Drug Profile

Pregnancy Warning

This drug caused harm to developing fetuses in animal studies. This drug should be used during pregnancy only for clear medical reasons. Tell your doctor if you are pregnant or thinking of becoming pregnant before you take this drug.

The FDA updated the information for this entire class of antipsychotic drugs relating to their potential risk to newborns when used during pregnancy. The drugs’ product labels have been updated to include information stating that when mothers are treated with these drugs during the third trimester of pregnancy, there is a potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in their newborns.

Breast-feeding Warning

There are no data on the transfer of thiothixene to breast milk. However, many drugs are excreted in breast milk. Chlorpromazine, another drug in this class, has a warning not to nurse because of the potential for serious adverse effects on the nursing infant.

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Thioridazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis.

Decreased Sweating

This drug may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or in hot weather while you are taking this medication, since overheating may result in heatstroke. Also, hot baths or saunas may make you feel dizzy or faint when you are taking this medication.

Product Warnings

Ask a doctor or pharmacist before use if you are taking antibiotics.

When using this product, tiredness, drowsiness or dizziness may occur. Be careful driving or operating machinery.

Stop using and ask a doctor if symptoms get worse, diarrhea lasts more than two days or you get abdominal swelling or bulging. These may be signs of a serious condition.

If pregnant or breast-feeding, ask a health care professional before use.

Older adults are especially sensitive to the harmful anticholinergic effects of this drug. Drugs in this family should not be used unless absolutely necessary.

Mental Effects: confusion, delirium, short-term memory problems, disorientation and impaired attention.

Physical Effects: dry mouth, constipation, difficulty urinating (especially for a man with an enlarged prostate), blurred vision, decreased sweating with increased body temperature, sexual dysfunction and worsening of glaucoma.

Do not use if you have or have had:

• blood diseases
• bone marrow depression
• central nervous system depression
• drug-induced coma
• collapse of blood vessels

Tell your doctor if you have or have had:

• allergies to drugs
• alcohol dependence
• peptic ulcer
• enlarged prostate or difficulty urinating
• glaucoma
• heart or blood vessel disease
• lung disease or breathing problems
• Parkinson’s disease
• epilepsy, seizures
• liver disease
• Reye’s syndrome
• pregnancy or are breast-feeding

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

• It may take two to three weeks before you can tell that the drug is working.
• Do not stop taking this drug suddenly. Your doctor must give you a schedule to lower your dose gradually, to prevent withdrawal symptoms such as nausea, vomiting, and stomach upset.
• Until you know how you react to this drug, do not drive or perform other activities requiring alertness. This drug may cause blurred vision, drowsiness, and fainting.
• Do not drink alcohol or use other drugs that can cause drowsiness.
• You may feel dizzy when rising from a lying or sitting position. When getting out of bed, hang your feet over the side of the bed for a few minutes, then get up slowly. When getting out of a chair, stay by the chair until you are sure that you are not dizzy.
• If you plan to have any surgery, including dental, tell your doctor that you take this drug.
• Take caution during exercise or in hot weather or when taking hot baths to avoid heatstroke.
• Avoid unprotected skin exposure to the sun. Use sunblock products that protect against both UVA and UVB rays. Don’t use sunlamps or tanning booths.
• Avoid spilling liquid medication on skin or clothing; it can cause irritation.
• Try sugarless gum or candy, ice, or a saliva substitute for dry mouth.

• If you miss a dose, take it as soon as you remember, but skip it if it is almost time for the next dose. Do not take double doses.
• Do not share your medication with others.
• Take the drug at the same time(s) each day.
• Take with food or milk.
• Do not break, chew, or crush this drug.
• Store at room temperature with lid on tightly. Do not store in the bathroom. Do not expose to heat, moisture, or strong light. Do not freeze the liquid form. Keep out of reach of children.
• If you take antacids or diarrhea drugs, wait for two hours before taking your antipsychotic drug.

The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:

ADRENALIN (also in bee sting kits), alcohol, cabergoline, DOSTINEX, DURAQUIN, epinephrine, ketorolac, LARODOPA, levodopa, pergolide, PERMAX, PRIMATENE MIST, QUINAGLUTE DURA-TABS, QUINIDEX, quinidine, SINEMET, TORADOL.

Central nervous system (CNS) depressant drugs, including alcohol, antidepressants, antihistamines, antipsychotics, some blood pressure medications (reserpine, methyldopa, beta-blockers), motion sickness medications, muscle relaxants, narcotics, sedatives, sleeping pills, and tranquilizers.

Call your doctor immediately if you experience:

• signs of tardive dyskinesia (can also occur after discontinuing the drug): lip smacking, chewing movements, puffing of cheeks, rapid, darting tongue movements, uncontrolled movements of arms or legs
• signs of parkinsonism: difficulty speaking or swallowing, loss of balance, masklike face, muscle spasms, stiffness of arms or legs, trembling and shaking, unusual twisting movements of body
• signs of dystonia: difficulty swallowing, cannot move eyes, twisting and spasms of body
• signs of restless leg (akathisia): restless pacing, a feeling of the “jitters”
• signs of akinesia: weakness, muscular fatigue, listlessness, depression. Although often confused with true depression, akinesia is actually the most common of a group of adverse effects called extrapyramidal effects.
• signs of neuroleptic malignant syndrome (NMS): troubled or fast breathing, high or low blood pressure, increased sweating, loss of bladder control, muscle stiffness, seizures, unusual tiredness, weakness, fast heartbeat, irregular pulse, pale skin
• fever and sore throat
• yellow eyes or skin
• skin rash
• fainting
• changed or blurred vision
• difficulty urinating

Call your doctor if these symptoms continue:

• constipation
• decreased sweating
• dry mouth
• increased appetite and weight
• increased skin sensitivity to sun
• stuffy nose
• changes in menstrual period
• decreased sexual ability
• swelling or pain in breasts in males and females
• unusual secretion of milk
• mild drowsiness
• dizziness or fainting

Signs of overdose:

• convulsions
• severe tiredness or weakness
• coma
• severe breathing problems
• severe dizziness
• severe drowsiness
• fever
• severe muscle trembling
• stiffness
• jerking or uncontrolled movements
• seizures
• unusual excitement
• unusually fast heartbeat
• tiny pupils

If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.

Ask your doctor which of these tests should be done periodically while you are taking this drug:

• complete blood count
• eye examinations
• liver function tests
• observation for early signs of tardive dyskinesia
• reevaluation of need for the drug
• urine tests for bile and bilirubin