78/100 · Elevated
Manufactured by SpecGx LLC
Temazepam Adverse Events: High Incidence of Serious Reactions and Drug Interactions
90,302 FDA adverse event reports analyzed
Last updated: 2026-05-12
TEMAZEPAM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by SpecGx LLC. Based on analysis of 90,302 FDA adverse event reports, TEMAZEPAM has a safety score of 78 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for TEMAZEPAM include FATIGUE, DRUG INEFFECTIVE, NAUSEA, PAIN, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TEMAZEPAM.
Temazepam has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 90,302 adverse event reports for this medication, which is primarily manufactured by Specgx Llc.
The most commonly reported adverse events include Fatigue, Drug Ineffective, Nausea. Of classified reports, 75.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Temazepam reports include a high number of serious adverse events, particularly related to respiratory issues and falls.
The drug is frequently reported to be ineffective, leading to patient dissatisfaction. There is a significant risk of drug interactions, especially with other sedatives and antipsychotics.
Patients taking Temazepam should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Temazepam can interact with a variety of drugs, including other sedatives and antipsychotics, potentially leading to increased sedation and respiratory depression. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Temazepam received a safety concern score of 78/100 (high concern). This is based on a 75.0% serious event ratio across 36,906 classified reports. The score accounts for 90,302 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 20,879, Male: 13,662, Unknown: 68. The most frequently reported age groups are age 58 (752 reports), age 61 (634 reports), age 64 (628 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 36,906 classified reports for TEMAZEPAM:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Temazepam can interact with a variety of drugs, including other sedatives and antipsychotics, potentially leading to increased sedation and respiratory depression.
If you are taking Temazepam, here are important things to know. The most commonly reported side effects include fatigue, drug ineffective, nausea, pain, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should avoid driving or operating heavy machinery until they know how Temazepam affects them. Inform your healthcare provider about all medications you are taking to avoid potential drug interactions. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA closely monitors Temazepam due to its high rate of serious adverse events, particularly respiratory issues and falls. Healthcare providers should be vigilant and consider alternative treatments for patients with a history of these issues.
The FDA has received approximately 90,302 adverse event reports associated with Temazepam. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Temazepam include Fatigue, Drug Ineffective, Nausea, Pain, Headache. By volume, the top reported reactions are: Fatigue (2,802 reports), Drug Ineffective (2,413 reports), Nausea (2,400 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Temazepam.
Out of 36,906 classified reports, 27,669 (75.0%) were classified as serious and 9,237 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Temazepam break down by patient sex as follows: Female: 20,879, Male: 13,662, Unknown: 68. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Temazepam adverse events are: age 58: 752 reports, age 61: 634 reports, age 64: 628 reports, age 62: 599 reports, age 54: 586 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Temazepam adverse event reports is Specgx Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Temazepam include: Toxicity To Various Agents, Diarrhoea, Dyspnoea, Insomnia, Death. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Temazepam to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Temazepam has a safety concern score of 78 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Temazepam reports include a high number of serious adverse events, particularly related to respiratory issues and falls.
Key safety signals identified in Temazepam's adverse event data include: Over 1600 reports of death, making it one of the most serious adverse events.. More than 1000 reports of falls, indicating a risk of injury.. Over 800 reports of drug interactions, highlighting the need for caution with concurrent medications.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Temazepam can interact with a variety of drugs, including other sedatives and antipsychotics, potentially leading to increased sedation and respiratory depression. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Temazepam.
Patients should avoid driving or operating heavy machinery until they know how Temazepam affects them. Inform your healthcare provider about all medications you are taking to avoid potential drug interactions.
Temazepam has 90,302 adverse event reports on file with the FDA. The drug is frequently reported to be ineffective, leading to patient dissatisfaction. The volume of reports for Temazepam reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Temazepam due to its high rate of serious adverse events, particularly respiratory issues and falls. Healthcare providers should be vigilant and consider alternative treatments for patients with a history of these issues. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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