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Rozerem Side Effects

Generic Name: ramelteon

Note: This document contains side effect information about ramelteon. Some of the dosage forms listed on this page may not apply to the brand name Rozerem.

For the Consumer

Applies to ramelteon: oral tablet

Along with its needed effects, ramelteon (the active ingredient contained in Rozerem) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects of ramelteon may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Dizziness
  • sleepiness or unusual drowsiness
Less common
  • Body aches or pain
  • change in taste
  • chills
  • cough
  • difficulty in breathing
  • difficulty in moving
  • discouragement
  • ear congestion
  • fatigue
  • feeling sad or empty
  • fever
  • general feeling of discomfort or illness
  • irritability
  • joint pain
  • loss of appetite
  • loss of interest or pleasure
  • loss of taste
  • loss of voice
  • muscle aching or cramping
  • muscle pain or stiffness
  • nasal congestion
  • nausea
  • pain in joints
  • runny nose
  • shivering
  • sleeplessness
  • sneezing
  • sore throat
  • sweating
  • swollen joints
  • trouble concentrating
  • trouble sleeping
  • unable to sleep
  • unusual tiredness or weakness
  • vomiting

For Healthcare Professionals

Applies to ramelteon: oral tablet

Psychiatric

Common (1% to 10%): Exacerbated insomnia
Frequency not reported: Behavioral changes, complex behaviors, amnesia, hallucinations, anxiety[Ref]

Nervous system

Common (1% to 10%): Somnolence, dizziness[Ref]

Immunologic

Rare (less than 0.1%): Severe anaphylactic and anaphylactoid reactions (e.g., angioedema)[Ref]

Gastrointestinal

Common (1% to 10%): Nausea[Ref]

Other

Common (1% to 10%): Fatigue[Ref]

References

1. "Product Information. Rozerem (ramelteon)." Takeda Pharmaceuticals America, Lincolnshire, IL.

Some side effects of Rozerem may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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