Active Ingredients

Clofazimine – Effect, Application & Risks


The red dye clofazimine is used as a drug in human medicine to treat leprosy . The active ingredient is suitable for this due to its bactericidal properties. Off-label, ie outside the area of ​​approval, there is also an area of ​​application for the treatment of massive skin diseases .

What is clofazimine?

Clofazimine is a red dye. It is used to treat leprosy due to its bactericidal properties. In addition, there is an off-approval field of application for the drug. This is used outside of the area approved by the regulatory authorities authorized by public law (so-called off-label use) to treat severe skin diseases.

According to the specified area of ​​application, clofazimine should be used together with other leprosy drugs in order to prevent the development of resistance . These include dapsone or rifampicin .

In chemistry and pharmacology , clofazimine is described with the empirical formula C 27 – H 22 – Cl 2 – N 4 . This roughly corresponds to a moral mass of 473.39 g/mol. The literature reports that the chemical properties of clofazimine closely resemble those of cationic amphiphilic drugs (CAD).

Pharmacological effect on body & organs

The exact effect of clofazimine on the human body has not yet been fully clarified. Various approaches have been developed in science to explain the bactericidal effects of the red dye. However, all explanatory models have in common that they understand clofazimine as a functional inhibitor of acid sphingomyelinase (FIASMA for short). It is therefore considered certain that clofazimine causes an inhibition of the enzyme acid sphingomyelinase. The red dye is also undisputedly at least slightly bactericidal.Apart from the mechanism of action, clofazimine can be considered to be well researched. The melting point of the substance, which is present as a brownish powder at room temperature, is around 212 degrees Celsius.

Medicinal Application & Use for Treatment & Prevention

Within the European Union, clofazimine is only permitted in France. Here the active ingredient is marketed under the trade name Lamprene®. In the Federal Republic of Germany, this preparation could be imported by pharmacies from abroad until 2005 . Since some changes in the law, which among other things led to the loss of approval, clofazimine can only be obtained from the WHO. In exceptional cases, direct purchase from the manufacturer is also possible.

In France and other licensed countries, clofazimine is primarily used to treat leprosy. The active ingredient is prescribed for oral administration as a film-coated tablet and is subject to pharmacy and prescription requirements. A purchase is therefore only possible after prior medical prescription in a state-licensed pharmacy.

Clofazimine is indicated for the treatment of leprosy. However, the therapy is always carried out together with other medications such as rifampicin or dapsone.

It can also be sold off-label as a drug for the treatment of massive skin diseases. These include granulomatous mycoses and Melkersson-Rosenthal syndrome .

Risks & side effects

Even when taken completely properly, clofazimine can cause unwanted side effects . However, this also applies to other medicines. An application must be avoided if an intolerance or allergy to the active ingredient is known.According to the literature, numerous studies have shown that there is a connection between the intake of clofazimine and the development of skin discoloration. In some subjects, red or brown-black spots developed more frequently, especially in areas exposed to light. Discoloration of the stool , urine , sputum or hair can also occur. Sweat discoloration has also been reported.

Furthermore, keratinization disorders of the skin (in the professional world: ichthyosis ) can occur after taking clofazimine .

Other side effects are disorders of the gastrointestinal tract , which are primarily expressed in diarrhea (diarrhoea), abdominal or stomach pain , vomiting and loss of appetite . The formation of a pathogen increased sensitivity to light (photosensitivity) is also a potential side effect that should be considered.

Lisa Newlon
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Hello! I am Lisa Newlon, and I am a medical writer and researcher with over 10 years of experience in the healthcare industry. I have a Master’s degree in Medicine, and my deep understanding of medical terminology, practices, and procedures has made me a trusted source of information in the medical world.