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Enoxolone

AEMPS

Plant-derived anti-inflammatory agent, a liquorice root derivative

ATC code: D03AX10

Updated · Methodology

Indications

C

Sore throat

Adjunct

In a Spanish pharmacy enoxolone exists only inside combinations: Angileptol and Deratin Complex are lozenges where it sits next to chlorhexidine and benzocaine. The AEMPS ficha técnica assigns the roles directly: chlorhexidine provides the antiseptic action, enoxolone the anti-inflammatory one, benzocaine the local anesthesia. Adults and adolescents from 12 years dissolve one lozenge every 2 to 3 hours, at most 8 a day, children from 6 years less often. Separate clinical trials of enoxolone in sore throat are few, and the contribution of this particular component cannot be isolated from the combination – so this card promises no more than symptom relief for a few days. The ficha asks people to stop if nothing improves within 3 to 5 days.

Sources

  1. AEMPS: Ficha técnica de enoxolona (2021)

ICD-10: R07.0

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

D

Peptic ulcer disease

Not recommended

Liquorice derivatives have a long ulcer history: in the 1960s and 1970s carbenoxolone, a close relative of enoxolone, was prescribed for gastric ulcer until it was displaced first by H2 blockers and then by proton pump inhibitors. Today's ulcer management rests on two things: acid suppression and eradication of Helicobacter pylori. Enoxolone does neither. The HMPC monograph on liquorice root permits only traditional use for stomach discomfort, without antiulcer promises, and keeps the 4 to 6 week limit. The price of long use is known: sodium retention, edema, rising blood pressure, potassium loss. If liquorice or enoxolone was offered as ulcer treatment instead of gastroscopy and a Helicobacter pylori test, consider seeking a second opinion.

Sources

  1. EMA HMPC: European Union herbal monograph on Glycyrrhiza glabra L. radix (2020)
  2. AEMPS: Ficha técnica de enoxolona (2021)

ICD-10: K27 · ICD-11: DA61

F

Liver support and “hepatoprotection”

Not recommended

Liquorice and its derivatives are sold as «liver protection»: glycyrrhizin and glycyrrhetinic acid go into supplements with a promise to restore liver cells and remove inflammation. There is no evidence base for that use. The HMPC monograph on liquorice root recognizes only traditional use for cough and stomach discomfort, limits the course to 4 to 6 weeks outright, and names exceeding the dose as a source of pseudohyperaldosteronism. For hepatoprotection liquorice appears in no European recommendation. Something else matters more: in people with liver disease, edema, sodium retention and potassium loss are more dangerous than in healthy people, and that is exactly what liquorice produces. If a «liver» supplement with liquorice or enoxolone was recommended to restore the liver, consider seeking a second opinion.

Sources

  1. EMA HMPC: European Union herbal monograph on Glycyrrhiza glabra L. radix (2020)
  2. AEMPS: Ficha técnica de enoxolona (2021)
How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Glycyrrhetinic acid, the hydrolysis product of glycyrrhizin from liquorice root. In mucosa it suppresses local inflammation, which is why it appears in throat lozenges alongside an antiseptic and an anesthetic. The main property of the substance lies elsewhere: enoxolone blocks 11-beta-hydroxysteroid dehydrogenase type 2, the renal enzyme that converts cortisol into inactive cortisone. Without that enzyme cortisol reaches the mineralocorticoid receptor and acts like aldosterone: sodium and water are retained, potassium leaves in the urine, blood pressure rises. The picture is called pseudohyperaldosteronism, and it explains why the ficha técnica caps the dose: above 60 mg a day with prolonged use, edema and hypertension appear.

Safety

Contraindications

  • Hypersensitivity to enoxolone or other components of the combination
  • Arterial hypertension and edema: enoxolone retains sodium
  • Hypokalemia
  • Pregnancy and breastfeeding

Serious adverse effects

  • Pseudohyperaldosteronism at high doses and with prolonged use: edema, arterial hypertension, hypokalemia
  • Methemoglobinemia caused by the benzocaine in the combination
  • Anaphylactic reactions to chlorhexidine

Common adverse effects

  • Burning in the mouth
  • Altered taste
  • Staining of teeth and tongue from the chlorhexidine in the combination

Pregnancy: can you take Enoxolone?

Combination lozenges with enoxolone are not used in pregnancy. The ficha técnica notes separately that a dose above 60 mg a day with prolonged use retains sodium, causes edema and raises blood pressure, which is particularly unwelcome in pregnancy.

Breastfeeding: can you take Enoxolone?

There are no data on enoxolone passing into breast milk. Combination lozenges are not used while breastfeeding.

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Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

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Frequently asked

What is Enoxolone used for?

Enoxolone is evaluated for the following indications with varying evidence strength: Sore throat (evidence tier C), Peptic ulcer disease (evidence tier D), Liver support and “hepatoprotection” (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Enoxolone?

Common side effects of Enoxolone (≥ 1 in 100): Burning in the mouth, Altered taste, Staining of teeth and tongue from the chlorhexidine in the combination. See the Safety section for uncommon and serious reactions.

Is Enoxolone safe during pregnancy?

Combination lozenges with enoxolone are not used in pregnancy. The ficha técnica notes separately that a dose above 60 mg a day with prolonged use retains sodium, causes edema and raises blood pressure, which is particularly unwelcome in pregnancy.

Is Enoxolone compatible with breastfeeding?

There are no data on enoxolone passing into breast milk. Combination lozenges are not used while breastfeeding.

Who should not take Enoxolone?

Enoxolone is contraindicated in: Hypersensitivity to enoxolone or other components of the combination; Arterial hypertension and edema: enoxolone retains sodium; Hypokalemia; Pregnancy and breastfeeding. Full list in the Safety section.

Official sources

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