Baclofen

Baclofen Intrathekal Sintetica, Lioresal · ATC code M03BX01

Also known as: baklofen · Brand names: Baclofen Intrathekal Sintetica, Lioresal, Baclaxiro, Baclofen Al, Baclofen Dura, Baclofen Neuraxpharm, Baclofen Ratiopharm, Baclofen Sun, Gablofen, Leodizcol, Baclofen Sintetica Intratekal, Baclorex, Baxen, Fleqsuvy, Lioresal (baclofen)

Key facts
Active substance: Baclofen
Drug class: Muscle relaxant
ATC code: M03BX01
Authorisation: authorised nationally; no central EU authorisation
Information as of: 2026-10-27

Key facts

Baclofen is a muscle relaxant. It is used to relieve spasticity from multiple sclerosis, particularly flexor spasms with pain, clonus and muscular rigidity.

What it is used for

Spasticity resulting from multiple sclerosis, particularly flexor spasms with pain, clonus and muscular rigidity
May be of some value in spinal cord injuries and other spinal cord diseases
Not indicated for skeletal muscle spasm from rheumatic disorders; efficacy in stroke, cerebral palsy and Parkinson's disease not established

Dosing

Individual titration: start low and increase gradually to optimum effect (usually between 40 and 80 mg daily)
Suggested schedule: 5 mg, 10 mg, 15 mg, then 20 mg three times daily, each for 3 days
Maximum 80 mg daily (20 mg four times daily)
Use the lowest dose compatible with an optimal response; withdraw slowly if no benefit
Impaired renal function: give with caution; dose reduction may be necessary

Contraindications

Hypersensitivity to baclofen

Important warnings

Abrupt withdrawal: hallucinations and seizures have occurred; reduce the dose slowly except for serious adverse reactions
Neonatal withdrawal symptoms when the mother took oral baclofen throughout pregnancy
Impaired renal function: excreted mainly unchanged by the kidneys
Stroke: no significant benefit and poor tolerability

Side effects

Most common: transient drowsiness (10 to 63%)
Dizziness (5 to 15%), weakness (5 to 15%), fatigue (2 to 4%)
Confusion (1 to 11%), headache (4 to 8%), insomnia (2 to 7%)
Nausea (4 to 12%), constipation (2 to 6%), hypotension (0 to 9%), urinary frequency (2 to 6%)
Rarely hallucinations, depression, visual disturbances, epileptic seizures

Pregnancy and breastfeeding

If oral baclofen is continued during pregnancy, gradually reduce and stop it before delivery; otherwise neonatal withdrawal (increased tone, tremor, seizures) may occur
Increased omphaloceles in fetuses of rats at high doses

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

Baclofen Intrathekal SinteticaSintetica Gmbh · 1 register entry
LioresalNovartis Pharma Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

BaclaxiroMedical Valley Invest Ab · 1 register entry
Baclofen AlAliud Pharma Gmbh · 1 register entry
Baclofen DuraViatris Germany Gmbh · 1 register entry
Baclofen Intrathekal SinteticaSintetica Gmbh · 1 register entry
Baclofen NeuraxpharmNeuraxpharm Arzneimittel Gmbh · 2 register entries
Baclofen RatiopharmRatiopharm Gmbh · 1 register entry
Baclofen SunSun Pharmaceuticals Germany Gmbh · 1 register entry
GablofenPiramal Critical Care B.V. · 1 register entry
LeodizcolEssential Pharma Limited · 1 register entry
LioresalNovartis Pharma Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

Baclofen Sintetica IntratekalINPHARMUS İLAÇ SAN. TİC. A.Ş., TRPHARM İLAÇ SAN. TİC. A.Ş. · 7 register entries
BaclorexVEM İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
BaxenCENTURİON İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
LioresalNOVARTİS SAĞLIK GIDA VE TARIM ÜRÜNLERİ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

FleqsuvyAzurity Pharmaceuticals, Inc. · 1 register entry
GablofenPiramal Critical Care Inc · 1 register entry
Lioresal (baclofen)Amneal Pharmaceuticals LLC · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Brand names in 27 more European countries

Belgium: Baclofen Esspharm, Baclofen Intrathecal Aguettant, Baclofen Viatris, Lioresal, Spacyr
Bulgaria: Баклофен Фармадвайс
Croatia: Baklofen Intratekalni Sintetica, Fezea, Lioresal
Cyprus: Colmifen
Czechia: Baclofen Polpharma, Baclofen Sintetica
Denmark: Baclofen Accord, Baclofen Medical Valley, Baclofen Sintetica, Baklofen Alternova, Baklofen Viatris, Gablofen, Leodizcol, Lionova, Lioresal
Estonia: Baclofen Sintetica
Finland: Baclofen Afortas, Baclofen Sintetica, Baklofen Viatris, Lioresal
France: Baclocur, Baclofen Aguettant, Baclofene Aguettant, Baclofene Biogaran, Baclofene Eg, Baclofene Essential Pharma, Baclofene Micro Labs, Baclofene Neuraxpharm, Baclofene Sun, Baclofene Viatris, Baclofene Zentiva, Baclofene Zydus, Lioresal, Liorésal, Spacyr
Greece: Baclofen Sintetica, Miorel, Miorelique, Vioridon
Hungary: Baclofen Pol, Baclofen Sintetica, Lioresal
Iceland: Baclofen Í Mænuvökva Sintetica, Baklofen Viatris
Ireland: Baclofen Syri Pharma, Baclopar, Lioresal
Italy: Baclofene Bioindustria L.I.M., Baclofene Doc, Baclofene Mylan Generics, Leodizcol, Lioresal, Neteka
Latvia: Baclofen Sintetica, Baclosal
Lithuania: Baclosal
Luxembourg: Lioresal
Malta: Baclofen Thame, Baclofene Bioindustria L.I.M., Colmifen
Netherlands: Baclofen Aurobindo, Baclofen Intrathecaal Sintetica, Baclofen Mylan, Baclofen Xiromed, Gablofen, Leodizcol, Lioresal
Norway: Baclofen Accord, Baclofen Afortas, Baclofen Sintetica, Baklofen Viatris, Leodizcol, Lionova, Lioresal
Poland: Baclofen Polpharma, Baclofen Sintetica
Portugal: Baclofeno Generis, Lioresal
Romania: Lioresal
Slovakia: Baclofen Polpharma, Baclofen Sintetica
Slovenia: Baklofen Sintetica, Fezea
Spain: Baclofen, Baclofeno Combix, Inabex, Lioresal
Sweden: Baclofen Accord, Baclofen Afortas, Baclofen Medical Valley, Baclofen Sintetica, Baklofen Alternova, Baklofen Viatris, Gablofen, Leodizcol, Lionova, Lioresal

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

U.S. Food and Drug Administration. Baclofen (Eywa Pharma Inc) – Prescribing Information, 2026-05-16. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7ec59f6b-7c4f-432d-ba27-442861806b6c
EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
Wikidata (CC0): ATC M03BX.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.