Skip to Content

The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.


Generic Name: thiothixene (THYE-oh-THIX-een)
Brand Name: Navane

Navane is an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Navane is not approved to treat mental problems caused by dementia.

Navane is used for:

Treating schizophrenia. It may also be used for other conditions as determined by your doctor.

Navane is an antipsychotic. It works by blocking dopamine receptors in the brain.

Do NOT use Navane if:

  • you are allergic to any ingredient in Navane
  • you have blood disorders or bone marrow problems, or severe circulation problems (eg, circulatory collapse)
  • you have severe drowsiness
  • you are taking tramadol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Navane:

Some medical conditions may interact with Navane. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines (including phenothiazines), foods, or other substances
  • if you have a history of seizures, brain damage, brain tumors, breast cancer, blood disorders, lupus, liver problems, intestinal blockage, eye or vision problems (eg, glaucoma), dementia, Alzheimer disease, alcohol abuse, or depression
  • if you have heart or blood vessel problems, Parkinson disease, or high or low blood pressure
  • if you are regularly exposed to extreme heat
  • if you have a history of alcohol abuse or if you drink more than 3 alcohol-containing drinks per day
  • if you will be having a myelogram

Some MEDICINES MAY INTERACT with Navane. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Medicines that may lower blood pressure because the risk of severe low blood pressure may occur
  • Anticholinergics (eg, benztropine), antihistamines (eg, diphenhydramine), barbiturates (eg, phenobarbital), opiates (eg, codeine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Navane's side effects
  • Carbamazepine because it may decrease Navane's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Navane may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Navane:

Use Navane as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Navane by mouth with or without food.
  • If you miss a dose of Navane, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Navane.

Important safety information:

  • Navane may cause drowsiness, dizziness, or fainting. These effects may be worse if you take it with alcohol or certain medicines. Use Navane with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Navane; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Navane may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Navane may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Navane may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Navane. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Do not become overheated in hot weather or while you are being active; heatstroke may occur.
  • Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Navane. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
  • Some patients who take Navane may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Navane in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Navane.
  • Tell your doctor or dentist that you take Navane before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including liver and kidney function and complete blood cell counts, may be performed while you use Navane. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Navane may cause false results in some pregnancy tests. Check with your doctor if you have any questions or concerns. Make sure your doctor and laboratory personnel know you are using Navane.
  • Use Navane with caution in the ELDERLY; they may be more sensitive to its effects.
  • Navane is not recommended for use in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Navane while you are pregnant. Using Navane during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Navane, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Navane:

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:

Changes in appetite; constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; lightheadedness; nasal congestion; nausea; sleeplessness; tired feeling; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; blurred vision or other vision changes; changes in breasts; changes in menstrual period; changes in sexual function; chest pain; confusion; difficulty speaking; difficulty swallowing; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; inability to move the eyes; inability to urinate; involuntary movements of the tongue, face, mouth, or jaw; lip smacking or puckering; mask-like face; mental confusion; muscle spasms of the face, neck, or back; numbness of the arms and legs; prolonged or painful erection; puffing of cheeks; restlessness; seizures; severe stomach pain; shuffling walk or stiff arms or legs; swelling of the arms or legs; tension in the leg; tightness in the throat or jaw; tremors of the hands; twitching or twisting movements; unusual or excessive sweating; weakness of the arms or legs; yellowing of the skin or eyes.

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.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include deep sleep or loss of consciousness; fast or irregular heartbeat; muscle spasms or stiffness; restlessness; seizures; tremors; twitching.

Proper storage of Navane:

Store Navane at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Navane out of the reach of children and away from pets.

General information:

  • If you have any questions about Navane, please talk with your doctor, pharmacist, or other health care provider.
  • Navane is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Navane or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Navane. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Navane. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Navane.

Issue Date: June 3, 2015