Tranxene T-Tab Side Effects

Generic Name: clorazepate,clorazepate dipotassium

Please note - some side effects for Tranxene T-Tab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Tranxene T-Tab - for the Consumer

Tranxene T-Tab

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tranxene T-Tab:

Blurred vision; clumsiness; confusion; dizziness; drowsiness; dry mouth; headache; lightheadedness; nervousness; stomach upset; unsteadiness; unusual weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased urination or change in the amount of urine produced; double vision; new or worsening mental or mood changes (eg, depression, agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, inability to sit still); new or worsening seizures; slurred speech; suicidal thoughts or actions; tremor; trouble sleeping.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Tranxene T-Tab Side Effects - for the Professional

Tranxene T-Tab

The side effect most frequently reported was drowsiness. Less commonly reported (in descending order of occurrence) were: dizziness, various gastrointestinal complaints, nervousness, blurred vision, dry mouth, headache, and mental confusion. Other side effects included insomnia, transient skin rashes, fatigue, ataxia, genitourinary complaints, irritability, diplopia, depression, tremor, and slurred speech.

There have been reports of abnormal liver and kidney function tests and of decrease in hematocrit.

Decrease in systolic blood pressure has been observed.

To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck Inc. at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects have been common and including drowsiness, dizziness, nervousness, fatigue, confusion, and headache. Less common nervous system effects have included insomnia, irritability, delirium, diplopia, depression, tremor, and slurred speech. A case of a rage reaction has been associated with clorazepate therapy.

Other

Other side effects have included withdrawal symptoms after abrupt cessation of clorazepate. These have included agitation, restlessness, nervousness, anxiety, insomnia, convulsions, tremor, nausea, headache and sweating.

Respiratory

Respiratory side effects including respiratory depression is theoretically possible and has been reported during therapy with other benzodiazepines.

Hepatic

Hepatic side effects have included a case of jaundice followed by focal hepatocellular necrosis.

Dermatologic

Dermatologic side effects including a case of photo-onycholysis has been reported in association with clorazepate therapy. Another case of skin blistering in association with an overdose of amitriptyline and clorazepate has also been reported.

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