Mucolytic Pregnancy: Not recommended in pregnancy or breast-feeding. There is no experience of the use of erdosteine in pregnant women and experience in lactation is missing; therefore the use of erdosteine in pregnant or breast-feeding women is not recommended.

Erdosteine

Brand names: Erdotin

Erdosteine is an oral mucolytic agent used to reduce sputum viscosity in chronic respiratory disorders associated with excessive or tenacious mucus.

Adult dose

Dose: Adults and elderly above 18 years: 300 mg twice daily, for a maximum of 10 days

Route: Oral. The capsules must be swallowed whole with a glass of water.

Frequency: Twice daily, for a maximum of 10 days

Max: 300 mg twice daily for a maximum of 10 days (the SPC gives no higher dose and no longer course)

The whole of section 4.2 of this SPC reads: 'Elderly and adults above 18 years: 300 mg twice daily for maximum 10 days. The capsules must be swallowed whole with a glass of water.' It gives no other regimen, and no dose for anyone aged 18 years or under. MILD LIVER FAILURE: section 4.4 states that no increase in adverse events has been observed with erdosteine in patients with mild liver failure, however these patients should not exceed a dose of 300 mg PER DAY - i.e. half the standard daily amount. This is a hepatic-impairment restriction, not the general ceiling. Erdosteine is not recommended in patients with creatinine clearance below 25 mL/min or with severe liver failure, as there are no data in these patients (section 4.3). INTERACTIONS: section 4.5 states that no adverse interactions have been reported.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the other excipients
Patients with active peptic ulcer
Not recommended in patients with creatinine clearance below 25 mL/min (no data)
Not recommended in patients with severe liver failure (no data)

Side effects

Taste alterations, nausea, vomiting, diarrhoea
Epigastric pain
Headache (uncommon)
Cold, dyspnoea (uncommon)
Angioedema and cutaneous hypersensitivity reactions, such as urticaria, erythema, oedema and eczema (uncommon)

Clinical monograph

How it works

It is a prodrug whose active metabolites contain free thiol groups that break disulphide bonds in mucus glycoproteins, reducing sputum viscosity and supporting expectoration; it also has reported antioxidant properties.

Prescribing in practice

Avoid in active peptic ulceration and use with caution in significant hepatic or renal impairment.
It is contraindicated in patients with homocystinuria.
Treatment is generally intended for short-term use to relieve mucus hypersecretion rather than long-term continuation.

Monitoring

Review symptomatic response and discontinue if no benefit, with no routine laboratory monitoring required for short courses.

Counselling the patient

Take the capsules with a glass of water.
Tell your prescriber if you have a stomach ulcer or liver problems.
Stop and seek advice if your breathing worsens or symptoms do not improve.

Evidence & guidelines

Erdosteine is used as an adjunct mucolytic, with evidence supporting reduced sputum viscosity and symptom relief in chronic bronchitis.

Reference: NICE NG115; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Drugs

Pathways