Tranxene

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 Recordati Rare Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Read the entire FDA prescribing information for Tranxene (Clorazepate Dipotassium)

Tranxene is a prescription medication used to treat anxiety and as an add-on medication to treat partial seizures.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Tranxene.

Common side effects of Tranxene include the following:

• drowsiness
• dizziness
• upset stomach
• blurred vision
• dry mouth
• confusion

This is not a complete list of Tranxene side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Clorazepate is used to relieve symptoms of anxiety and alcohol withdrawal. This medicine may also be used with other medicines to treat partial seizures.

Clorazepate is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

This medicine is available only with your doctor's prescription.

Applies to clorazepate: oral capsule, oral tablet, oral tablet extended release

Along with its needed effects, clorazepate (the active ingredient contained in Tranxene) 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:

• 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:

• Change in consciousness
• drowsiness
• loss of consciousness
• relaxed and calm
• sleepiness

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:

• 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