Idebenone: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: September 19, 2025🚩 Report this page

Idebenone

Other Psychostimulants and Nootropics

Sold as Raxone · Puldysa · Sovrima

EU EMAGB MHRA

Drug class: Other Psychostimulants and Nootropics
Availability: See label
Markets covered: 2
Products on record: 2

N06BXOther Psychostimulants and Nootropics

Overview

Idebenone is an active pharmaceutical ingredient in the Other Psychostimulants and Nootropics group (N06BX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
EU European Union	EMA	1	August 20, 2025
GB United Kingdom	MHRA	1	September 19, 2025

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised August 20, 2025[1]

1).

How to take

EUOfficial regulatory label· revised August 20, 2025

GBUnited Kingdom· MHRA

1 product

1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [2].

Sources & citations

[1]European Medicines Agency · EMEA/H/C/003834 · revised August 20, 2025
[2]MHRA (UK) · PLGB088290204 · revised September 19, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised August 20, 2025[1]

Summary of the safety profile The most commonly reported adverse reactions to idebenone are mild to moderate diarrhoea (usually not requiring the discontinuation of the treatment), nasopharyngitis, cough and back pain. Tabulated list of adverse reactions The following adverse reactions emerging from clinical trials in LHON patients or reported post- marketing in other indications are tabulated below.
Frequency groupings are defined to the following convention: very common (≥1/10), common (≥1/100 to <1/10), not known (cannot be estimated from the available data). System Organ Class Preferred Term Frequency Infections and Infestations Nasopharyngitis Very common Bronchitis Not known Blood and lymphatic system disorders Agranulocytosis, anaemia, leukocytopenia, thrombocytopenia, neutropenia Not known Metabolism and nutrition disorders Blood cholesterol increased, blood triglycerides increased Not known 5 System Organ Class Preferred Term Frequency Nervous system disorders Seizure, delirium, hallucinations, agitation, dyskinesia, hyperkinesia, poriomania, dizziness, headache, restlessness, stupor Not known Respiratory, thoracic and mediastinal disorders Cough Very common Gastrointestinal disorders Diarrhoea Common Nausea, vomiting, anorexia, dyspepsia Not known Hepatobiliary disorders Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, gamma- glutamyltransferase increased, blood bilirubin increased, hepatitis Not known Skin and subcutaneous tissue disorders Rash, pruritus Not known Musculoskeletal and connective tissue disorders Back pain Common Pain in extremity Not known Renal and urinary disorders Azotaemia, chromaturia Not known General disorders and administration site conditions Malaise Not known Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised August 20, 2025[1]

Monitoring Patients should be regularly monitored according to local clinical practice. Hepatic or renal impairment Caution should be exercised when prescribing Raxone to patients with hepatic or renal impairment. Adverse events have been reported in patients with hepatic impairment, which have resulted in temporary interruption or discontinuation of treatment.
e. a reddish-brown discoloration of the urine. This effect is harmless, not associated with haematuria, and does not require any adaptation of dose or discontinuation of treatment. g. renal or blood disorders). Lactose Raxone contains lactose.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take Raxone. Sunset yellow Raxone contains sunset yellow (E110) which may cause allergic reactions.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

EUEuropean Union· EMA

GBUnited Kingdom· MHRA

Drugs in the same class

Sources & citations