Home FDA labels 9cad5010-4359-8a0f-e053-2a95a90a9114 FDA label 9cad5010-4359-8a0f-e053-2a95a90a9114 openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
SPL set ID 74f261c5-a960-44ef-be4c-4dcefd881c3f
SPL ID 9cad5010-4359-8a0f-e053-2a95a90a9114
Version 3
Effective date 2020-01-21
Source export date 2026-09-28
Source partition 4
Source file https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
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adverse reactions ADVERSE REACTIONS SECTION During controlled clinical studies in which 1076 patients received temazepam at bedtime, the drug was well tolerated. Side effects were usually mild and transient. Adverse reactions occurring in 1% or more of patients are presented in the following table: Temazepam Placebo % Incidence (n=1076) % Incidence (n=783) Drowsiness 9.1 5.6 Headache 8.5 9.1 Fatigue 4.8 4.7 Nervousness 4.6 8.2 Lethargy 4.5 3.4 Dizziness 4.5 3.3 Nausea 3.1 3.8 Hangover 2.5 1.1 Anxiety 2.0 1.5 Depression 1.7 1.8 Dry Mouth 1.7 2.2 Diarrhea 1.7 1.1 Abdominal Discomfort 1.5 1.9 Euphoria 1.5 0.4 Weakness 1.4 0.9 Confusion 1.3 0.5 Blurred Vision 1.3 1.3 Nightmares 1.2 1.7 Vertigo 1.2 0.8 The following adverse events have been reported less frequently (0.5% - 0.9%): Central Nervous System – anorexia, ataxia, equilibrium loss, tremor, increased dreaming Cardiovascular – dyspnea, palpitations Gastrointestinal – vomiting Musculoskeletal – backache Special Senses – hyperhidrosis, burning eyes Amnesia, hallucinations, horizontal nystagmus, and paradoxical reactions including restlessness, overstimulation and agitation were rare (less than 0.5%).
adverse reactions table <table> <col/> <col/> <col/> <thead> <tr> <td valign="top"/> <td align="center" valign="top"> Temazepam</td> <td align="center" valign="top"> Placebo</td> </tr> <tr> <td valign="top"/> <td align="center" valign="top"> % Incidence (n=1076) </td> <td align="center" valign="top"> % Incidence (n=783) </td> </tr> </thead> <tbody> <tr> <td valign="top"> Drowsiness</td> <td align="center" valign="top"> 9.1</td> <td align="center" valign="top"> 5.6</td> </tr> <tr> <td valign="top"> Headache</td> <td align="center" valign="top"> 8.5</td> <td align="center" valign="top"> 9.1</td> </tr> <tr> <td valign="top"> Fatigue</td> <td align="center" valign="top"> 4.8</td> <td align="center" valign="top"> 4.7</td> </tr> <tr> <td valign="top"> Nervousness</td> <td align="center" valign="top"> 4.6</td> <td align="center" valign="top"> 8.2</td> </tr> <tr> <td valign="top"> Lethargy</td> <td align="center" valign="top"> 4.5</td> <td align="center" valign="top"> 3.4</td> </tr> <tr> <td valign="top"> Dizziness</td> <td align="center" valign="top"> 4.5</td> <td align="center" valign="top"> 3.3</td> </tr> <tr> <td valign="top"> Nausea</td> <td align="center" valign="top"> 3.1</td> <td align="center" valign="top"> 3.8</td> </tr> <tr> <td valign="top"> Hangover</td> <td align="center" valign="top"> 2.5</td> <td align="center" valign="top"> 1.1</td> </tr> <tr> <td valign="top"> Anxiety</td> <td align="center" valign="top"> 2.0</td> <td align="center" valign="top"> 1.5</td> </tr> <tr> <td valign="top"> Depression</td> <td align="center" valign="top"> 1.7</td> <td align="center" valign="top"> 1.8</td> </tr> <tr> <td valign="top"> Dry Mouth</td> <td align="center" valign="top"> 1.7</td> <td align="center" valign="top"> 2.2</td> </tr> <tr> <td valign="top"> Diarrhea</td> <td align="center" valign="top"> 1.7</td> <td align="center" valign="top"> 1.1</td> </tr> <tr> <td valign="top"> Abdominal Discomfort</td> <td align="center" valign="top"> 1.5</td> <td align="center" valign="top"> 1.9</td> </tr> <tr> <td valign="top"> Euphoria</td> <td align="center" valign="top"> 1.5</td> <td align="center" valign="top"> 0.4</td> </tr> <tr> <td valign="top"> Weakness</td> <td align="center" valign="top"> 1.4</td> <td align="center" valign="top"> 0.9</td> </tr> <tr> <td valign="top"> Confusion</td> <td align="center" valign="top"> 1.3</td> <td align="center" valign="top"> 0.5</td> </tr> <tr> <td valign="top"> Blurred Vision</td> <td align="center" valign="top"> 1.3</td> <td align="center" valign="top"> 1.3</td> </tr> <tr> <td valign="top"> Nightmares</td> <td align="center" valign="top"> 1.2</td> <td align="center" valign="top"> 1.7</td> </tr> <tr> <td valign="top"> Vertigo</td> <td align="center" valign="top"> 1.2</td> <td align="center" valign="top"> 0.8</td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.