Tranxene Side Effects
Generic name: clorazepate
Medically reviewed by Drugs.com. Last updated on Sep 12, 2024.
Note: This document provides detailed information about Tranxene Side Effects associated with clorazepate. Some dosage forms listed on this page may not apply specifically to the brand name Tranxene.
Applies to clorazepate: oral tablet.
Important warnings
This medicine can cause some serious health issues
Oral route (tablet)
Risks from Concomitant Use with Opioids; Abuse, Misuse, and Addiction; and Dependence and Withdrawal Reactions. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and sedation.The use of benzodiazepines, including clorazepate, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death.
Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes.
Before prescribing clorazepate and throughout out treatment, assess each patient’s risk for abuse, misuse, and addiction.The continued use of benzodiazepines, including clorazepate, may lead to clinically significant physical dependence.
The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose.
Abrupt discontinuation or rapid dosage reduction of clorazepate after continued use may precipitate acute withdrawal reactions, which can be life-threatening.
To reduce the risk of withdrawal reactions, use a gradual taper to discontinue clorazepate or reduce the dosage.
Precautions
It is very important that your doctor check the progress of you or your child at regular visits to see if the medicine is working properly. Blood tests may be needed to check for any unwanted effects.
Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during the later pregnancy may cause problems in your newborn baby (eg, sedation or withdrawal symptoms). Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, feeding problems, a high-pitched cry, irritability, low muscle tone, restlessness, shakiness or tremors, sluggishness, trouble breathing, weight loss, vomiting, or fails to gain weight. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally. Also, this medicine may cause double vision or other vision problems. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.
This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, benzodiazepines, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your medical doctor or dentist before taking any of the above while you are using this medicine.
Do not Stop taking clorazepate (the active ingredient contained in Tranxene) without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, including hallucinations, nausea or vomiting, seizures, stomach or muscle cramps, tremors, or unusual behavior.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
If you or your child develop any unusual or strange thoughts and behavior while taking this medicine, be sure to discuss it with your doctor. Clorazepate may cause confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), thoughts of killing oneself, and unusual excitement, nervousness, or irritability.
Symptoms of an overdose include: change in consciousness, changes in patterns and rhythms of speech, hallucinations, lack of coordination, loss of consciousness, loss of strength or energy, mood or mental changes, muscle pain or weakness, nightmares, sleepiness or unusual drowsiness, shakiness and unsteady walk, slurred speech, trouble in speaking, trouble sleeping, unsteadiness, trembling, or other problems with muscle control or coordination, unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness, unusual excitement, nervousness, restlessness, or irritability, or unusual weak feeling. Call your doctor right away if you notice these symptoms.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Serious side effects of Tranxene
Along with its needed effects, clorazepate may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking clorazepate:
Less common side effects
- bladder pain
- bloody or cloudy urine
- difficult, burning, or painful urination
- frequent urge to urinate
- lower back or side pain
- shakiness and unsteady walk
- slurred speech
- trembling or shaking of the hands or feet
- unsteadiness, trembling, or other problems with muscle control or coordination
Get emergency help immediately if any of the following symptoms of overdose occur while taking clorazepate:
Symptoms of overdose
- agitation
- change in consciousness
- changes in patterns and rhythms of speech
- drowsiness
- loss of consciousness
- loss of strength or energy
- mood or mental changes
- nightmares
- shakiness and unsteady walk
- sleepiness
- slurred speech
- talkativeness
- trouble speaking
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- unusual excitement, nervousness, restlessness, or irritability
Other side effects of Tranxene
Some side effects of clorazepate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common side effects
- blurred vision
- diarrhea
- discouragement
- dizziness
- double vision
- dry mouth
- feeling sad or empty
- headache
- indigestion
- irritability
- loss of appetite
- loss of interest or pleasure
- mental confusion
- nausea or vomiting
- nervousness
- passing of gas
- seeing double
- skin rash
- stomach pain, fullness, or discomfort
- trouble with concentrating
- trouble with sleeping
- unusual tiredness or weakness
For healthcare professionals
Applies to clorazepate: oral tablet.
General adverse events
The most commonly reported side effect was drowsiness.[Ref]
Nervous system
- Frequency not reported: Ataxia, dizziness, drowsiness, headache, nervousness, slurred speech[Ref]
Psychiatric
- Frequency not reported: Depression, insomnia, irritability, mental confusion, suicidal ideation/behavior[Ref]
Gastrointestinal
- Frequency not reported: Dry mouth, various gastrointestinal complaints[Ref]
Ocular
- Frequency not reported: Blurred vision, diplopia[Ref]
Dermatologic
- Frequency not reported: Transient skin rash[Ref]
Other
Genitourinary
- Frequency not reported: Genitourinary complaints[Ref]
Hepatic
- Frequency not reported: Abnormal liver function tests[Ref]
Renal
- Frequency not reported: Abnormal kidney function tests[Ref]
Hematologic
- Frequency not reported: Decreased hematocrit[Ref]
Cardiovascular
- Frequency not reported: Decrease in systolic blood pressure[Ref]
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References
1. (2001) "Product Information. Tranxene (clorazepate)." Abbott Pharmaceutical
More about Tranxene (clorazepate)
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Further information
Tranxene side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.