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Thioridazine is associated with the rare but potentially severe risk of causing irregular heartbeats, known as QT prolongation, which can be fatal. It is recommended for use only in patients who have not responded to or cannot tolerate at least two other antipsychotic medications.

Key Safety Information:

• Heart Risks: Thioridazine can lead to serious heart rhythm issues. Avoid using this medication with others that may cause slow or irregular heartbeats.
• Elderly Patients with Dementia: There is a slightly elevated risk of severe side effects, including heart failure, irregular heartbeat, and pneumonia, in older adults with dementia. Thioridazine is not approved for managing behavioral problems related to dementia.
• Consultation: Discuss with your healthcare provider to understand the risks and benefits, and explore alternative treatments that may be safer and more effective for dementia-related issues.

It is crucial to discuss with your healthcare provider before starting thioridazine, especially if you have a history of heart problems or are taking other medications.

Thioridazine may cause dizziness, lightheadedness, drowsiness, difficulty urinating, constipation, restlessness, headache, and blurred vision. While these side effects are generally mild, they can be bothersome. To reduce the risk of dizziness and lightheadedness, rise slowly from sitting or lying positions. If these symptoms persist or worsen, consult a healthcare professional.

Serious side effects requiring immediate medical attention include shaking (tremors), a mask-like facial expression, shuffling walk, muscle spasms, persistent sore throat, fever, and vision changes like sudden difficulty seeing at night. Severe dizziness, fainting, slow heartbeat, or seizures are very serious and demand urgent medical help.

Thioridazine may rarely cause tardive dyskinesia, leading to unusual movements, especially in the face or limbs. It can also increase prolactin levels, causing symptoms like unwanted breast milk, menstrual changes, or sexual dysfunction. Report these symptoms to a doctor immediately.

Neuroleptic malignant syndrome (NMS) is a rare but serious condition associated with this medication. Symptoms include fever, muscle stiffness, severe tiredness, confusion, sweating, and irregular heartbeat. Seek emergency care if these occur.

Allergic reactions are rare but require immediate attention if you experience rash, itching/swelling, severe dizziness, or trouble breathing. Always inform a healthcare provider if you notice any other unusual effects.

Certain medications can interact with this drug. These include asunaprevir, cabergoline, and lithium. Other medications, such as amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (like erythromycin), and ziprasidone, can affect heart rhythm by causing QT prolongation. Additionally, some drugs, including bupropion, cinacalcet, dacomitinib, duloxetine, mirabegron, pindolol, propranolol, rolapitant, terbinafine, and certain SSRIs (such as fluoxetine, fluvoxamine, and paroxetine), may influence how thioridazine is metabolized, potentially altering its effectiveness. Thioridazine itself can also accelerate the elimination of other medications, including elacestrant, lonafarnib, mavacamten, and the combination of ombitasvir/paritaprevir/ritonavir, which could impact their efficacy.

This medication may reduce the effectiveness of hormonal birth control methods like pills, patches, or rings, which could lead to pregnancy. It is advisable to discuss with your healthcare provider whether you should use an additional form of reliable birth control. Notify your doctor if you experience any unusual spotting or bleeding, as these may indicate that your birth control is not functioning properly.

Inform your healthcare provider if you are taking any other substances that cause drowsiness, such as opioid pain medications (like codeine or hydrocodone), alcohol, cannabis, sleep or anxiety medications (like alprazolam, lorazepam, or zolpidem), muscle relaxants (like carisoprodol or cyclobenzaprine), or antihistamines (such as cetirizine or diphenhydramine). Be sure to check the labels of all your medications, including those for allergies or coughs and colds, as they might contain ingredients that induce drowsiness. Consult your pharmacist for advice on using these products safely.