Rozerem Side Effects
Generic Name: Ramelteon
Please note - some side effects for Rozerem may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Rozerem - for the consumer
Rozerem
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Rozerem:
Seek medical attention right away if any of these SEVERE side effects occur when using Rozerem:Diarrhea; dizziness; drowsiness; fatigue; nausea: tiredness.
TopSevere allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); absence of a menstrual cycle; decreased sex drive; fever; hallucinations; headache; irregular heartbeat; mental or mood changes; muscle aches; muscle or joint pain; pounding in the chest; problems with fertility; suicidal thoughts or behaviors; unexplained breast milk production; vision changes; worsening of depression; worsening of sleeplessness.
For the professional
Rozerem
Overview
The data described in this section reflect exposure to Rozerem in 4251 subjects, including 346 exposed for 6 months or longer, and 473 subjects for one year.
Adverse Reactions Resulting in Discontinuation of Treatment
Six percent of the 3594 individual subjects exposed to Rozerem in clinical studies discontinued treatment owing to an adverse event, compared with 2% of the 1370 subjects receiving placebo. The most frequent adverse events leading to discontinuation in subjects receiving Rozerem were somnolence (0.8%), dizziness (0.5%), nausea (0.3%), fatigue (0.3%), headache (0.3%), and insomnia (0.3%).
Rozerem Most Commonly Observed Adverse Events in Phase 1-3 trials
Table 1 displays the incidence of adverse events during the Phase 1 through 3 trials.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of other drugs, and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
| MedDRA Preferred Term | Placebo (n=1370) | Ramelteon 8 mg (n=1250) |
| Headache NOS | 7% | 7% |
| Somnolence | 3% | 5% |
| Fatigue | 2% | 4% |
| Dizziness | 3% | 5% |
| Nausea | 2% | 3% |
| Insomnia exacerbated | 2% | 3% |
| Upper respiratory tract infection NOS | 2% | 3% |
| Diarrhea NOS | 2% | 2% |
| Myalgia | 1% | 2% |
| Depression | 1% | 2% |
| Dysgeusia | 1% | 2% |
| Arthralgia | 1% | 2% |
| Influenza | 0 | 1% |
| Blood cortisol decreased | 0 | 1% |
More resources:
Rozerem - Includes detailed dosage instructions.
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