Molindone
Molindone is an antipsychotic medicine taken by mouth as tablets to manage schizophrenia.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Older adults with dementia-related psychosis who take antipsychotic medicines have a higher risk of death. In trials lasting about 10 weeks, about 4.5% of people on these drugs died, compared with about 2.6% on placebo.
Most deaths appeared to be heart-related (such as heart failure or sudden death) or infections (such as pneumonia). Molindone Hydrochloride Tablets are not approved to treat dementia-related psychosis. If you care for someone with dementia who takes this medicine, talk with their prescriber.
📖 Molindone: Patient Information Guide
A plain-language walkthrough of Molindone — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Molindone is used for
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Molindone is an antipsychotic with one supported use.
- Molindone Hydrochloride Tablets (oral) are used for the management of schizophrenia.
How Molindone works
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Molindone behaves like other antipsychotic medicines. In animal studies it reduced activity and aggressiveness and blocked behaviors caused by amphetamines. EEG studies suggest it acts on the ascending reticular activating system, a brain network involved in alertness.
In human studies, it produced an antipsychotic effect without muscle-relaxing or incoordinating effects.
How Molindone is taken (dosage)
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Molindone Hydrochloride Tablets are taken by mouth. Your prescriber individualizes both the starting and long-term doses.
- Treatment usually starts low and is raised over several days.
- Your dose may be adjusted up or down based on your symptoms and response.
- Maintenance dosing is usually spread over several doses a day.
- Older and debilitated people start on lower doses.
Follow your prescriber's directions and the pharmacy label.
Molindone side effects in detail
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The most common effect is drowsiness at the start. Other effects include:
- Restlessness (akathisia)
- Depression, hyperactivity or euphoria
- Blurred vision
- Dry mouth and extra saliva
- Nausea and fast heartbeat
- Constipation or trouble urinating
Seek care quickly for severe muscle spasms, fever with stiffness and confusion, uncontrolled face or tongue movements, or a painful erection that will not go away.
Molindone warnings and precautions
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- Higher risk of death in older adults with dementia-related psychosis. This drug is not approved for them.
- Tardive dyskinesia: involuntary movements that may be permanent. Risk rises with longer treatment and higher total dose.
- Falls: drowsiness and low blood pressure on standing can cause falls and fractures.
- Neuroleptic malignant syndrome: a rare, potentially fatal reaction with fever, rigid muscles, confusion and unstable pulse or blood pressure.
- Dystonia: early muscle spasms, more likely in males and younger people.
Molindone interactions: what it interacts with
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The label reports few interaction concerns, but some points matter.
- Alcohol, barbiturates and narcotics: severe central nervous system depression from these is a reason not to use molindone.
- Anticholinergic drugs used for movement side effects: may worsen constipation and urinary retention.
- Barbiturates, chloral hydrate and antiparkinson drugs: no added toxicity was seen in animal studies.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
Before taking Molindone
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- Do not use it if you are allergic to molindone.
- Do not use it with severe central nervous system depression or in a comatose state.
- Not approved for dementia-related psychosis.
- Older and debilitated people are started on lower doses.
- Tell your prescriber about conditions or medicines that could cause drowsiness or dizziness.
- Tell your prescriber about prior neuroleptic malignant syndrome or tardive dyskinesia.
Molindone overdose: if you take too much
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Treatment of an overdose is symptom-based and supportive. Gastric lavage (stomach pumping) may be used to reduce absorption. Inducing vomiting is not appropriate in a comatose patient. Movement symptoms have responded to diphenhydramine, amantadine and anticholinergic antiparkinson drugs. Call poison control or emergency services right away.
Pharmacodynamics: what Molindone does in the body
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In animals, molindone reduces spontaneous movement and aggressiveness. It also blocks behaviors caused by amphetamines. In people, it produces an antipsychotic effect without muscle-relaxing or incoordinating effects. EEG studies suggest it acts on the ascending reticular activating system.
Pharmacokinetics: how your body processes Molindone
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Molindone tablets are absorbed rapidly and broken down quickly after you swallow them. Unchanged drug peaks in the blood at about 1.5 hours. The effect of a single dose lasts 24 to 36 hours. The body forms 36 metabolites, and less than 2 to 3% leaves unchanged in urine and stool.
How to store Molindone
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Store at 20° to 25°C (68° to 77°F) . Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
📄 Written from Molindone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Molindone
31 supplements and herbal products have documented interactions with Molindone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 18
- Minor · 10
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Molindone: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Molindone — the kind of thing our pharmacy team would talk through with you at the counter.
What is Molindone used for?
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How should I take it?
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Will it make me sleepy?
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What side effects should I call about?
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Can I drink alcohol with it?
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Is it safe for an older relative with dementia?
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Is Molindone available over the counter?
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When was Molindone first available?
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Who makes Molindone?
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💬 Answers drafted from Molindone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Molindone on HelloPharmacist
💊 Molindone forms and strengths (how it comes)
Molindone is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Molindone Hydrochloride Tablets are used for the management of schizophrenia.
- Molindone Hydrochloride Tablets are taken by mouth, with the dose individualized by your prescriber.
- Molindone Hydrochloride Tablets are usually started at a lower dose in elderly and debilitated patients.
📊 Molindone on the U.S. market: products, makers and brands
How Molindone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Molindone is used (Medicaid data)
A general measure of how commonly Molindone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q3 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Molindone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Molindone prescribed? Of the 1,599 medications we measure, Molindone ranks #1,442 by Medicaid prescriptions — more than 10% of them.
Utilization by Molindone product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
molindone hydrochloride 25 MG Oral Tablet
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1298906
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Molindone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Molindone NDCs with Medicaid activity.
🔍 Compare Molindone products
A representative set of FDA-listed product records for Molindone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 5 mg | Oral | Epic Pharma, Llc × 3 listings | ANDA | View NDC → |
| 10 mg | Oral | Epic Pharma, Llc × 3 listings | ANDA | View NDC → |
| 25 mg | Oral | Epic Pharma, Llc × 3 listings | ANDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Apicore Pharmaceuticals Private Limited | BULK INGREDIENT | View NDC → |
Showing 10 of 10 products — FDA National Drug Code Directory. See every product, package size and price: browse all 10 Molindone NDCs →
📈 Molindone side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Molindone — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Molindone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Molindone FDA approval history
How Molindone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Molindone recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 7019 1 dose form · 5 strengths
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Dose form (SCDF) Oral Tablet RxCUI 372949In current FDA listingsClinical drug / strength (SCD) hydrochloride 10 MGRxCUI 1298816hydrochloride 100 MGRxCUI 1298818hydrochloride 25 MGRxCUI 1298906hydrochloride 5 MGRxCUI 1298910hydrochloride 50 MGRxCUI 1298922
Look up RxCUI 7019 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Molindone supply and shortage status
Whether Molindone is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Molindone brand names
🏭 Who makes Molindone: manufacturers and labelers
Molindone drug class (RxNorm)
Molindone belongs to the Typical Antipsychotic class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Molindone page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Epic Pharma, Llc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.