Prescription medication · Typical Antipsychotic (Phenothiazine)
thioridazine
Also sold as Mellaril. Thioridazine is used to manage schizophrenia in adults and children.
Data updated 2026-05-15
- 51
- FDA reportsRarely reported
- 17
- InteractionsSeveral interactions
- $0.45
- Generic price (NADAC)
What the data shows
thioridazine (Mellaril) is a prescription Typical Antipsychotic (Phenothiazine), among the least-reported drugs the FDA tracks (51 FDA reports), with 17 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
thioridazine (Mellaril) is a prescription Typical Antipsychotic (Phenothiazine). Thioridazine is used to manage schizophrenia in adults and children.
Thioridazine is a medicine used to treat schizophrenia. It is only used when other antipsychotic medicines have not worked well enough.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from thioridazine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 51 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for thioridazine, by number of reports
- Weight Increased
Weight Increased
8 reports
- Dyspnoea
Dyspnoea
7 reports
- Dystonia
Dystonia
6 reports
- Hyperglycaemia
Hyperglycaemia
6 reports
- Hypoxia
Hypoxia
6 reports
- Malaise
Malaise
6 reports
- Muscle Spasms
Muscle Spasms
6 reports
- Pruritus
Pruritus
6 reports
- Psychotic Disorder
Psychotic Disorder
6 reports
- Tinnitus
Tinnitus
6 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for thioridazine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where thioridazine sits
thioridazine has more FDA adverse-event reports than 0% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is thioridazine; the line is the median (50th percentile).
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
Reports Mentioning Death
8
15.7% of reports — not proof of cause
Hospitalization Reports
17
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | WEIGHT INCREASED | 8 |
| 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 |
| 16 | BACK PAIN | 5 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: 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...
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.
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.
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...
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I take thioridazine with other medicines?
What should I avoid while taking thioridazine?
How long does it take for thioridazine to work?
Can I stop taking thioridazine suddenly?
What if I feel worse after starting thioridazine?
Will thioridazine make me gain weight?
Can thioridazine cause diabetes?
Does thioridazine affect my heart?
Can I drive while taking thioridazine?
What are the symptoms of Torsades de pointes?
What are the common side effects of thioridazine?
Does thioridazine interact with other medications?
What drug class is thioridazine?
What pregnancy or breastfeeding source fields are listed for thioridazine?
Related Medications in Typical Antipsychotic (Phenothiazine)
Other drugs grouped near thioridazine - same-class peers and common alternatives.
acamprosate
Campral
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alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
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amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
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amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
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aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for thioridazine: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 51.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 15.69%.
- enoxaparin Δ 0.02 pts · 55,714 reports · Low-Molecular-Weight Heparin 15.70%death share
- furosemide Δ 0.06 pts · 387,984 reports · Loop Diuretic 15.63%death share
- magnesium oxide Δ 0.08 pts · 39,831 reports · Mineral Supplement 15.77%death share
- palonosetron Δ 0.10 pts · 3,330 reports · 5-HT3 Receptor Antagonist (Antiemetic) 15.59%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 51 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: November 11, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages