Drug Safety Information for ROZEREM (Ramelteon)

Safety-related Labeling Changes for ROZEREM (RAMELTEON) Rx Drug: FDA Link

Adverse Drug Reactions for ROZEREM* (Ramelteon)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with ROZEREM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective*695
2Initial insomnia440
3Middle insomnia375
4Somnolence*284
5Insomnia*274
6Poor quality sleep211
7Nausea190
8Dizziness181
9Fatigue*179
10Headache*178
11Feeling abnormal156
12Nightmare*127
13Abnormal dreams*123
14Anxiety*113
15Depression89
16Overdose89
17Vomiting87
18Diarrhoea81
19Dyspnoea76
20Pain71

* This side effect also appears in "Top 10 Side Effects of ROZEREM " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ROZEREM
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Insomnia*3976
2Product used for unknown indication794
3Sleep disorder644
4Middle insomnia252
5Initial insomnia*239
6Prophylaxis178
7Schizophrenia, paranoid type74
8Circadian rhythm sleep disorder47
9Prophylaxis of nausea and vomiting44
10Sleep disorder therapy34

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for ROZEREM

Total Reports Filed with FDA: 13140


Number of FDA Adverse Event Reports by Patient Age for ROZEREM

Total Reports Filed with FDA: 13140*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ramelteon (Ramelteon, Rozerem)

Charts are based on 13140 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and ROZEREM Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

Visit   DrugInformer.com more on ROZEREM's side effects.