In the pharmaceutical industry, Levamisole is currently primarily classified as a veterinary anthelmintic. While it was once a staple in human medicine, its status has changed significantly due to safety concerns.

As of February 2026, the European Medicines Agency (EMA) has recommended that medicines containing levamisole be withdrawn from the EU market. This follows a similar withdrawal in the United States in 2000. The consensus among global health authorities is that for most human uses, the potential for severe, life-threatening side effects now outweighs the benefits.

Serious Safety Risks

• Leukoencephalopathy: A rare but serious condition that damages the white matter of the brain. It can occur after even a single dose and symptoms (like confusion, muscle weakness, or speech loss) can appear months later.

• Agranulocytosis: A dangerous depletion of white blood cells (neutrophils), which severely weakens the immune system and makes the body highly susceptible to fatal infections.

• Vasculitis and Skin Necrosis: Levamisole can cause inflammation of the blood vessels, leading to painful skin lesions and tissue death (necrosis), particularly on the ears, cheeks, and extremities.

Current Status of Human Use

• Withdrawal: It is no longer approved for human use in the US (since 2000) and is being phased out in the EU (as of early 2026).

• Limited Availability: In some regions, like India, it is still manufactured under brand names like Vermisol or Dicaris to treat certain worm infections (like Ascariasis) and as an immunomodulator for nephrotic syndrome in children.

• Veterinary Use: It remains a standard dewormer for cattle, sheep, and swine.

  The “Cocaine Adulterant” Crisis

For your B2B platforms and marketing authority, it is important to be aware of a major public health issue: Levamisole is a common cutting agent in street cocaine.

• Why it’s used: It is inexpensive, looks like cocaine, and is believed to intensify or prolong the “high” by releasing dopamine or being metabolized into Aminorex (an amphetamine-like stimulant).

• The Result: Most modern cases of levamisole toxicity in humans (including “Levamisole-Induced Necrosis Syndrome”) are actually linked to contaminated illicit drugs rather than prescribed medicine.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai:

• The “Regulatory Shift”: With the 2026 EMA withdrawal, the global market for human-grade Levamisole is shrinking. You should consider shifting focus to safer alternatives like Albendazole or Mebendazole for your international B2B catalogs.

• Technical Advice: If you are still supplying Levamisole in markets where it is legal, your product dossiers must emphasize the need for regular blood count monitoring to detect neutropenia early.

• Dossier Support: We provide full CTD/eCTD Dossiers for safer anthelmintic alternatives to help you pivot toward more regulatory-compliant portfolios for the EU and US markets.