2026 (SPL set 9de82310-70e8-47b9-b1fc-6c6848b99455), via openFDA; the full label on DailyMed
What do FAERS reports show?
7,347 reports list ramelteon among the medicines taken, each a report of something that happened, not proof the medicine caused it; 802 are coded as a death and 2,087 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ramelteon: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions