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
1	Drug ineffective*	695
2	Initial insomnia	440
3	Middle insomnia	375
4	Somnolence*	284
5	Insomnia*	274
6	Poor quality sleep	211
7	Nausea	190
8	Dizziness	181
9	Fatigue*	179
10	Headache*	178
11	Feeling abnormal	156
12	Nightmare*	127
13	Abnormal dreams*	123
14	Anxiety*	113
15	Depression	89
16	Overdose	89
17	Vomiting	87
18	Diarrhoea	81
19	Dyspnoea	76
20	Pain	71

* 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
1	Insomnia*	3976
2	Product used for unknown indication	794
3	Sleep disorder	644
4	Middle insomnia	252
5	Initial insomnia*	239
6	Prophylaxis	178
7	Schizophrenia, paranoid type	74
8	Circadian rhythm sleep disorder	47
9	Prophylaxis of nausea and vomiting	44
10	Sleep disorder therapy	34

*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.

Historical 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.