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Orphenadrine

ATC code M03BC01

Also known as: Orphenadrin, Orfenadrin

Key facts
Active substance
Orphenadrine
Drug class
Muscle relaxant
ATC code
M03BC01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Orphenadrine (as orphenadrine citrate extended-release tablets) is a muscle relaxant with anticholinergic action. Per the US prescribing information, it is used as an adjunct for acute painful musculoskeletal conditions.

What it is used for

  • Adjunct to rest, physical therapy and other measures for relief of discomfort in acute painful musculoskeletal conditions
  • Its mode of action is not clearly identified and may relate to analgesic properties; it does not directly relax tense muscles

Dosing

  • Adults: two tablets per day, one in the morning and one in the evening
  • Safety and effectiveness in pediatric patients not established
  • Adverse effects can usually be reduced by lowering the dose; for tablet strength see the full prescribing information

Contraindications

  • Glaucoma
  • Pyloric or duodenal obstruction, stenosing peptic ulcers
  • Prostatic hypertrophy or obstruction of the bladder neck
  • Cardiospasm (mega-esophagus) and myasthenia gravis
  • Previous hypersensitivity to orphenadrine

Important warnings

  • Transient light-headedness, dizziness or syncope may occur
  • May impair the ability to drive or operate machinery
  • Caution in tachycardia, cardiac decompensation, coronary insufficiency and cardiac arrhythmias
  • Safety of long-term therapy not established; with prolonged use, periodic monitoring of blood, urine and liver function
  • Toxic in overdose, typically with anticholinergic effects

Side effects

  • Mainly anticholinergic and dose-related: dry mouth is usually the first
  • Tachycardia, palpitation, urinary hesitancy or retention, blurred vision, pupil dilatation, increased ocular tension
  • Weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, hallucinations, agitation, tremor
  • Occasional confusion in elderly patients; very rare aplastic anemia (no causal relationship established)

Interactions

  • Propoxyphene: confusion, anxiety and tremors reported with concomitant use; reduce the dose or stop one or both agents

Pregnancy and breastfeeding

  • Not known whether it can cause fetal harm; use in pregnancy only if clearly needed

Summary of the official product information, written with AI on 2026-10-29. 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.

Germany

  • NorflexViatris Healthcare Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Brand names in 5 more European countries
Denmark
Lysantin
Finland
Norflex
Greece
Orphedrin
Italy
Disipal
Sweden
Norflex

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. ORPHENADRINE CITRATE (Lupin Pharmaceuticals, Inc.) – Prescribing Information, 2025-09-10. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7b76c8a7-dd0c-481c-8299-26dfd38ce066
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. Wikidata (CC0): ATC M03BC.

Editorial: Medelix editorial team · last updated 2026-10-29 · 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.