Adverse reactions with levamisole vary according to its indications and misuse: A systematic pharmacovigilance study

Abstract

Levamisole was initially prescribed for the treatment of intestinal worms. Because of immunomodulatory properties, levamisole has been used in inflammatory pathologies and in cancers in association with 5-fluorouracil. Levamisole is misused as a cocaine adulterant. Post-marketing reports have implicated levamisole in the occurrence of adverse drug reactions (ADRs) and its use is now limited in Europe and North America. In contrast, all other parts of the World continue to use single-dose levamisole as an anthelmintic. The aim of this study was to identify ADRs reported after levamisole exposure in VigiBase, the World Health Organisation's pharmacovigilance database, and analyse their frequency compared to other drugs and according to levamisole type of use.Methods: All levamisole-related ADRs were extracted from VigiBase. Disproportionality analyses were conducted to investigate psychiatric, hepatobiliary, renal, vascular, nervous, blood, skin, cardiac, musculoskeletal and general ADRs associated with levamisole and other drugs exposure. In secondary analyses, we compared the frequency of ADRs between levamisole and mebendazole and between levamisole type of use.Results: Among the 1763 levamisole-related ADRs identified, psychiatric disorders (reporting odds ratio with 95% confidence intervals: 1.4 [1.2-2.6]), hepatobiliary disorders (2.

Pulmonary Renal Syndrome: Perilous Presentation in Pediatrics

“…Pulmonary lesions and mild kidney involvement respond to immunosuppression [4]. Other adverse effects of levamisole therapy include general malaise, fatigue and hypersensitivity [5]. We could not find any report of PRS associated with levamisole therapy, especially in children.…”

Safety evaluation of a potential anti-rheumatoid arthritis candidate, levamisole

“…LVM has been associated with neurological demyelinating diseases as an adverse reaction, which has been widely reported in clinical settings (Campillo et al 2022). However, many reports of adverse reactions are related to drug combinations, such as cocaine (Michels et al 2022;Vonmoos et al 2018).…”

Safety and Efficacy of Levamisole in Loiasis: A Randomized, Placebo-controlled, Double-blind Clinical Trial

“…That AEs are more frequent in high baseline MFDs is consistent with the hypothesis of massive destruction of mfs. However, levamisole modes of action are multiple and complex [ 33 ] and its effects on mfs need to be clarified.…”