ROZEREM
Rozerem Adverse Events Reported to the FDA Over Time
How are Rozerem adverse event reports trending over time?
This graph shows volume of adverse events submitted to the FDA by quarter for Rozerem, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Rozerem is flagged as the suspect drug causing the adverse event.
Most Common Rozerem Adverse Events Reported to the FDA
What are the most common Rozerem adverse events reported to the FDA?
| Drug Ineffective | 675 (10.52%) |
| Initial Insomnia | 464 (7.23%) |
| Middle Insomnia | 385 (6%) |
| Somnolence | 270 (4.21%) |
| Poor Quality Sleep | 223 (3.47%) |
| Insomnia | 214 (3.33%) |
| Feeling Abnormal | 149 (2.32%) |
| Fatigue | 147 (2.29%) |
| Dizziness | 140 (2.18%) |
| Abnormal Dreams | 133 (2.07%) |
| Nightmare | 131 (2.04%) |
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This graph shows the top adverse events submitted to the FDA for Rozerem, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Rozerem is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.
Adverse Event Categories for Rozerem
What are the most common Rozerem adverse events reported to the FDA?
| Sleep Disorders | 1380 (21.5%) |
| Therapeutic And Nontherapeutic Effe... | 809 (12.6%) |
| Neurological | 610 (9.5%) |
| Sleep Disturbances | 268 (4.18%) |
| Medication Errors | 243 (3.79%) |
| Gastrointestinal Signs | 197 (3.07%) |
| Anxiety Disorders | 181 (2.82%) |
| Headaches | 152 (2.37%) |
| Disturbances In Thinking | 111 (1.73%) |
| Epidermal And Dermal Conditions | 103 (1.6%) |
| Respiratory | 82 (1.28%) |
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Share/Embed Graph Export Data
This graph shows the top categories of adverse events submitted to the FDA for Rozerem, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Rozerem is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.
Common Uses of Rozerem According to Those Reporting Adverse Events
Why are people taking Rozerem, according to those reporting adverse events to the FDA?
| Insomnia | 1407 |
| Drug Use For Unknown Indication | 189 |
| Sleep Disorder | 186 |
| Initial Insomnia | 149 |
| Middle Insomnia | 101 |
| Circadian Rhythm Sleep Disorder | 19 |
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Drug Labels
| Label | Labeler | Effective |
|---|---|---|
| Rozerem | Physicians Total Care, Inc. | 20-JAN-10 |
| Rozerem | Rebel Distributors Corp | 11-NOV-10 |
| Rozerem | Takeda Pharmaceuticals America, Inc. | 16-NOV-10 |
| Rozerem | Lake Erie Medical DBA Quality Care Products LLC | 15-NOV-11 |
Rozerem Case Reports
What Rozerem safety concerns are being reported by doctors and researchers in the medical literature?
About Results
This report contains aggregated drug side effects and adverse events for Rozerem. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.
DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.
DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.
Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.
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