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thioridazine

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Brand names: Mellaril

Typical Antipsychotic (Phenothiazine) Rx

Thioridazine is a medicine used to treat schizophrenia. It is only used when other antipsychotic medicines have not worked well enough.

Drug Pricing (NADAC)

Generic Price

$0.45/unit

Generic Available

Yes (6 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Thioridazine is used to manage schizophrenia in adults and children.

Common side effects

Drowsiness, Dry mouth, Blurred vision

Key warnings

Thioridazine can cause a life-threatening heart rhythm problem called Torsades de pointes, which can lead to sudden death.

How It Works

Thioridazine affects the balance of certain chemicals in the brain. These chemicals, like dopamine, can affect mood and behavior. By changing the balance, thioridazine helps to reduce symptoms of schizophrenia.

How to Take It

Take thioridazine exactly as your doctor tells you. Adults usually start with 50 mg to 100 mg three times a day. Your doctor may slowly increase the dose up to 800 mg per day if needed. You can take this medicine with or without food.

Pregnancy & Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if thioridazine will harm your unborn baby. Talk to your doctor about the risks and benefits of taking thioridazine during pregnancy and breastfeeding.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store thioridazine tablets at room temperature (68° to 77°F) and protect them from light.

Side Effects (from patient reports)

Based on 64 FDA adverse event reports.

Weight gain
8
Medicine not working
7
Shortness of breath
7
Muscle spasms and contractions
6
High blood sugar
6
Low oxygen levels
6
Feeling unwell
6
Muscle cramps
6
Itching
6
Mental disorder with hallucinations or delusions
6

FDA Adverse Event Report Analysis

Detailed analysis of 51 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

51

Death-Related Reports

8

Hospitalization Reports

17

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 28 (58%)
Male 20 (42%)

Age Distribution

0–17 5
18–44 13
45–64 10
65–74 4
75+ 8

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 WEIGHT INCREASED 8
2 DRUG INEFFECTIVE 7
3 DYSPNOEA 7
4 DYSTONIA 6
5 HYPERGLYCAEMIA 6
6 HYPOXIA 6
7 MALAISE 6
8 MUSCLE SPASMS 6
9 PRURITUS 6
10 PSYCHOTIC DISORDER 6
11 TINNITUS 6
12 TOXICITY TO VARIOUS AGENTS 6
13 ABDOMINAL DISTENSION 5
14 ABDOMINAL PAIN 5
15 AKATHISIA 5

Reactions in Death Reports

COMPLETED SUICIDE 3
OVERDOSE 3
TOXICITY TO VARIOUS AGENTS 3
ACUTE RESPIRATORY FAILURE 1
ALCOHOL USE 1
COGNITIVE DISORDER 1
DEATH 1
DRUG ABUSE 1
EATING DISORDER 1
INFECTION 1

Reactions in Hospitalization Reports

DRUG INEFFECTIVE 4
AKATHISIA 3
COGNITIVE DISORDER 3
LEUKOPENIA 3
SUICIDE ATTEMPT 3
WEIGHT INCREASED 3
ACUTE HEPATIC FAILURE 2
ACUTE KIDNEY INJURY 2
ANTIPSYCHOTIC DRUG LEVEL BELOW THERAPEUTIC 2
DISINHIBITION 2

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Thioridazine can cause a life-threatening heart rhythm problem called Torsades de pointes, which can lead to sudden death. Because of this risk, only use thioridazine if other antipsychotic medicines have not worked. Elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death.

Known Drug Interactions

NSAIDs, Aspirin, Warfarin): May potentiate the risk of bleeding ( 7.4 ) Drugs Tightly Bound to Plasma Proteins: May cause a shift in plasma concentrations ( 7.6 , 7.7 ) Olanzapine: When used in combination with fluoxetine, also refer to the Drug Interactions section of the package insert for Symbyax ( 7.7 ) Drugs that Prolong the QT Interval: Do not use fluoxetine with thioridazine or pimozide. Thioridazine — Thioridazine should not be administered with fluoxetine or within a minimum of 5 weeks after fluoxetine has been discontinued, because of the risk of QT Prolongation [see Contraindicat...

Mechanism: These drugs can cause serious heart rhythm problems when used at the same time. Because fluoxetine stays in your system for a long time, the danger remains even after you stop taking it.

What to do: Do not take these drugs together, and wait at least five weeks after stopping fluoxetine before starting thioridazine.

Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Pimozide and Thioridazine Clinical Impact Increased plasma concentrations of pimozide and thioridazine, drugs with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias. Intervention Paroxetine is contraindicated in patients taking pimozide or thioridazine [see Contraindications ( 4 )] .

Mechanism: Paroxetine increases the amount of thioridazine in your blood by slowing down its breakdown. This can lead to a dangerous heart condition where the heart's electrical timing is thrown off.

What to do: This combination is contraindicated and should never be used. Your healthcare provider will need to adjust your treatment plan to use safer alternatives.

Table 4: Clinically Relevant Interactions Affecting Drugs Co-Administered with VARUBI CYP2D6 Substrates Narrow Therapeutic Index Drugs (Thioridazine and Pimozide) Clinical Impact: Increased plasma concentrations of thioridazine and pimozide are associated with serious and/or life-threatening events of QT prolongation and Torsades de Pointes. Intervention: VARUBI is contraindicated in patients taking CYP2D6 substrates with a narrow therapeutic index such as thioridazine and pimozide. If patients require these drugs, use an alternative antiemetic to VARUBI or an alternative to thioridazine or...

Mechanism: Rolapitant prevents the body from processing thioridazine, causing it to build up to unsafe levels. High levels of this drug can cause life-threatening heart rhythm issues.

What to do: This combination must be avoided. Ask your doctor for a different treatment option for either your nausea or your mental health condition.

moderate abiraterone

Avoid co-administration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine).

Mechanism: Abiraterone interferes with the enzyme that breaks down thioridazine. Because thioridazine has a very narrow safety range, even a small increase in its levels could lead to dangerous side effects.

What to do: Avoid taking these two medications at the same time. Your healthcare provider should look for safer alternatives.

moderate darifenacin

7 DRUG INTERACTIONS Caution should be taken when darifenacin extended-release tablets are used concomitantly with medications that are predominantly metabolized by CYP2D6 and which have a narrow therapeutic window, such as flecainide, thioridazine and tricyclic antidepressants ( 7.2 ) The concomitant use of darifenacin extended-release tablets with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision and other anticholinergic pharmacological effects. 7.3 CYP2D6 Substrates Caution should be taken when darifenacin extended-release ...

Mechanism: Darifenacin can slow down the way your body breaks down thioridazine. This can cause thioridazine to build up to unsafe levels in your blood, which may lead to dangerous side effects.

What to do: Use this combination with caution. Your doctor may need to adjust your dosage or monitor you more frequently for side effects.

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Common Questions

Can I take thioridazine with other medicines?
Thioridazine can interact with many medicines. Tell your doctor about all the medicines you take, including over-the-counter drugs and supplements.
What should I avoid while taking thioridazine?
Avoid alcohol while taking thioridazine, as it can increase drowsiness and other side effects.
How long does it take for thioridazine to work?
It may take several weeks for thioridazine to fully control your symptoms.
Can I stop taking thioridazine suddenly?
Do not stop taking thioridazine without talking to your doctor. Stopping suddenly can cause withdrawal symptoms.
What if I feel worse after starting thioridazine?
Tell your doctor if your symptoms get worse or if you have any new or worsening side effects.
Will thioridazine make me gain weight?
Weight gain is a possible side effect of thioridazine. Talk to your doctor about ways to manage your weight.
Can thioridazine cause diabetes?
Thioridazine may increase your risk of developing diabetes. Your doctor may monitor your blood sugar levels.
Does thioridazine affect my heart?
Yes, thioridazine can cause heart problems, including a prolonged QTc interval. Your doctor may check your heart with an EKG.
Can I drive while taking thioridazine?
Thioridazine can cause drowsiness and blurred vision. Do not drive or operate machinery until you know how this medicine affects you.
What are the symptoms of Torsades de pointes?
Symptoms can include dizziness, lightheadedness, fainting, and a fast or irregular heartbeat.
What are the common side effects of thioridazine?
The most commonly reported side effects of thioridazine include Drowsiness, Dry mouth, Blurred vision, Constipation, Nausea. Based on 64 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does thioridazine interact with other medications?
Yes, thioridazine has 17 known drug interactions. Notable interactions include fluoxetine, paroxetine, rolapitant. Always inform your doctor about all medications you are taking.
What drug class is thioridazine?
thioridazine belongs to the Typical Antipsychotic (Phenothiazine) drug class. It requires a prescription (Rx). Thioridazine is used to manage schizophrenia in adults and children.
Is thioridazine safe during pregnancy?
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if thioridazine will harm your unborn baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for thioridazine

The FDA label for thioridazine (sold under brand names such as Mellaril) classifies it as a prescription-only medication in the Typical Antipsychotic (Phenothiazine) class. Thioridazine is used to manage schizophrenia in adults and children. Official labeling lists 8 commonly reported side effects, including Drowsiness, Dry mouth, Blurred vision.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 64 voluntary reports. The database also lists 17 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.45.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: November 11, 2025

All federal data sources used on this page