Fluanxol
Antipsychotic (Thioxanthene) for Schizophrenia and Psychotic Disorders
Quick Facts About Fluanxol
Key Takeaways About Fluanxol
- Treats schizophrenia and psychotic disorders: Fluanxol is a first-generation (typical) antipsychotic that blocks dopamine receptors in the brain to reduce symptoms such as hallucinations, delusions, and disordered thinking
- Gradual dose adjustment is essential: Treatment typically starts at 1 mg three times daily and is gradually adjusted to 4–6 mg per day; avoid taking the last dose after 4 PM due to risk of insomnia
- Watch for movement disorders: Side effects such as akathisia (restlessness), tremor, and tardive dyskinesia (involuntary mouth/tongue movements) can occur and should be reported to your doctor immediately
- Avoid alcohol: Alcohol significantly enhances the sedative effects of Fluanxol and should be avoided throughout treatment
- Do not stop abruptly: Suddenly stopping Fluanxol can cause withdrawal symptoms including nausea, insomnia, restlessness, and anxiety – always taper under medical supervision
What Is Fluanxol and What Is It Used For?
Fluanxol contains the active substance flupentixol and belongs to a group of medicines called antipsychotics (also known as neuroleptics). It works by modifying nerve pathways in the brain, helping to correct dopamine imbalances that cause psychotic symptoms. Fluanxol is primarily used to treat schizophrenia and other psychotic conditions.
Flupentixol, the active ingredient in Fluanxol, is classified as a first-generation (typical) antipsychotic belonging to the thioxanthene chemical class. Thioxanthenes are structurally related to phenothiazines but have a slightly different chemical backbone. Like other typical antipsychotics, flupentixol primarily exerts its therapeutic effect by blocking dopamine D2 receptors in the brain’s mesolimbic pathway, which is believed to be overactive in psychotic disorders. This blockade helps reduce positive symptoms of schizophrenia, including hallucinations (hearing or seeing things that are not there), delusions (strongly held false beliefs), and thought disorder (confused or disorganised thinking).
In addition to its dopamine-blocking activity, flupentixol also acts on serotonin 5-HT2A receptors and alpha-1 adrenergic receptors. This broader receptor profile contributes to its clinical effectiveness but also accounts for some of its side effects, such as sedation and blood pressure changes. At lower doses (0.5–3 mg per day), flupentixol has been reported to have anxiolytic and antidepressant properties, making it useful in some clinical settings for patients with mixed anxiety and depressive symptoms, although this use is less well established than its antipsychotic indication.
Schizophrenia is a complex, chronic mental health condition that affects approximately 1 in 100 people worldwide, according to the World Health Organization (WHO). It typically emerges in late adolescence or early adulthood and can significantly impact a person’s thoughts, emotions, and behaviour. Antipsychotic medications like Fluanxol remain the cornerstone of treatment, often combined with psychological therapies and social support. The American Psychiatric Association (APA) and the National Institute for Health and Care Excellence (NICE) both recommend long-term antipsychotic treatment for people with schizophrenia to prevent relapse.
Fluanxol is manufactured by H. Lundbeck A/S, a Danish pharmaceutical company specialising in psychiatric and neurological medications. It is available in many countries worldwide and has been used in clinical practice for several decades, establishing a well-characterised safety and efficacy profile.
Flupentixol is also available as a long-acting depot injection (Fluanxol Depot) for patients who may have difficulty maintaining regular oral medication. The depot formulation is injected into a muscle every 2–4 weeks and provides a steady release of medication, which can improve treatment adherence and reduce the risk of relapse.
What Should You Know Before Taking Fluanxol?
Before starting Fluanxol, inform your doctor about all your medical conditions, particularly liver problems, history of seizures, cardiovascular disease, and any other medications you take. Fluanxol is contraindicated in patients with severe circulatory disturbance, reduced consciousness, pheochromocytoma, and certain blood disorders.
Contraindications
You should not take Fluanxol if any of the following apply to you:
- Allergy to flupentixol or any other ingredient in the medicine – symptoms of an allergic reaction may include skin rash, itching, swelling, or difficulty breathing
- Severe circulatory disturbance – Fluanxol can worsen circulatory problems and should not be used in patients with significant cardiovascular compromise
- Reduced consciousness – including states caused by alcohol intoxication, sedative medications, or opioid analgesics (morphine or similar)
- Certain blood disorders – particularly conditions affecting white blood cell counts, which could be further impaired by the medication
- Pheochromocytoma – a rare, usually benign tumour of the adrenal glands that produces excess adrenaline; Fluanxol can trigger dangerous blood pressure fluctuations in these patients
Warnings and Precautions
Talk to your doctor or pharmacist before taking Fluanxol if you have or have had any of the following conditions:
- Impaired liver function – flupentixol is extensively metabolised in the liver, and impaired hepatic function can lead to accumulation and increased side effects; dose adjustments may be necessary
- History of seizures or epilepsy – antipsychotics can lower the seizure threshold, potentially increasing the risk of convulsions
- Brain damage caused by alcohol, solvent exposure, or other toxic injury – these patients may be more sensitive to the effects of antipsychotics
- Risk factors for stroke – including smoking, high blood pressure, diabetes, atrial fibrillation, and advanced age; a small increased risk of cerebrovascular events has been observed with antipsychotic use in elderly patients
- Low white blood cell count (leukopenia) – either currently or in the past; Fluanxol can further decrease white blood cells, potentially impairing the immune system
- Cardiovascular disease or heart rhythm changes – Fluanxol can prolong the QT interval on ECG, which may lead to serious heart rhythm disturbances in susceptible individuals
- Other antipsychotic medications – combining antipsychotics increases the risk of side effects and should be done only under specialist supervision
- Agitation or hyperactivity – Fluanxol may sometimes worsen these symptoms; inform your doctor if you feel more restless or agitated after starting treatment
- Personal or family history of blood clots – antipsychotic medications have been associated with venous thromboembolism (blood clots in veins)
Dry mouth is a common side effect of Fluanxol and can lead to dental problems and oral mucosa damage during long-term treatment. Brush your teeth carefully with fluoride toothpaste at least twice daily, stay well hydrated, and attend regular dental check-ups. Sugar-free chewing gum or saliva substitutes may help manage dry mouth symptoms.
Use in Children and Adolescents
Fluanxol is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of flupentixol have not been adequately established in this patient population. Younger patients may be more susceptible to the movement-related side effects (extrapyramidal symptoms) of typical antipsychotics. If antipsychotic treatment is required for a child or adolescent, other medications with better-established paediatric evidence should be considered under specialist psychiatric supervision.
Pregnancy and Breastfeeding
If you are pregnant, think you might be pregnant, or are planning to have a baby, consult your doctor before using Fluanxol. This medication should not be used during pregnancy unless your doctor considers it absolutely necessary and the potential benefits outweigh the risks to the unborn child.
Newborn babies whose mothers used Fluanxol during the last three months (third trimester) of pregnancy may experience withdrawal symptoms after birth. These can include tremors, muscle stiffness or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your baby develops any of these symptoms, contact a healthcare professional immediately.
Flupentixol passes into breast milk, but at therapeutic doses it is unlikely to affect the nursing infant. However, if you are breastfeeding or plan to breastfeed, discuss this with your doctor, especially if you are using Fluanxol on a regular basis. Your doctor will help you weigh the benefits of breastfeeding against the potential risks of medication exposure to your baby.
Fluanxol may also affect fertility in both men and women. Antipsychotics can increase levels of the hormone prolactin, which may lead to menstrual irregularities in women and sexual dysfunction in men. If you have concerns about fertility, discuss them with your doctor.
Driving and Operating Machinery
Fluanxol can impair your ability to react quickly and maintain alertness. This is particularly relevant when driving vehicles or operating heavy machinery. The sedative effects are most prominent at the start of treatment and after dose increases. You are responsible for assessing whether you are fit to drive or perform tasks that require alertness. If you experience drowsiness, dizziness, or blurred vision, do not drive or operate machinery and discuss the issue with your doctor or pharmacist.
Excipient Information
Fluanxol film-coated tablets contain lactose monohydrate as an inactive ingredient. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine. The 5 mg tablets also contain para-orange (E110), a colouring agent that may cause allergic reactions in some individuals, particularly those with aspirin sensitivity.
How Does Fluanxol Interact with Other Drugs?
Fluanxol can interact with a wide range of medications, including antidepressants, lithium, blood pressure medications, anti-epileptics, levodopa, and drugs that affect heart rhythm. Always inform your doctor about all medications you are taking, including over-the-counter products and herbal supplements.
Drug interactions with Fluanxol can occur through several mechanisms. Flupentixol affects the central nervous system and can enhance the sedative effects of other CNS depressants. It can also affect heart rhythm (QT prolongation), which can be worsened by other QT-prolonging drugs. Additionally, some drugs can alter the metabolism of flupentixol, changing its blood levels and effectiveness. The following tables outline the most clinically significant interactions.
Major Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Lithium | Mood stabiliser | Increased risk of neurotoxicity (encephalopathic syndrome); may alter lithium and flupentixol levels | Monitor lithium levels closely; watch for neurological symptoms |
| Levodopa / Dopamine agonists | Parkinson’s disease treatment | Fluanxol blocks dopamine receptors, directly opposing the effect of levodopa and worsening Parkinson’s symptoms | Avoid combination if possible; use alternative treatments |
| QT-prolonging drugs (quinidine, cisaprid, moxifloxacin, erythromycin, mefloquine, methadone) | Various (antiarrhythmics, antibiotics, antimalarials) | Additive QT prolongation increasing risk of serious cardiac arrhythmias including torsades de pointes | Avoid combination; ECG monitoring if unavoidable |
| Other antipsychotics | Antipsychotics | Increased risk of extrapyramidal symptoms, sedation, QT prolongation, and neuroleptic malignant syndrome | Avoid combination; only use under specialist psychiatric supervision |
Moderate Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Fluoxetine / Paroxetine | SSRI antidepressants | May inhibit flupentixol metabolism, increasing plasma levels and risk of side effects | Monitor for increased sedation and extrapyramidal symptoms |
| Venlafaxine | SNRI antidepressant | Additive CNS depression; potential pharmacokinetic interaction | Use with caution; monitor for increased side effects |
| Blood pressure-lowering medications | Antihypertensives | Fluanxol can enhance the hypotensive effect, increasing risk of dizziness and fainting | Monitor blood pressure; adjust antihypertensive doses if needed |
| Barbiturates and sedatives | CNS depressants | Enhanced sedation and respiratory depression | Avoid concurrent use where possible; reduce doses |
| Anti-epileptic medications | Anticonvulsants | Fluanxol lowers the seizure threshold; some anticonvulsants may reduce flupentixol levels through enzyme induction | Monitor seizure control and antipsychotic efficacy |
| Thiazide diuretics | Diuretics | Risk of electrolyte imbalance (low potassium/magnesium) which increases QT prolongation risk | Monitor electrolytes regularly; correct any deficiencies |
| Metoclopramide | Antiemetic / GI motility agent | Additive risk of extrapyramidal symptoms (movement disorders) | Avoid combination; use alternative antiemetics |
| Codeine | Opioid analgesic | Enhanced CNS depression; increased sedation and respiratory depression risk | Use with caution; monitor for excessive sedation |
| Bromocriptine / Cabergoline | Dopamine agonists (prolactin inhibitors) | Fluanxol (dopamine antagonist) directly opposes the dopamine-stimulating effects of these drugs | Avoid combination; effect of both drugs may be reduced |
Food and Alcohol Interactions
Fluanxol can be taken with or without food. However, you should not drink alcohol during treatment, as alcohol can significantly enhance the sedating effects of the medication. This combination increases the risk of excessive drowsiness, impaired coordination, and slowed reflexes, which can be dangerous, particularly when driving or performing activities that require alertness.
What Is the Correct Dosage of Fluanxol?
The usual maintenance dose of Fluanxol for adults is 4–6 mg per day, divided into 2–3 doses. Treatment typically begins at 1 mg three times daily and is gradually adjusted based on individual response. The last dose should not be taken after 4 PM to avoid sleep disturbances.
Always take Fluanxol exactly as your doctor has prescribed. The dose is carefully individualised based on your specific condition, symptom severity, and response to treatment. Do not change your dose or stop taking the medication without consulting your doctor first. Swallow the tablets whole with a glass of water.
Adults
Standard Adult Dosing
Starting dose: 1 mg three times daily (3 mg/day total)
Maintenance dose: 4–6 mg daily, divided into 2–3 doses
Dose range: In some cases, significantly higher or lower doses may be necessary depending on the severity of the condition
Timing: The final dose of the day should not be taken after 4 PM, as the medication can cause sleep disturbances (insomnia) when taken in the evening
Your doctor will typically start you on a lower dose and gradually increase it over days to weeks until the optimal balance between symptom control and side effects is achieved. This process is called dose titration and is essential for minimising adverse effects while maximising the therapeutic benefit. It is important to keep regular appointments with your doctor during this period so your progress can be monitored.
Elderly Patients
Elderly Patient Dosing
Starting dose: At the lower end of the dosage range
Adjustment: Dose increases should be more gradual and cautious
Monitoring: Elderly patients require more frequent monitoring for side effects, particularly extrapyramidal symptoms, sedation, and cardiovascular effects
Elderly patients are generally more sensitive to the effects of antipsychotic medications due to age-related changes in metabolism, kidney function, and brain sensitivity. They are at increased risk of falls due to sedation and orthostatic hypotension (a sudden drop in blood pressure upon standing). Regular monitoring of blood pressure, heart rhythm, and neurological function is recommended.
Children
Paediatric Use
Fluanxol is not recommended for children and adolescents under 18 years of age. Safety and efficacy have not been established in this age group.
Missed Dose
If you forget to take a dose of Fluanxol, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your normal dosing schedule. Do not take a double dose to compensate for the one you missed. If you frequently forget to take your medication, talk to your doctor about strategies to help you remember, or discuss whether a long-acting depot injection formulation might be more suitable.
Overdose
If you take more Fluanxol than prescribed, or if someone else accidentally takes your medication, seek medical attention immediately by contacting your local emergency services or a poison control centre. An overdose of Fluanxol can cause serious symptoms that require urgent medical treatment.
- Significant drowsiness or loss of consciousness
- Breathing difficulties or respiratory depression
- Rapid heartbeat (tachycardia) or palpitations
- Seizures or convulsions
- Severe muscle rigidity
- Dangerous drop in blood pressure (hypotension)
Stopping Treatment
The duration of treatment with Fluanxol is determined by your doctor based on your clinical condition. Do not stop taking Fluanxol without first consulting your doctor, even if you feel well. Abrupt discontinuation – particularly after long-term use – can lead to withdrawal symptoms (also called discontinuation syndrome). These may include:
- Nausea, vomiting, loss of appetite, and diarrhoea
- Runny nose and excessive sweating
- Muscle pain and abnormal sensations (tingling, crawling feelings)
- Insomnia, restlessness, anxiety, and agitation
Your doctor will typically reduce your dose gradually over a period of weeks to months to minimise these symptoms. If you experience any new or worsening symptoms during dose reduction, contact your doctor for advice.
What Are the Side Effects of Fluanxol?
Like all antipsychotic medications, Fluanxol can cause side effects. The most common include drowsiness, restlessness (akathisia), movement disorders, and dry mouth. Most side effects are most pronounced at the start of treatment and tend to diminish over time. Some rare side effects – such as neuroleptic malignant syndrome – require immediate medical attention.
Not everyone who takes Fluanxol will experience side effects. The type and severity of side effects can vary considerably between individuals and are often dose-dependent. Many side effects are most noticeable during the first weeks of treatment and gradually improve as your body adjusts to the medication. However, some side effects, particularly movement disorders (extrapyramidal symptoms), may develop during long-term treatment and require careful monitoring.
- High fever, unusual muscle stiffness, altered consciousness – especially with sweating and rapid heartbeat; these may be signs of neuroleptic malignant syndrome (NMS), a rare but life-threatening condition
- Unusual movements of the mouth and tongue – this may be an early sign of tardive dyskinesia, a potentially irreversible movement disorder
- Yellowing of the skin or eyes – this may indicate liver damage (jaundice)
- Swelling, pain, or redness in the legs – these may be signs of a blood clot (deep vein thrombosis), which can travel to the lungs and cause chest pain and breathing difficulties
- Fever with severely impaired general condition, severe sore throat – these may indicate a dangerous decrease in white blood cells (agranulocytosis)
Very Common
- Drowsiness (somnolence)
- Restlessness and inability to sit still (akathisia)
- Involuntary movements (hyperkinesia)
- Slow or decreased movements (hypokinesia)
- Dry mouth
Common
- Rapid heartbeat (tachycardia), palpitations
- Tremor, muscle spasms (dystonia), dizziness, headache
- Difficulty focusing the eyes (accommodation disturbance), visual disturbances
- Breathing difficulties (dyspnoea)
- Increased salivation, constipation, vomiting, indigestion, diarrhoea
- Urinary difficulties, inability to urinate (urinary retention)
- Increased sweating, itching
- Muscle pain (myalgia)
- Increased appetite, weight gain
- Fatigue, weakness (asthenia)
- Insomnia, depression, nervousness, agitation, decreased sex drive
Uncommon
- Abnormal involuntary movements (dyskinesia), parkinsonism, speech difficulties, seizures
- Involuntary circular eye movements (oculogyration)
- Unusual mouth and tongue movements (early sign of tardive dyskinesia)
- Abdominal pain, nausea, flatulence
- Skin rash, photosensitivity, eczema
- Muscle rigidity
- Decreased appetite
- Low blood pressure (hypotension), hot flushes
- Abnormal liver function tests
- Sexual dysfunction (ejaculation failure, erectile dysfunction)
- Confusion
Rare
- Low platelet count (thrombocytopenia), low white blood cells (neutropenia, leukopenia)
- Elevated prolactin levels (hyperprolactinaemia)
- High blood sugar (hyperglycaemia), impaired glucose tolerance
- Allergic reactions (hypersensitivity), severe allergic reaction (anaphylaxis)
- Breast enlargement in men (gynaecomastia), excessive milk production (galactorrhoea), absent menstruation (amenorrhoea)
- QT prolongation (ECG changes), irregular heartbeat (ventricular arrhythmias, torsades de pointes)
- Cardiac arrest (reported in rare cases)
A small increase in the number of deaths has been reported in elderly patients with dementia who are treated with antipsychotic medications, compared with those who do not receive such treatment. The reasons for this increased risk are not fully understood, but may involve cardiovascular and infectious complications. Antipsychotic medications should be used with particular caution and at the lowest effective dose in this population.
How Should You Store Fluanxol?
Store Fluanxol out of the sight and reach of children. No special storage conditions are required. Do not use after the expiry date printed on the packaging.
Keep Fluanxol in its original packaging to protect it from light and moisture. This medicine does not require any special temperature conditions for storage – room temperature is appropriate. Do not use Fluanxol after the expiry date stated on the carton or label after “EXP”. The expiry date refers to the last day of that month.
Do not dispose of medications by flushing them down the toilet or throwing them in household waste. Return unused or expired medicines to your pharmacy for proper disposal. These measures help protect the environment and prevent accidental ingestion by children, pets, or other individuals.
What Does Fluanxol Contain?
The active substance in Fluanxol is flupentixol (as flupentixol dihydrochloride). Available in 0.5 mg, 1 mg, and 5 mg film-coated tablets containing various inactive ingredients including lactose monohydrate.
Each Fluanxol film-coated tablet contains flupentixol dihydrochloride equivalent to 0.5 mg, 1 mg, or 5 mg of flupentixol. The other (inactive) ingredients are:
- Tablet core: Betadex (beta-cyclodextrin), lactose monohydrate, maize starch, hydroxypropylcellulose, microcrystalline cellulose, croscarmellose sodium, talc, hydrogenated vegetable oil (cottonseed oil), magnesium stearate
- Film coating (0.5 mg and 1 mg tablets): Polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), yellow iron oxide (E172)
- Film coating (5 mg tablets): Polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), para-orange aluminium lake (E110)
Appearance and Pack Sizes
| Strength | Appearance | Markings | Size |
|---|---|---|---|
| 0.5 mg | Round, slightly biconvex, yellow film-coated | FD | 6.5 mm diameter |
| 1 mg | Oval, slightly biconvex, yellow film-coated | FF | 8 × 5.5 mm |
| 5 mg | Oval, slightly biconvex, ochre-yellow film-coated | FK | 8 × 11.8 mm |
Fluanxol film-coated tablets are available in containers of 100 tablets and in blister packs of 100 tablets. Not all pack sizes may be marketed in all countries.
Frequently Asked Questions About Fluanxol
Fluanxol (flupentixol) is an antipsychotic medication primarily used to treat schizophrenia and other psychotic disorders. It works by blocking dopamine receptors in the brain, helping to reduce symptoms such as hallucinations, delusions, and disordered thinking. It belongs to the thioxanthene class of antipsychotics and has been used in clinical practice for several decades.
The most common side effects of Fluanxol include drowsiness (somnolence), restlessness and inability to sit still (akathisia), involuntary movements (hyperkinesia), reduced movements (hypokinesia), and dry mouth. These effects are usually most noticeable at the start of treatment and tend to improve over time. Other common side effects include tremor, weight gain, constipation, and fatigue.
No, you should avoid alcohol while taking Fluanxol. Alcohol can significantly enhance the sedative effects of the medication, increasing drowsiness, dizziness, and impaired coordination. This combination can be particularly dangerous when driving or operating machinery. If you have questions about alcohol use during treatment, discuss them with your doctor.
Some effects of Fluanxol, such as sedation and a calming effect, may be noticed within the first few days. However, the full antipsychotic effect on symptoms such as hallucinations and delusions typically takes 2 to 4 weeks of consistent use. It is important to continue taking Fluanxol as prescribed even if you do not feel an immediate improvement, and never stop without consulting your doctor.
Fluanxol should generally not be used during pregnancy unless your doctor considers it absolutely necessary. Newborns whose mothers used Fluanxol during the third trimester may experience withdrawal symptoms such as tremors, muscle stiffness, drowsiness, agitation, breathing problems, and feeding difficulties. If you are pregnant, planning to become pregnant, or discover you are pregnant while taking Fluanxol, contact your doctor immediately to discuss the best course of action.
If you miss a dose, take it as soon as you remember unless it is nearly time for your next dose. In that case, skip the missed dose and continue with your regular schedule. Never take a double dose to make up for a forgotten one. If you frequently forget doses, talk to your doctor – they may suggest strategies to improve adherence or consider switching to a depot injection formulation.
References and Sources
- World Health Organization (WHO). Mental Health: Schizophrenia. WHO Fact Sheet, 2022. Available at: who.int
- American Psychiatric Association (APA). Practice Guideline for the Treatment of Patients with Schizophrenia. 3rd Edition, 2020. DOI: 10.1176/appi.books.9780890424841
- National Institute for Health and Care Excellence (NICE). Psychosis and schizophrenia in adults: prevention and management. Clinical guideline CG178, updated 2024.
- British Association for Psychopharmacology (BAP). Evidence-based guidelines for the pharmacological treatment of schizophrenia. J Psychopharmacol, 2020; 34(1): 3–78. DOI: 10.1177/0269881119889296
- European Medicines Agency (EMA). Flupentixol – Summary of Product Characteristics. Available via national medicines agencies.
- British National Formulary (BNF). Flupentixol. NICE, updated 2025.
- Leucht S, Cipriani A, Spineli L, et al. Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis. The Lancet, 2013; 382(9896): 951–962. DOI: 10.1016/S0140-6736(13)60733-3
- Lundbeck. Fluanxol Product Information. H. Lundbeck A/S, Valby, Denmark.
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