Thiothixene is an antipsychotic medicine that is used to treat schizophrenia.

Thiothixene may also be used for purposes not listed in this medication guide.

You should not use thiothixene if you are allergic to it, or if you have:

• a blood cell disorder such as anemia, low white blood cell counts, or low platelets; or
• drowsiness, slow breathing, weak pulse, or decreased alertness (such as after drinking alcohol or taking medicines that make you sleepy).

Thiothixene may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have ever had:

• epilepsy or other seizure disorder;
• heart disease;
• low white blood cell (WBC) counts;
• breast cancer; or
• alcoholism.

Tell your doctor if you are pregnant or if you become pregnant. Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Thiothixene is not approved for use by anyone younger than 12 years old.

Use Navane (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

High doses or long-term use of thiothixene can cause a serious movement disorder that may not be reversible. The longer you use thiothixene, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• stiffness in your neck, tightness in your throat, trouble breathing or swallowing;
• seizure (convulsions);
• a light-headed feeling, like you might pass out;
• severe constipation;
• low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing; or
• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects may include:

• dry mouth;
• blurred vision;
• nausea, vomiting, diarrhea, constipation;
• fast heartbeats, feeling restless;
• breast swelling or discharge;
• changes in weight or appetite; or
• swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Thiothixene can decrease sweating and you may be more prone to heat stroke.