RESTORIL
Restoril Adverse Events Reported to the FDA Over Time
How are Restoril adverse event reports trending over time?
This graph shows volume of adverse events submitted to the FDA by quarter for Restoril, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Restoril is flagged as the suspect drug causing the adverse event.
Most Common Restoril Adverse Events Reported to the FDA
What are the most common Restoril adverse events reported to the FDA?
| Anxiety | 43 (2.81%) |
| Depression | 43 (2.81%) |
| Amnesia | 39 (2.55%) |
| Hallucination | 37 (2.42%) |
| Completed Suicide | 36 (2.35%) |
| Drug Ineffective | 34 (2.22%) |
| Insomnia | 32 (2.09%) |
| Confusional State | 30 (1.96%) |
| Suicidal Ideation | 29 (1.9%) |
| Nervousness | 25 (1.64%) |
| Feeling Abnormal | 23 (1.5%) |
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Share/Embed Graph Export Data
This graph shows the top adverse events submitted to the FDA for Restoril, 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 Restoril 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 Restoril
What are the most common Restoril adverse events reported to the FDA?
| Neurological | 91 (5.95%) |
| Anxiety Disorders | 86 (5.62%) |
| Sleep Disorders | 83 (5.43%) |
| Suicidal And Self-injurious Behavio... | 82 (5.36%) |
| Injuries | 66 (4.32%) |
| Therapeutic And Nontherapeutic Effe... | 63 (4.12%) |
| Mental Impairment | 49 (3.2%) |
| Depressed Mood Disorders | 48 (3.14%) |
| Gastrointestinal Signs | 48 (3.14%) |
| Disturbances In Thinking | 42 (2.75%) |
| Mood Disorders | 41 (2.68%) |
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Share/Embed Graph Export Data
This graph shows the top categories of adverse events submitted to the FDA for Restoril, 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 Restoril 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 Restoril According to Those Reporting Adverse Events
Why are people taking Restoril, according to those reporting adverse events to the FDA?
| Insomnia | 499 |
| Sleep Disorder | 331 |
| Product Used For Unknown Indication | 162 |
| Drug Use For Unknown Indication | 148 |
| Sleep Disorder Therapy | 70 |
| Depression | 39 |
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Drug Labels
| Label | Labeler | Effective |
|---|---|---|
| Restoril | Mallinckrodt, Inc. | 11-JUL-11 |
| Restoril | Physicians Total Care, Inc. | 11-JUL-11 |
| Restoril | Cardinal Health | 10-AUG-11 |
Restoril Case Reports
What Restoril 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 Restoril. 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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