Hydroxychloroquine

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Hydroxychloroquine on Prescriptsy

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Hydroxychloroquine (brand name Plaquenil) is a disease-modifying antirheumatic drug (DMARD) used to treat rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and discoid lupus erythematosus.

It is available as 200 mg film-coated tablets and is a prescription-only medicine in the United Kingdom.

Originally developed as an antimalarial agent, hydroxychloroquine was found to have significant immunomodulatory and anti-inflammatory properties, and it is now one of the most widely prescribed medicines in rheumatology and lupus care.

This page provides a comprehensive clinical overview of hydroxychloroquine, including how it works, dosing guidance, side effects, essential safety monitoring, and how to obtain it in the UK.

Rheumatoid arthritis affects approximately 400,000 people in the UK.

It is a chronic autoimmune condition in which the immune system attacks the synovial membranes lining the joints, causing pain, swelling, stiffness, and progressive joint damage.

Systemic lupus erythematosus (SLE) is a multisystem autoimmune disease affecting approximately 15,000 people in the UK, predominantly women of childbearing age.

SLE can affect the skin, joints, kidneys, brain, heart, and lungs, and follows a relapsing-remitting course.

Discoid lupus is a chronic skin condition characterised by well-defined, scaly, disc-shaped plaques, most commonly on sun-exposed areas.

Hydroxychloroquine plays a central role in the management of all three conditions.

Important safety information about hydroxychloroquine

Before reading further, note the following essential safety points about hydroxychloroquine.

• Hydroxychloroquine is a prescription-only medicine and must be used under specialist supervision.
• The maximum daily dose must not exceed 5 mg per kilogram of actual body weight to minimise the risk of retinal toxicity.
• Regular eye screening is essential: baseline assessment within the first year, then annual screening from year 5 onward.
• Report any visual changes (blurred vision, difficulty reading, light sensitivity) to your prescriber immediately.
• Hydroxychloroquine is highly toxic in overdose. Keep out of reach of children.

Understanding rheumatoid arthritis and lupus

Rheumatoid arthritis is a chronic inflammatory condition characterised by symmetrical joint pain, swelling, morning stiffness, and fatigue.

It most commonly affects the small joints of the hands and feet, though any synovial joint can be involved.

Without effective treatment, RA leads to erosion of cartilage and bone, progressive joint deformity, and significant disability.

The cause of RA involves a complex interplay of genetic predisposition, environmental triggers (particularly smoking), and immune dysregulation.

NICE guideline NG100 recommends early aggressive treatment with DMARDs to suppress disease activity, prevent joint damage, and maintain function.

Systemic lupus erythematosus (SLE) is a prototypic autoimmune disease in which the immune system produces antibodies against the body's own cells and tissues.

It can affect virtually any organ system.

Common manifestations include joint pain and swelling, a characteristic butterfly-shaped rash across the cheeks and nose, skin sensitivity to sunlight, fatigue, hair loss, mouth ulcers, and Raynaud phenomenon (fingers turning white or blue in the cold).

Serious complications include lupus nephritis (kidney inflammation), neuropsychiatric lupus, serositis (inflammation of the linings around the heart or lungs), and haematological abnormalities.

SLE follows a relapsing-remitting course, and treatment aims to control symptoms, prevent organ damage, and reduce the frequency and severity of flares.

Discoid lupus erythematosus (DLE) is a chronic skin condition that may occur in isolation or as part of SLE.

It produces well-defined, round or oval, scaly, erythematous plaques that can cause scarring, pigment changes, and permanent hair loss if it affects the scalp.

Sun protection and hydroxychloroquine are the cornerstones of treatment.

How hydroxychloroquine works: mechanism of action

Hydroxychloroquine exerts its therapeutic effects through multiple immunomodulatory mechanisms. It accumulates within lysosomes and endosomes of immune cells, raising intracellular pH.

This interferes with the processing and presentation of antigens by antigen-presenting cells (macrophages and dendritic cells), reducing the activation of T-helper cells and the downstream production of pro-inflammatory cytokines.

Specifically, hydroxychloroquine inhibits Toll-like receptor (TLR) 7 and TLR 9 signalling, which are key pathways in the innate immune response to nucleic acid-containing immune complexes, a hallmark of lupus pathogenesis.

Additional mechanisms include inhibition of cyclo-oxygenase and phospholipase A2 (reducing prostaglandin and leukotriene synthesis), stabilisation of lysosomal membranes, and interference with the production of reactive oxygen species.

These combined effects produce anti-inflammatory, immunomodulatory, and photoprotective actions. Importantly, hydroxychloroquine does not cause the broad immunosuppression associated with agents such as methotrexate, azathioprine, or mycophenolate.

This means it carries a much lower risk of serious infections and is safe to use in combination with other DMARDs.

In SLE, hydroxychloroquine has been shown to reduce disease flares, improve survival, reduce the risk of organ damage (particularly renal involvement), improve lipid profiles, reduce the risk of thrombosis, and have a favourable effect on bone mineral density.

For these reasons, international lupus guidelines (including EULAR and BSR) recommend that all patients with SLE should receive hydroxychloroquine unless there is a specific contraindication.

Clinical evidence and UK prescribing guidance

The efficacy of hydroxychloroquine in RA has been demonstrated in multiple randomised controlled trials.

It is most commonly used as part of combination DMARD therapy (typically with methotrexate and sulfasalazine, known as "triple therapy") in accordance with NICE NG100, which recommends early treatment with a combination of DMARDs for active RA.

Hydroxychloroquine monotherapy may be appropriate for very mild RA or palindromic rheumatism.

In SLE, the landmark LUMINA (LUpus in MINorities: NAture versus nurture) study and multiple other observational cohorts have demonstrated that hydroxychloroquine use is associated with reduced disease flares, reduced organ damage accrual, improved survival, lower risk of thrombotic events, and better pregnancy outcomes.

The 2023 EULAR recommendations for SLE management state that hydroxychloroquine should be offered to all patients with SLE, at a dose not exceeding 5 mg/kg/day.

For discoid lupus, the BAD guidelines recommend hydroxychloroquine as first-line systemic treatment for lesions that do not respond to potent topical corticosteroids and sun protection. Treatment should be continued for at least 3 months before efficacy is assessed.

The BNF lists hydroxychloroquine under DMARDs for rheumatic disease and under antimalarial drugs. Prescribing and monitoring are typically managed by a rheumatologist or dermatologist, with shared care arrangements with the patient's GP for ongoing prescriptions and blood test monitoring.

Hydroxychloroquine compared with other DMARDs

Methotrexate is the anchor DMARD for RA and is generally more effective than hydroxychloroquine as monotherapy for suppressing joint inflammation and preventing erosive damage.

However, methotrexate requires regular blood test monitoring (full blood count and liver function), is teratogenic and contraindicated in pregnancy, and carries risks of hepatotoxicity, bone marrow suppression, and pulmonary toxicity.

Hydroxychloroquine has a more favourable side-effect profile, does not require frequent blood monitoring (aside from eye screening), and is safe in pregnancy.

It is therefore often used alongside methotrexate as part of combination DMARD therapy.

Sulfasalazine is another first-line DMARD for RA. Leflunomide, azathioprine, and mycophenolate mofetil are used for more severe or refractory disease.

Biologic DMARDs (such as adalimumab, etanercept, rituximab, and tocilizumab) and targeted synthetic DMARDs (JAK inhibitors such as tofacitinib and baricitinib) are reserved for patients who do not respond adequately to conventional DMARDs.

Hydroxychloroquine is commonly maintained as a background therapy even when patients escalate to biologic treatments.

Dosage and administration

The standard dose of hydroxychloroquine is 200 to 400 mg daily, taken in one or two divided doses with food or milk.

The dose must not exceed 5 mg per kilogram of actual body weight per day. This dosing cap is critical for minimising the long-term risk of retinal toxicity.

Your prescriber will calculate the appropriate dose based on your weight.

Onset of action is slow: 4 to 12 weeks for initial benefit, up to 6 months for full effect. Treatment is typically long-term, often continuing for many years.

Do not stop taking hydroxychloroquine without consulting your specialist, as this may trigger a disease flare.

Side effects of hydroxychloroquine

Common side effects

Gastrointestinal symptoms (nausea, diarrhoea, abdominal cramps, loss of appetite) are the most common side effects and usually settle with continued treatment or by taking the tablets with food. Headache and dizziness are reported occasionally.

Skin and hair effects

Photosensitivity (increased susceptibility to sunburn) occurs in some patients. Use a broad-spectrum SPF 30+ sunscreen daily, wear protective clothing, and avoid excessive sun exposure.

Hair thinning or changes in hair pigmentation (lightening or greying) have been reported but are usually reversible on dose reduction or discontinuation.

Retinal toxicity

Hydroxychloroquine retinopathy is the most important long-term risk. The drug accumulates in the retinal pigment epithelium and is toxic to photoreceptor cells.

Early changes (detectable only by OCT and visual field testing) may be reversible if the drug is stopped promptly.

Advanced retinopathy produces a characteristic "bull's eye maculopathy" that is irreversible and can lead to permanent central vision loss.

The risk of retinopathy is strongly related to daily dose (exceeding 5 mg/kg/day), duration of use (more than 5 years), renal impairment, concomitant tamoxifen use, and pre-existing macular disease.

Annual screening by an ophthalmologist from year 5 onward (or earlier in high-risk patients) is recommended by the RCOphth.

Cardiac effects

Very rarely, long-term use has been associated with cardiomyopathy (heart muscle disease) and cardiac conduction abnormalities including QT prolongation. Symptoms may include breathlessness, palpitations, ankle swelling, and fatigue. If cardiomyopathy is suspected, hydroxychloroquine should be stopped and cardiac investigations arranged.

Other rare effects

Neuromuscular effects (myopathy, peripheral neuropathy), blood disorders (leucopenia, thrombocytopenia, aplastic anaemia), and liver enzyme elevation are rare but recognised. Tinnitus and hearing loss have been reported very rarely.

When to seek urgent medical advice

Contact your rheumatology team, GP, or call NHS 111 if you experience visual changes, persistent muscle weakness, unusual bleeding or bruising, or signs of infection.

Call 999 if you develop chest pain, severe breathlessness, collapse, or signs of a severe allergic reaction.

Report suspected adverse reactions to the MHRA via the Yellow Card scheme at yellowcard.mhra.gov.uk .

Warnings and precautions

Eye monitoring

All patients starting hydroxychloroquine should have a baseline ophthalmic assessment including best-corrected visual acuity, optical coherence tomography (OCT), and automated visual field testing.

From year 5 of treatment (or from the outset in high-risk patients), annual screening by an ophthalmologist is recommended.

If any abnormality is detected, hydroxychloroquine must be stopped and the patient referred urgently to ophthalmology.

Cardiac monitoring

Consider an ECG before starting treatment in patients with cardiac risk factors or those taking other QT-prolonging medicines. Periodic cardiac assessment may be warranted during long-term therapy.

Drug interactions

Hydroxychloroquine may increase plasma levels of digoxin and ciclosporin. It should be used with caution alongside other QT-prolonging drugs (amiodarone, macrolide antibiotics, fluoroquinolones, certain antipsychotics).

Antacids and kaolin reduce absorption; separate doses by at least 4 hours. Live vaccines should be avoided in patients on combination immunosuppressive therapy.

Pregnancy and breastfeeding

Hydroxychloroquine is considered safe in pregnancy.

BSR guidelines recommend continuing it throughout pregnancy in women with SLE or RA, as stopping may trigger disease flares that pose greater risk to the pregnancy than the drug itself.

It is excreted in breast milk in small amounts and is considered compatible with breastfeeding.

Overdose

Hydroxychloroquine is extremely dangerous in overdose. Toxic doses can cause rapid cardiovascular collapse, cardiac arrhythmias, seizures, and death.

As few as 3 to 4 tablets may be lethal in a small child. Store securely and keep out of reach of children at all times.

How to get hydroxychloroquine in the UK

Hydroxychloroquine is a prescription-only medicine, typically initiated by a rheumatologist or dermatologist.

Ongoing prescriptions are often managed through shared care arrangements between the hospital specialist and the patient's GP.

Regular blood tests and eye screening are part of the monitoring protocol. Authorised online prescribers registered with the GPhC may prescribe hydroxychloroquine following an appropriate specialist-level clinical assessment.

The NHS prescription charge in England is currently 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Living with rheumatoid arthritis or lupus: lifestyle advice

Managing an autoimmune condition involves more than medication. Regular gentle exercise helps maintain joint mobility, muscle strength, and cardiovascular fitness.

Physiotherapy and occupational therapy can provide tailored exercise programmes and joint protection advice.

Fatigue management is important, as chronic fatigue is a common and disabling symptom in both RA and SLE.

Sun protection (high-factor sunscreen, protective clothing, avoiding peak UV hours) is essential for patients with lupus. Smoking cessation improves cardiovascular risk and may enhance DMARD efficacy.

Psychological support, peer support groups, and access to specialist rheumatology or lupus nurses can improve coping and quality of life.

Sources

• Plaquenil 200 mg Film-Coated Tablets, Summary of Product Characteristics (EMC)
• Hydroxychloroquine sulfate, British National Formulary (BNF)
• NICE NG100: Rheumatoid arthritis in adults: management
• Rheumatoid arthritis, NHS
• Lupus (SLE), NHS
• RCOphth Hydroxychloroquine Retinopathy Screening Recommendations
• MHRA Yellow Card Scheme