Baclofen: A UK Patient Guide

MedWatch Signal: Two MHRA product alerts are active for specific baclofen products. This is not a confirmed national shortage of all baclofen brands. Do not stop baclofen suddenly. If your usual brand or form is affected, ask your pharmacist, GP or specialist about alternatives. Evidence base: MHRA alerts, eMC SmPC, NHS, NICE. Last reviewed: 13 May 2026.

Baclofen is a prescription-only medicine used to relieve spasticity — stiff, tight or spasming muscles caused by problems with the brain or spinal cord. In the UK it is commonly prescribed for people with multiple sclerosis (MS), cerebral palsy, motor neurone disease (MND), and after spinal cord injury or stroke. NICE recommends baclofen as a first-line drug option for MS-related spasticity.

Important: This article is for information only. It does not replace advice from your pharmacist, GP or specialist. Never start, stop or change your baclofen without speaking to a healthcare professional.

Current UK Shortage Status

As of May 2026, MedWatch shows two active MHRA alerts affecting specific baclofen products. These are targeted supply issues, not a national shortage of all baclofen brands.

1. SyriMed Baclofen 10mg/5ml Oral Solution — Class 2 Medicines Recall (EL(26)A/06)

• Issued: 3 February 2026
• Reason: Crystallisation observed over time in the oral solution. Testing showed the filtered solution did not meet licensed specifications, creating a potential risk of sub-therapeutic dosing.
• Batches affected: EBB25001A1 (expiry 31/03/2027) and EBB24001A1 (expiry 30/09/2026).
• Action: Pharmacy and wholesaler level recall. If you have this product, continue taking it as prescribed and do not stop suddenly. Speak to your pharmacist about supply.
• Source: MHRA Class 2 Recall

2. RxFarma Baclofen 10mg Tablets — Class 4 Medicines Defect Notification (EL(25)A/51)

• Issued: 27 November 2025
• Reason: The Patient Information Leaflet (PIL) in certain batches did not include updated safety information about encephalopathy (a reduction in brain function). The tablets themselves are not affected; this is a leaflet-information defect, not a medicine quality issue.
• Batches affected: EBJ25001F01, EBJ25002F01, EBJ25003F01 (all expiry 31/01/2028).
• Action: No product recall. Pharmacists should provide the updated PIL when dispensing these batches.
• Source: MHRA Class 4 Notification

If your usual brand is affected, ask your pharmacist whether an alternative brand of the same medicine is available. Do not stop taking baclofen without medical advice.

What Baclofen Is Used For

Baclofen relieves spasticity of voluntary muscle. According to the UK Summary of Product Characteristics (SmPC), it is used for conditions including:

• Multiple sclerosis (MS)
• Spinal cord lesions, tumours or injuries
• Cerebral palsy
• Motor neurone disease (MND)
• Syringomyelia
• Transverse myelitis
• Traumatic head injury
• Cerebrovascular accidents (stroke)

It is most useful when spasticity makes daily activities or physiotherapy harder. Baclofen can also be used alongside other medicines for trigeminal neuralgia (facial pain).

Source: eMC SmPC, MS Trust

How Baclofen Works

Baclofen is a derivative of GABA (gamma-aminobutyric acid), a chemical that calms nerve activity. It works mainly in the spinal cord, where it stimulates GABA-B receptors. This reduces the release of excitatory chemicals (glutamate and aspartate) that make muscles contract, so muscles become less stiff and spasms are reduced. It does not affect the nerves that control muscles directly.

Source: eMC SmPC section 5.1

Forms and Strengths Available in the UK

Availability varies by product and time; not all forms may be stocked locally. Intrathecal baclofen uses a much smaller dose than oral because the medicine goes directly into the fluid around the spinal cord.

Source: eMC search results, MS Trust

Brand and Generic Names

Baclofen is the generic (non-branded) name. UK brand names include:

• Lioresal (Novartis)
• Lyflex (Rosemont Pharmaceuticals)
• Gablofen (Piramal Critical Care)

Many pharmacies also supply unbranded "baclofen" tablets. Ask your pharmacist which brands are currently available.

Source: eMC search results

Invention and Approval History

Baclofen was developed in the 1960s and later found to be effective for muscle spasticity. It has been used clinically since the 1970s and has been available in the UK for several decades. Exact synthesis dates and early development details should be verified against primary regulatory or peer-reviewed sources if required.

How Baclofen Is Made

Baclofen is manufactured synthetically as an active pharmaceutical ingredient (API), not extracted from plants. It is produced through controlled chemical synthesis under Good Manufacturing Practice (GMP) standards. The finished API is formulated into tablets, oral liquid or intrathecal solutions. Manufacturing is subject to regulatory inspection and quality control.

UK Suppliers and Marketing Authorisation Holders

The following UK companies hold or have held marketing authorisations for baclofen products:

• ADVANZ Pharma
• Aguettant Ltd
• Novartis Pharmaceuticals UK Ltd
• Piramal Critical Care Ltd
• Rosemont Pharmaceuticals Limited
• Sovereign Medical
• Strides Pharma UK Ltd
• SyriMed
• Viatris (formerly Mylan)

This means that if one brand is temporarily unavailable, another may still be in stock. Pharmacists can check which brands are available through their usual wholesalers. A listed marketing authorisation does not guarantee live availability.

Source: eMC ingredient page

Common Side Effects

Side effects are most common at the start of treatment or after a dose increase. They often settle as your body adjusts.

Very common (may affect more than 1 in 10 people):

• Sleepiness (somnolence)
• Sedation
• Nausea

Common (may affect up to 1 in 10 people):

• Dizziness
• Confusion
• Fatigue
• Headache
• Weakness
• Dry mouth
• Constipation or diarrhoea
• Low blood pressure (hypotension)
• Difficulty sleeping
• Sweating
• Rash
• Needing to urinate more often
• Visual problems

Taking tablets with food or milk can help reduce nausea. If side effects are troublesome, speak to your GP — your prescriber may review the dose or titration plan.

Source: eMC SmPC section 4.8

Serious Side Effects and When to Get Urgent Help

Seek urgent medical attention (A&E or call 999) if you or someone you care for has:

• Signs of encephalopathy: increased sleepiness, confusion, muscle jerks (myoclonus), or reduced consciousness. These have been reported at normal prescribed doses and usually reverse after stopping baclofen under medical supervision.
• Severe breathing problems
• Seizures
• Signs of an allergic reaction: swelling of the face, lips or tongue; difficulty breathing; severe rash

Contact NHS 111 or your GP urgently if you have:

• New or worsening confusion or hallucinations
• Fainting or severe dizziness
• Unable to pass urine
• Severe muscle weakness that affects walking or self-care

If encephalopathy is suspected, seek immediate medical advice. Clinicians will decide whether baclofen should be stopped or adjusted.

Source: MHRA Class 4 Notification, eMC SmPC

Interactions and Cautions

Baclofen can interact with other medicines and substances. Tell your doctor or pharmacist if you take:

• Other medicines that cause drowsiness: such as benzodiazepines, opioid painkillers, other muscle relaxants (for example tizanidine), or antihistamines. The combination can increase sedation and breathing problems.
• Alcohol: can increase drowsiness and dizziness. Ask your pharmacist or doctor what is safe for you.
• Levodopa / carbidopa (for Parkinson's disease): mental confusion, hallucinations and worsening Parkinson's symptoms have been reported.
• Tricyclic antidepressants: can increase muscle relaxation to an undesirable degree.
• Lithium: can worsen hyperkinetic symptoms.
• Blood pressure medicines: baclofen may add to their effect, causing dizziness on standing.
• Medicines that affect kidney function: because baclofen is removed by the kidneys, anything that reduces kidney function can increase baclofen levels and toxicity.

Source: eMC SmPC section 4.5

Pregnancy, Breastfeeding, Driving, Alcohol and Kidney Cautions

Pregnancy: Baclofen crosses the placenta. It should only be used in pregnancy if essential. A case of neonatal convulsions has been reported after the mother took oral baclofen throughout pregnancy. If you are pregnant or planning a pregnancy, speak to your specialist urgently. If baclofen is continued into late pregnancy, your baby may need monitoring after birth for withdrawal signs.

Breastfeeding: Baclofen passes into breast milk in small amounts. It is not known to cause side effects in breastfed babies, but watch your baby for unusual sleepiness, poor feeding, dry mouth, rash, vomiting or diarrhoea, and seek advice if these occur.

Driving and machinery: Baclofen can cause drowsiness, dizziness and visual problems. Do not drive or operate machinery if you experience these effects.

Alcohol: Avoid or minimise alcohol — it worsens drowsiness and dizziness. Ask your pharmacist or doctor what is safe for you.

Kidney problems: Baclofen is cleared by the kidneys. People with kidney impairment are at higher risk of toxicity, including confusion and excessive drowsiness, even at low doses. If you have kidney disease or are on dialysis, your prescriber will use a much lower dose and monitor you closely.

Source: eMC SmPC sections 4.4, 4.6, 4.7, NHS pregnancy advice

Missed Doses and Stopping Baclofen

Missed dose: Check your pack leaflet or ask your pharmacist for advice. As a general rule, take the next dose when it is due and do not take a double dose unless a healthcare professional has told you to.

Stopping suddenly: Do not stop baclofen abruptly unless a doctor tells you to. Sudden withdrawal can cause serious symptoms including anxiety, confusion, hallucinations, seizures, high temperature, fast heartbeat, worsening spasticity and muscle breakdown (rhabdomyolysis). If treatment needs to end, your doctor will usually reduce the dose gradually over one to two weeks.

Source: eMC SmPC section 4.4

Monitoring Requirements

The reviewed UK SmPC does not specify a routine blood-test schedule for oral baclofen. Monitoring is based on symptoms, dose changes, kidney function risk, age and clinical judgement. Your doctor will monitor you clinically, especially:

• When starting treatment or increasing the dose
• If you have kidney problems
• If you are elderly
• If you develop new neurological or psychiatric symptoms

If your doctor switches you to tizanidine or dantrolene, those medicines do require regular liver function tests — but this does not apply to standard oral baclofen.

Source: eMC SmPC

What to Ask Your Pharmacist or GP During Supply Issues

If your usual baclofen brand is affected by a recall or is out of stock, ask:

1. Is a different brand of the same strength available?
2. Can my prescription be switched from tablets to liquid (or vice versa) if one form is affected?
3. Should I be concerned if my current pack is from an affected batch?
4. How should I manage if I cannot get my next supply before running out?

Do not stop taking baclofen without a plan from your healthcare team. If you are completely unable to obtain a supply, contact your GP or specialist promptly.

Related Medicines a Clinician May Discuss

If baclofen does not control your spasticity or causes troublesome side effects, your specialist may consider:

• Tizanidine — another muscle relaxant; requires liver function monitoring.
• Diazepam — a benzodiazepine; usually for short-term use due to sedation and dependence risk.
• Dantrolene — works directly on muscle rather than the nervous system; also requires liver monitoring.
• Cannabis-based medicines — NICE recommends a THC:CBD spray (Sativex) for adults with moderate to severe MS spasticity if other treatments have not worked, under specialist supervision.

Source: NICE NG144, Kent & Medway Formulary

Frequently Asked Questions

Is there a baclofen shortage in the UK?

Not a national shortage of all brands. As of May 2026, there are two MHRA product alerts: a Class 2 recall for SyriMed oral solution and a Class 4 defect notification for RxFarma 10mg tablets. Other brands and forms may still be available.

Can I use another brand of baclofen?

Possibly. Ask your pharmacist whether an alternative brand of the same strength and form is in stock. Do not switch brands or forms without checking with your pharmacist or GP first.

What should I do if my baclofen is affected by a recall?

Continue taking it as prescribed unless a healthcare professional tells you otherwise. Do not stop suddenly. Speak to your pharmacist about obtaining an unaffected batch or alternative brand.

Can I stop baclofen if I cannot get my usual supply?

No — do not stop suddenly. Contact your GP or specialist promptly if you are at risk of running out. They can arrange an alternative supply or a supervised taper if needed.

What side effects need urgent help?

Seek emergency help (999/A&E) for signs of encephalopathy (severe confusion, reduced consciousness, muscle jerks), breathing problems, seizures, or severe allergic reaction. Contact NHS 111 or your GP for new confusion, hallucinations, fainting, or severe weakness.

Official Sources and How to Report Problems

• Patient Information Leaflets and SmPCs: electronic Medicines Compendium (eMC)
• NHS Medicines A-Z: NHS — Baclofen
• MHRA drug alerts: GOV.UK drug alerts
• Report side effects: MHRA Yellow Card
• NICE MS guidance: NG220
• NICE cannabis-based medicines: NG144

If you think you have experienced a side effect from baclofen, report it through the Yellow Card scheme. This helps the MHRA monitor medicine safety.

Corrections: If you spot an error or have a source we should add, contact MedWatch or mention it in our Discord. This page is reviewed regularly and updated when new MHRA alerts or supply information becomes available.